Polyene Phosphatidyl Choline Separation And Preparation Process Of Research

Polyene phosphatidyl choline is always applied in treatment of liver disease. Our country depends on importation of the raw material to produce polyene phosphatidyl choline injection. The high cost of material restricts the development of this preparation and therefore keeps the selling price of product drug up. This research focuses on isolating polyene phosphatidyl choline from granulesten and purifying it, and tries to find out the preparation of polyene phosphatidyl choline injection.Based on previous researches, this one mainly does the following research:Research on isolation process of polyene phosphatidyl choline and optimization of technological conditions.Exploration of the technology of isolating polyene phosphatidyl choline with urea adduction fractionation.Research on preparation of polyene phosphatidyl choline injectionThrough the preceding experiment, the following conclusion can be obtained:1) Make sure that it is an easy approach to isolate polyene phosphatidyl choline from granulesten. The technology of neutral A12O3 used as column to isolate polyene phosphatidyl choline is obtained. 90% ethanol is uesd as eluent in the process of A12O3 column choromatography purifying PC, flow rate 4ml/min, biggest load 0.08gPC·(gA12O3)-1.. Under such technological condition, purity of this product is up to 99%, its yield 69.19%, iodine value 96-115, and phosphorus content and peroxide value are up to the level of the same products in Lipoid company.2) It is not feasible to isolate polyene phosphatidyl choline with Urea Adduction Fractionation. Too many branched chains are in the structure of lecithin, therefore, urea is impossible to form inclusion compound for it.3) This research obtains the technological recipe and the preparing technology of polyene phosphatidyl choline injection. The formula of 1000ml preparation is as follows: polyene phosphatidyl choline (principal drug)50g, sodium deoxycholate (surfactant, micelle stabilizer)26g, benzyl alcohol(bacteriostatic agent, micelle stabilizer)9g, NaOH(PH adjustor), injection water up to 1000ml. This formula meets the requirements of product quality, and has good stability.The innovation of this research lies in: 1) The whole experiment is under protection of anti-oxidation, such as N2, in order to make sure that polyene phosphatidyl choline obtained by isolation is not oxidized.2) Attempt to isolate polyene phosphatidyl choline with urea adduction fractionation.