Study On Compound MLN Injection

Guided with the theory of traditional chinese medicine and the requirements of morden Chinese pharmaceutical industry, the research group has developed the Compound MLN injection. Compound MLN injection is a intravenous injection which is prepared from extracts of Jinyinghua; Niuxi; Xuanshen and Shihu, Its functions is promote blood circulation to remove blood stasis; Nourish yin and dregging the meridian. It can be used to treat Thrombo angiitis Obliterans (TAO), venous thrombosis, Athero sclerotic occlusion (ASO), Transient cerebral ischemic attack (TIA), Thrombosis and Sequelae, etc. The MLN Injection has many limitations itself, such as unstable, precipitation in the storation, unconvence of transportion, etc. The issue is to slove these limitations, and developed Frozen Powder Injection, which is stable, easy to portable and storation.The main research of this subject include the literature; preparation; quality standard and preliminary stability of Compound MLN injection. The literature summarized the clinical use of MLN injectinon, the main ingredients; quantative and qualitive of jinyinghua; Niuxi; Xuanshen and shihu. And the freezing technique of related literature, It developed a good base for the research for Compound MLN injection.In the process of experiment research, the test results of Chinese Materia Medica are in accordance with Pharmacopoeia of the People’s Republic of China 2005 edition(sectionⅠ).In the research of technics, the research group pick out the best method of extraction with the orthogonal experiment; take the effective components Chlorogenic acid and Cinnamic Acid, as quality control indications. The result is the best extraction technology as follows, adding 8 times amount of 60% Ethanol to extracting, decocting for 3 times, 1.5 hours each time. the research group also researched the separation; puriation; concentration; dtying and fluid preparing, The result is the add 1 time water to extraction liquid, stir well-distributed, and then keep temperature at 95℃with 30 minutes, then cold storage at 4℃for 24 hours, then offcenter, regulate the liquid of pH at 2.0, use 2 Volumes of Ethyl Acetute to the liquid extracting 6 times, then recycle Ethyl Acetute, and the extract and the Injection water to separate the useful elements of Compound MLN injection, then concentrate and dry the liquid of extraction; In molding and the drying technics, add 300mg of Mannitol per Compound MLN injection, regulate the pH to 7.0-8.0, and wipe off the pyrogens by membrane separation technology and adsorption of Photocatalytic, sterilization by filtration, and drying at the Freez-drying Curve in Freez-drying machine. All these are the pipeline of Compound MLN injection technology.In the research of quality standard, jinyinghua. Niuxi. Xuanshe and shihu were identified by TLC; Meanwhile, we researched the check item of Compound MLN injection(such as visible particles; Sub-visible Particles; pH; related substance; Heavy metals; Arsenic; Microbial Contamination; pyrogens; etc. And the content of Cinnamic Acid was determined by HPLC. The preliminary quality standard of Compound MLN injection has been established.In the experiment of preliminary stability(6 months Acceleration stability and 12 months Long-term stability), the appearance, Distinction, Inspection and the quantity of Cinnamic acid in Compound MLN injection were stable, and predict the period of validity is 2 years.