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目的:对含天麻超微粉体神安颗粒(超微神安颗粒)与含天麻普通粉体神安颗粒(普通神安颗粒)2种制剂进行剂型和生物利用度的研究,探讨超微神安颗粒的优势。方法:采用浆法对2种神安颗粒进行溶化性、水溶出物量、天麻素溶出度的比较测定,对结果采用t检验进行统计分析,同时按威布尔分布模型进行数据处理。采用HPLC法测定给药后不同时段家兔体内血浆中天麻素的含量,采用DAS软件进行药动学参数模拟,对2种神安颗粒的生物利用度进行比较。结果:超微神安颗粒溶化后肉眼未见颗粒,而普通神安颗粒肉眼可见悬浮的颗粒;超微神安颗粒水溶出物量是普通神安颗粒的1.11倍;威布尔模型分析超微神安颗粒T90 44.50min、m0.7790,而普通神安颗粒T90 66.19min、m0.5978;超微神安颗粒药动学参数分别为:Tmax48.18min,Cmax9.09μg/m L,AUC4848.17mg/L·min,T_(1/2)334.30min;普通神安颗粒药动学参数分别为:Tmax105.45min,Cmax7.30μg/m L,AUC4041.54mg/L·min,T_(1/2)300.91min,超微神安颗粒相对普通神安颗粒的生物利用度为1.1996。结论:超微粉碎技术可以提高神安颗粒的生物利用度。
OBJECTIVE: To study the dosage forms and bioavailability of two kinds of preparations containing Shenmai Granules of Tianma (super micro-Shen An Granules) and ordinary powder of Shenmai Granules (ordinary Shen An Granules) Ann particles advantage. Methods: The dissolubility, the amount of water-soluble matter and the dissolution of gastrodin in two kinds of Shenan granules were determined by the plasma method. The results were analyzed by t-test and the data were processed according to the Weibull distribution model. The contents of gastrodin in plasma of rabbits at different time points after administration were determined by HPLC. The pharmacokinetic parameters were simulated by DAS software. The bioavailability of the two kinds of granules was compared. Results: The results showed that there was no particle in the human eye after dissolving Granule, but the amount of water leached by ordinary Granule was 1.11 times that of ordinary Granule; the Weibull model Granule T90 44.50min, m0.7790, while the general Shenan Granule T90 66.19min, m0.5978; Pharmacokinetic parameters of the Granule Granule: Tmax48.18min, Cmax9.09μg / m L, AUC4848.17mg / L · Min, T_ (1/2) 334.30min. The pharmacokinetic parameters of common Shenan granules were: Tmax105.45min, Cmax7.30μg / m L, AUC4041.54mg / L · min, T 1/2 , Bio-Shen An particles relative to ordinary bioavailability of bio-safety 1.1996. Conclusion: AMD can improve the bioavailability of Shenan granules.