Quality Management

On the Quality of Borneolum Syntheticum of National Chinese Herbal Pieces

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  • (1)Xinjiang Uygur Autonomous Region Institute of Drug Control, Urumqi 830054 , China; (2)Xinjiang Adverse Drug Reactions (Medical Device Adverse Events) Surveillance Centre, Urumqi 830054 , China; (3)National Institutes for Food and Drug Control, Beijing 100050 , China

Online published: 2022-09-21

Abstract

Objective: To understand the present situation and existing problems of the overall quality of borneol in the Chinese herbal pieces market, further improve the quality standard of borneol, and put forward feasible suggstions for the quality control and market supervision of the borneol pieces, through the special work of sampling and testing of Chinese herbal pieces. Method: A total of 116 batches of borneol produced by 42 factories were inspected according to the legal standards, and the technical solutions were established through the inspection of key items and the discovery of the quality problems of unqualified items. Result: Among the 116 batches of borneol, 30 batches were unqualified, so the unqualified rate was as high as 25.9%, and the unqualified rate of properties was 12.9%, so the unqualified rate of melting point and non-volatile was 10.3%, and the unqualified rate of camphor limit was 24.1%, the unqualified rate of borneol content was 11.2%. Conclusion: The high unqualified rate of sampling for Borneolum Syntheticum reflects that the synthetic Borneolum Syntheticum is not produced in strict accordance with the process, which seriously damages the vital interests of the people who use the medicine. It is necessary to strengthen the supervision of the users and the production units.

Cite this article

Xu Hong, Deng Jihua, Yu Rui, Zhou Yang, Yu Xinlan, Sun Lei . On the Quality of Borneolum Syntheticum of National Chinese Herbal Pieces[J]. Chinese Pharmaceutical Affairs, 2022 , 36(9) : 1026 -1033 . DOI: 10.16153/j.1002-7777.2022.09.008

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