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Investigation of the demands of chemometrics guidelines in China’s pharmaceutical industry

Drug Standards of China.2024;25(1):005-009. doi:10.19778/j.chp.2024.01.001

Objective: To understand and grasp the current situation and actual demands of China’s pharmaceutical industry, in order to provide a basis for the establishment of the chemometrics guideline in the Chinese Pharmacopoeia.
Methods: Online questionnaire was adopted to investigate the chemometrics backgrounds and demands of pharmaceutical industry practitioners.
Results: The practitioners of China’s pharmaceutical industry had certain expectations and demands for the chemometrics guideline, but the situation of talent reserves was not that optimistic.
Conclusions: It is extremely urgent to develop the chemometrics guideline, as general chapters of the Chinese Pharmacopoeia, which serve as the legal basis to guide the data quality control, the establishment of analytical methods and the verification of analytical methods in analytical practice, so as to ensure the scientific of multivariate analysis methods and reliability of analytical results, and will be conducive to promoting the improvement of China’s pharmaceutical level.

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Investigation on pharmacognosic identification of two Yi Medicine in Yunnan province

LIN Chunyan ; FU Xingqing ; REN Jie ; DONG Yuan ; ZHANG Wenjie

Drug Standards of China.2024;25(1):010-017. doi:10.19778/j.chp.2024.01.002

Objective: To understand their appearance and microscopic characteristics, as well as their differences by studying the pharmacognosy of Yi medicine Elsholtzia rugulosa and Elsholtzia bodinieri, in order to provide a basis for identification and improvement of quality standards.
Methods: Stereo microscopy and optical microscopy and the macroscopic and microscopic identification methods were adopted to compare identification and digital representation for Elsholtzia rugulosa and Elsholtzia bodinieri from overall character, local characteristics, the microscopic identification characteristics, the transverse section and the powder.
Results:There were significant differences in the the macroscopic and the microscopic identification characteristics of Elsholtzia rugulosa and Elsholtzia bodinieri.
Conclusion: This study summarized the exclusive and practical features in pharmacognosic identification of Elsholtzia rugulosa and Elsholtzia bodinieri, it provides a useful reference for supervision the clinical medication,inspection,and standard drafting.

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Updates and amendments of the quality standard of nitroglycerin tablets in the Chinese Pharmacopoeia 2020

LI Ziying ; YANG Mei ; LI Weiling ; WU Liangyong ; DONG Shunling

Drug Standards of China.2024;25(1):018-024. doi:10.19778/j.chp.2024.01.003

Objective: To propose updates and amendments for the nitroglycerin tablets quality in the Chinese pharmacopoeia 2020 due to the failure of effective separation of 4 known impurities and nonseparation of free nitrate ion and excipients.
Methods: Related substances were analyzed using gradient elution by HPLC, and free nitrate ion was determined on SAX column by different HPLC method.
Results: Using the improved method to test the related substances and free nitrate ion of nitroglycerin tablets,the content of the maximum individual impurity were not more than 0.5%, the total content was not more than 2.4% and the content of free nitrate ion was not more than 6.3%.
Conclusion: The improved method is accurate and feasible. It provided a reference for the updates and amendments of the quality standard of nitroglycerin tablets in the Chinese Pharmacopoeia 2020.

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Determination of residual EDTA-2Na in Japanese encephalitis attenuated live vaccine by capillary electrophoresis with electrophoretically mediated microanalysis

WU Jinfeng ; BAI Jianqiu ; LIU Wei ; LIN Yao ; JIANG Tingfu

Drug Standards of China.2024;25(1):025-029. doi:10.19778/j.chp.2024.01.004

Objective: To establish a capillary electrophoresis (CE) with electrophoretically mediated microanalysis (EMMA) method for the determination of EDTA-2Na in Japanese encephalitis attenuated live vaccine.
Methods: The test was performed in disodium hydrogen phosphate buffer with pH 2.5, the online metal ions complexation of 1.5 mg·mL^-1 Fe³⁺ and incubation time of 3 min. The separation voltage was 25 kV, the detection wavelength was 257 nm, and. the column temperature was 25.0 ℃.
Results: The established method had a good linear relationship in the concentration range of 0.01-0.5 mg·mL^-1 (r=0.999 9), the detection limit was 5 μg·mL^-1, and the relative standard deviation (RSD) of the measured samples was less than 2.87%. The recoveries of spiked samples were between 96.49%-101.02%.
Conclusion:The optimized method was applied to the determination of EDTA-2Na in Japanese encephalitis attenuated live vaccine. The satisfactory experimental results were obtained.

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Results and discussion on various laboratories proficiency-testing for assays of bismuth potassium citrate capsules by complexometric titration

YANG Yixue ; HUANG Dan ; WANG Yeru ; WU Fengru ; LIU Yitao ; BEI Qihua ; YAN Quanhong ; XIANG Xinhua

Drug Standards of China.2024;25(1):030-034. doi:10.19778/j.chp.2024.01.005

Objective: To design the proficiency testing (PT) project (No. NIFDC-PT-183) for assays of bismuth potassium citrate capsules and organize to assess the proficiency of complexometric titration in laboratories, and provide some technical analyses and advices.
Methods: Two groups of samples with different concentration were prepared. The uniformity was evaluated with one-way analysis of variance and the stability was confirmed with t-test, whose results all conformed the requirements. The samples with three combinations were randomly distributed to 279 laboratories. The determination was performed according to the assays of bismuth potassium citrate capsules in Volume Ⅱ of the Chinese Pharmacopoeia 2015. The median value and normalized interquartile range (NIQR) of robust statistical analysis was adopted and Z-scores were used to evaluate the results from each of laboratories.
Results: Among 279 laboratories, 240 laboratories results were satisfactory, 23 were questionable, and the other 16 were unsatisfied. The satisfaction rate was 86.0%.
Conclusion: The overall capacity of national laboratories for assays of bismuth potassium citrate capsules is good while a portion of participants require further improvement.

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Comparation and considerations for general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia

ZHU Jia ; LOU Yongjun ; PAN Fangfang ; GENG Xiaoting ; TANG Dengfeng ; SHANG Yue ; ZHENG Jinqi ; ZHENG Cheng ; TAO Qiaofeng

Drug Standards of China.2024;25(1):035-040. doi:10.19778/j.chp.2024.01.006

Objective: The characteristics and differences of the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia were investigated to provide references and suggestions for the compilation of the Chinese Pharmacopoeia.
Methods: From the perspective of frame structure and main contents, the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia was compared.
Results: Each volume of the Chinese Pharmacopoeia had its general notice, including 34 to 48 items and 10 to 12 chapters based on different varieties collected in each volume. The Japanese Pharmacopoeia had 49 items not arranged by chapters. There are many differences on the general notice between the Chinese Pharmacopoeia and the Japanese Pharmacopoeia, such as the definitions and expressions of names, determination of appearance, revision rules, risk assessment and quality control conception. The framework of the general notice in the Chinese Pharmacopoeia was clear, the content was specific and the operation was friendly. The term description of the general notice in the Japanese Pharmacopoeia was concise, and some terms need to be implemented under the guidance of professional knowledge.
Conclusion: In light of comparative study, every volume’s general notice of the Chinese Pharmacopoeia has its own characteristics. By integrating advanced analytical technique, combining the requirements with laws and regulations, and optimizing content and terms, all volume’s general notice could be explored to be coordinated and unified.

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Updates and amendments of standards for Chinese medicinal materials and decoction pieces characteristics in the Chinese Pharmacopoeia

LI Zhengguo ; ZHANG Hongwei ; WANG Haibo ; HE Yi ; TU Pengfei

Drug Standards of China.2024;25(1):041-047. doi:10.19778/j.chp.2024.01.007

According to the relevant requirements of the Chinese Pharmacopoeia and relevant reports, this article briefly introduces the basic principles, research ideas, and precautions for the revision of the “characteristics” standards of Chinese medicinal materials and decoction pieces. In recent years, enterprises and social media reported that the characteristics of Chinese medicinal materials in the market did not fully comply with the characteristics specified in the Chinese Pharmacopoeia. Therefore, this article explored the variation in the characteristics of Chinese medicinal materials and decoction pieces and its main reasons, scientific and reasonable revision of the “characteristics” of Chinese medicinal materials and decoction pieces, the new methods for identifying properties, as well as the issues that need to be noted in revising the characteristics of Chinese medicinal materials and decoction pieces, which provided reference for the revision of the “characteristics” standards of Chinese medicinal materials and decoction pieces.

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Simultaneous determination of four diterpene lactones in Lianzhi Xiaoyan capsules by QAMS

BI Fujun ; LU Qiaoyin ; LIN Tong

Drug Standards of China.2024;25(1):048-054. doi:10.19778/j.chp.2024.01.008

Objective: To set up a multi-components by single maker (QAMS) method for determination of four diterpene lactones in Lianzhi Xiaoyan capsules.
Methods: Shimadzu Shim-pack C₁₈ column（250 mm×4.6 mm,5 μm）was adopted with 35 ℃. Acetonitrile-0.1% phosphoric acid aqueous solution as the mobile phase in gradient mode was used at flow rate of 1.0 mL·min^-1. The detection wavelength was set at 203 nm. Andrographolide was used as reference to calculate the relative correction factors of the other three components.
Results: The linear relationships of four components were good （r≥0.999 9） within their ranges, and their average recoveries were 100.0%-102.8% with RSDs 1.1%-2.2%. The results obtained by QAMS were close to those obtained by external standard method.
Conclusion: This rapid, precise and reproducible method can be used for the quality control of Lianzhi Xiaoyan capsules.

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Limit test for 5-hydroxymethylfurfural in Yueju Baohe pills

NIU Chenjin ; AN Jie ; QIU Shuowen ; QU Jia

Drug Standards of China.2024;25(1):055-061. doi:10.19778/j.chp.2024.01.009

Objective: To establish an HPLC method to detect the limit of 5-hydroxymethylfurfural in Yueju Baohe pills.
Methods: A Zafex Acutfex PW-C₁₈ column（4.6 mm×250 mm, 5 μm） was adopted with mobile phase consisted of acetonitrile-0.1% formic acid aqueous solution（2:98）at the flow rate of 1.0 mL·min^-1. The column temperature was 40 ℃ and the detective wavelength was set at 284 nm.
Results: The linear range of 5-hydroxymethylfurfural was 0.491 9-122.98 μg·mL^-1 (r=1.000). The average recovery(n=6) was 97.99% with RSD 0.61%. All of the RSDs for precision,repeatability and stability met the methodological requirements. According to the proposed limit, 17 of the 65 batches of samples did not meet the requirements, and the failure rate was 26.15%.
Conclusion: The established method is suitable for the limit test of 5-hydroxymethylfurfural in Yueju Baohe pills.There was a significant difference in the content of 65 batches of samples. It is necessary to investigate the limit of 5-hydroxymethylfurfural in Yueju Baohe pills.

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HPLC-RID method for the determination of glucosamine hydrochloride in amitriptyline enteric-coated tablets

YUAN Jinye ; CHEN Qi ; XUE Qiaoru ; CHEN Hua

Drug Standards of China.2024;25(1):062-067. doi:10.19778/j.chp.2024.01.010

Objective: To establish a method for the determination of glucosamine hydrochloride content in aminoglycine enteric coated tablets by high-performance liquid chromatography with differential refractive detector.
Methods: Waters XBridge Amide (4.6 mm×250 mm, 3.5 μm) column was used. The mobile phase was 80% acetonitrile solution (1 000 mL containing 1 mL ammonia) at the flow rate of 1.2 mL·min^-1. Column temperature was set on 40 ℃; Injecting volume was 20 μL with differential refraction detector (RID) detection.
Results: The detection limit of glucosamine hydrochloride was 0.03 mg·mL^-1, and the limit of quantification was 0.125 mg·mL^-1. It showed a good linear relationship in the mass concentration range of 0.72-7.56 mg·mL^-1. The average recovery was 99.4% (RSD=0.85%,n=9). The content of glucosamine hydrochloride in 7 batches of aminosamine enteric-coated tablets was measured in the range of 93%-107%.
Conclusion: The proposed method is fast, accurate, specific and durable, and can be used for the determination of glucosamine hydrochloride, which provides a reference for effectively controlling the quality of aminoxymetacin enteric-coated tablets.

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