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yxfbbiedtj · Wysłany: Śro 4:28, 16 Mar 2011

Qi granules preparation and quality control

00/0.5 method for the determination. Methods polarimetry. Take the test amount, accurately weighed, dissolved in water and diluted into children per 1II solution containing 60nag to determine the optical rotation of hydroxyethyl starch 200/0.5, and further determination of hydroxyethyl starch 200/0.5 content. Determination of the results of optical rotation and specific rotation after conversion [] calculated the ratio of content, limits development of a 102.0% to 97.0%. Conclusion This method is simple, fast, accurate and reliable and can be used to determine the content of hydroxyethyl starch 200/0.5. [Key words] Polarimetry; hydroxyethyl starch 200/0.5; determination of hydroxyethyl starch 200/0.5 is widely used in the treatment capacity of plasma extender, as close to its structure and glycogen , the lowest incidence of allergic reactions in recent years, a higher evaluation. Hydroxyethyl starch 200/0.5 API amylopectin by high branch by acid hydrolysis, obtained after hydroxyethylation,[link widoczny dla zalogowanych], low degree of substitution is a medium molecular weight hydroxyethyl starch. Chemical Name: Poly (0-2 a-hydroxyethyl) starch,[link widoczny dla zalogowanych], hydroxyethyl starch 200/0.5 common name 【1J. The quality of the author of the study of hydroxyethyl starch. Hydroxyethyl starch 200 1 reagent (lot number: 070301,070302,070303) from Hangzhou of East China Pharmaceutical Co., Ltd. to provide China and the U.S.. Hydroxyethyl starch 200 (batch number: 060201,060202,060203) from Chifeng Pharmaceutical (Group) Co., Ltd. to provide. Hydroxyethyl starch 200 reference standard for Hangzhou of East China Pharmaceutical Co., Ltd. Sino-US imports of hydroxyethyl starch injection from the extract, measured by GPC-MALIs law molecular weight of 21.68 million. 2 Determination to take loss on drying under the test appropriate, accurately weighed, dissolved in water and diluted into each 1mL contains 60mg of the solution, according to measured optical rotation ¨ (Chinese Pharmacopoeia 2005 edition Appendix Ⅵ E),[link widoczny dla zalogowanych], the following formula calculate the content of hydroxyethyl starch 200. Content (%). Other × 100%. C: 1mL containing the amount of hydroxyethyl starch 200 (g) 2.1 Determination of conditions of equipment: AUTOPOL1V Automatic Polarimeter, WZZ Automatic Polarimeter-1, PE a 241 automatic polarimeter,[link widoczny dla zalogowanych], tube length: 1dm, water bath temperature : 20 ℃. Hydroxyethyl starch 200 2.2 Specific rotation value of the reference substance +188.5. Received date :2008-09-23 Author: Tieling City Drug Control, Liaoning, said precision determination of Tieling 112000 learn about 0.6g of dried reference substance 2 200 copies of hydroxyethyl starch, dissolved in water, made 0. 06g/mE solution. 3 sets of different manufacturers were measured on a polarimeter rotation, rotation than calculated,[link widoczny dla zalogowanych], the results shown in Table 1. According to the measured results, than the value set at +188.5 curl. . Table 1 hydroxyethyl starch reference standard for determination of 200 rotation results than the results of three batches of 3 results were found to be determined. Table 2. Table 2 Determination results of hydroxyethyl starch 200 Lot 070301070302070303060201060202060203 content (%) 99.599.699.298.7100.599.84 discuss product is a polymeric oxygen (2 - hydroxyethyl) a starch hydrolyzate not with the general capacity analysis and instrumental analysis determined content. I refer to 2005 edition of two agents and dextran, and glucose and preparations [2 and other varieties of items, with the determination of optical rotation and specific rotation translated [0 /. ]. 20 ℃ to calculate the ratio of content, will limit development of a 102.0% to 97.0%.