通便胶囊的制备工艺和质量标准研究

发布时间：2018-06-26 01:41

  本文选题：通便胶囊 + 糖尿病便秘　； 参考：《北京中医药大学》2017年硕士论文

【摘要】：实验目的近些年,临床上糖尿病便秘患者逐渐增多,发病机理复杂,中医认为其为人体气血阴阳失调的一种表现。目前市场已有通便保健食品,但配方和适用人群各不相同。本配方由番泻叶、苦杏仁、西洋参三味中药组成,具有通便,补气生津的功能。期望对糖尿病便秘能有较好的改善效果。本课题结合现代制剂相关技术,优选出其提取工艺和成型工艺,并对其质量标准进行了研究。实验方法本课题从通便胶囊的提取工艺,成型工艺和质量标准三个方面进行研究。1提取工艺:经查阅药典和相关文献,确定三味药中指标性和药理活性成分的提取溶剂和提取方法。番泻叶为后下药,在乙醇浓度、提取时间单因素实验基础上设计四因素(乙醇浓度、乙醇倍量、提取时间、提取次数)三水平正交实验,以药理活性成分番泻苷A、番泻苷B的含量为指标确定最佳工艺;苦杏仁设计三因素(加水倍量、提取时间、提取次数)三水平正交实验以《中国药典》2015年版规定的成分苦杏仁苷的含量以及干膏得率为指标确定最优提取工艺;西洋参为另煎兑服药,以人参总皂苷为指标性成分设计四因素(乙醇浓度、乙醇倍量、提取时间、提取次数)三水平正交实验来确定最优提取工艺。2成型工艺:根据药粉吸湿性,流动性,制粒难易程度等确定辅料种类,对湿法制粒中的润湿剂的浓度,药辅比等进行了考察,对半成品颗粒的休止角和临界相对湿度进行了测定、控制。3质量标准:为保证制剂的稳定性,方便对该制剂的质量进行控制,本课题从定性和定量两方面初步制定其质量标准。采用薄层色谱法对制剂中番泻叶、苦杏仁、西洋参进行了定性鉴别;采用高效液相色谱法对通便胶囊中活性成分番泻苷A、番泻苷B进行含量测定。实验结果1提取工艺结果:番泻叶最佳醇提工艺:E1倍G1乙醇浓度,提取F1次,每次T1。浓缩至相对密度1.15左右,置于50℃、-0.10MPa烘箱干燥;苦杏仁最佳水提工艺:E2倍的水提取T2;西洋参最佳醇提工艺:E3倍的G2的乙醇,提取次数F2次,每次T3。2成型工艺结果:药粉与糊精按J混合均匀,以K乙醇为润湿剂,环境相对湿度控制在L以下N目筛湿法制粒,H干燥颗粒T4,P筛整粒,灌装胶囊,包装即得成品胶囊。3质量标准的建立:建立了番泻叶、苦杏仁、西洋参的薄层色谱定性鉴别方法;建立了高效液相色谱法测定通便胶囊中番泻苷A、番泻苷B的含量测定方法。含量测定条件为:WatersSunf1reC18(250mm×4.6mm,5μm)色谱柱:以乙腈(A)-0.1%磷酸(B)作为流动相,洗脱条件为:0→50min,(A)20%;50→51min,(A)20%→95%;51→60min,(A)95%;60→61min,(A)95%→20%;61→70min,(A)20%,流速 1.0mL/min,柱温30℃,检测波长为271nm。通便胶囊每粒含番泻苷A、番泻苷B不得少于1.575mg。实验结论确定了通便胶囊的最佳制备工艺并建立了质量标准,方法合理可行,稳定可靠,能有效控制该制剂的质量,为其开发成保健食品奠定了基础。
[Abstract]:Objective in recent years, the number of patients with diabetes mellitus constipation is increasing, and the pathogenesis is complicated, which is regarded by TCM as a manifestation of the disorder of qi and blood yin and yang. At present, the market has defecated health food, but different formulations and applicable population. This formula is composed of Senna leaf, bitter almond and American ginseng. It is expected to improve the constipation of diabetes mellitus. In this paper, the extraction process and molding technology were selected, and the quality standards were studied. Experimental methods: the extraction technology of Tongbian capsule, molding technology and quality standard were studied in three aspects: 1. After consulting pharmacopoeia and related documents, To determine the extraction solvent and extraction method of index and pharmacological active components in three kinds of drugs. Senna leaf was used as the later drug. Based on the single factor experiment of ethanol concentration and extraction time, three level orthogonal experiments were designed for four factors (ethanol concentration, ethanol doubling, extraction time, extraction times). The content of pharmacological active components of sennoside A and sennoside B was taken as the index to determine the optimum process, and the three factors of bitter almond design (water doubling, extraction time, extraction time) were used to determine the optimum process. The optimum extraction process was determined by the content of amygdalin and the yield rate of dried ointment in the 2015 edition of the Chinese Pharmacopoeia. Four factors (ethanol concentration, ethanol doubling, extraction time, extraction times) were designed to determine the optimal extraction process by using total ginsenosides as index components. The kinds of auxiliary materials were determined, the concentration of wetting agent and the ratio of wetting agent in wet granulation were investigated, and the angle of repose and critical relative humidity of semi-finished granules were measured. 3 quality control standard: in order to ensure the stability of the preparation and facilitate the quality control of the preparation, this paper preliminarily formulates the quality standard from the qualitative and quantitative aspects. Senna leaf, bitter almond and American ginseng were identified by TLC, and the active components of Tongbian capsule were determined by HPLC. Results 1 extraction of Senna leaves: the best alcohol extraction process was: 1. E1 times G1 ethanol concentration, F1 extraction times, each time T1. Concentrate to about 1.15, put in 50 鈩，

本文编号：2068490