| Shuangshen Shengmai capsule is clinical experience prescription from Professor Jiang Liangduo in Dongzhimen Hospital of Beijing Traditional Chinese Medicine ,which was applicated more than 20 years.The prescription composed by Hongshen, Danshen, Ophiopogon, Schisandra, Guizhi and Chenpi six Chinese herbal medicine, with relanishing qi and generating body fluid, relanishing yin , warm and accessible yang, activating and operating blood.It is an effective medicine to treat primary hypotention, chronic fatigue syndrome, coronary heart disease,this study will develop new drug. In the pre-research on the basis of pharmacological and clinical studies, primarily on the basis of requirements of disclosure of information of new drugs in Chinese medicine, under the guidance of Chinese medicine theory, combined with modern research methods ,this study is to explore the material in a clear and effective foundation on an integrated optimization of extraction process of scoring, using thin-layer chromatography and high-performance liquid chromatography-color standardized quality-spectrum research, in the Chinese Pharmacopoeia 2005, to test the stability of Shuangshen Shengmai capsules and experimental study on the initial stability.Objective: To explore incidence of Essential Hypotension (chronic fatigue syndrome) and material basis for efficacy of its clinical treatment of drug Shuangshen Shengmai capsule through the literature; to determine pilot research methods of optimum extraction process, quality standards and stability, in terms of curative effects on a clear foundation; in accordance with Chinese Pharmacopoeia in 2005 version of I, under the requirements of capsules, inspecte disintegration three batches of samples, moisture, differences in quantity, microbial limits Arsenic salts and heavy metals. Methods: To research the incidence,clinical medicine of essential hypotension and material basis for efficacy Shuangshen Shengmai capsule through ancient literature and research databases at home and abroad of new drugs (chronic fatigue syndrome). Applicating methods of alcohol-water combination to prepare Shuangshen Shengmai capsules, the use of L9 (34) orthogonal test, the general score analysis of variance method to optimize the extraction conditions, to determine the best extraction process of three types of active ingredients. Using Thin-layer Chromatography (TLC) method to identificate Danshensu, Ophiopogon, Schisandra, Chenpi of preparations; the use of high-performance liquid chromatography (HPLC) method to determinate the content of tanshinone IIA of preparation .Results: Efficacy substances of Shuangshen Shengmai Capsule into three categories: saponins, flavonoids and polysaccharides; preparation process was determined , the conditions for the ethanol extraction process was 10 times the amount of 80% of the ethanol extract 2 times ,per time 1h; After alcohol mentioning the dregs and Chenpi, Guizhi mention by water, add 6 times the volume of water extracted 3 times per time 2h. Add Hongshen powder and accessories to made preparations, load into the capsules ,as the best technology; TLC Identification of Danshen, Ophiopogon, Schisandra, Chenpi spots are clear, tanshinone IIA has the scope of linear good relationship at injection volume between 0.04656ug and 0.2328ug , the recovery rate are at 95% ~ 100%, RSD are less than 5%.Conclusion: The literature to explore the material basis of Shuangshen Shengmai Capsule is simple, clear, theoretical, which provids effective theory for long-term clinical uesfulness. Set up a combination of alcohol-water extraction method, the Composite score Optimize material composition of the three types of effective optimum extraction, TLC Identification of Danshen, Ophiopogon, Schisandra, Chenpi, spots are clear, simple. Red ginseng at least a small proportion of the amount, it will be determination of tanshinone IIA as a target, methods, sophisticated, more science and rationality.
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