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目的:在避免使用助溶剂的情况下解决盐酸川芎嗪氯化钠注射液长期放置后易析出细小白点、白块等可见异物问题。方法:选择柠檬酸钠作为本品pH调节剂,调节药液pH至4.0,使川芎嗪尽量以盐形式溶解于溶液中,对按改进处方制备的3批中试产品进行影响因素试验、长期稳定性和加速稳定性试验。结果:改进后处方为盐酸川芎嗪0.8 g,氯化钠9.0 g,加注射用水制成1 L,加适量10%枸橼酸和10%枸橼酸钠调节药液pH。3批中试产品在室温(25±2)℃留样24个月、加速试验(40±2)℃6个月及影响因素试验条件下,产品质量稳定,未出现细小白点、白块。结论:改进后处方与制备方法稳定可行。pH调节剂的变更未使药物物质基础发生改变,不影响药品的质量可控性、安全性和有效性,且药物稳定性更好。
Objective: To avoid the use of cosolvent solution of ligustrazine hydrochloride sodium chloride injection after long-term easy to precipitate fine white spots, white blocks and other visible foreign body problems. Methods: Sodium citrate was selected as the pH adjusting agent of this product. The pH value of the liquid was adjusted to 4.0. The ligustrazine was dissolved in the solution as much as possible in the form of salt. Influencing factors were tested on 3 batches of pilot products prepared according to the improved prescription. Sexual and accelerated stability test. Results: The modified prescription was ligustrazine 0.8 g, sodium chloride 9.0 g, water for injection 1 L, and proper amount of citric acid 10% and sodium citrate 10% to adjust the liquid pH. Three batches of samples were left for 24 months at room temperature (25 ± 2) ℃ and accelerated for 40 months (40 ± 2) ℃ for 6 months. Under the experimental conditions of influencing factors, the product quality was stable and no white spots and white spots appeared. Conclusion: The improved prescription and preparation method are stable and feasible. Changes in pH adjuster did not change the basis of the drug substance, did not affect the quality of the drug controllable, safe and effective, and drug stability better.