Since the outbreak of coronavirus disease 2019 (COVID-19) in 2019,it has brought many great changes and impacts on the global pharmaceutical work scene,practitioners,work methods and business scope,among which many changes are related to the future development of global pharmacy and the adjustment of health policies.The International Pharmaceutical Federation (FIP) has been paying attention to the changes in the pharmaceutical field caused by the COVID-19 pandemic,analyzing emerging trends,gaining insight into the opportunities and jointly coping with the challenges to be faced.This article reviews the trend analysis of FIP on the COVID-19 pandemic.Combined with China's national conditions,the global pharmaceutical development and trends are discussed and judged from the aspects of pharmaceutical practice,pharmaceutical research and pharmaceutical education,in order to cope with the challenges brought by the COVID-19 pandemic to the future development of the pharmaceutical field.
In recent years, drug repurposing had gained popularity in the field of drug discovery and development.Many existing drugs and drug candidates underwent preclinical and clinical trials were redeveloped for new indications.The development of drug repurposing were developed by successful re-purposing of some famous drugs, including aspirin, thalidomide, sildenafil, and remdesivir.The discussion on drug repurposing could be divided into two parts:one was based on clinical treatment needs;The other was based on the discovery of new indications.Here we reviewed three drug repurposing strategies based on clinical treatment needs.One strategy is to select drugs that were already on the market according to the symptoms of the new disease.With a comprehensive understanding of the pathology and available drug options, drug repurposing could be done based on the root causes.Besides, consulting consensual empirical treatment plans of new diseases could be another valid strategy.
Objective To establish an ultra-high performance liquid chromatography (UPLC) method for the simultaneous determination of four saponins contents (notoginsenoside R1, ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1) in rat skin, and then the skin retention characteristics of four saponins in two skin topical preparations (Panax notoginseng saponin transfersomes and Panax notoginseng saponin liposomes spray) were preliminarily evaluated. Methods The chromatographic column was Waters BEH C18 column (2.1 mm × 100 mm, 1.7 μm), and the mobile phase was acetonitrile (A)-water (B) with gradient elution (0~8 min, 19% A → 25% A;8~9 min, 25% A → 42% A;9~12 min, 42% A→55% A), with the flow rate of 0.5 mL·min-1. The detection wavelength was set at 203 nm, the injection volume was 1 μL, and the column temperature was 30 ℃. Results The calibration curve exhibited excellent linearity in the range of 0.208-20.800, 0.852-85.200, 0.116-11.600 and 0.904-90.400 μg for notoginsenoside R1, ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1 (r>0.999 0), respectively. The RSDs of inter-day and intra-day precision were all lower than 15%.The extraction recoveries were 90.31%-102.70%.The RSDs of room temperature, freeze-thaw, and long-term freeze-thaw stability were all lower than 15%.The retention rates of notoginsenoside R1, ginsenoside Rg1 and ginsenoside Re in whole skin and cuticle 12 hours after administration was in the ranking of panax notoginseng saponin liposomes spray > panax notoginseng saponin transfersomes spray.The result of ginsenoside Rb1 was opposite. Conclusion Simultaneous determination of four saponins in rat skin by UPLC can greatly shorten the detection time.The method is simple, accurate, and sensitive, which can provide a scientific basis for the study of skin penetration of Panax notoginseng saponins.
Objective To investigate the effect of Rutin on renal injury in mice with systemic lupus erythematosus. Methods Ten female healthy Balb/c mice were set as the normal control group (n=10), and 50 female MRL/lpr mice were randomly divided into five groups (n=10): the model control group, prednisone acetate group (0.1 mg·kg-1), Rutin low-dose group (25 mg·kg-1), Rutin medium dose group (50 mg·kg-1), and Rutin high dose group (100 mg·kg-1). Continuous intragastric administration began at eight weeks of mice age for eight weeks.Urine protein concentration, serum anti-dsDNA IgG and IgM, interleukin (IL) -6, interferon IFN-γ, serum creatinine (CRE), and blood urea nitrogen (BUN) were detected.The pathological changes of renal tissues in each group were observed under a light microscope by hematoxylin-eosin (HE) staining, and clinical observation was made in mice.The levels of P-JAK2, JAK2, p-STAT3 and STAT3 were detected by Western blotting. Results Compared with model control group, Rutin dose groups reduced the levels of urine protein content, serum BUN, CRE concentration. anti-dsDNA IgG, anti-dsDNA IgM in each dose group of rutin decreased significantly, and the pathological injury of the kidney was reduced. The contents of IL-6, IFN-γ in serum was significantly reduced. The levels of P-JAK2 and P-STAT3 were down-regulated. In addition, the protective effect of Rutin was dose-dependent. Conclusion Rutin has a protective effect on the renal lesion in MRL/lpr mice, and its mechanism may be related to the inhibition of JAK2-STAT3 signaling pathway activation.
Dipeptidyl peptidase Ⅳ (DPP4) inhibitors have been widely used as a second-line treatment of type 2 diabetes mellitus (T2DM). The therapeutic effects of DPP-4 inhibitors are due to their ability to increase circulating levels of the intact biologically active form of the incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Rheumatic immunological diseases are a group of immune-mediated diseases that mainly affect bones, joints, and soft tissues, and are related to the autoimmune system, causing injury to multiple organ systems such as joints. The immune system has a complex and sophisticated regulatory mechanism, so it needs to be individualized and targeted treatments in the treatment of rheumatic immune diseases. With the discovery of the implication of DPP4 in antifibrotic response and immune regulation in recent years, the relationship between DPP4 inhibitors and rheumatic diseases has also attracted more and more attention. In this article, we review the recent advances of DPP4 in immune regulation and autoimmune rheumatic disease, aiming to provide useful information for the selection of DPP4 inhibitors in patients with or prone to rheumatic disease.
As a traditional Chinese medicine compound for the treatment of rheumatoid arthritis, Wutou decoction has been used as a classic remedy for the treatment of paralysis for rheumatoid arthritis (RA) in China for thousands of years. A series of clinical studies have confirmed that Wutou decoction has a good effect on improving RA joint inflammation, swelling and pain. At the same time, as a supplementary alternative therapy, the combined application of Wutou decoction with western medicine can reduce the dosage of western medicine, reduce the side effects of western medicine, and improve the safety and effectiveness of existing RA treatment regimens. With the advancement of pharmacology research of Wutou decoction and the pathological mechanism of rheumatoid arthritis, many advances have been made in the treatment of RA, especially in anti-inflammatory, analgesic, immunomodulatory and angiogenic inhibition. This study systematically reviewed the progress of Wutou decoction in the treatment of rheumatoid arthritis from clinical research and experimental research.
There is an interaction between chronic hepatitis C (CHC) and hyperuricemia. As a systematic disease, CHC, caused by hepatitis C virus (HCV), can lead to renal failure, liver dysfunction, and metabolic abnormality, which in turn affect uric acid metabolism, such as abnormal serum uric acid (SUA) level. Meanwhile, high SUA level can also promote hepatic steatosis, which accelerates the progression of CHC. Although direct-acting antiviral agents (DAAs) have been widely used for treating CHC patients, the effect of DAAs on uric acid metabolism is still unclear. In this article, we overview recent findings regarding the impact of DDA-treated CHC on SUA level.
Rheumatoid arthritis is a systemic autoimmune joint disease with synovitis and joint bone destruction, which may cause disability in severe cases.Various types of immune cells are involved in the progression of RA.B cells play an important role in RA and have received increased attention in recent years as the core group mediating humoral immunity.This review reported the latest research progress of B cell-related targeted drugs for RA.
Objective To investigate the effect of autophagy promoter rapamycin (RAPA) on the proliferation of fibroblast-like synoviocytes (FLS) induced by tumor necrosis factor α (TNF-α) by regulating the Nod-like receptor protein 3 (NLRP3) inflammasome activation. Methods FLS were cultured and divided into three groups according to different intervention methods:control group, TNF-α group, RAPA group.Cell viability was detected by the CCK-8 method.Autophagy was detected in FLS cells by immunofluorescence and transmission electron microscopy (TEM).Western blotting was used to detect the expressions of key proteins NLRP3, caspase-1, and autophagy marker proteins LC3-Ⅱ/LC3-Ⅰ, Beclin-1, and P62. Results Compared with control group, TNF-α could significantly induce the proliferation of FLS cells, the corresponding NLRP3 inflammasome signaling pathway was activated(P<0.05). Compared with TNF-α group, the autophagy promoter RAPA could significantly inhibit synovial cell proliferation, while LC3-Ⅱ and Beclin1 were significantly up-regulated, and the expression level of P62 was down-regulated;The expression levels of NLRP3 and caspase-1 were both decreased (P<0.05). Conclusion The autophagy promoter RAPA could inhibit the proliferation of synovial cells induced by TNF-α, which may be closely related to the enhancement of autophagy and the negative regulation of the activation of the NLRP3 inflammasome signaling pathway.
Objective To compare the efficacy and safety of flurbiprofen axetil in postoperative pain treatment from two manufacturers based on real-world data. Methods Data of patients who used flurbiprofen axetil injection for analgesia after surgery in the Departments of Orthopedics and General Surgery of Nanjing Drum Tower Hospital were extracted from January 2019 to December 2020.Patients were divided into two groups by using flurbiprofen axetil from manufacturer A (Group A,centralized purchasing drugs in Jiangsu Province) or B (Group B,non-centralized purchasing drugs in Jiangsu Province) for postoperative pain.The degree of pain,sleep quality,and adverse drug reactions at rest or activity at 6,24,48,and 72 hours postoperatively were compared between two groups. Results A total of 1009 patients were included in the study,with 470 patients (235 in each group) using Propensity Score Matching (PSM) to balance baselines.Compared with group B,the proportion of patients who achieved good pain control in Group A was less than Group B (55.7% vs.74.0%,P<0.01).Static VAS scores at 6,24,48,72 h and dynamic VAS score at 6 h in Group A were higher than Group B (2.5±1.6 vs.1.6±1.3,P<0.01;3.2±1.6 vs. 2.8±1.2,P=0.003;1.6±1.4 vs.1.25±1.17,P=0.008;1.0±1.1 vs. 0.7±0.9,P=0.002;0.7±1.2 vs. 0.5±0.8,P=0.002).Patients in Group A received more analgesic rescue times than those in Group B (0.5±1.1 vs. 0.2±0.5,P<0.01).The proportion of patients with good sleep quality in Group A was higher than that in Group B (87.7% vs. 80.4%,P=0.032).The difference in safety between the two groups was not statistically significant. Conclusion There is no significant difference in safety between flurbiprofen axetil injections from the two manufacturers.However,the analgesic efficacy of flurbiprofen axetil injection from manufacturer A is certainly not as good as that of manufacturer B.
Objective To summarize and analyze the clinical efficacy of agomelatine combined with pramipexole in treating iRBD patients with anxiety and depression, to provide a reference for the clinical treatment of iRBD patients with anxiety and depression. Methods A total of 60 cases of iRBD complicated with anxiety and depression patients admitted to the Sleep Medical Center of the First Hospital of Wuhan from September 2018 to December 2021 were collected, and the brain MRI and other imaging examinations were completed. The sleep state of patients at night for 12 hours was recorded by polysomnography (PSG). Using the principle of randomized control, the patients were randomly divided into control group and experimental group, 30 cases in each group. The control group was given pramipexole tablets 0.125 mg once a night, and the treatment group was given 25 mg of agomelatine on the basis of the control group for 3 months. Before treatment and 3 months after treatment, Pittsburgh sleep quality index (PSQI), Epworth Sleepiness Scale (ESS), Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA) Anxiety Self-Evaluation Scale (SAS), Depression Self-Evaluation Scale (SDS) and Rapid-eye-movement Sleep Behavior Disorder Screening Questionnaire (RBDSQ) were used to evaluate the sleep, mental state, dream and abnormal of RBD of the two groups. Results Before treatment, there was no difference in gender, age, course of disease, and PSG parameters between the two groups;There was no significant difference in PSQI, ESS, HAMD, HAMA, SAS, SDS, and RBDSQ (P>0.05);After three months of treatment, the scores of PSQI, ESS, HAMD, HAMA, SAS, SDS and RBDSQ in the experimental group decreased significantly compared with those in the control group (P<0.05). Conclusion Agomelatine combined with pramipexole treatment can not only improve sleep quality, anxiety, and depression status of iRBD patients, but also better improve the behavioral disorders during rapid eye movement sleep.
N-Butylphthalide (NBP) is a multi-targeted anti-cerebral ischemia drug, which protects mitochondria, provides anti-oxidation, and inhibits neuroinflammation.NBP is mainly used for treating mild to moderate acute ischemic stroke, which can improve the neurological function, cognitive function, and living ability of patients with ischemic stroke, with definite curative effect and good safety.In recent years, many studies have shown that the target of NBP is consistent with the main pathological pathway of Parkinson's disease (PD), which can significantly improve the clinical symptoms and vital signs of patients, and has great potential for the treatment of PD.Therefore, this paper summarizes the preclinical studies and clinical trial studies of NBP for the treatment of PD to provide new ideas for the treatment of PD.
Intestinal ischemia/reperfusion (IR) injury is a common clinical disease, which mainly refers to the local tissue injury caused by blood reperfusion of intestinal tissue after short-term or long-term ischemia. It is commonly seen in organ transplantation, cardiopulmonary and cerebral resuscitation, various types of shock, post-traumatic blood transfusion and mesenteric artery embolization.IR destroys the integrity of the intestinal mucosal barrier causing to the entry of harmful substances into the systemic circulation, which eventually leads to a series of complications, such as systemic inflammatory response syndrome (SIRS), multiple organ dysfunction syndrome (MODS), with high morbidity and mortality. In recent years, more and more studies have found that many anesthetic drugs have protective effects on perioperative intestinal IR injury, and then reduce intestinal mucosal injury, which provides new research ideas for the prevention and treatment of intestinal IR injury in clinical research.This paper reviews the recent research on the protective effect of anesthetics on intestinal barrier dysfunction caused by IR injury, and further discusses the protective effect of rational use of anesthetics on intestinal IR injury.
Heart failure (HF)is the final "battlefield" in cardiology, currently, based on the measurement of left ventricular ejection fraction it has been divided into three distinct phenotypes. Among that, heart failure with preserved ejection fraction (HFpEF) has complex pathophysiological mechanisms and poor prognosis, and the treatment strategy is limited. Recent studies have shown some progress in pharmacological therapy for HFpEF, such as sodium-dependent glucose transporters 2 inhibitors (SGLT-2), angiotensin receptor-neprilysin inhibitor, pirfenidone, anti-inflammatory drugs, soluble guanylate cyclase agonists, intravenous iron supplementation therapy, and peptide drugs.In this article, the advanced in pharmacological treatments for HFpEF have been reviewed.
Objective The Box-Behnken response surface methodology combined with the entropy weighting method was used to optimize the preparation method of colchicine transethosomes. Methods The soya lecithin,sodium deoxycholate,and ethanol were taken as the investigation factors.The indexes such as the particle size,polymer dispersity index (PDI),Zeta potential,and entrapment efficiency were examined.Box-Behnken response surface methodology was used to construct a three-factor three-level experimental design.Then,the entropy weighting method was used to assign each index with different weights.Finally,comprehensive scoring was used as the evaluation index of the preparation method to screen for the best preparation conditions of colchicine transethosomes,and the process was validated. Results The optimized formulation of colchicine transethosomes contains 500 mg of soya lecithin,50 mg of sodium deoxycholate,and 4 mL of ethanol. Conclusion The optimized process for the formulation of colchicine transethosomes is optimized based on the Box-Behnken response surface methodology and entropy weighting method,which is stable,objective,and predictable.This method provides a basis for the prescription screening study for formulating such preparations.
Objective To establish a method for simultaneously determining 19 exogenous risk substances such as organophosphorus pesticides and plant growth regulators in Lycium barbarum by QuEChERS combined with UPLC-MS/MS. Methods First, Lycium barbarum samples were extracted by QuEChERS extraction package and purified by QuEChERS purification tube.Next, the extracted solution was eluted with 5 mmol·L-1 of ammonium acetate solution(containing 0.1% formic acid) and acetonitrile as the mobile phase.Finally, the extracted solution was separated by the Agilent HD C18 (50 mm×2.1 mm,1.8 μm) column, and detected by mass spectrometry. Results Among the 50 batches of Lycium barbarum samples, 11 batches of Lycium barbarum samples detected the residues of banned pesticides such as carbofuran and fenitrophos, and 18 batches of Lycium barbarum samples detected the residues of plant growth regulators such as chlormequat, ketamine, 4-nitrophenol sodium. Conclusion This method can detect the residues of 19 exogenous risk substances in Lycium barbarum.It shows a risk of residues of banned pesticides and plant growth regulators in Lycium barbarum.
Objective To establish an inductively coupled plasma mass spectrometry (ICP-MS) method to determine the content of 10 kinds of elemental impurities(Pb,Cd,Hg,Co,V,Ni,As,Li,Cu,Sb) in metronidazole API(for injection). Methods 74Ge, 115In, 45Sc were chosen as internal standard elements. The samples were processed by microwave digestion and measured by ICP-MS with following conditions:test mode was collision cell mode with kinetic energy discrimination (KED), the RF power was 1600 W, collision gas flow was 4.60 mL·min-1 (5.50 mL·min-1 for testing Pb and Hg), the atomization gas flow was 1.00 L·min-1, peristaltic pump speed was 35 r·min-1. Results The correlation coefficients of standard curves of the 10 elements were beyond or equal to 0.999 8, the limits of detection were in the ranges of 0.002-0.331 μg·g-1, the limits of quantification were in the ranges of 0.006-1.102 μg·g-1, and the recoveries of the spiked samples ranged from 76.58% to 116.48%. The contents of the 10 elements in the three batches of samples did not exceed the elemental limits. Conclusion The method is simple, fast and accurate. It can be used for the determination of elemental impurities in metronidazole API (for injection).
Objective Based on the concept of quality by design (QbD),the preparation process of Baoyuan granules was screened,the consistency of the granules was evaluated by physical fingerprint,and the content determination method by HPLC was established for its quality control research. Methods Taking forming rate,moisture absorption rate,melting rate and angle of repose as evaluation indicators,different types of excipients and proportions were investigated,and the process parameters of Baoyuan decoction dry granulation were optimized by orthogonal experiment;The physical fingerprint of granules was established by using relative homogeneity index,loose density,vibrating density,moisture,hygroscopicity,repose angle and Hausner ratio as secondary physical indexes,and the consistency of quality of different batches of granules was evaluated.A method for the determination of Ginsenoside Rg1,Rb1,calyx isoflavone glucoside and ammonium glycyrrhizinate in granules was established by HPLC. Results Baoyuan decoction granule was prepared with maltodextrin as auxiliary material,and the mass ratio of drug and adjuvant was 2:1,and the dry granulation process parameters were roller pressure 22 bar,roller speed 8 r·min-1,feed speed 120 r·min-1.The similarity of physical fingerprint of granules was more than 0.99.Ginsenoside Rg1,Rb1,calyx isoflavone glucoside and ammonium glycyrrhizinate had a good linear relationship in the range of 9.515 6-1218,8.406-1076,1.168 0-149.5 and 8.453-1082 μg·mL-1, respectively (R2=0.999 6-0.999 8),and the average recovery rates were 102.45%,103.21%,105.83%,96.35%. Conclusion The established preparation process is stable and feasible,and the quality of granules can be controlled.The physical fingerprint characterization shows that the prepared granules have good consistency.HPLC method was established for the content determination.The above work has laid the foundation for the research and development of related classical famous prescription preparations.
Objective To analyze the incident rate of post-neurosurgical meningitis (PNM) after prophylactic use of cefuroxime/ceftriaxone in patients after three class I incisions in neurosurgery department, and to compare the effectiveness and economy of prophylactic medication. Methods A retrospective analysis was performed on the clinical data of patients who underwent spinal fusion, microvascular decompression and acoustic neuroma resection surgery in neurosurgery from July 2020 to March 2021. A total of 386 cases who met the criteria were included, including 176 cases in the cefuroxime group and 210 cases in the ceftriaxone group. Differences in the incidence of PNM, hospitalization and drug expenses between cefuroxime and ceftriaxone for perioperative period prophylaxis were compared. Results The incidence of PNM in the cefuroxime group was 6.82% (12/176), and the incidence of PNM in the ceftriaxone group was 5.24% (11/210). There was no significant difference in the incidence of PNM between the two groups (P>0.05). Subgroup analysis of patients with reasonable perioperative prophylactic medication showed no significant difference in the incidence of PNM between the two groups (P>0.05). There was no difference in the overall length of hospital stay between two prophylactic drug groups, and there was statistically significant difference in total hospitalization cost (P<0.05). Among the three types of incision neurosurgery, the total cost of drugs and antibacterial drugs in the cefuroxime group was significantly lower than that in the ceftriaxone group (P<0.01). Conclusion The prophylactic effect of cefuroxime for meningitis after class I incision surgery in neurosurgery is similar to that of ceftriaxone, and it has advantages in terms of pharmacoeconomics.
Objective The purpose of this study is to discuss the mode of grading pharmaceutical care in patients with diabetes. Methods Combined with guidelines on diabetes, the standards for grading pharmaceutical services were formulated.Ninety-nine patients are divided into intervention group and control group.And patients were given different levels of pharmaceutical care with three levels of grading standards (Level Ⅰ-Ⅲ).Before the intervention, three months, and six months after the intervention, grading scores, medication compliance, and adverse reactions of two groups were compared. The blood glucose, glycosylated hemoglobin A1c (HbA1c), average hospital stays and the number of admissions was observed. Results Compared with the control group, the incidence of adverse reactions was reduced by 17.52%, and the readmission rate was reduced by 16.42% after six months of intervention. The ratio of Level Ⅰ and Ⅱ was significantly decreased, and the ratio of Level Ⅲ was significantly increased after six months of intervention (P<0.05).The rate of HbA1c and medication adherence were improved significantly (P<0.01). Conclusion The grading of pharmaceutical care for patients with diabetes can improve the quality of pharmaceutical care and its clinical outcome.
Objective To investigate the clinical characteristics of linezolid-induce optic neuritis. Methods PubMed, Elsevier Science Direct, Embase, Springer- Link, Wiley Online Library, Scopus, CNKI, and Wanfang databases were searched, and the clinical features of linezolidine-induced optic neuritis reported in journals were collected. Results A total of 36 patients with linezolid-induce optic neuritis were collected, including 16 male and 19 female patients, and one patient with unclosed gender, with an age range of 6-81 years old. The reasons for the nedication induced tuberculosis, bone, and joint infections. Regarding drug dose, the highest dose in one patient was 1.6 g·d-1, and other patients did not exceed the recommended dose on the label. The duration of optic neuritis in patients ranged from ten days to 1125 days, with a median of 210 days, and the cumulative linezolid dose ranged from 16.8 g to 894 g, with a median of 162 g.The clinical manifestations showed different degrees of visual impairment, and all patients were discontinued from the drug treatment.The recovery time of visual acuity was seven days to nine months, with a median time of three months.Visual acuity did not improve in two patients, and visual acuity recovered in the rest of the patients. Conclusion Linezolid can cause optic neuritis, and the duration of medication may be a related risk factor.Clinical attention should be paid to this adverse reaction to ensure the safety of drug use.
Objective To study on the acute generalized exanthematous pustulosis (AGEP) caused by drugs, and to provide evidence-based medical evidence for guiding future clinical diagnosis, prevention, and treatment. Methods The clinical data of 45 hospitalized patients with AGEP admitted to the Department of Dermatology of Wuhan First Hospital from January 2012 to December 2020 were retrospectively analyzed, the predisposing factors, clinical manifestations and characteristics, treatment and outcomes of AGEP were analyzed. Results A total of 45 AGEP inpatients with 24 males and 21 females had a history of medication before the onset of the disease, and the incubation period of AGEP was 0.5-10 days. Among them, 23 patients (51.11%) developed fever, and body temperature returned to normal in 1-5 days. And 4 patients (8.89%) had mucosal damage, and none of them had systemic damage. Twenty-eight patients (62.22%) had elevated leukocytes, and 37 patients (82.22%) had elevated C-reactive protein, and 7 patients (15.56%) had elevated eosinophils. After the systemic or topical corticosteroid therapy, rashes completely subsided and condition recovered. Conclusion Systematic use of antibiotics is the main predisposing factor for AGEP in our hospital, of which the most common used antibiotics is β-lactams. The disease can be effectively controlled by immediate withdrawal of suspected drugs. Topical potent glucocorticoids or systemic use of small to moderate doses of glucocorticoids can effectively control the AGEP.
Objective To analyze the main reasons for the failures of subjects in bioequivalence trials due to laboratory screening, so as to provide ideas for the targeted measures that may be taken in the follow-up test and to improve the success rate of screening. Methods A total of 1117 healthy subjects who participated in the screening and had blood collected were collected from 13 bioequivalence tests completed in the Phase I Clinical Research Center of the Department of Pharmacy of Xuanwu Hospital, and the unqualified subjects were analyzed to summarize the main reasons for the failure of different tests. Results Of 1117 subjects whose blood was collected, 261 (23.4%) failed in laboratory screening. Among them, blood biochemistry accounted for 52.1%, followed by blood routine (19.6%), urine routine (13.7%), infectious disease examination (9.2%), coagulation function (5.4%), and blood pregnancy examination (accounting for all the women, 1.8%). The most common causes for screening failure were elevated transaminase and uric acid in male subjects, and elevated platelet and anemia in female subjects. Conclusion By strengthening health education, improving lifestyle, and careful physical examination, it is helpful to improve the success rate of screening.
Objective To establish a mechanism for forming an alternative library of medicines on the National Essential Medicines List for Children and to design a selection plan for an alternative library of children's medicines for China. Methods Based on learning from the selection experience of children's lists in typical countries and regions, combined with the operability of promoting the adjustment of children's essential drug lists in China at this stage, and focusing on its positioning to guide clinical rational drug use and its connection with medical insurance policies, the formation mechanism of alternative drug library was designed from theory and practice Starting from the level of drug use. Using the existing public information and the drug procurement situation of children's hospitals in Jiangsu province in 2020, the path simulation of the alternative library formation mechanism was carried out to verify the feasibility of the scheme. Results The formation mechanism of the drug candidate library of the China Children's Essential Drug List can be based on the Children's Drugs in the Clinical Diagnosis and Treatment Guidelines, the "China National Formulary (Chemical Drugs and Biological Products Volume-Children's Edition)", and the "List of Children's Drugs Encouraged for R&D and Application".In addition, Medicare medicines and children's hospital medicines are important supplements. Conclusion Under this mechanism, it is of great significance to form a scientific, authoritative and appropriate national list of essential medicines for children which not only reflects the implementation of the concept of evidence-based decision-making in drug selection, but also fully respects clinical opinions, and realizes the connection between the essential drug policy and the medical insurance policy.
Multi-dose Traditional Chinese Medicine formula granules are one of the important application forms of Traditional Chinese Medicine formula granules. The layout of the dispensing room, environmental temperature and humidity, dust and other factors directly affect the quality of Traditional Chinese Medicine formula granules. In this paper, the relevant factors affecting the quality of multi-dose Traditional Chinese Medicine formula granules are analyzed and measured. And the housing construction standards of the dispensing room on this basis are proposed, in order to improve the dispensing quality of multi-dose Traditional Chinese Medicine formula granules and promote the standardization level of dispensing.
During the trial period of Traditional Chinese Medicine formula granules, only six enterprises had been approved for trial production.In this process, each medical institutions generally only choose one as a supplier.In recent years, with the continuous introduction of the national policy on the praduction enterprises of Traditional Chinese Medicine formula granules, the production enterprises of Traditional Chinese Medicine formula granules have developed to more than 60 enterprises at present, and the exclusive supply mode of Traditional Chinese Medicine formula granules is no longer suitable for the development of the times.In this paper, combined with the exploration of the mixed supply and blending mode of Traditional Chinese Medicine formula granules piloted by our hospital, the method is discussed and analyzed to provides a reference for medical institutions to change the supply and blending methods of formula granules.