20 July 2025, Volume 39 Issue 7
    

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    Supervision & Administration
  • Li Hao, Ni Long, Hao Bo, Zhao Yuxin, Shen Mingrui, Zhang Qingbo, He Yi
    Chinese Pharmaceutical Affairs. 2025, 39(7): 725-731. https://doi.org/10.16153/j.1002-7777.2025-05-0055
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To provide a reference for practitioners to better understand and accurately implement the standards for compound and single herb preparation of traditional Chinese medicine (CSHP) in Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I). Methods: The main contents and characteristics of the additions and revisions of the standards for CSHP in Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I) were analyzed and summarized. Results and Conclusion: In Pharmacopoeia of the People’s Republic of China 2025 edition (Volume I), 28 new monographs of CSHP have been added, over 200 monographs have been revised, and 19 monographs are no longer included. The standards for CSHP are added or revised to ensure the safety, effectiveness, and quality controllability of medication, which continuously improves the overall level of standards, refines the formation mechanism of standards, and strengthens the technical support role of scientific supervision. The new edition of Chinese Pharmacopoeia could provide stronger technical supports for further promoting the improvement of quality standards for CSHP, promoting the high-quality development of the Chinese medicine industry and ensuring the safety of people’s medication.
  • Wang Xin, Cao Yi, Zhou Yong, Bai Jianxue, Xiao Jie
    Chinese Pharmaceutical Affairs. 2025, 39(7): 732-738. https://doi.org/10.16153/j.1002-7777.2025-02-0022
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    Objective: To analyze the challenges and difficulties faced by drug regulatory inspections with the widespread application of informatization and intelligent equipment in the field of drug production, and to propose suggestions on how to improve the capabilities and level of production inspection. Methods: The documents issued by drug regulatory agencies and international drug cooperation organizations in various countries were analyzed, and the current development status and existing problems of intelligent manufacturing of drugs in China were investigated. Results and Conclusion: China’s drug enterprises have begun to implement intelligent manufacturing in some scenarios, but have not yet formed a scale and integration. There are still many challenges in regulatory inspection, it is suggested to continuously exert efforts in issuing relevant inspection guidelines, improving the professional quality of inspectors, continuously exploring the application risk management, and developing regulatory science, etc., to jointly promote the intelligent manufacturing of drug production in China to the world.
  • Wu Siyu, Zhang Wen, Wang Linning, Chang Feng
    Chinese Pharmaceutical Affairs. 2025, 39(7): 739-748. https://doi.org/10.16153/j.1002-7777.2025-03-0033
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    Objective: To evaluate the impact of the bidding access for drugs with generics available on drug accessibility, and make recommendations with a view to improving bidding access and enabling drugs to be used in a wider range of regions, to be consumed at more economical treatment costs. Methods: The article sorted out the 2020Q1-2023Q4 procurement data of 17 drugs entered in the medical insurance catalogue through bidding access in 2022 in the Menet-Key City Public Hospital Chemical Drug Terminal Competitive Pattern Database. From the aspect of drug acquisition, drug availability, defined drug dose numbers, expenditure were selected, and from the aspect of disease affordability, defined daily drug cost was selected. The changes of the paramaters above were analyzed by combining descriptive statistical analysis and interrupted time series model. Results: 80% of the included cities were equipped with more than or close to 48% drugs. The quarterly average defined drug dose numbers for all types of drugs rose and exceeded 50%, and the growth rate of neurological drugs, antineoplastic drugs and immunomodulators reached 2638.88% and 1209.99%, respectively, whose growth rate ranked in the top two. The growth rates of the expenditure of neurological drugs, systemic anti-infective drugs, antineoplastic drugs and immunomodulators were higher, respectively 719.58%, 400.08% and 293.91%. The defined daily drug costs of all types of drugs decreased, more than half of which fell to>50% of the original, and the declines of blood and hematopoietic organ drugs, and neurological drugs were more significant, respectively 80.36% and 70.07%. At the same time, changes in the above paramaters were statistically significant for most drugs. Conclusion: While continuing to promote bidding access, the structure of access drugs needs to be further optimized and drug access channels should be gradually broadened.
  • Quality Management
  • He Yingmei, Xie Nan, Ma Xiao, Guo Zhaohui, Guo Lirong, Yang Lingxia, Liu Zhihao, Zhang Jianmin, Yang Pengwei, Zhang Zihao
    Chinese Pharmaceutical Affairs. 2025, 39(7): 749-755. https://doi.org/10.16153/j.1002-7777.2025-05-0004
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    Objective: To provide references for drug production and regulatory departments to strengthen the management and enforcement of drug quality standards, standardize the formulation and revision of such standards, and improve the accuracy of drug registration information, ultimately contributing to the high-quality development of the industry. Methods: By investigating the management and enforcement of quality standards in pharmaceutical production enterprises and medical institution pharmacies, combined with the issues identified through drug supervision sampling inspections and commissioned testing, the corresponding improvement measures and suggestions were addressed for the challenges existing in drug quality standard inquiries, management and enforcement, formulation and revision, drug instruction leaflet management, and drug registration (re-registration). Results and Conclusion: The management and implementation of drug quality standards should be organically integrated with drug production, drug registration management, drug instruction leaflet management, and drug supervision. It is necessary to strengthen the learning, training, and implementation of relevant laws, regulations, and technical norms to guarantee the rigorous implementation of the most stringent standards and ensure drug safety, efficacy, quality control.
  • Wang Mei, Wu Zhi’ang
    Chinese Pharmaceutical Affairs. 2025, 39(7): 756-763. https://doi.org/10.16153/j.1002-7777.2025-03-0006
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    Objective: To reduce the quality risks in the multi-product co-production of CAR-T cell therapy products by CDMO enterprises and ensure product quality. Methods: Based on the characteristic that the operation procedures of the proposed co-produced CAR-T cell therapy products were roughly the same, failure mode, effects and criticality analysis (FMECA) method was adopted, combined with the literature analysis method and expert interview method, to establish a quality risk management model for co-production of CAR-T cell therapy products in CDMO enterprises. Results and Conclusion: The established process was applied to the proposed co-produced products. Using the feasibility assessment table, applicability assessment table, risk assessment and control table of the process, the new risks brought by multi-product co-production were evaluated from the aspects of personnel, machinery, materials, methods and environment. After adding control measures for medium and high risks, the final co-production risks could all be acceptable. After applying the process, the risk index of the co-production link had significantly decreased. The model provided a reference for the improvement of the risk management effect of co-production of CAR-T cell therapy products in CDMO enterprises.
  • Chen Jiao, Zhang Lei
    Chinese Pharmaceutical Affairs. 2025, 39(7): 764-770. https://doi.org/10.16153/j.1002-7777.2024-11-0038
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    Objective: To understand the overall quality status and existing problems of Bao’erning pharmaceutical preparations, to provide technical support for the supervision of Bao’erning pharmaceutical preparations, and to ensure the safety of public medication. Methods: According to the current legal standards, 43 batches of Bao’erning pharmaceutical preparations samples were inspected from 2021 to 2023, and the exploratory research was carried out from the aspects affecting the safety and efficacy of the drug, and the analysis was carried out according to qualified rate of samples and the contents of active ingredients and heavy metal. Results: A total of 43 batches of this drug were sampled and tested over 3 years. Inspection according to current standards, the 43 batches had a 100% qualified rate of samples. Exploratory research was conducted on the contents of active ingredients in Bao’erning syrup and heavy metal contents in Bao’erning granules. There were significant differences in the contents of active ingredients in different batches of Bao’erning syrup, and the contents of Pb, Cd, Hg, As, and Cu in Bao’erning granule samples were far below the limit. Conclusion: The quality of Bao’erning pharmaceutical preparations are good, but the inspection standards still need to be further improved and perfected. The two detection methods established through exploratory research are easy to operate, accurate in results, and highly sensitive, which have good reference value for improving the quality standards of Bao’erning pharmaceutical preparations.
  • Liu Lina, Chang Yan, Xiang Xinhua, Jin Hongyu, Wei Feng
    Chinese Pharmaceutical Affairs. 2025, 39(7): 771-778. https://doi.org/10.16153/j.1002-7777.2025-02-0018
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    Objective: To evaluate the detection ability of zearalenone residue which participated in the proficiency testing for zearalenone residue determination and improve the quality of residual testing. Methods: According to the requirements of the relevant documents of the China National Accreditation Service for Conformity Assessment, the ‘interference samples’ were designed to verify the determination ability of zearalenone residue in each laboratory. The uniformity and stability of the samples were tested, and the samples were distributed according to the project plan. The median value of the laboratory test results was used as the specified value, and the Z score was used to perform statistical analysis of the proficiency testing results. Results: Among the 150 enrolled laboratories, 147 provided valid data for the calculation of the specified value, and 119 laboratories achieved satisfactory results with a satisfaction rate of 81.0%. Conclusion: The laboratories participating in the detection of zearalenone residue have a relatively good ability to implement the standards and quality assurance system. Unsatisfactory laboratories should find out the reasons and carry out rectification to improve the laboratory’s testing ability.
  • Regulatory Technology
  • Yang Yalan, Qi Zhiyun, Liu Chunyu, Cui Yongfei, Guo Luyun, Yu Chuanfei
    Chinese Pharmaceutical Affairs. 2025, 39(7): 779-787. https://doi.org/10.16153/j.1002-7777.2025-04-0027
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    Objective: To evaluate the batch consistency and stability of the anti-programmed death receptor 1 (anti-PD-1) monoclonal antibody by conducting a trend analysis of the test results of key quality control items. Methods: Statistical and trend analyses were performed on the detection results of 93 batches of anti-PD-1 monoclonal antibodies for key quality control items from the National Institutes for Food and Drug Control(NIFDC) and the manufacturer. The analyzed items included SEC monomer content, HIC front peak(1+2) content, biological activity, protein content, and pH value. Alert and action limits were established, and abnormal results were investigated. Results: The results of the SEC monomer content by the two laboratories were both between 99.7% and 99.9%. The protein content, biological activity and pH value were all within the action limit range. The average values of the HIC front peak(1+2) content of the enterprise and NIFDC were (5.42±0.33)% and (5.44 ± 0.34)% respectively. The biological activity and protein content by the two laboratories were statistically analyzed, and the results showed no statistical difference. Based on the aforementioned trend and statistical analyses, this study identified a year-on-year increasing trend in the HIC front peak(1+2) content detection results from the manufacturer. NIFDC promptly informed the manufacturer to initiate cause investigation and risk assessment. Conclusion: The quality monitoring strategy combined with trend analysis and statistical analysis used in this study effectively identified potential quality fluctuations during the production and testing of anti-PD-1 monoclonal antibody. This study provided critical quality assurance to ensure batch consistency and clinical safety of anti-PD-1 monoclonal antibody.
  • Feng Jiangjiang, Qiu Ting, Lu Fang, Wu Yue, Shen Yulan
    Chinese Pharmaceutical Affairs. 2025, 39(7): 788-794. https://doi.org/10.16153/j.1002-7777.2025-04-0002
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    Objective: To investigate the methods of determining water activity across global industries, aiming to promote the application of water activity in China’s pharmaceutical industry and provide references for improving related regulations. Methods: By summarizing and analyzing regulations related to water activity determination across various industries globally, combined with relevant literature and the current application status of water activity measuring instruments in the domestic market, the types of determination methods and their influencing factors were analyzed and compared. Results: The determination of water activity of drugs primarily relied on four instrumental methods, with the measurement process being significantly affected by factors such as instrument calibration, temperature, equilibrium, and sample preparation. Conclusion: This study systematically summarizes water activity determination methods of drugs, introduces their principles and characteristics, and aims to provide practical guidance in selecting appropriate methods based on specific needs and ensuring accurate determination of water activity in pharmaceutical products.
  • Wang Ganggang, Wang Sijin, Ma Shihong
    Chinese Pharmaceutical Affairs. 2025, 39(7): 795-800. https://doi.org/10.16153/j.1002-7777.2025-03-0034
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    Objective: Taking the active pharmaceutical ingredient A as an example, the risk assessment methods and strategies for reducing the microbial limit tests quantity were studied. Methods: By using a data model based on the Poisson distribution, the probability of misjudgment of results under different test amounts was simulated, and the impact of reducing the test quantity on the accuracy of the test results was analyzed. Different influencing factors and scoring rules were set for two dimensions: the quality stability of the active pharmaceutical ingredient and the degree of its impact on the pharmaceutical preparation. A risk assessment strategy was proposed to evaluate the microbial contamination risk of the active pharmaceutical ingredients. Results and Conclusion: When the manufacturing process of the active pharmaceutical ingredient A was stable and controllable, a test quantity of 10 mg could be used for accurate result judgment, which could meet the requirements for identifying and controlling the microbial contamination risk of this active pharmaceutical ingredients. The evaluation methods and strategies used in this paper can help determine the test quantity and test method when the microbial limit tests quantity of raw materials cannot meet the requirements of the pharmacopoeia.
  • He Shuang, Wu Tao, Zhang Hanxu, Huang Yang, Zhou Jing, Wang Xiaoliang
    Chinese Pharmaceutical Affairs. 2025, 39(7): 801-807. https://doi.org/10.16153/j.1002-7777.2025-04-0019
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    Objective: To study the cause of unstable moderate positive sensitization of formaldehyde in pharmaceutical packaging material skin sensitization positive control test, compare the influences between factors, and provide effective improvements. Methods: Taking formaldehyde concentration and sensitization rate as standards, an evaluation of different tapes and sealing materials which influencing skin sensitization positive control test was conducted. Results: All the different tapes and sealing materials influenced formaldehyde volatilization rate and sensitization rate. By using the combination of medical non-woven cloth patch and single layer polyethylene film, the formaldehyde volatilization in 48 h was reduced, and the sensitization rate was increased higher than 60%. Conclusion: Formaldehyde volatilization rate is the key of sensitization rate in skin sensitization positive control test. Combination of medical non-woven cloth patch and single layer polyethylene film can significantly increase sensitization rate.
  • Chen Xiaoxue, Wang Haijun, Qiao Bin
    Chinese Pharmaceutical Affairs. 2025, 39(7): 808-813. https://doi.org/10.16153/j.1002-7777.2025-03-0036
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    Objective: To compare the quality of 5 batches of imported Arnebiae Radix, provide a reference for the quality evaluation of imported Arnebiae Radix. Methods: The characteristics of five batches of imported Arnebiae Radix were compared. The contents of acetylshikonin, isobutyrylshikonin, β,β’- dimethylacrylalkannin, and isovalerylshikonin in five batches of imported Arnebiae Radix were determined by high performance liquid chromatography (HPLC) performed on a Venusil MP C18 column (4.6 mm × 250 mm, 5 μm), with a mobile phase of acetonitrile-0.05% formic acid water (70 ∶ 30) at a flow rate of 1.0 mL · min-1, ultraviolet detection at 275 nm, and column temperature at 30 ℃. Results: There were significant differences in the characteristics of the five batches of imported Arnebiae Radix. Good linear relationships were observed for acetylshikonin, isobutyrylshikonin, β,β’- dimethylacrylalkannin, and isovalerylshikonin within the ranges of 0.2024-2.024 μg(r=1), 0.04072-0.4072 μg(r=0.9998), 0.2062-2.062 μg(r=1), 0.2678-2.678 μg(r=1), respectively. The average recovery rate were 101.2% to 104.1% with RSD<2.4%. The contents of acetylshikonin, isobutyrylshikonin, β,β’- dimethylacrylalkannin, and isovalerylshikonin in the five batches of imported Arnebiae Radix were 0.030%-0.52%, 0.029%-0.43%, 0.19%-2.02%, 0.39%-1.30%, respectively. Conclusion: There is a certain relationship between the appearance and internal chemical components of the imported Arnebiae Radix. The established content determination method is simple, accurate, and has good repeatability, which can provide a basis for the quality evaluation and control of multi-index components of imported Arnebiae Radix.
  • Zhang Guoliang, Yu Huanhuan, Xu Jing, Wang Xiaotong, Wang Ying, Yang Jihong
    Chinese Pharmaceutical Affairs. 2025, 39(7): 814-821. https://doi.org/10.16153/j.1002-7777.2025-04-0014
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    Objective: To compare the pharmacokinetic differences of a total of 9 ganoderic acids(Ganoderic acid C2, C6, G, B, A, D2, C1, Luwdenic acid A and Gancderenic acid D) in rats after multiple administrations of sporoderm-broken and sporoderm-removed Ganoderma lucidum spore powder. Methods: Normal SD rats were randomly divided into sporoderm-broken G. lucidum spore powder group, sporoderm-removed G. lucidum spore powder high-dose group and low-dose group with 6 rats in each group, and were administered orally for 7 consecutive days, blood was taken from the inner canthus of the eye on the 7th day at 0, 0.1, 0.2, 0.5, 1, 2, 3, 4, 6, and 12 h. Blood concentration was determined by UPLC-MS/MS, and the pharmacokinetic parameters were calculated by Winnonlin 8.1 pharmacokinetic software. Results: In the sporoderm-removed G. lucidum spore powder group, the time to peak (Tmax) of 9 ganoderic acids was around 1 h, the half-life (t1/2) was less than 6 h, and the accumulation factor (Rac) was around 1.00, whereas no ganoderic acid was detected in the sporoderm-broken G. lucidum spore powder group. Compared with the sporoderm-removed G. lucidum spore powder low-dose group, the maximum concentrations (Cmax) of 9 ganoderic acids in the high-dose group was significantly higher (P < 0.05 or P < 0.01), and the mean area under the blood concentration-time curve (AUC0-t) was higher than that of the low-dose group by about 10-40 times. Conclusion: Sporoderm-removed G. lucidum spore powder maintains rapid absorption after multiple administrations, with no significant accumulation observed. Its bioavailability is significantly superior to that of sporoderm-broken spore powder, and it exhibits distinct dose dependency.
  • Shan Chun, Zuo Xin, Jia Yue, Li Yulong, Cao Chunran, Lin Fei
    Chinese Pharmaceutical Affairs. 2025, 39(7): 822-828. https://doi.org/10.16153/j.1002-7777.2024-12-0022
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    Objective: To establish and optimize four animal models of gastric mucosal injury through the detection of the known positive agent, omeprazole magnesium salt, providing a basis for the revision of technical standards for drugs and health foods, etc. Methods: The groups with omeprazole magnesium salt at doses of 2.5, 5.0 and 10.0 mg·kg-1 and deionized water model control group were set up to quantitatively refine four acute and chronic animal models, including gastric mucosal injury caused by water immersion stress in mice, gastric mucosal injury induced by absolute ethanol in rats, gastric mucosal injury caused by pyloric ligation in rats, and gastric mucosal injury impregnated with glacial acetic acid in rats. Results: The model control group exhibited clear and distinguishable gastric mucosal injury sites in the four optimized animal models, facilitating accurate counting of injury numbers or measurement of lesion areas. Omeprazole magnesium salt at all tested doses demonstrated significant protective effects on gastric mucosal injury in both mice and rats. When the dose was ≥2.5 mg·kg-1, the inhibition rates of mucosal injury area in the first three models reached more than 63.5%, 50.0% and 47.5% , respectively and the inhibition rate of ulcer area ≥28.8% in the fourth model. When the dose was ≥5.0 mg·kg-1, the inhibition rate of ulcer volume was ≥45.4% in the fourth model. There were significant differences in statistical analysis (P<0.05). Conclusion: During the modeling period, the fasting time and fasting method of rats and mice should be strictly implemented to ensure gastric emptying. Quantitative gastric filling and fixation with 1% formaldehyde solution effectively stretch the wrinkled gastric mucosa, enabling accurate observation, ulcer counting, and measurement of ulcer injury areas, thus minimizing misjudgment and significantly improving precision. The optimized method can be better applied to evaluate the protective effect of drugs or health foods on gastric mucosal injury. At the same time, it provides a basis for the dose selection of omeprazole magnesium salt.
  • Hospital Pharmacy
  • Wang Hailing, Yang Li, Yang Liping, Shang Ran, Si Yanbin, Zhao Zhigang
    Chinese Pharmaceutical Affairs. 2025, 39(7): 829-836. https://doi.org/10.16153/j.1002-7777.2025-05-0017
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    Objective: To construct an intelligent management and pharmaceutical service model for inpatient pharmacy, and systematically evaluate its application effectiveness. Methods: Based on the operational improvements and practices in the inpatient pharmacy, this study focused on the intelligent management and service across key pharmaceutical processes, including drug requisition, dispensing, delivery, and medication guidance. It elaborated on the operational status of specific systems and platforms, such as the intelligent drug requisition system, pre-prescription review system, automated drug dispensing platform, closed-loop drug delivery management system, home-based pharmaceutical logistics delivery service, core database for post-discharge medication guidance, and “Internet+” medication consultation services. Additionally, a comparative analysis was conducted to evaluate the error rates and work efficiency before and after the implementation of the intelligent management and pharmaceutical service model. Results: After implementing the intelligent management and pharmaceutical service model, the number of drug requisition personnel was streamlined from 6 to 3. There were significant reductions in the average total completion time of requisition plans, the total number of missed medication items, and the monthly total number of drug requisition submissions [(164.9 ± 3.4) vs. (63.2 ± 1.9) min (P<0.05); (21 ± 3.4) vs. (0 ± 0.0) items (P<0.05); (129 ± 6.9) vs. (35 ± 1.9) times (P<0.05)]. The number of inappropriate solvent selection orders for injectable medications dropped to zero. The average medication delivery time in the inpatient pharmacy was reduced by 69 minutes, and delivery efficiency improved by 39.3%. Patients’ awareness of safe medication use at home increased significantly. Conclusion: The whole-process intelligent management and pharmaceutical service model of the inpatient pharmacy has significantly shortened the drug dispensing and delivery time, improved the working efficiency of pharmacists, reduced the risk of medication errors, and ensured the safety of patients’ medication.
  • Xiang Rong, Yang Lining, Yao Linqing
    Chinese Pharmaceutical Affairs. 2025, 39(7): 837-844. https://doi.org/10.16153/j.1002-7777.2025-04-0018
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    Objective: To investigate the current status of clinical pharmaceutical services in county and municipal hospitals in Gansu Province, identify existing problems, and proposes solutions to provide references for the high-quality development of clinical pharmacy services in hospitals of our province. Methods: In June 2024, a questionnaire survey method was conducted to investigate the implementation of clinical pharmacy services in secondary and tertiary hospitals under the jurisdiction of county and municipal administrative regions throughout the province. The results were statistically analyzed. Results: A total of 168 valid questionnaires were collected, with 75.6% of the respondents coming from secondary hospitals. The configuration rate of the prescription pre-audit systems was 33.3%, the staffing rate of clinical pharmacists was 67.3%. The implementation rate of clinical pharmaceutical services, regular prescription review and special prescription review was 81.0%, 79.2% and 87.5% respectively, while pharmacy clinics’ rate was 22.0%. Conclusion: The clinical pharmaceutical services in county and municipal hospitals in Gansu Province have achieved certain development, but there is a gap compared with the overall development level in China. In the future, it is necessary to further promote the high-quality development of clinical pharmacy services by strengthening information technology construction and pharmacy talent training.