1.Urgency of clinical evaluation of traditional Chinese medicine decoction pieces.
Wen-Ke ZHENG ; Li ZHANG ; Shu-Jie ZAN
China Journal of Chinese Materia Medica 2019;44(3):624-628
Decoction piece is the basic unit of traditional Chinese medicine(TCM) prescriptions, and it is also the main material basis for clinical efficacy of TCM. The clinical efficacy of TCM decoction pieces is very important for the overall efficacy of TCM prescriptions. However, the current quality evaluation of TCM decoction pieces mainly focuses on the amount of intrinsic substances and compositions. The basic researches such as toxicology and pharmacology are deeply, but lacking with the evidences from clinical evaluation. Therefore, the current decoction pieces quality evaluation system is difficult to objectively reflect the clinical effect of traditional Chinese medicine, forming the only componential theory or blindly pursuing the large volume and heavy weight of medicine materials. The quality standard of Chinese decoction pieces is biased,with concerns that "TCM will die from Chinese medicine". Therefore, this paper proposes that it is urgent to clinically evaluate the TCM decoction pieces,and regard the clinical evaluation as a starting point and a foothold for the quality evaluation of TCM decoction pieces, based on the origin identification, origin evaluation, product evaluation, content evaluation, and harmful substance detection as an auxiliary support. Finally a new quality evaluation system for TCM decoction pieces with a clinical evaluation as the core is formed, which is composed of six steps, aiming to promote the quality improvement of TCM decoction pieces. Of course, because there is no mature experience in the clinical evaluation of TCM decoction pieces, the quality evaluation system has some challenges such as complex processes and high cost, but it is essential for maintaining the quality of medicinal materials and life safety. Therefore, it is of importance and urgency to construct and implement the quality evaluation system.
Drugs, Chinese Herbal
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standards
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Medicine, Chinese Traditional
2.Current quality research situation of precious Chinese patent medicine.
Li LIN ; Xiao-Qiu LIU ; Hui XU
China Journal of Chinese Materia Medica 2008;33(3):329-333
Along with the development of modern medicinal manufacture and pharmaceutical analysis technology, the precious Chinese patent medicine is also growing quickly. However, after the investigation of the dosage-forms and relative government standards, we find that the precious Chinese patent medicine needs more variety in administration and more precise and full-scale analysis standards based on the chemical materials because of the contradiction between the "global thoughts" logic in traditional Chinese medicine (TCM) theory and the "local study" of modern pharmaceutical analysis technology. Currently rising theories, metabonomics and coordination chemistry of TCM, with the superiority of entirety, can not only fulfill the requirement for " local study" but also accord with the "global thoughts" logic in TCM theory. They will be the reasonable guide for the development of the precious Chinese patent medicine.
Drugs, Chinese Herbal
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standards
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Medicine, Chinese Traditional
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standards
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Patents as Topic
3.Exploring in integrated quality evaluation of Chinese herbal medicines: the integrated quality index (IQI) for aconite.
Ding-kun ZHANG ; Jia-bo WANG ; Ming YANG ; Cheng PENG ; Xiao-he XIAO
China Journal of Chinese Materia Medica 2015;40(13):2582-2588
Good medicinal herbs, good drugs. Good evaluation method and indices are the prerequisite of good medicinal herbs. However, there exist numerous indices for quality evaluation and control in Chinese medicinal materials. However, most of these indices are non-interrelated each other, as well as having little relationship with efficiency and safety. The results of different evaluatior methods may not be consistent, even contradictory. Considering the complex material properties of Chinese medicinal materials, single method and index is difficult to objectively and comprehensively reflect the quality. Therefore, it is essential to explore the integrated evaluation methods. In this paper, oriented by the integrated evaluation strategies for traditional Chinese medicine quality, a new method called integrated quality index (IQI) by the integration of empirical evaluation, chemical evaluation, and biological evaluation was proposed. In addition, a study case of hypertoxic herb Aconitum carmichaelii Debx. was provided to explain this method in detail. The results suggested that in the view of specifications, the average weight of Jiangyou aconite was the greatest, followed by Weishan aconite, Butuo aconite, Hanzhong aconite, and Anxian aconite; from the point of chemical components, Jiangyou aconite had the characteristic with strong efficacy and weak toxicity, next was Hanzhong aconite, Butuo aconite, Weishan aconite, and Anxian aconite; taking toxicity price as the index, Hanzhong aconite and Jiangyou aconite have the lower toxicity, while Butuo aconite, Weishan aconite, and Anxian aconite have the relatively higher one. After the normalization and integration of evaluation results, we calculated the IQI value of Jiangyou aconite, Hanzhong aconite, Butuo aconite, Weishan aconite, and Anxian aconite were 0.842 +/- 0.091, 0.597 +/- 0.047, 0.442 +/- 0.033, 0.454 +/- 0.038, 0.170 +/- 0.021, respectively. The quality of Jiangyou aconite is significantly better than the others (P < 0.05) followed by Hanzhong aconite, which is consistent with the traditional understanding of genuineness. It can be concluded that IQI achieves the integrated control and evaluation for the quality of Chinese medicinal materials, and it is an exploration for building the good medicinal herbs standards. In addition, IQI provides technical supports for the geoherbalism evaluation, selective breeding, the development of precision decoction pieces, high quality and favourable price in market circulation, and rational drug use.
Aconitum
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chemistry
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Drugs, Chinese Herbal
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standards
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Medicine, Chinese Traditional
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standards
4.Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example.
Manrong TAN ; Dan YAN ; Lingling QIU ; Longhu CHEN ; Yan YAN ; Cheng JIN ; Hanbing LI ; Xiaohe XIAO
China Journal of Chinese Materia Medica 2012;37(8):1122-1126
For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.
Drugs, Chinese Herbal
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standards
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Medicine, Chinese Traditional
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standards
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Quality Control
5.Several common types of counterfeit and inferior drugs in Chinese medicinal materials market.
China Journal of Chinese Materia Medica 2012;37(8):1089-1092
Though there are many species of counterfeit and inferior drugs of Chinese Medicinal Materials in the market, the means of fabrication is common. According to our investigating and reports in the literature it is found that the counterfeits and inferior drugs exist in 4 styles: counterfeits, reused medicinal materials and their slices which have been extracted by boiling water or ethanol, medicinal materials and their slices which have been added with non-medicinal parts or chemicals, medicinal materials which have no enough growth time or have been reserved for a long time. Through summarizing the styles and their common characteristics of the counterfeits and inferior drugs,it is helpful to raise vigilance and detect them.
China
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Drugs, Chinese Herbal
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standards
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Quality Control
6.Evidence-based evaluation on safety of Tripterygium wilfordii preparations.
Xue FENG ; Sai-Nan FANG ; Yu-Xin GAO ; Jian-Ping LIU ; Wei CHEN
China Journal of Chinese Materia Medica 2018;43(3):425-439
The study was aimed to conduct an evidence-based evaluation on the safety of Tripterygium wilfordii(TW) preparations through a method combined bibliometrics research with evidence-based evaluation research, to provide evidence-based safety information of the TW preparations(nephrotoxicity) for the government decision-making and clinical application, and to provides methods and suggestions for evaluating nephrotoxicity of Chinese herbal medicine(CHM) in the future. We searched relevant databases at home and abroad systematically, and six Chinese and English databases including CNKI, SinoMed, VIP, WanFang, PubMed, and Cochrane library were comprehensively searched. All types of research documents about the safety of TW preparations. Literature were screened and extracted based on inclusion and exclusion criteria. The methodology quality of all included studies were assessed by internationally recognized evaluation tools or standards. The incidence rate was analyzed by using R software. Subgroup analysis were conducted according to the type of disease treated, drug delivery way, medication time, and study types.
Bibliometrics
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Drugs, Chinese Herbal
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standards
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Tripterygium
7.Study on benchmark preparation technology of boiled and powdered classical prescriptions by taking Houpo Wenzhong Decoction as an example.
Ju-Yuan LUO ; Gong-Sen CHEN ; Dong-Han LIU ; Yu-Jia MO ; Xiang-Long YU ; Shou-Ying DU ; Jie BAI ; Yang LU ; Yu-Ming WANG ; Cun LIU
China Journal of Chinese Materia Medica 2019;44(18):3994-3999
In recent years,the development and application of classical famous prescriptions have attracted much attention. However,the differences between ancient and modern conditions lead to difficulties in carrying out practical work. In this paper,with Houpu Wenzhong Decoction as an example,the key technologies of boiling granularity,water addition,boiling time and sample pretreatment methods were investigated on the basis of sufficient literature research. The experimental results showed that there was no significant difference in the concentration of index components between those with different granularity( 2 mm and 3-5 mm) and different decocting time( 30 min and 60 min),but the extraction rate of index components was relatively high when the granularity of powder was 2 mm and decocting time was 30 min. With the increase of water content,the concentration of index components and the extraction rate were increased in varying degrees. A certain proportion of methanol aqueous solution was used as the resolvent before content determination of the reference sample of Houpu Wenzhong Decoction,which could take into account both the spectral information of water-soluble components and fat-soluble components in the prescription,and help to display the overall information of the prescription' s chemical components more comprehensively. At the same time,the boiling and dispersing classical prescriptions in the Catalogue of Ancient Classical Prescriptions( the first batch) were collected and summarized in this study; the key influencing factors of decocting process were analyzed from different angles,and preliminary research suggestions were put forward,so as to provide a certain direction and reference for the establishment of quality standard of Houpu Wenzhong Decoction,as well as for the development,research and clinical application of boiling and dispersing classical prescriptions.
Drugs, Chinese Herbal/standards*
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Powders
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Prescriptions
8.Research on current situation of standardization of Chinese medicine and acupuncture in Oceania.
Yi YANG ; Zi-Xu WANG ; Yi GUO
Chinese Acupuncture & Moxibustion 2013;33(4):351-356
The development status of standardization of Chinese medicine and acupuncture in Australia and New Zealand is respectively introduced from 3 levels-national standard, regional standard and association standard. A national registration standard for Chinese medicine has been implemented since July 1, 2012 in Australia. The Oceania Federation of Chinese Medicine and Acupuncture Societies was also founded in capital of New Zealand. Four characteristics are revealed from researches and analyses: people's needs and the relevant system are the foundations of national standards of Chinese medicine; legislation on Chinese medicine is the guarantee for setting and implementing national standards, where necessity, scientificity, vitality, diversity and breakthroughs are embodied; registration standards are the key in international standardization of Chinese medicine; and international organizations are major force in promoting standardization of Chinese medicine and acupunc ture.
Acupuncture Therapy
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standards
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Australasia
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Drugs, Chinese Herbal
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standards
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Humans
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Medicine, Chinese Traditional
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standards
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Oceania
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Reference Standards
9.Technical standards of traditional Chinese medicine industry.
China Journal of Chinese Materia Medica 2010;35(12):1644-1647
Basing on the basic theory of traditional Chinese medicine (TCM), the technical standards of TCM industry is such a Link that it is to clarify the internal relations between the basic theory of TCM and developing of TCM industry. This article analyzed several problems of technical standards of TCM industry, such as basic theory of TCM and standardization problem of TCM industry. Technical standards of TCM industry must receive the guidance of basic theory of TCM, so that it will promote the process of modernization and internationalization of TCM industry.
China
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Drug Industry
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standards
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Drugs, Chinese Herbal
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standards
10.Quality evaluation of guizhi fuling capsule using self-control method of reference Chinese medicine preparation.
Ting GENG ; Zai-juan ZHANG ; Yan-jing LI ; Gang DING ; Yu-an BI ; Zhen-zhong WANG ; Wei XIAO
China Journal of Chinese Materia Medica 2014;39(21):4127-4132
Taking guizhi fuling capsule (GZFL) for instance, a new method about reference Chinese medicine preparation which was used as standard substance for the quality evaluation of complex Chinese medicine preparation by the fingerprint of reference preparation instead of standard fingerprint was proposed. It could eliminate the errors from different instruments, chromatographic columns and solve the problem of similarity matching in the absence of standard fingerprint. The qualification of reference GZFL was evaluated according to the quality control method of GZFL from Chinese Pharmacopoeia. Then multiple batches of GZFL were estimated, taking fingerprint of reference preparation and standard fingerprint as references, respectively, at different instruments and chromatographic columns. Finally, the packaging and expiration date for reference GZFL were confirmed according to the results of stability investigation. The results indicated that the fingerprint of reference GZFL could be used to assess the quality of GZFL better than standard fingerprint. The data of accelerated stability and long-term stability test demonstrated that reference GZFL was stable in the conditions of double blister package. Therefore, reference GZFL can be used as standard substance in quality control of GZFL.
Capsules
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Drug Stability
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Drugs, Chinese Herbal
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chemistry
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standards
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Reference Standards