Black prepared lateral root of aconite extracting solution and shenfu injection obtained by adopting real-time release method in automatic black prepared lateral root of aconite extracting process

Abstract

The invention discloses a black prepared lateral root of aconite extracting solution and shenfu injection obtained by adopting a real-time release method in the automatic black prepared lateral root of aconite extracting process, and relates to the field of traditional Chinese medicine injection production testing. The real-time release method in the automatic black prepared lateral root of aconite extracting process comprises the steps of collecting and detecting the alkaloid content and a chromatographic fingerprint spectrum of a black prepared lateral root of aconite raw material sample; preparing acid volume extraction according to the alkaloid content of black prepared lateral root of aconite raw materials, and adopting an ultrafiltration membrane for removing impurities to obtain theblack prepared lateral root of aconite extracting solution; performing online collecting and detecting on the alkaloid content and the chromatographic fingerprint spectrum of the black prepared lateral root of aconite extracting solution sample; according to the alkaloid content of the black prepared lateral root of aconite extracting solution, black prepared lateral root of aconite extracting technological parameters are adjusted. Due to the fact that different raw materials correspond to different technological parameters, the stable effective ingredient is obtained, the batched stability and safety for reducing toxicity and increasing effect of the black prepared lateral root of aconite are improved, meanwhile, application of a poisonous and harmful reagents is lowered, the product quality stability of the obtained black prepared lateral root of aconite extracting solution and shenfu injection is good, and the clinic pharmaceutical safety and effectiveness are high.

Description

technical field [0001] The invention relates to the field of production and detection of traditional Chinese medicine injections, and in particular to an extract of Heishun tablets and Shenfu injection obtained by adopting a real-time release method in the automatic extraction process of Heishun tablets. Background technique [0002] The currently marketed traditional Chinese medicine injection products are subject to inspection and release standards, which can only evaluate the compliance of product quality. This model is "after-event control", and the feedback on the safety and effectiveness of clinical medication lags behind. However, the composition of traditional Chinese medicine injections is complex, and the inspection and release can only be carried out by random inspection of the inspection indicators in the existing quality standards, which cannot fully represent the internal quality of the product and the consistency between batches. Shenfu Injection, as a common ...

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Problems solved by technology

[0003] As the raw material of Shenfu injection, Heishun tablets have been used clinically for more than 30 years. The current quality standard for Heishun tablets is only the upper limit of diester alkaloids and the lower limit of monoester alkaloids, which cannot fully reflect the quality of Heishun tablets. Quality conditions, and the inspection process involves the use of a large number of toxic and harmful organic reagents, such as the application of isopropanol and methylene chloride for alkaloid extraction, which have a greater impact on the health of inspectors and environmental pollution

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