【作者】 吴静；

【导师】 刘玉梅； 金向群；

【作者基本信息】 吉林大学 ， 药物化学， 2009， 硕士

【摘要】 本文以七味药材共同作用起效为目的研究制备了六类新药—参花妇康胶囊。在中药提取方面,采用正交实验法,以提取物中含丹参酮ⅡA的量为指标,对丹参乙醇提取的最佳工艺进行了考察;以提取物中含芍药苷的量为指标,对水煎煮提取的最佳工艺进行了考察。在制剂成型工艺方面,筛选了适用的辅料,并对制剂成型工艺进行了研究。在质量标准方面,定性研究采用TLC法对制剂中的当归,川芎,香附,苦参四味药材进行了鉴别;定量研究采用HPLC法对制剂中芍药苷和丹参酮ⅡA进行了方法学考察和含量测定,并制定了本制剂的含量限度。在制剂稳定性方面,分别对制剂的定性鉴别、含量测定、检查等项进行了考察,常温试验考察了12个月,目前仍在继续考察;加速试验考察了3个月。通过本科题的研究,提供了参花妇康胶囊制备工艺、质量标准、含量测定、稳定性考察等方面药学部分的资料,为申报该新药品种药学部分奠定了基础。更多还原

【Abstract】 Shenhua fukang Capsule is a kind of oral preparation composed of Traditional Chinese Medicine (TCM).It is experied from effective prescription of TCM after properly disposed according to pharmacological results and clinical practices. The prescription is prepared by extracts from seven kinds of TCM including Angelica sinensis (Oliv.) Diels、Salvia miltiorrhiza Bge、Paeonia lactiflora Pall、Ligusticum chuanxiong Hort、Cyperus rotundus L、Carthamus tinctorius L、Sophora flavescens Ait which are all recorded in the Chinese Pharmacopoeia. The pharmaceutical formulation of Shenhua fukang Capsule is compounded with rationality and novelty and it is creatively used in the treatment of stagnation of vital energy and blood stasis type of pelvic inflammation with dramatic curative effect.The purpose of this research is to investigate the preparation procedure and quality control standards of Shenhua fukang capsule. The dosage form in this study is capsule and the preparation thchnology, the quality control standards as well as the stability of Shenhua fukang capsule were lucubrated and the results are as follows:(1) The preparation thchnology of Shenhua fukang capsule1. The alcohol extraction technics of Salvia miltiorrhiza Bge was studied by testing the content of tanshinoneⅡA. The optimum alcohol concentration was tested firstly, then the extraction time, the extraction times and the alcohol amount were selected as the investigating factors.The optimum preparation procedure was studied by orthogonal text and then the reasonable and available process conditions were established.2. The optimum condition of extrating volatile oil from Angelica sinensis (Oliv.) Diels and Cyperus rotundus L were estabolished using the method of wet distillation by seclecting the extraction time as the consideration factor.3. The ethanol extraction technics of paeonia lactiflora pall and other drugs and the remainder of Radix Salviae Miltiorrhizae after alcohol extraction were studied by testing extract content and the content of Paeoniflorin. The water amount, the decoction time, the decoction times and error were chosen as the consideration factors and the optimum preparation thchnology was studied by orthogonal text so as to establish the reasonable and available process conditions. (2) The molding preparation procedure of Shenhua fukang capsuleThe kinds of accessories, the dosage of the accessories and other adjuvants of the Shenhua fukang capsule were studied in detail and then optimum preparation modeling technique was established.(3) The quality control standards of Shenhua fukang capsuleThe qualitative thin-layer chromatography (TLC) and quantitative high efficiency liquid chromatography (HPLC) research of Shenhua fukang capsule were also accomplished in this study.The Salvia miltiorrhiza Bge, Paeonia Lactiflora Pall, Ligusticum chuanxiong Hort and Sophora flavescens Ait in the preparation of Shenhua fukang capsule were identified by TLC. The experimental results indicated that the spots on the chromatograms are clear, characteristic, with good reproducibility and without interference by negative material. This illustrates that TLC is applicable in the qualitative identification of Shenhua fukang Capsule.The concentratios of TanshinoneⅡA and Paeoniflorin in the preparation of Shenhua fukang capsule were quantitatively determined by HPLC. The experimental results suggested that their linearity, precision, reproducibility, recovery are all satisfactory. Their content limits were both regulated: the content of tanshinoneⅡA is no less than 0.08mg per pill and the content of Paeoniflorin is no less than 2mg per pill.(4) The stability research of Shenhua fukang capsuleIn order to investigate the stability of the preparation of Shenhua fukang capsule, the outward appearance character, the load difference, the disintegration time limit, the microorganism limit, the qualitative distinction as well as the the content determination of the preparation were researched by normal temperature test for 12 months and by acceleration test for 3 months separately and the results showed that the items mentioned above did not changed obviously. This illustrates that the preparation of Shenhua fukang capsule has good stability in the storage time.The results of this study showed that the preparation procedure of Shenhua fukang Capsule is reasonable in technics, controllable in quality and good in stability. This research provided integrated pharmaceutical document for the declaration of Shenhua fukang capsule.更多还原