Quality standard of traditional Chinese medicines: comparison between European Pharmacopoeia and Chinese Pharmacopoeia and recent advances.
Leong Fong,Hua Xue,Wang Mei,Chen Tongkai,Song Yuelin,Tu Pengfei,Chen Xiao-Jia
Chinese medicine
Traditional Chinese medicine (TCM) are becoming more and more popular all over the world. However, quality issues of TCM may lead to medical incidents in practice and therefore quality control is essential to TCM. In this review, the state of TCM in European Pharmacopoeia are compared with that in Chinese Pharmacopoeia, and herbal drugs that are not considered as TCM and not elaborated by TCM working party at European Directorate for the Quality of Medicines & Health Care (EDQM) but present in both European Pharmacopoeia and Chinese Pharmacopoeias are also discussed. Different aspects in quality control of TCM including origins, identification, tests and assays, as well as sample preparation, marker selection and TCM processing are covered to address the importance of establishing comprehensive quality standard of TCM. Furthermore, advanced analytical techniques for quality control and standard establishment of TCM are also reviewed.
10.1186/s13020-020-00357-3
[Establishment of quality standard and discussion on standard decoction containing volatile oil pieces-Cinnamomi Ramulus pieces].
Deng Zhe,Feng Wei-Hong,Zhang Jun,Jiao Meng-Jiao,Zhang Guo-Yuan,Wang Shu-Hui,Cheng Jin-Tang,Liu An
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
To prepare Cinnamomi Ramulus pieces standard decoction and establish its quality standard, provide quality reference for formula granules and other clinic non-traditional forms of medicines, and lay a foundation for standard decoction research for the pieces containing essential oil. 14 batches of Cinnamomi Ramulus pieces with different quality were collected from market and their extraction process was further improved based on the preparation principle of standard decoction to prepare the standard decoction of Cinnamomi Ramulus pieces. Then its transfer rate of Cinnamaldehyde, dry extract rate and pH value were calculated to evaluate its process stability; and a method for chromatographic fingerprint and content determination was also established. Results revealed that the dry extract rate for standard decoction of Cinnamomi Ramulus pieces was from 6.06%-8.95%, with an average value of 7.18%; the transfer rate of cinnamaldehyde was at the range of 29.6%-54.3%, with an average of 43.2%; and the pH value was at the range of 4.33-4.82. The fingerprint similarities between 14 batches of standard decoction of Cinnmomi Rammulus pieces and reference fingerprint were all>0.9. The established method for standard decoction was stable and its quality standard was perfect, suitable for evaluating the quality of standard decoction of Cinnanomi Ramulus pieces.
10.19540/j.cnki.cjcmm.20170609.002
[Study on quality standard of fried Vaccariae Semen standard decoction].
Shan Wang,Bo-Nan Liu,Xin-Lin Lyu,Jiao-Yan Yang,Yong-Xin Zhang,Yao-Hua Liang,Ji Shi,Jing-Jing Zhu
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
According to the preparation principle of standard decoction of Chinese herbal medicines, fourteen batches of fried Vaccariae Semen decoction were prepared in this study and the quality research was carried out to establish a quality evaluation method for the standard decoction of fried Vaccariae Semen. The contents of vaccarin were determined, and its transfer rate from decoction piece to standard decoction was calculated. The extract rate and pH value were measured, and HPLC fingerprint method was established for analysis. The results of the 14 batches of samples revealed that the transfer rates of vaccarin were between 58.98%-93.94%; the extract rates were between 8.67%-17.83%, and the pH values were between 5.55-6.44. Moreover, 9 common chromatographic peaks were identified in fingerprints analysis. The similarities of the 14 batches of samples were analyzed and compared, and the results showed that the similarities were all higher than 0.96. In this study, the preparation process for fried Vaccariae Semen standard decoction was standard, with high similarities in fingerprint. A convenient and reliable method of comprehensive quality evaluation was established in this study, with a high precision, stability and repeatability, which can provide a reference for the quality control of fried Vaccariae Semen standard decoction, dispensing granule and related Chinese classical formulas(decoction).
10.19540/j.cnki.cjcmm.20200602.302
[Research and application of quality standard for standard decoction of Chrysanthemi Flos].
Hao Ya-Dong,Li Dong-Hui,Wang Jian-Nong
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
Standard decoction of traditional Chinese medicine (TCM) is prepared by standardized process, and can be used as references to evaluate the quality of dosage forms such as decoction and dispensing granules. In order to determine the quality evaluation method for standard decoction of Chrysanthemi Flos and investigate its application, 10 batches of white chrysanthemum of Hangzhou were collected to prepare the standard decoction of white chrysanthemum of Hangzhou with standardized process parameters. Parameters such as traits, relative density, pH value, extraction ratio, transfer rate and fingerprint were selected as the indexes for quality evaluation. The established quality evaluation method for standard decoction of Chrysanthemi Flos was applied in the detection of two types of commercial Chrysanthemum dispensing granules. The results showed that the standard decoction of Chrysanthemi Flos was a clear yellow-brown aqueous solution; the relative density was 1.007-1.011; the pH value was between 5.37-5.56; the average extraction ratio was 23.6%, ranging from 19.93% to 29.69%; the average transfer ratewas 56.2% in terms of chlorogenic acid, 57.4% in terms of luteoloside and 30.6% in terms of 3,5--dicaffeoylquinic acid. Fingerprint similarity was between 0.864-0.989.The method showed good precision, stability and repeatability in fingerprint analysis, indicating reliable and representative results for standard decoction of Chrysanthemi Flos, and it can be used to evaluate and standardize other dosage forms.
10.19540/j.cnki.cjcmm.2018.0086
[Study on quality evaluation method of classical prescription Mahuang Decoction primary standard substances].
Chen Peng-Yue,Zhang Guo-Yuan,Chen Sha,DI Ji-Peng,Yang Lin-Yong,Liu Yan,Liu An
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
This study aimed to establish the HPLC characteristic chromatogram and content determination method for index components with the primary standard substances of the classical prescription Mahuang Decoction, and to provide data basis for the establishment of its quality standard and the development and utilization of compound preparations. First, HPLC was used to establish the material reference chromatograms of Mahuang Decoction, and 15 batches of standard samples of Mahuang Decoction were determined. Their similarity was calculated by the median method. Secondly, the content of the standard substances was determined and a simplecontent determination method was established by HPLC. Relevant methodology was investigated, and the extraction ratio, index component transfer rate and moisture content of 15 batches of primary standard samples were calculated. The results showed that the two sets of HPLC methods had their own characteristics. The six chromatographic peaks identified from the 10 common peaks in the former characteristic chromatogram covered all the herbal medicines in the standard substances, which can better indicate the quality characteristics of the standard substances of Mahuang Decoction. The latter method(content determination method) was simple and practical, so it was suitable for establishing the quality standard of its compound preparation. Two sets of methods were jointly used to evaluate the quality of 15 batches of Mahuang Decoction. The results were as follows: the similarity of 15 batches of samples was greater than 0.90; the average extraction ratio was 18.1%; the average moisture content was 9.7%; the average content and transfer rate of the standard ingredients ephedrine hydrochloride and total pseudoephedrine hydrochloride were 2.3% and 26.7% respectively, and the average content and transfer rate of amygdalin were 2.2% and 48.3% respectively. None of the data showed dispersion(beyond 70%-130% of the mean value), which met the application data requirements for the substance standards of ancient classical Chinese herbal compound preparations(draft for comments). Based on the above research, the primary substance quality standard of Mahuang Decoction was established in order to provide reference for the development and research of the compound preparation of Mahuang Decoction.
10.19540/j.cnki.cjcmm.20200908.301
[Study on quality of standard decoction of Coptidis Rhizoma based on traditional decoction process].
Guo Shuang,Shen Qian-Neng,Cao Hong-Hong,Li Ping,Zhang Ke-Wei,Xie Hui,Yan Guo-Jun,Lu Tu-Lin,Mao Chun-Qin
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
In order to determine the quality evaluation method for standard decoction of Coptidis Rhizoma,15 batches of standard decoction of Coptidis Rhizoma were prepared by using standardized process. Parameters such as traits,p H value,indicative component content,fingerprint similarity,composition transfer rate and dry extract rate were selected as the indexes for quality evaluation. Similarity evaluation and cluster analysis were performed for HPLC fingerprint of standard decoction,and mathematical model was used to study the correlation between dry extract rate,berberine content,berberine transfer rate in standard decoction and berberine content in decoction pieces. The results showed that the similarity of fingerprints was greater than 0. 99 for these 15 batches of standard decoctions of Coptidis Rhizoma. In cluster analysis,the standard decoctions of Coptidis Rhizoma from 4 producing areas were classified into 3 categories,consistent with the content determination results,indicating that there were quality differences among different producing areas.R2 in three linear regression mathematical models established was all greater than 0. 9,with significant difference. The validation of three batches of data showed that the models had good accuracy. Therefore,this model can be used to predict the quality of standard decoction prepared from different Coptidis Rhizoma pieces. In the standard decoction process established in this study,the integrity of the traditional process was greatly preserved,and the established quality evaluation method could be used to comprehensively examine the quality of the standard decoction,which can provide a demonstration for the related research of water extraction preparation containing Coptidis Rhizoma pieces.
10.19540/j.cnki.cjcmm.20190630.303