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The standard expression of strength of Chinese patent medicines and discussion on related problems
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Yue-hua ZHOU1, Yan-long HONG2, Zong-hua SONG3, Zhong DAI4, Shen JI5, Lei ZHANG2, Hai-nan WANG6
Chinese Journal of New Drugs | 2021, 30(23) : 2153 - 2156
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Chinese Journal of New Drugs | 2021, 30(23): 2153-2156
The standard expression of strength of Chinese patent medicines and discussion on related problems
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Yue-hua ZHOU1, Yan-long HONG2, Zong-hua SONG3, Zhong DAI4, Shen JI5, Lei ZHANG2, Hai-nan WANG6
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • 2Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
  • 3Chinese Pharmacopoeia Commission, Beijing 100061, China
  • 4National Institutes for Food and Drug Control, Beijing 102629, China
  • 5Shanghai Institute for Food and Drug Control, Shanghai 201203, China
  • 6National Medical Products Administration, Beijing 100037, China
Published: 2021-12-15
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In order to standardize the expression of the strength of Chinese patent medicine (CPM), the connotation, significance, characteristics and standard expression of CPM strengths are systematically summarized and analyzed in this paper. Furthermore, the related issues which need to be paid attention to in the implementation of “Technical Guideline for Strengths Expression of Chinese Patent Medicines” are discussed, and the following suggestions are put forward: According to the requirements of “Technical Guideline for Strengths Expression of Chinese Patent Medicine”, the theoretical amount (or marked amount) of prescription composition in each dosage should be indicated in the strengths of CPM. Drug strengths have nothing to do with the types of excipients used. It is suggested that the strengths should be reasonably expressed according to prescription composition, dosage form, usage and other characteristics of CPM. Drug strengths and capacity specification should be distinguished to facilitate the registration and management of drugs and to clarify the scope of powers of National Medical Product Administration and the Provincial Medical Product Administration. The strengths of CPM should be expressed according to the equivalent amount of decoction pieces in each dosage, which does not affect the check of capacity difference of the product.

Chinese patent medicine  /  strength  /  capacity specification  /  labeling
周跃华, 洪燕龙, 宋宗华, 戴忠, 季申, 张磊, 王海南. 中成药规格的规范表述及相关问题探讨. 中国新药杂志, 2021 , 30 (23) : 2153 -2156 .
Yue-hua ZHOU, Yan-long HONG, Zong-hua SONG, Zhong DAI, Shen JI, Lei ZHANG, Hai-nan WANG. The standard expression of strength of Chinese patent medicines and discussion on related problems[J]. Chinese Journal of New Drugs, 2021 , 30 (23) : 2153 -2156 .
Appendix
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Year 2021 volume 30 Issue 23
59
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Article Info
  • Online Date：2026-10-28
  • Published：2021-12-15
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  • Accepted：2021-07-01
Affiliations
    1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
    2Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
    3Chinese Pharmacopoeia Commission, Beijing 100061, China
    4National Institutes for Food and Drug Control, Beijing 102629, China
    5Shanghai Institute for Food and Drug Control, Shanghai 201203, China
    6National Medical Products Administration, Beijing 100037, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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