| The subject of Danshu capsule, Danshu soft capsule and Jiejing zhentong tincture of three drugs, according to the basic drug evaluation requirements, in accordance with the statutory standards of the species were tested. Based on the analysis of the testing data and quality factors, the quality control indexes were explored, and the suggestions for improving and perfecting the drug standards were put forward to further improve the quality of drugs. The main contents and conclusions are as follows:? Study on quality evaluation and standard of Danshu capsule and Danshu soft capsule1 According to the current standard test, the result conforms to the provisions,the test results were evaluated.2 The chromatographic fingerprints of Danshu capsule and Danshu soft capsule were established by gas chromatography, and the method is specific and easy to operate.3 The near infrared spectrum consistency model of Danshu capsule was established by near infrared spectrometer and OPUS software, which can realize the requirement of the rapid test of drug.? Study on quality evaluation and standard of Jiejing zhentong tincture1 According to the national standard test of each factory, the result conforms to the provisions,the test data were analyzed and evaluated.2 A TLC method for the identification of hesperidin was established.3 The content of capsaicin was determined by RP-HPLC. The method has high specificity and good separation effect.4 The contents of menthol and methyl salicylate were determined by GC. The contents of the two components were determined by PEG-20 M capillary column and FID detector. The peaks of the chromatographic peaks were separated effectively by naphthalene as the internal standard.5 HPLC was used to determine the Sudan pigment which could be incorporated into pepper raw material by using the two-wavelength, gradient elution method.? To draft the quality standard and optimize the production process. |
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