老君升白胶囊的研制及质量标准的制定

【作者】 丁志英；

【导师】 崔炯谟； 董方言；

【作者基本信息】 延边大学 ， 药剂学， 2001， 硕士

【摘要】 老君升白胶囊是由黄芪、刺五加、何首乌、知母、黄柏、五味子等八味中药组成的中药复方新制剂。 本实验根据老君升白汤剂处方所含药物的性质与剂量，进行剂型改进，制成胶囊剂，以克服汤剂剂型本身存在的缺陷和临床应用的不便。同时，对胶囊剂的制备工艺进行相应的探讨，为确定该胶囊剂的制备工艺提供试验依据；对君药黄芪采用薄层扫描法进行含量测定，对臣药、佐药、使药分别采用薄层色谱法进行定性鉴别，为确定该胶囊剂的质量标准提供试验依据；实验中对含量测定作了方法学考察。制备过程中采用减压干燥法进行半成品的干燥。本实验还进行了中试生产，对中试老君升白胶囊从性状、鉴别、含量测定等方面考察了初步稳定性。 实验采用正交设计法分别优化了黄芪、五味子和剩余六味中药组成的复方的最佳提取工艺条件，结果表明，以黄芪甲苷的含量为指标，黄芪的最佳提取工艺为：60％乙醇回流提取2次，每次2h，乙醇用量为药材量的6倍。以五味子乙素的含量为指标，五味子的最佳提取工艺为：80％乙醇回流提取2次，每次2h，乙醇用量为药材量的8倍。剩余六味中药组成的复方以黄柏中的小檗碱的含量为指标，采用水煎醇沉工艺进行正交设计，结果表明，最佳提取工艺为： 老君升白胶囊的研制及质量标准的制定 丁志英＠水煎2次，每次Zh水的用量为药材量的8倍，醇沉浓度为60％。 含量测定的方法学考察结果为：：老君升白胶囊中黄蔑甲昔的薄层扫 描最大测定波长为入s－530urn，参比波长为入R＝700nm；从老君升 白胶囊中提取的黄蔑甲苦的薄层色谱斑点在lh内基本稳定。精密 度、重现性、回收率试验结果表明：该方法灵敏、简便、准确和重 现性好，可作为该制剂的质量控制标准。实验中，对黄蔑药材中黄 蔑甲昔的含量进行了测定，结果为 1刀612mg／g，即0．106％，符合药 典不低于0刀4％的要求，说明黄蔑为合格药材。中试复方黄蔑胶囊 中的黄蔑甲苦含量为 0．594ling／g。薄层色谱定性鉴别结果显示： 刺五加、何首乌、知母和黄柏都具有明显的特征指纹图谱。初步稳 定性考察结果显示：老君升白胶囊在室温条件下放置基本稳定。更多还原

【Abstract】 The prescription of Laojunshengbai capsules, consists of eight medicinal herbs- ASTRAGALUS ACANTHOPANAX POLYGONUM ANEMARRHERA ZIZIPHUS etc. It was experimented and developed on the basis of clinical practice of doctor of traditional Chinese medicine. It belongs to a new form of the type medicine. --3-- According to the chemical properties and dosage of the herbal medicine, the decoction were improved and made CAPSULES in order to overcome it抯 shortcomings of herbal medicine. Conditions for the extraction were studied by orthogonal experimental design as guided by the content of ASTRAGALIN present in the extract. Provides a scientific basis for studying on extraction process of Laojunshengbai capsules; The content of Aastragalin , the main active principle in the granule derived from ASTRAGAL]IN was assayed by TLCS and the presence of ACANTHOPANAX POLYGONUM ANEMARRHERA ZIZIPHUS etc were identified by TLC. The formulation of a standard for the quality control of Laojunshengbai capsules was studied. Provides a certain evidence for controlling the quality of Laojunshengbai capsules. We have gone into operation of medium-sized scope for Laojunshengbai capsules. We investigated the quality of the stability for Astragalin compound capsules. --4-- As the main active principle in the Astragalus compound capsules Astragalin could elevate leukocyte count. More and more Leukcyte come to body. The second active principle ACANTHOPANAX and POLYGONUM contributes to increase the amount of blood. The third active principle ANEMARRHERA ZLZIPHUS were antipyretic and antidote. ZIZIPHUS etc were the fourth active principle. They build up brains. The extracted techniques of the Laojunshengbai capsules were determined by orthogonal design method by assay of Astragalin in the extraction. The optimal technical parameters were as follow: using 6times animount of 60% alcohol as extracting solvent to reflux for 2hours and twices. The extracted techniques of the Fructus ligustri were determined by orthogonal design method by assay of Schizandrin in the extraction. The optimal technical parameters were as follow: using 8times ammount of 80% alcohol as extracting solvent to reflux for 2hours and twices. Conditions for the extraction were studied by orthogonal --5-- ~+ flfl(j~ experimental design as guided by the content of Berberine vulgaris present in the extract. The optimum condition for the extraction of the other six traditional Chinese medicine such as ANEMARRI-IERA was to decoct medicinal herbs twice 2h and eightfold. There is some sediment in the decoction medicinal herbs by 60% alcohol. Using pressure reducer to dry the drug, In order to control the quantity of the main active principle in the granule derived from Laojunshengbai capsules was assayed by TLC to break parts ASTRAGALIN. The presence of ACANTHOPANAX POLYGONUM ANEMARRHERA ZIZIPHUS etc Chinensis were indentified by TLC. The content of Astragalin the main active principle in the granule derived from ASTRAGALUS was assayed by inC. the greatest wavelength of A更多还原