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@#Pharmaceutical excipients of animal origin, an important part in pharmaceutical excipients, are widely used in pharmaceutical preparations.However, compared with the pharmaceutical excipients of other origins, pharmaceutical excipients of animal origin have more special requirements in many aspects, such as raw materials, production, quality control, storage, supervision, etc.Chinese Pharmacopoeia 2020 first included the Guideline for Pharmaceutical Excipients of Animal Origin, which introduces the basic ideas and technical requirements for the life cycle quality control of pharmaceutical excipients of animal origin based on the risk management concept.This article illustrates the specificity of the pharmaceutical excipients of animal origin, and interprets the main contents of this guideline in conjunction with relevant domestic and foreign regulations and technical documents, thereby providing comprehensive reference for the implementation of the guideline.
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Based on the previous literatures, the overview on the history and recent advance of the quantitative analysis of multi-components by single-marker (QAMS) was summarized. The key questions of QAMS were also highlighted. It could be considered as a feasible method for the quality control of Traditional Chinese Medicines.
Assuntos
Cromatografia , Medicamentos de Ervas Chinesas , Controle de Qualidade , Projetos de PesquisaRESUMO
Objective: To establish a RP HPLC for determination of puerarin in Heat clearing Toxin resolving Decoction. Methods: A Hypersil C 18 column with acetonitrile 2% glacial acetic acid (8.5:91.5) as a mobile phase was used. The flow rate was 0.8ml?min 1 and the detective wavelength was 250nm. Results: The calibration curve was linear at a range of 0.424 4.240?g for the puerarin (r=0.9998). The average recovery was 101.3% and the relative standard deviation (RSD) was 1.4%. Conclusion: The methld is simple, accurate with a good reproducibility and can be used as a quantitative analysis method for this preparation.
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Objective: To establish a method for the determination of cinnamic acid in Lingguizhugan Decoction (Poria, Ramuls Cinnamomi, Rhizoma Atractylodis macrocephalae, Radix Glycrrhizae, etc.). Methods: Using RP HPLC with Hypersil C 18 column, methanol acetonitrile water acetic acid (10∶22∶70∶1.4,v/v) as mobile phase, detection wavelength at 254nm and p dimethylaminobenzaldehyde as the internal standard.Results: The mean recovery and RSD were 98.2% and 1.9% ( n =6), respectively, the linear range of cinnamic acid was 8.4～168?g?mL -1 ( r =0.9999). Conclusion: The method is simple, rapid, accurate and reproducible, and may be used for the determination of cinnamic acid in Lingguizhugan Decoction.
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Objective: To study the compatibility and therapeutical basis of composite herbal medicines of Lingguishugan Decoction(LD)(Poria, Ramulus Cinnamomi, Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae.)Methods: Ethanol extract test solutions of the different combinations were prepared according to the orthogonal layout L 16 (4 5). Pharmacologic experiments, such as the time of survival of mice in shortage of oxygen in normal pressure, the antagonistic effect on arrhythmia induced by chloroform and the diuretic effect were carried out with LD. Variance analysis, canonical correlation and stepwise regression analysis were applied to interelationship between the amount of each drug and the pharmacologic data. Then, the fingerprints of the solutions were tested by HPLC method and 50 chromatographic peaks were obtained. Correlation and regression analysis was applied to interelationship between the area of each peaks and the pharmacologic data.Results: The results confirmed the poria and cinnamon twig are the basis, while ovate atractylodes and licorice are the adjuvans. 17 peaks, which were established as the therapeutical basis of the decoction, were selected from all compounds, and cinnamic acid of cinnamomum cassia, glycyrrhizin of Glycyrrhiza uralensis and dehydrotumulosic acid of Poria cocos were selected as the markers to evaluate the quality of the decoction.Conclusion: This study provided a significant try of studying the compatibility of composite herbal medicines.