【作者】 李静；

【导师】 高晓黎；

【作者基本信息】 新疆医科大学 ， 药剂学， 2007， 硕士

【摘要】 目的:本课题参照《卫生部药品标准中药成方制剂》第五册中健儿消食口服液处方,研制健儿消食口服液新产品。并以此方为基础,优化制备工艺,提高制剂的质量标准,初步考察制剂稳定性,并与市售产品进行药效学对比。方法:(1)以总多糖含量、黄芩苷含量和水浸出物量为指标,采用单因素试验和正交试验优化提取工艺和澄清工艺。(2)建立健儿消食口服液质量标准,用薄层色谱(TLC)法对方中黄芩、黄芪、白术、陈皮进行定性鉴别;采用高效液相色谱(HPLC)法测定制剂中黄芩苷和橙皮苷的含量。(3)根据中国药典2005年版(附录ⅪⅩC)药物稳定性试验指导原则,按照建立的质量标准,进行加速试验和长期试验,考察制剂稳定性。(4)以市售健儿消食口服液为阳性对照,采用小鼠小肠炭末推进率试验、大鼠胃液分泌量及胃蛋白酶活性测定、小鼠游泳试验,进行药效学对比研究。结果:(1)优化的制备工艺为:加水量为处方药材量的10倍,浸泡2小时后煎煮,所得水提液浓缩为生药与药液之比为1:3,缓慢加入乙醇使含醇量达40%,放置10小时,即得。(2)建立的质量标准可有效控制制剂质量。(3)经加速试验6个月及长期试验9个月,供试品的各项指标均未见明显变化。(4)本品可促进小鼠胃肠蠕动,增加大鼠胃液分泌量和提高大鼠胃蛋白酶活性,以及延长脾虚小鼠游泳时间。与市售制剂对比,各项药效学试验指标无统计学差异,对比研究认为新产品与市售制剂等效。结论:(1)优化的制备工艺稳定、可行,可用于工业化生产。(2)制剂的质量标准可行,质量可控。(3)制剂的初步稳定性良好,为处方工艺及包装材料的可行性提供依据。(4)自制产品具有与市售产品相同的药效。更多还原

【Abstract】 Objectives: The purpose of the research is according to the prescription of Jianer Xiaoshi Oral Liquid,which is included the Department of Health drug standard.This project include four important sections:to optimize the prescriptions and prepare techniques;to establish the quality standard;to study the stability of Jianer Xiaoshi Oral Liquid,and to study pharmacodynamics. Methods: (1)The extractive technology of Jianer Xiaoshi Oral Liquid was screened by means of optimal experiment design,basing on the content of polysaccharide,baicalin and extractum.(2)Establish the quality standard of Jianer Xiaoshi Oral Liquid.Identified atractylodes macrocephalia,astragalus,baicalin and hesperidin in Jianer Xiaoshi Oral Liquid by TLC.Determined the content of baicalin and hesperidin in Jianer Xiaoshi Oral Liquid by HPLC.(3)Accelerating and long-term tests were conducted according to guidelines regarding the experiments of stability of medicine from the Chinese Pharmacopoeia(Edition 2005)(as attached XIXC) to evaluate the stability of the product.(4)We use Jianer Xiaoshi Oral Liquid which had sold in drugstore as reference preparation to study the speed of small intestine moving forward,secretory volume of gastric juice,the activity of gastric proteinase,and swimming test. Results: (1)The optimal conditions of preparation process is with an amount of 10 times of water for 3 times of extractions.Then,condense the extraction solution to 1:3 and add alcohol to make contain alcohol attain to 40%.The filtrate were placed 10 hours.(2)The quality standard of Jianer Xiaoshi Oral Liquid can practicably control the quality.(3)There was no obvious change with all indicators of the samples of the experiments monitored through the 6-month period of accelerating and 9-month period of long-term tests.(4)The result of the statistical analysis showed that test drugs and control group can promote gastrointestinal motility,increase secretory volume of gastric juice and the activity of gastric proteinase. Conclusions: (1)The preparation process is stable and suitable for Pharmacia production.(2)The quality standard of the preparation is feasible and controllable.(3)The initial stability of the preparation is sound and provides evidence for the feasibility of technological and packing materials.(4)The test group possess the same drug action as the control group.更多还原