ABSTRACT
Objective:To establish the grade evaluation standard of Salviae Miltiorrhizae Radix et Rhizoma decoction pieces combining traditional character evaluation and modern intrinsic quality analysis. Method:The appearance character parameters （thickness and weight） and contents of internal index components （tanshinones and salvianolic acid B） of 18 batches of Salviae Miltiorrhizae Radix et Rhizoma decoction pieces were determined， and the relative quality constant was calculated. The maximum value of the percentage quality constants of the tested samples was assumed to be 100%， the value ≥80% was classified as the first-class， ≥50% and <80% as the second-class， <50% as the third-class. Result:The relative quality constants of 18 batches of Salviae Miltiorrhizae Radix et Rhizoma decoction pieces ranged from 349 to 884. According to the percentage quality constant， 18 batches of samples were successfully divided into three grades. The relative quality constant of the first-class product was ≥707， including samples ds5， ds8 and ds14， accounting for about 17% of the total number of samples. The relative quality constant of the second-class product was ≥442 and <707， accounting for about 61% of the total number of samples. the other samples were of the third-class， and their relative quality constants were all <442. Conclusion:The method of relative quality constant overcomes the one-sidedness of the single method in the grade evaluation of Salviae Miltiorrhizae Radix et Rhizoma decoction pieces， and the evaluation results can objectively， reasonably and scientifically classify the grade of the decoction pieces， which can provide reference for the establishment of the grade standard of other decoction pieces.
ABSTRACT
The consistency of quality on Chinese patent drugs is a hotspot and difficulty in the control of traditional Chinese medicine preparations, and has become one of the bottlenecks restricting its internationalization. Based on the analysis of current studies on quality and problems of Chinese patent drugs, this paper explored relevant methods of quality evaluation on Chinese patent drugs and possible factors affecting the consistency of quality in the pharmaceutical cycle by consulting relevant literatures about quality evaluation methods and consistency control techniques of large-scale Chinese patent drugs. And it put forward the evaluation system on high-quality Chinese patent drugs with "consistency" as the core, so as to promote the overall improvement of the quality of Chinese patent drugs, guide the rational price of Chinese patent drugs of the same species, and provide a new reference model for the quality evaluation of Chinese patent drug.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription DrugsABSTRACT
With continuous introduction of relevant national policies on famous classical formulas, the research of famous classical formulas is popular all over the country. Different from other new drugs, in the research and development process of famous classical formulas, substance benchmark is earlier than the product, suggesting that the research and development of substance benchmark is of great significance. Based on previous work of the authors, content of substance benchmark of famous classical formulas was analyzed, which was included in the document <italic>The Management Regulation of Simplified Registration and Approval over Chinese Herbal Medicine Compound Preparations of Ancient Famous Classical Formulas</italic> released by the National Medical Products Administration in May 2018. In this paper, the significance of substance benchmark development was described, a five-stage of research strategy was proposed, covering the prescription textual research and historical evolution, the collection and quality evaluation of medicinal materials, the processing method and quality evaluation of decoction pieces, the preparation and quality research of substance benchmark, the drafting and formulating of quality standard over substance benchmark. At the same time, some suggestions were put forward to the feasibility of compound preparations development over famous classical formulas, the implementation difficulty of resource evaluation over Chinese medicinal materials, and the irrationality on the quality correlation of Chinese medicinal materials. All of these are expected to provide reference and enlightenment for the development and policy officially landed over ancient famous classical formulas.
ABSTRACT
Objective::To establish a scientific and reasonable grade evaluation standard for Polygoni Multiflori Caulis. Method::The quality constant method was used to conduct a grade evaluation study on Polygoni Multiflori Caulis. A total of 16 batches of samples were collected from Chinese herbal slices enterprises and medicinal materials markets. By measuring its appearance traits (average quality and average thickness of the decoction pieces) and the intrinsic quality indicators (content of 2, 3, 5, 4′-tetrahydroxystilbene-2-O-β-D-glucoside), then its quality constant and percentage quality constant were calculated comprehensively, finally, the grades of Polygoni Multiflori Caulis were classified by quality constant method. Result::The quality constant of 16 batches of the decoction pieces was 0.054-0.417, and the percentage quality constant was 12.98-100.00.If these samples were divided into three grades, the quality constant shall be ≥0.334 for the first-grade decoction pieces, the quality constant shall be <0.334 and ≥0.209 for the second-grade decoction pieces, while for the third-grade decoction pieces, the quality constant shall be <0.209. Conclusion::The grade evaluation method based on quality constant can overcome the shortcomings of traditional evaluation method for decoction pieces, and can realize scientific, objective and simple classification of Polygoni Multiflori Caulis. This study enriches the research data of modern grade evaluation of Polygoni Multiflori Caulis, and provides reference for grade evaluation and market circulation of other decoction pieces.