降脂灵的制备工艺及质量标准研究

【作者】 王霞；

【导师】 李小芳；

【作者基本信息】 成都中医药大学 ， 中药药剂学， 2005， 硕士

【摘要】 降脂灵是由丹参、川芎、制何首乌等五味中药制成的复方制剂,具有养血活血,化饮除湿的功效。主要用于治疗痰湿血瘀型高脂血症。 本课题以中医药理论为指导,运用现代制药技术,对降脂灵进行临床前药学部分的研究。方中三七为贵重药材,将其打粉入药,并在成型时作为一种赋形剂,达到“药辅合一”的效果。然三七味苦,而咀嚼片要求口感好,因此以口感为指标,对三七的粉碎粒径进行考察,发现三七打成超微细粉后,口感细腻,苦味消减并带回甜。同时气流超微粉碎是在全封闭无粉尘的系统中进行,可有效避免外界污染。方中其余四味药,根据其成分、理化性质以及现代药理研究,采用正交试验方法,以多指标综合评分,筛选出最佳提取工艺条件:制何首乌、泽泻两味药材加6倍量70%乙醇回流3次,前两次各1.5h,第三次1h;醇提后的药渣与丹参、川芎加6倍量水合煎3次,每次1.5h。醇提液用滤布(350目)滤过除杂,水提液采用离心(5000r/min)方法除杂。除杂后的醇提液和水提液分别浓缩成相对密度为1.10(60℃)的清膏,均匀混合后喷雾干燥。喷雾干燥粉末与上述三七超微细粉混匀,加入1.0%甜蜜素,0.8%柠檬酸,5%微晶纤维素成型。 同时,对该制剂进行质量标准和初步稳定性的研究。按照《中国药典》2000版一部附录ID项下对三批中试样品进行重量差异、微生物、重金属和砷盐检查。采用TLC对降脂灵中的丹参、川芎等五味药进行定性鉴别,其专属性强,检出斑点清晰。据文献资料报道,制何首乌中所含的大黄素为降脂的有效成分,故采用高效液相色谱法对样品中大黄素进行含量测定,控制降脂灵产品质量。 研究结果表明,该制剂制备工艺合理可行,质量稳定可控。更多还原

【Abstract】 Jiangzhiling is a kind of compound medicament made by Radix Salviae Miltiorrhizae, Rhizoma Ligustici Chuanxiong, Radix Polygoni Multiflori praeparata cum succo glycines sotae etc. five Chinese medicine, which has the function of nourishing and activating the blood, and can also dissolve the wet in the body. It is mainly used to cure Hyperlipemia caused by block of blood and phlegm.Guided by Chinese medicine theory, operating the modern technology of pharmacy, the disquisition is focused on the medicament before clinic use of JiangZhiLing. In addition, because Radix et Rhizoma Notoginseng in the prescription is precious, so it should be smashed into powders first, then put into medicament. Meanwhihe, the powder of Radix et Rhizoma Notoginseng also can be used as excipients which could achieve the effect of "medicine and adjuvants become one". But Radix et Rhizoma Notoginseng tastes bitter either, while chewable tablets require good tastes; so considering tastes as an index, inspect the powder diameter of it. As a result, if smash Radix et Rhizoma Notoginseng to super-micro powder, it would be fine. At the same time, the super-micro smashing be air current is full-sealed and without dust, meaning it can avoid pollution outside effectively and control the microbes and dusts in medicament. About other four herbs in prescription, according to their components, physical and chemical nature charastic and modern pharmacological researchment, decide to use crosscing-experiment; use certain kinds of indexes to evalvate; and sift the best abstracting conditions: add 6 mutliple, 70% Ethanol to Radix Polygoni Multiflori praeparata cum succo glycines sotae, Rhizoma alismatis, then eddy them for 3times, 1 h the last; the medicine dregs after Ethanol-extracting would be put with Radix Salviae Miltiorrhizae and Rhizoma Ligustici Chuanxiong together, then add 6 mutiple water to decoct for 3 time, 1.5h a time; filter the Ethanol-extracting fluid directly by filter-clothes (350nets); get rid of impurity of water-extracting fluid by separated machine (5000r/min) ; condense the Ethanol-extracting and water-extracting after purity to the paste with density更多还原