中成药肾宁胶囊的制备与质量标准控制分析.docx

摘要
摘 要
目的: 研究用于治疗急、慢性肾小球炎,肾病综合征的纯中药制剂肾宁胶囊的制备方法、
确定其生产工艺,并建立对处方中主药黄芪、丹参、熟地、山茱萸的薄层色谱鉴别方法。确保制剂质量,保证它的有效性、稳定性和安全性,为临床科学、方便、合理用药提供基础。
方法:
、确定工艺路线,生产纯中药制剂肾宁胶囊。
、丹参、熟地、山茱萸进行进行薄层色谱(TLC)鉴别,检测粒度;测定水分含量,HPLC 法测定丹参素含量。建立可靠的质量控制标准。
《中国药典》之《药物稳定性试验指导原则》和基于回归分析的药品有效期测算方法确定在 0、1、2、3、6、12 个月考察成品在室温下稳定性,通过恒温加热加速试验,推算出成品有效期。
:采用 软件,均数样本采用方差齐性检验、t 检验,非参数据采用秩合检验。通过 Excel 2003 软件进行数据分析。
结果
,制剂研制成功。
、丹参、熟地、山茱萸的定性鉴别方法(TLC 法) 和丹参素定量测定方法(HPLC 法)建立,确定了该制剂质量控制标准。
,推算出肾宁胶囊成品有效期为 年。结论肾宁胶囊制备工艺可靠,制剂质量控制标准中对处方中主药黄芪、丹参、熟地、山
茱萸的薄层色谱鉴别方法快速,丹参素定量测定方法重现性好,稳定性强。制剂研制成功。
关键词 慢性肾病 肾宁胶囊 质量控制标准 薄层色谱
Abstract
Abstract
PURPOSE:
The study aim at reform prescription of the Chinese patent medicine SHENNING capsule, which can be used in treating acute and chronic glomerulonephritis and chronic nephropathy, determine the crafts of fabrication, establish a mothed on distinguish the position of Astragalus, Salvia, Rehmannia and Dogwood by thin layer chromatography, insure their quality, effectiveness,stability and safty, provide a scientifical, reasonable and conveniently medicine for clinical.
METHOD:
the fabricate mothed, determine the crafts, and provide a pure Chinese traditional medicine SHENNING capsule.
Distinguish the monarch medcine such as Astragalus, Salvia, Rehmannia and Dogwood by thin layer chromatography mothed, check the granularity, water content, measure the contents of miltiorrhiza by HPLC method and establish a resonable quality control mothed.
Ascertain the stability after inspecting the capsule in 0th, 1st, 2nd, 3rd, 6th and 12th month under the room temperature according to the "Chinese pharmacopoeia" that "The medicine stability tests principle" , speculate the period of validity by warming up accelerate test and regression analysis-based method.
method: carry out data analysis by SPSS , the mean of sample adopt
homogeneity of variance analysis, t test