| To meet the needs of Traditional Chinese Medicine Modernization and introduce Traditional Chinese Medicine to the world wide, the standardized research in quality of Chinese traditional medicine preparation is the essence to control the quality, it is also the only way to achieve modernization of Chinese traditional medicine. we need to not only change its unitary status of one form and develop more forms other than Pill of Chinese Medicine. Take Xiaojin Wan as the subject investigated, research pharmaceutical technology and quality standard.The formula of Xiaojin Wan comes from Chinese Pharmacopoeia 2005 edition. It consists of sweetgum resin, prepared wild aconite root, trogopterus, earth worm, momordica seed, olibanum frankincense, myrrh, Chinese angelica, musk and Chinese ink. It is good at resolving phlegm and removing dampness, eliminating blood stasis and removing obstruction from channels. It is applicable for yin-cellulitis due to stagnation and accumulation of cold dampness manifested with no change of skin color, swollen, hard and painful abscess[1].Objective: Prepare Xiaojin Wan soft capsule. We stipulate for pharmaceutical technology, establish quality standard, and carry out preliminary stability of the preparation.Methods: (1) Take settling ratio and fluidity of soft capsule's content as the subject investigated, We do orthogonal experiment, filtrate prescription and ascertain the good match. (2) Carry on the thin-layer chromatography to identify all kinds of medicinal materials in the formula, Chinese angelica, Earth worm, Olibanum frankincense and Myrrh, Momordica seed, Manpower musk, the limited control of aconitine in the preparation. Take ferulic acid as the target, reversed-phase high performance liquid chromatography method was developed to determine Chinese angelica in the preparation.(3) According to Chinese Pharmacopoeia 2005 edition, the stability requirements for capsule, we check content weight differential and disintegration of the preparation.(4) According to《Stability test requests for the new Chinese traditional medicine》, We carry out preliminary stability of the preparation. Results: filtrating prescription, ascertain the match of medicinal materials powder : soybean oil(1.12:1), beeswax(4%), tween 80(1.5%) , stearic acid(1%) in the content of soft capsule, fluidity and stability of the content is good.In the TLC identification, the sample displayed the same spots or fluorescence spots as the reference medicinal materials in the TLC, while the blank did not, specialization is good. In the limited control of aconitine, the result shows that sample's aconitine is in the limited scope.In the determination test, ferulic acid concentration presented a good linear range of 3～18μg.mL-1, Y=100708.7X+24 (r=0.9991). The RSD of precision was 0.55%, The RSD of repeatability was 1.41%, the average recovery of 100.6%,RSD=1.86%.And in each of Xiaojin Wan soft capsule, Content of ferulic acid was no less than 6.0μg.The examination of the preparation, the result show that Properties: brown, Weight differential<±10%, Disintegration<1h, accord with the requirement of Chinese Pharmacopoeia 2005 Edition. Through inspection on preliminary stability of the sample for 3 months, There is no great change and no other abnormal quality changes, which have been observed.Conclusion: The pharmaceutical technology of the preparation is not reported in China. According to the research of pharmaceutical technology, establish the technological parameter, the preliminary quality standard of Xiaojin Wan soft capsule was established, and it is good for controlling the preparation's quality, the inspection on preliminary stability of preparation showed that it is stable quality, the purpose is achieved.
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