Traditional Chinese medicine solid preparation and its preparing process and use

Abstract

The invention relates to a method for preparing the traditional solid medicine, which uses the saikoside, baicalin and houttuynine sodium bisulfite sodium at different mass percentages, to build technical checking method and solubility testing method, via antiviral tests to select the best combination, and uses the solubility test to find the preparation.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine pharmacy, in particular to a traditional Chinese medicine solid preparation containing total saponins of Bupleurum baicalin, baicalin and houttuyonin sodium, a preparation method and application thereof. Background technique [0002] Chaihuang Granules and Chaihuang Tablets, issued by the Ministry of Traditional Chinese Medicine, are used to treat fever, general discomfort, headache, dizziness, and sore throat caused by colds. The compatible application of Bupleurum and Scutellaria comes from Xiaochaihu Decoction in "Treatise on Febrile Diseases". Fire detoxification, Bupleurum expells half-exterior and half-inside evils, Scutellaria baicalensis half-exterior and half-inner evils, Bupleurum opens Qingyang, and Scutellaria baicalen reduces turbid fire. Bupleurum preparations are prepared into preparations through the compatibility of Bupleurum and Scutellaria baicalensis. Trad...

AI Technical Summary

Problems solved by technology

[0006] Based on the above reasons, we have innovatively optimized the composition based on the effective parts of the total saponins of Bupleurum saponins, the active ingredients of baicalin and houttuyniatin sodium through the screening and systematic evaluation of the composition and proportion of the drug. Distributed into five prescriptions, they have synergistic and complementary effects on each other, and play a comprehensive regulatory therapeutic effect through multi-components or components, multi-targets, and multi-systems. It has a good therapeutic effect, especially for colds with respiratory tract, upper respiratory tract bacterial infection, and viral infection; the active ingredients or the effective parts of the components are quantified by high performance liquid chromatography, and the active ingredients or active ingredients in the prescription are comprehensively and objectively quantified. The content of the effective part of the component, the quality control system is precise, and the quality of the product is objectively and comprehensively reflected; based on the shortcomings of the total saponins of Bupleurum saponins and houttuyonin sodium and the poor stability of baicalin, through the optimization of the formulation prescription and process Research, establish the dissolution method, take the dissolution as the screening index, in addition to adding the conventional excipients of traditional Chinese medicine solid preparations, preferably add one or more of sodium bicarbonate, sodium hydroxide, potassium hydroxide and meglumine To increase stability and improve solubility, it is preferred to add one or two of poloxamer and sodium lauryl sulfate to help dissolve, so that the total saponin, baicalin, and houttuyniatin sodium can be dissolved in 45 minutes. Reaching more than 80%, on the basis of meeting the pharmacopoeia standard (the pharmacopoeia standard is that the dissolution rate reaches more than 70% in 45 minutes), the dissolution rate includes two processes of disintegration and dissolution, and the in vitro dissolution rate is related to the in vivo bioavailability. The establishment of dissolution standards is the key and basis for improving bioavailability. Good bioavailability is the guarantee for the product to exert its curative effect and the efficacy of traditional Chinese medicine. It is the development goal of innovative traditional Chinese medicine and the standardization of traditional Chinese medicine preparations.

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