论文部分内容阅读
目的:研究障眼明分散片提取与制剂成型工艺;以葛根素作为对照品,建立HPLC法控制障眼明分散片的质量。方法:制备工艺以葛根素提取总量与崩解时限等为考察指标;含量测定采用Hypersil BDS C18色谱柱(5μm,4.6mm×200mm),用甲醇-水(25∶75)为流动相,检测波长250nm,柱温30℃,流速1.0mL/min。结果:障眼明分散片在3min内迅速崩解且全部颗粒通过2号筛,分散均匀,葛根素含量在0.1699～1.3594μg范围内呈良好线性关系,得回归方程y=3.054×106x-24019(r=0.9998),平均加样回收率及RSD分别为100.03%和1.79%。结论:障眼明分散片制备新工艺合理可行,以葛根素为对照品,采用HPLC法控制障眼明分散片质量的方法简便快速、准确可靠、重现性好、专属性强。
OBJECTIVE: To study the process of extraction and preparation of barrier disintegrant tablet. The puerarin was used as a reference substance to establish the HPLC method to control the quality of dismembered tablets. Methods: The preparation process was based on the total amount of puerarin extracted and the time of disintegration. The content was determined by Hypersil BDS C18 column (5μm, 4.6mm × 200mm) with methanol-water (25:75) as the mobile phase. Wavelength 250nm, column temperature 30 ℃, flow rate 1.0mL / min. Results: Baoganming dispersible tablet disintegrated rapidly in 3min and all particles passed through No.2 sieve. The results showed that there was a good linear relationship between the content of puerarin and 0.1699 ~ 1.3594μg. The regression equation was y = 3.054 × 106x-24019 ( r = 0.9998). The average recoveries and RSDs were 100.03% and 1.79% respectively. CONCLUSION: The new process of preparation of barrier ocular surface dispersible tablets is reasonable and feasible. The method of using puerarin as reference substance to control the barrier ocular surface dispersible tablet quality is simple, rapid, accurate, reliable, reproducible and specific.