The “Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions” was developed by standards-based process from WHO.The guideline was referenced to the WHO Essential Medicines List,WHO Medicines and Health Products Programme Strategic Framework (2016—2030),and the relevant policy and system documents of developed countries and regions,including the United States, Europe, Japan and so on.Experts reached consensus on the scoring system for drug evaluation and selection were reached through the Delphi method in this guideline.In the end, to develop this guideline, we also took the actual conditions of Chinese medical institutions into account.
The new China’s“Guideline for Good Clinical Practice (GCP)” was officially executed on July 1,2020. This article provides an overview of the revision base of the new GCP,focused on discussing the experience and lessons that we have received since 2003 GCP version has been executed in China. The revision prosses of GCP was guided by the opinions on the deepening the reform of the review and approval system to encourage innovation in pharmaceuticals and medical devices of the Office of central committee of Chinese Communist Party and the Office of the State Council. Besides,the new GCP is modified and supplemented by reference to the content of ICH GCP. The new edition of GCP of China has become more targeted,normative and instructive than before. This paper generalizes the main points for the application of the new version of GCP by highlighting that the investigator’s brochure and drug protocol are the core documents to reflect the scientific characteristics of the clinical trial. Moreover,this article summarizes the core spirit of medical ethics of Helsinki Declaration of the World Medical Congress,emphasizes the basic elements of strengthening the construction of the Independent Ethics Committee,and further analyzes the importance of carefully writing and reviewing informed consent forms in the application of medical ethics in clinical trials of pharmaceuticals.
Objective To study the inhibitory effect of cucurbitacin α(CUBα) on methyl-nitrosourea(DMBA)-induced breast tumor growth in mice. Methods The mice were randomly divided into 6 groups according to their body weight,including blank control group,model control group,tamoxifen (positive control) group and CUBα low-dose,medium dose and high-dose groups. DMBA induced breast tumor model was establshed in mice except blank control group.CUBα was orally administered to mice at three doses [low (12.5 mg·kg-1),middle (25 mg·kg-1)and high dose (50 mg·kg-1)].Temperature,body and tumor mass,and pulmonary metastasis were observed.WBC,Viscera index of thymus and spleen were measured.Serum levels of estrogen and progesterone were determinated.Plasma levels of TNF-α and IL-6 were assayed by ELISA. levels of WBC,TNF-α,IL-6 and Viscera index of thymus and spleen were measured.Activities of Na+-K+-ATP enzyme ,Ca2+-Mg2+-ATP enzyme,superoxide dismutase(SOD) and glutathione peroxidase(GSH-Px) were determined. Results Compared with model control group,CUBα(25 and 50 mg·kg-1) could remarkably inhibit breast tumor growth and ameliorate the signs (P<0.05),reduce the level of estradiol and progesterone, protect the activities of SOD and GSH-Px, and suppress pulmonary metastasis rate.Compared with tamoxifen group, CUBα(50 mg·kg-1) significantly improve the levels of WBC, TNF-α and IL-6, and Viscera index of thymus and spleen;and increased the activities of Na+-K+-ATP enzyme and Ca2+-Mg2+-ATP enzyme(P<0.05). Conclusion CUBα could inhibit tumor growth and ameliorate the signs.The mechanism may be related to regulating the immune system.
Objective To observe the therapeutic effect of Gnaphaliumaffine D.Don on rat models with gouty arthritis and the effects on NALP3 inflammasomes (NACHT-LRR-PYD-containing protein-3,NALP3)-related signaling pathways. Methods Sixty rats were randomly divided into normal control group,model control group,low-dose group,medium-dose group,high-dose group of Gnaphaliumaffine,and colchicine group.Except the normal control group,a rat model of acute gouty arthritis was made by injecting sodium urate into the right ankle joint cavity of the hind limb.The normal control group and the model control group were given 0.9% sodium chloride solution by gavage.In the low-dose group,medium-dose group and high-dose group,rats were given 0.4,0.8,1.6 g·kg-1,respectively.And colchicine group was given colchicine 0.97 mg·kg-1 by gavage.In each group,the volume was 2 mL,once per day for 8 days.After the administration,the rat paw swelling rate at different time periods was measured.The uric acid (UA), xanthine oxidase (XOD),interleukin-1β (IL-1β), and tumor necrosis factor-α (TNF-α) in serum of each group were measured by enzyme-linked immunosorbent assay (ELISA).Western blot was used to detect the expression of NLRP3,apoptosis-related speckle-like protein (ASC),and caspase-1 in joint tissues.Hematoxylin-eosin (HE) staining was used to observe the histopathological changes of knee joints in each group of rats. Results Compared with the normal control group,the swelling rate of the ankle joint was significantly increased (P<0.01 or P<0.05).The contents of UA,XOD, IL-1β and TNF-α in the serum of the rats were significantly increased (P<0.01).The expressions of NALP3,ASC and Caspase-1 in synovial tissue were significantly increased (P<0.01),a large number of inflammatory cells infiltrated into the synovial tissue of ankle joint,and the cell proliferation was obvious.In the low-dose group, medium-dose group and high-dose groups of Gnaphaliumaffine, Gnaphaliumaffine could significantly reduce the swelling rate of the ankle joints in rats (P<0.01 or P<0.05).The contents of UA,XOD,IL-1β and TNF-α in serum were significantly decreased (P<0.01 or P<0.05).The protein expression of NLRP3,ASC,and Caspase-1 in synovial tissue was significantly decreased (P<0.01).And the degree of inflammatory infiltration and cell proliferation in joint tissue were significantly reduced. Conclusion Gnaphaliumaffine D.Don has a therapeutic effect on gouty arthritis induced by sodium urate in rats.The mechanism may be through inhibiting the expression of NALP3 inflammasome associated protein,inhibiting XOD activity,and reducing the production of UA,IL-1β and TNF-α in blood to reduce arthritis reactions.
Objective To study the in vitro drug release,transdermal rate and the pharmacokinetic characteristics of active component of Huoxue Quyu cataplasm, including Danshensu sodium,protocatechuic aldehyde,ferulic acid,rosmarinic acid and salvianolic acid B. Methods The effective components of the cataplasm were determined by HPLC after the processes of paddle plate and modified France diffussion pool. Results The cumulative releases in 180 min of danshensu sodium,protocatechuic aldehyde,ferulic acid,rosemic acid,and salbutamol acid B in the Huoxue Quyu cataplasm agent reached 89.40%,86.39%,88.94%,87.19% and 90.05% respectively;The skin transdermal rates of danshensu sodium,protocatechuic aldehyde,ferulic acid,rosmarinic acid,and salvianolic acid B isolated mice in 24 hours were 29.83%,28.69%,30.14%,30.03% and 30.60%;The kinetic fitting equation conforms to the Higuchi equation, and the quasi-compatibility degree has reached 0.9 or more. Conclusion The release rate of Huoxue Quyu cataplasm is good and the permeability is high.The kinetic equation shows that it is a skeleton sustained release preparation.
Objective To solve the problem of lack of chemical purity for certified reference material of progestin drugs at present, and to develop medroxyprogesterone acetate as a national level purity certified reference material with traceability. Methods According to the guiding principles of the development of National Standard Material, mass balance (MB) method and differential scanning calorimetry (DSC) method were selected to study the determination and uncertainty of the purity of certified reference material of medroxyprogesterone acetate. Results The purity and uncertainty value of medroxyprogesterone acetate certified reference material was(99.5±0.5)%(k=2,P=0.95) and it has been certified by the State Administration for Market Supervision. Conclusion The result is more accurate and meets the requirements of the certified reference material development code.It has filled the blank in the lack of traceable certified reference material and can be used as a measuring instrument for tracing and transferring the value of certified reference materials.
Objective To investigate the differences in aildenafil citrate metabolites in liver microsomes from different genders. Methods Aildenafil citrate were incubated with human liver microsomes from different gender in vitro, and a UPLC/Q-TOF MS method was developed to identify the metabolites of aildenafil in human liver microsomes from different genders.The chromatographic separation was performed on an Acquity UPLC BEH C18(2.1 mm×100 mm×1.7 μm)using a gradient elution with the mobile phase consisting of acetonitrile and methanol containing 0.4% formic acid at 0.3 mL·min-1 flow rate.A Micro mass-Q-Tof Premier mass spectrometer coupled to an ESI source was operated in positive ion mode. Results By comparing the retention time and fragment ions, 8 kinds of metabolites, as well as the parent compound, were identified in human liver microsomes from different genders.All metabolites were water-soluble molecules without obvious toxic structure.There were no differences among metabolites of different groups. Conclusion The liver microsomal incubation model of aildenafil citrate was established, and the research provided possible reasons that aildenafil citrate had consistent liver metabolic processes in different gender groups.
Objective To prepare testosterone undecanoate-loaded injectable in situ forming implants (TU-ISFI),and to investigate the influence on reproductive system and contraceptive effect in adult male rats. Methods The TU-loaded ISFI was prepare with adult male SD rats were treated with vehicle,TU-ISFI or TU injection.Fertility test,serum testosterone concentration,epididymal sperm count, motility,morphology and histology of testis were detected. Results The in vitro drug release test showed TU-loaded ISFI increased serum testosterone levels in rats steadily without fluctuations in three months.One month after administration, epididymal sperm count,sperm motility and percent of normal spermatozoa were all decreased significantly in all experimental groups.After three months,the animals treated with 600 and 300 mg TU-ISFI were 100% infertility,and no implantation sites were produced in the mated females.However,part of males in 150 mg TU-ISFI group and TU injection group still hold fertility but implantation were also significantly lower than control value. Conclusion The present findings suggest that TU-ISFI at an appropriate dose has potential as a long-acting male contraceptive drug or hormone replacement supplement drug.
Objective The polymorphs of mifepristone, ethinylestradiol and levonorgestrel were identified and characterized by Raman spectroscopy, and the structure analysis based on Raman spectrum information was carried out.The relationship between the polymorphs and the changes of Raman spectra was described. Methods The structures of the polymorphs of the three drugs were confirmed by PXRD, after the crystal forms were confirmed correctly, the Raman spectra of the samples were collected, and the identification analysis based on Raman spectrum information was carried out. Results The polymorphs of the three steroidal contraceptives have different characteristic information such as the relative intensity, the number and the position of the peaks due to the different arrangement and symmetry of the molecules.The form W of mifepristone is amorphous, and the relative intensity of the peak is weaker and the peak broadening is more blunt than the other two crystalline substances;The form B of ethinylestradiol is hydrate, and the form A is solvent-free. Therefore, the Raman spectra of the two forms are significantly different in the high wavenumber band of CH vibration;the vibration intensity of the carbon skeleton of levonorgestrel form α and form β is changed due to the difference of conformation, so the relative intensity of Raman spectra of the two forms is different. Conclusion Raman spectroscopy can be used to identify the polymorphs of three kinds of steroidal contraceptives,which provides a scientific basis for the study of polymorphs of these kinds of drug.
Female contraceptives are medicines or apparatus which can be used to achieve the purpose of anti-fertility by affecting different periods of the reproductive cycle.About 60 years have passed since the first female contraceptive Enovid® was approved in the 1960s.With the development of technology,new drugs were discovered.These drugs possess higher success rate of contraception and lower side effects.Furthermore,some of them even have therapeutic effect on endometriosis, primary dysmenorrhea and irregular menstruation.This article reviewed and analyzed the current use of female contraceptives,looking forward to providing some useful information for the development of relevant products.
Objective To assess the clinical efficacy and safety of salkubatrol/valsartan in combination with coenzyme Q10 in patients with chronic heart failure. Methods A total of 103 patients diagnosed with chronic heart failure in the Department of Cardiology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology were included and randomly divided into two groups according to a random number table.Patients in treatment group were given salkubatrol/valsartan and coenzyme Q10 on the basis of conventional treatment,while patients in control group were given salkubatrol/valsartan only on the basis of conventional treatment.We analyzed and assessed several items in all patients before and after treatment for 12 weeks,including clinical symptoms,serum N-terminal brain natriuretic peptide (NT-proBNP),cardiac function classification,alanine aminotransferase (ALT),glomerular filtration rate (eGFR),serum potassium,serum creatinine (Scr),left ventricular end diastolic diameter (LVEDD),left ventricular ejection fraction (LVEF),average hospitalization time and 30 day readmission rate. Results After 12-week treatment,patients in treatment group showed notable improvement in the aspects of clinical symptoms and cardiac function classification when compared with control group.The total effective rate in treatment group (86.54%) was also higher than that in control group (64.71%),which showed a significant statistical difference.In comparison with control group,patients in treatment group had lower levels of NT-proBNP [(1382.92±1160.75) pg·mL-1 vs(1978.19±1532.83) pg·mL-1],LVEDD [(57.32±9.72) mm vs(61.32±9.11) mm],ALT [(18.58±14.29) U·L-1 vs(22.37±14.40) U·L-1],and blood creatinine [(72.13±31.58) μmol·L-1 vs(86.29±26.53) μmol·L-1] after treatment,and the differences were statistically significant (P<0.05); However,patients in treatment group had higher levels of eGFR [(87.50±19.75) mL·min-1·(1.73 m2)-1 vs(73.27±19.77) mL·min-1·(1.73 m2)-1] and LVEF [(38.63±12.84)% vs(34.02±8.93) %] than that in control group after treatment,and the differences were statistically significant (P<0.05). Conclusion The clinical efficacy of salkubatrol/valsartan combined with coenzyme Q10 in patients with chronic heart failure is remarkable.In the chronic heart failure context,the combination treatment of salkubatrol/valsartan with coenzyme Q10 can significantly reduce NT-proBNP content with notable improvement on cardiac function and little adverse effect on renel function,indicating the good safety of the combination treatment.
Bamboo is a unique cash crop in China,and it is a Traditional Chinese Medicine with heat-clearing and detoxifying effects.The medicinal value and pharmacological effects of bamboo have been recorded in the "Compendium of Materia Medica" and "Shennong's Herbal Classic".Bamboo has also been reported of various biological activities such as anti-oxidation,anti-bacterial and anti-inflammatory,lowering blood pressure and lowering blood fat,according to the intensive studies of the chemical composition.Studies show that bamboo contains a variety of biologically active substances,such as carbon flavonoids,polysaccharides and various amino acids.At present,there are few studies on flavones in bamboo leaves in China.This paper mainly reviewed the pharmacological effects of bamboo leaf flavonoids.We expect to make new research on the medicinal value of bamboo as its utilization prospect.
Objective To establish a method for determining the content of total free amino acids and free amino acids in sika deer velvet antler which could be used to evaluate the quality of the drug. Methods A method for the determination of total free amino acids in sika deer velvet antler was established by Ultraviolet spectrophotometry with tryptophan as reference.The detection wavelength was 570 nm.A method for the determination of 16 free amino acids in sika deer velvet antler samples was established by UPLC-QqQ-MS/MS.An ACQUITY BEH Amide (2.1 mm×100 mm,1.7 μm) chromatographic column was adopted.The mobile phase was gradient elution with 20 mmoL·L-1 ammonium acetate aqueous solution: 0.5% formic acid acetonitrile = 15:85 as A solution,The aqueous solution of 20 mmoL·L-1 ammonium acetate containing 0.5% formic acid as B solution.The flow rate was set at 0.6 mL·min-1 and the column temperature was set at 35 ℃.Mass spectrometry was used multiple reactions monitoring (MRM) mode with electro-spray ionization source (ESI). Results There was a good linear relationship between the concentration and absorbance of total free amino acid components (r=0.999 6).The RSD values of precision,repeatability and stability were all less than 3.3%.The average recovery was 98.9% and RSD was 2.1%.There was a good linear relationship between the concentration and peak area of 16 free amino acids (r>0.999 5).The RSD values of precision,repeatability and stability were all <4.9%.The average recovery was between 97.7% and 99.8% with RSD ranged from 1.2% to 2.6%. Conclusion This method is simple,accurate and reliable,and can be used to evaluate the quality of sika deer velvet antler.
Objective To optimize the processing technology of vinegar-baked radix Angelicae sinensis using orthogonal design. Methods The content of tannin, ferulic acid and volatile oil was taken as indicators.The consumption of vinegar, frying temperature and frying time as factors.The indicators were determined by the methods of Chinese Pharmacopoeia (2015 edition). Results The optimum processing technology of vinegar-baked radix Angelicae sinensis was 15% vinegar, which was fried for 6.5 min at 120 ℃. Conclusion The optimized technology is stable, reasonable and feasible, which can provides scientific basis for industrial production of vinegar-baked radix Angelicae sinensis.
Objective To establish a method for the content determination of three anthraquinones in Pouzolzia Zeylanica ointment by quantitative analysis multi-components by single marker (QAMS) and to evaluate the adaptation and application of QAMS method in the quality control of Pouzolzia Zeylanica ointment. Methods Quercetin-3,7-2-O-α-L-dirhamnopyranoside was used as the internal reference to establish correction factor with the content of apigenin-6-C-α-L-arabin 8-C-β-D-glucoside and kaempferol-3,7-2-O-α-L-dirhamnopyranoside by HPLC, compared with the results of external standard method to verify the rationality and feasibility of QAMS. Results Among the 9 batches of samples,there was no significant difference between the calculated values of QAMS and the measured values of the external standard method. Conclusion The method is accurate and reliable, and can be used for the quality control of Pouzolzia Zeylanica ointment.
Objective To establish the ultra performance liquid chromatography-photo diode array (UPLC-PDA) method,and to analyze and evaluate the quality of leaves of Dendrobium aurantiacum Rchb.var.Denneanum (Kerr.) Z.H.Tsi.. Methods The method used tetrahydrofuran-acetonitrile-methanol (10:22:5) and 0.05% phosphoric acid as a mobile phase by gradient elution at a flow rate of 0.3 mL·min-1 equipped with ACQUITY UPLC-PAD® HSS T3 C18 column (2.1 mm×100 mm,1.8 μm) at 30 ℃.The detection wavelength was 337 nm.Under this chromatographic condition,the content of the "point" of three components (apigenin-6,8-di-c-glucoside,isophora,and rutin) and the "line" of the whole component of total flavonoids was determined.The "surface" of the fingerprint of the whole component of 10 batches of leaves of Dendrobium aurantiacum Rchb.var.Denneanum (Kerr.) Z.H.Tsi.was analyzed by whole component and similarity evaluation as well. Results The curves of the three single components and the total flavonoids displayed excellent linearity,the average recoveries and corresponding relative standard deviations (RSD) of which were 99.15% (2.48%),101.43% (1.86%),96.42% (2.29%),and 101.68% (2.17%),respectively.A total of 29 peaks were identified by fingerprinting,including 25 flavonoid peaks and 23 common peaks.The similarity of the same species was from 0.968 to 0.995.Otherwise,compared with the leaves of Dendrobium aurantiacum Rchb.var.Denneanum (Kerr.) Z.H.Tsi in Yunnan,the flavonoids in Sichuan of which were more and the content of apigenin-6,8-di-c-glucoside was lower.But the content of rutin and total flavonoids was higher. Conclusion The developed method showed high selectivity,accuracy and fast analysis speed,which could determine the content of the three single components and the total flavonoids of Dendrobium aurantiacum Rchb.var.Denneanum (Kerr.) Z.H.Tsi.at the same time, the established "point-line-face" quality analysis system could provide ideas and methods for the quantitative detection of flavonoids such as Chinese herbal medicines and proprietary Chinese medicines,as well as the quality control of fingerprints.
Objective To study the formulation and preparation of ponatinib loaded solid lipid nanoparticles(P-SLN) and to evaluate its characteristics. Methods The P-SLN were prepared using emulsion evaporation solidification at low temperature.The formulation was optimized with the high shear mixers based on the result of single factor experiments.The four main factors affecting its formulation were optimized by orthogonal design depending on the mean size, polydispersity index and encapsulation efficiency.Finally, the quality of P-SLN was evaluated. Results P-SLN were prepared with optimized emulsion evaporation solidification at low temperature method.The mean size of P-SLN was about (155.1±4.32) nm, polydispersity index was (0.152±0.009), Zeta potential was (-22.0±1.72) mV,and encapsulation efficiency was (67.7±1.84)%,respectively (n=3).The transmission electron microscope (TEM) tests indicated it was spherical.In vitro,P-SLN represented a significant control release effect and fitting Weibull equation.The cryoprotectants of P-SLN for lyophilization was chose as 5% mannitol,and differential scanning calorimetry (DSC) test showed P-SLN had formed a new phase. Conclusion The emulsification method combined with high-speed shear is suitable for the P-SLN preparation,P-SLN show regularly spherical particles in morphology,uniformly particle size distribution,highly encapsulation efficiency,and significantly effect of control release in vitro.
Objective To access the cost effectiveness of pirfenidone and nintedanib in the treatment of idiopathic pulmonary fibrosis and to compare the economic benefits of pirfenidone and nintedanib from the perspective of patients, so as to provide reference for clinical drug selection. Methods A Markov model was constructed using TreeAge Pro 2011 software.The effect parameters and probability parameters needed for the model were obtained through literature, and the cost parameters were obtained according to domestic drug pricing and hospital charging standards.A cost-effectiveness analysis of the two drugs was carried out and conclusions were drawn through comparison. Results In two years, the accumulated medical costs per patient in pirfenidone group and nintedanib group were 142 874.99 yuan and 439 758.26 yuan,respectively.The accumulated forced vital capacity percent predicted per patient decreased by 2.54 and 4.17 respectively in pirfenidone group and nintedanib group.Compared with nintedanib group, every reduction in deaths cost an additional 12 370 136.40 yuan and every reduction in serious adverse events cost an additional 4 193 266.58 yuan in pirfenidone group. Conclusion The patients in the pifenidone group have fewer pulmonary function deterioration and lower medical costs in the treatment of idiopathic pulmonary fibrosis for 2 years compared with the nintedanib group, so pifenidone has more economic advantages.
Objective To evaluate the accuracy of divided tablets and to provide references for reasonable application of divided tablets in clinic. Methods Quality analysis was performed in 9 kinds of tablets (36 divided tablets in total) which have various divided specification and often administer for patients.According the standard of Chinese Pharmacopoeia, we determine whether the quality of divided drugs meet the qualification. Results Among the 36 divided tablets, only metoprolol tartrate tablets and bisoprolol tablets half-tablets meet the standard of 《Chinese pharmacopoeia》, other divided tablets all failed. Conclusion Divided tablets can not meet the quality standard of the 《Chinese Pharmacopoeia》 . More types of dosage forms to meet the needs of patients with safe medication.
Objective To explore the clinical characteristics of severe adverse reactions of loxoprofen,and provide reference for rational drug use in clinical practice. Methods Severe adverse reactions of loxoprofen from January 2000 to December 2018 were retrieved through the key words “loxoprofen”(both in Chinese and English) in electronic databases,including CNKI, Wanfang,VIP and PubMed.The retrieved severe adverse reactions were statistically analyzed. Results A total of 21 cases in 20 literatures on severe adverse reactions of loxoprofen were retrieved,including 5 males (23.81%) and 16 females (76.19%).The minimum age of the patients was 26 and the maximum age was 87 (the average age was 53.19±19.21).The shortest occurrence time of severe adverse reactions was 30 minutes and the longest was 30 days.Nine cases (42.86%) were treated alone and 12 cases (57.14%) were combined with other drugs.There were many organ systems involved,allergic reactions in 4 cases,digestive system in 4 cases,urinary system in 3 cases,nervous system in 3 cases,cardiovascular system in 3 cases,respiratory system in 2 cases, blood system in 1 case and other 4 cases.Due to the timely and correct intervention measures,the prognosis was good and no fatal cases occurred. Conclusion The serious adverse reactions of loxoprofen is relatively rare,but still need to pay more attention to avoid loxoprofen-induced adverse reactions,so as to ensure the quality of life and safety of patients.
Standardizing the management of experimental drugs in clinical trial institutions is an important guarantee to improve the safety of subjects and ensure the accuracy and integrity of trial data. American Society of Health System Pharmacists(AHSP)issued the Guidelines for the Management of investigational drugs products in 2018,which detailed the six key links in the management of clinical trial drugs,namely,the significance and management mode of clinical trial pharmacies,storage infrastructure,personnel management,document management,process management,and supervision. At present,there is still a lack of comprehensive regulations on the management of investigational drugs products in China. In this paper,the key contents of the guidelines are interpreted and introduced in detail,so as to provide references for the management of investigational drugs products in China.
Objective To evaluate the technical innovation efficiency of pharmaceutical manufacturing industry in China and to analyze the causes of technical innovation efficiency fluctuation. Methods Data envelopment analysis (DEA) method was used to conduct an empirical study on the technological innovation efficiency of pharmaceutical manufacturing industry from 2007 to 2016 in major provinces (regions and cities) of China based on the study of hysteresis effect.The differences in the efficiency values of provinces (regions and cities) and the overall development trend in the past 10 years were explored, and the reasons were analyzed. Results The efficiency of technological innovation in central and eastern China was generally higher than 0.6.The scale efficiency (0.687) in the eastern region was the lowest,and the pure technical efficiency (0.345) in the northeast region was the lowest.On the whole,the technological innovation efficiency of China's pharmaceutical manufacturing industry showed a fluctuating and rising trend in the past 10 years. Conclusion The development of technological innovation efficiency varies greatly among different regions in China.Due to the diseconomies of scale in the eastern region,the scale should be reduced.In addition,the overall trend of technological innovation efficiency in China's pharmaceutical manufacturing industry is greatly affected by the national macroeconomic situation and policies.