Category of Chinese medicine registration:historical evolution,current status,and problems / 中国中药杂志

The development of traditional Chinese medicine(TCM) has always been highly valued and supported since 1949. However, Chinese medicine industry still faces great challenges in view of the current status of the industry and registration and approval of new products in recent years. Related policies also directly influence the development of the industry. The latest version of the Provisions for Drug Registration and Requirement on Registration Classification and Application Information of Traditional Chinese Medicines have been put into practice since 2020. Registration classification is the core content of the Chinese medicine registration management system, as it is closely related to the research, development, and registration of Chinese medicine and the innovative development of the industry. This article aims to systematically review the historical evolution of the category of Chinese medicine registration and analyze the current status and problems, which is expected to provide a reference for the formulation of supporting documents according to related laws and regulations.

Comparison and review on specifications of fermented Cordyceps sinensis products / 中国中药杂志

There are five kinds of fermented Cordyceps crude drug and their preparations that have been approved as medicine on the market. Since the initial strains of the crude drug were all isolated from natural Cordyceps sinensis， they have similar names， chemical components and even clinical applications. However， because of the different strain species and fermentation processes， there was significant difference in quality. As a result， they should be clearly distinguished in clinical use. Most of the products were researched and developed during the 1980s and 1990s， so there was difference in quality standards for different products， and their quality control levels of some products were not perfect. At present， some of the products are approved as Chinese medicine， others are approved as chemical drugs， with a confusion in products name， management and clinical application. In this paper， the approval numbers， quality standards and clinical applications， and current problems of these products were summarized and compared; some suggestions were put forward， such as standardizing the product name， unifying the management of approval number category， and increasing the specific quality control attributes， in order to provide reference for standard implementation， quality control and drug regulation for fermented Cordyceps crude drugs and their preparations.

Efficacy and safety of Shexiang Baoxin Pill combined with isosorbidedinitrate in the treatment of unstable angina pectoris / 药物评价研究

Objective To explore the efficacy and safety of Shexiang Baoxin Pill combined with isosorbidedinitrate in the treatment of unstable angina pectoris.Methods 80 cases of UAP patients from Jun.2014 to Jun.2016 were given basic treatment plan,and 40 cases were randomly selected and treated with isosorbidedinitrate as the control group,and the other 40 cases were treated with Shexiang Baoxin Pill combined with isosorbidedinitrate.The incidence of angina pectoris and nitroglycerin dosage,angina pectoris curative effect,electrocardiogram (ECG) curative effect and adverse drug reactions were compared between the two groups.Results Before treatment,daily anginal attacks and nitroglycerin dosage of two groups had no significant difference;after treatment,daily anginal attacks and nitroglycerin dosage between two groups were obviously decreased,the differences of same group before and after treatment was statistically significant (P ＜ 0.05);and the treatment group was significantly less than the control group (P ＜ 0.05).The total effective rate of angina pectoris in the treatment group was higher than that in the control group,the difference was statistically significant (P ＜ 0.05).The total effective rate of ECG in the treatment group was higher than that in the control group,the difference was statistically significant (P ＜ 0.05).Conclusions Shexiang Baoxin Pill combined with isosorbidedinitrate in the treatment of UAP can significantly improve the efficacy,and it's adverse reaction is less.

Simultaneous determination of six triterpenoid acids from Guizhi Fuling capsules by UPLC-MS/MS / 中国中药杂志

To establish a UPLC-MS/MS method for simultaneous determination of six triterpenoid constituents (pachymic acid, dehydropachymic acid, dehydrotumulosic acid, polyporenic acid C, dehydroeburicoic acid and dehydrotra metenolic acid) in Guizhi Fuling capsules (GFC). Chromatographic analysis was conducted on Agilent Porosheell 120 SB-C₁₈ column (4.6 mm×150 mm, 2.7 μm), with 0.1% formic acid aqueous solution-methanol as the mobile phase for gradient elution at a flow rate of 0.4 mL•min-1. The column temperature was 30 ℃ and the sample size was 5 μL. The samples were analyzed by tandem mass spectrometer with negative electrospray ionization (ESI) source, and monitored under a multiple reaction monitoring (MRM) mode, with the quantitative ion pairs m/z 527.8→465.5 (pachymic acid), m/z 525.6→465.6 (dehydropachymic acid), m/z 483.4→337.3 (dehydrotumulosic acid), m/z 481.5→419.5 (polyporenic acid C), m/z 467.4→337.1 (dehydroeburicoic acid), m/z 453.4→337.0 (dehydrotra metenolic acid). Six triterpenoid acids showed good linear relationships within the investigated concentration ranges (r> 0.996 8), with RSDs of precision less than 6.2%, and all RSDs of repeatability less than 5.9%. The average recovery rate was 97.90%, 100.2%, 99.60%, 101.7%, 102.6% and 103.0% respectively. The method was rapid, accurate, repeatable and could be used as a method for quantitative determination of triterpenoid acids in Chinese medicine prescriptions, providing a reference method for the quality control of Guizhi Fuling capsules and providing a reference for the content determination for Chinese medicine prescriptions containing Poria cocos.

Common questions and suggestions of evaluation for NDA of TCM / 中国中药杂志

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.

Studies on antiviral constituents in stems and leaves of Pithecellibium clypearia / 中国中药杂志

<p><b>OBJECTIVE</b>To study the antiviral constituents in the stems and leaves of Pithecellibium clypearia.</p><p><b>METHOD</b>The constituents of P. clypearia were systematically separated with various chromatographic techniques in combination with antiviral activity monitoring. Their structures were elucidated by physical and chemical properties and spectral data.</p><p><b>RESULT</b>Six compounds were isolated from P. clypearia and were identified as: tricetiflavan (5, 7, 3', 4', 5'-pentahydroxylflavan) (1), myricitrin (myricetin-3-O-alpha-L-rhamnopyranoside) (2), quercitrin (quercetin-3-O-alpha-L-rhamnopyranoside) (3), quereetin (4), methyl gallate (5) and gallic acid (6).</p><p><b>CONCLUSION</b>Compound 1 approximately 5 were obtained from this plant for the first time. Compound 4 was found to show an obvious anti-respiratory syncytial virus (RSV) activity.</p>