dvd刻录无损音乐:药剂翻译(中文翻译成英文)

来源:百度文库 编辑:杭州交通信息网 时间:2024/04/25 23:07:55
通脉注射液是根据《卫生部药品标准•中药成方制剂》中所收载的通脉冲剂经剂型改革而成的中药新制剂。其处方组成为:丹参500g、葛根500g、川芎500g,共制成500mL。具有活血通脉之功效,用于缺血性心脑血管疾病、动脉硬化、脑血栓、脑缺血等。
本课题按《新药审批办法》中药七类新药的研制要求,主要对通脉注射液制备工艺及质量标准进行系统研究,并对其影响因素和初步稳定性进行考察,为下一步临床试验做好准备。
1 通脉注射液的制剂工艺研究:采用正交试验设计以葛根素、阿魏酸提取量和相对密度三项指标综合评价,考察水煎煮提取工艺、纯化工艺。并以含量及澄明度为指标考察注射液pH值、辅料及活性炭用量,确定通脉注射液制备方法。
2 通脉注射液质量标准的研究:采用薄层色谱法对制剂中丹参酮ⅡA、葛根素、阿魏酸进行定性鉴别;采用高效液相色谱法对葛根素、阿魏酸进行含量测定,并进行方法学考察,建立通脉注射液质量标准。
通过正交试验优选出最佳提取工艺,即10倍水,提取2次,每次煎煮1h。使用0.04%壳聚糖絮凝纯化,用0.2%活性炭除热原,浓缩后调pH至6.8,加入1.6%吐温80制备通脉注射液。采用TCL定性鉴别和HPLC定量测定方法控制通脉注射液质量,建立的质量标准可作为通脉注射液质量标准。

中文翻译成英文

Tongmo injection fluid is based on the "Health standards • Chinese medicine set prescription drug agents," as containing the Tongmo grown by the new type of reform by the Chinese medicine preparations. Its prescription form : Salvia miltiorrhiza 500g, 500g bowl, mixed 500g total from 500mL. Hence the effectiveness of Tongmai for ischaemic heart cerebrovascular disease, arteriosclerosis, Naoxueshuan, brain blood. The topics under the "new vetting procedures" for the development of Chinese medicine seven categories of drugs, mainly to Tongmo injection fluid produced craft and carry out systematic research quality standards, and their impact factors and stability for the initial inspection, clinical trials ready for the next step. 1 Tongmo injection of liquid preparations craft research : using orthogonal tests designed to root Su, Awei acid extraction and relative density of three indicators comprehensive evaluation, inspection ground water extraction process, purification processes. And content to target for inspection and clean injecting fluid pH value, textiles and activated charcoal consumption, identify Tongmai injection fluid produced. 2 Tongmai injection fluid quality standards studies : use of agents in the lamina chromatography Dancantong II a, root Su, Awei acid qualitative identification; Gaoxiaoyexiang chromatography used to root Su, a Ewei acid content measured, and methodology inspection, the establishment Tongmai injection fluid quality standards. Best known for testing through orthogonal extraction processes, water 10 times, from 2, each placed 1h. 0.04% Qiaojutang use external components, using the original 0.2% activated charcoal, hot and enrichment after - pH to 6.8 by adding 1.6% used 80 prepared Tongmai injection fluids. Identification and characterization using HPLC main quantitative measurement methods Tongmai injection fluid quality control, the establishment of quality standards as Tongmo injection fluid quality standards.