Method for whole monitoring of radix bupleuri oral liquid quality

Abstract

The invention relates to a method for whole monitoring of radix bupleuri oral liquid quality. The method comprises the steps of firstly, constructing a fingerprint spectrum of a radix bupleuri medicinal material, intermediate extract and a finished radix bupleuri oral liquid product; secondly, detecting the fingerprint spectrum of the radix bupleuri medicinal material, the intermediate extract and the finished radix bupleuri oral liquid product; and thirdly, comparing the fingerprint spectrum of the radix bupleuri medicinal material, the intermediate extract and the finished radix bupleuri oral liquid product to a standard fingerprint spectrum; producing by taking the radix bupleuri medicinal material with integral similarity consistent with requirement as a raw material, turning to a next process when integral similarity of the fingerprint spectrum of the intermediate extract and the standard fingerprint spectrum is consistent with requirement, and delivering the finished radix bupleuri oral liquid product where integral similarity of the fingerprint spectrum therein and the standard fingerprint spectrum is consistent with requirement out of factory. The method can monitor quality from the medicinal material to the intermediate extract and to the finished product, so that the production process is easier to control, and more scientific and reasonable to regulate; and quality of the finished product is stable and consistent.

Description

technical field [0001] The invention relates to a quality monitoring method of traditional Chinese medicine preparations, in particular to a method for monitoring the quality of Bupleurum bupleuri oral liquid in the whole process. Background technique [0002] Bupleurum Oral Liquid is a national standard drug, an essential drug in Henan Province, made from a single Chinese herbal medicine, Bupleurum, which is extracted, concentrated, refined, and added with auxiliary materials to prepare an oral liquid. The key part of quality control in the current standard of this drug is the qualitative thin-layer identification of Bupleurum bupleurum medicinal material, which has poor specificity. There are control indicators for the uniformity of each batch of finished products, and the evaluation of drug quality is one-sided. It is difficult to ensure that different batches Whether the quality is stable, or whether it is consistent with similar drugs from other pharmaceutical manufactu...

AI Technical Summary

Problems solved by technology

The key part of the current national standard quality control of Bupleurum medicinal materials is the qualitative, quantitative detection and content determination of saikosaponin a and b, which are one-sided for evaluating the quality of medicinal materials, and it is difficult to ensure the stability and consistency of medicinal materials

In addition, there is no national standard for the intermediate extract produced during the production process, which makes it impossible to monitor the quality during the production process

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