Method for reducing relative deviation of berberine hydrochloride content transfer rate of compound berberine tablets

Abstract

The invention discloses a method for reducing the relative deviation of the berberine hydrochloride content transfer rate of a compound berberine tablet, and belongs to the technical field of drug inspection and detection.The method comprises the steps that during sample pretreatment, the temperature of water specified by slightly cold water is preferably not lower than 90 DEG C, and diluted hydrochloric acid is added preferably to obtain temporarily-used newly-prepared diluted hydrochloric acid. According to the present invention, the standard operation of the detection personnel is convenient, the purpose of reducing the RSD of the berberine hydrochloride content transfer rate during the compound berberine tablet production process is achieved, the RSD of the berberine hydrochloride content transfer rate during the compound berberine tablet production process is significantly reduced, the RSD of the raw material-to-finished product transfer rate is reduced to 2.4% from 4.2%, and the RSD of the intermediate product-to-finished product transfer rate is reduced to 2.0% from 4.5% so as to easily achieve the quality stability of the product production.

Description

technical field [0001] The invention relates to the technical field of drug inspection and detection, in particular to a method for reducing the relative deviation of the content transfer rate of berberine hydrochloride in compound berberine tablets. Background technique [0002] The current implementation standard of Compound Berberine Tablets is the 2020 edition of "Chinese Pharmacopoeia". [0003] 【Prescription】: Berberine Hydrochloride 30g, Woody Fragrance 116g, Evodia Evodia 40g, Paeoniae Alba 162g [Preparation method]: The above four flavors, 80g of woody fragrance and Evodia rutaecarpa are crushed into fine powder, sieved, the coarse powder that has not passed the sieve is mixed with white peony root and the remaining woody fragrance, percolated with 70% ethanol as solvent, collected Percolate, ethanol is recovered from the filtrate and concentrated into a thick paste, add the above fine powder, mix well, dry, pulverize, add berberine hydrochloride, mix well, make g...

AI Technical Summary

Problems solved by technology

However, the inventor found through a lot of practice that the current quality standards require too simple pretreatment parameters for the samples to be tested in Compound Berberine Tablets. Different operators operate according to their own understanding of the standards, and the detected berberine hydrochloride content values Large fluctuations, low precision, weak guidance on production process control, not conducive to accurate control of product quality, affecting product pass rate, and resulting in increased production costs

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