六神曲配方颗粒的制备工艺研究

Study on the Preparation Technology of Liushenqu Dispensing Granules

目的:以生物活性为指标,研究六神曲配方颗粒的制备工艺。方法:采用正交试验,以淀粉酶活性和出膏率为指标,考察提取工艺参数;以淀粉酶活性为指标,考察浓缩工艺;以干膏粉淀粉酶活性和含水量为指标,考察喷雾干燥工艺;以颗粒的性状和得率为指标,考察干法制粒工艺。结果:六神曲配方颗粒的最佳制备工艺为六神曲饮片40℃水浴提取3次,每次1h,加10倍量饮用水;50℃减压浓缩至相对密度1.08(50℃),经喷雾干燥制成干膏粉,加适量辅料混匀后进行干法制粒制成颗粒。结论:通过3批验证工艺,验证所得颗粒淀粉酶活性为55.37U(RSD=3.85%,n=3),表明该工艺稳定可行。

Objective：Based on the efficacy of biological activity to study the dispensing granules of Liushenqu. Methods-Taking enzyme activity of a-Amylase, yield of solid extracts as indexes, orthogonal test was enployed for optimize the extraction parameters. The temperature of vacuum concentration was screened by enzyme activity of a--Amylase. Taking enzyme activity of a-Amylase and extract powder yield to screen the parameters of spry drying technology. The parameters of dry granulation were screened by gran- ules property and granules yield. Results. The optimal preparation technology of Liushenqu dispensing granules was as follows as in bath at 40℃ ,adding 10 folds water, extracting for 3 times,lasting for 1. Oh each time;vacuum concentration temperature 50℃ and relative concentration density 1.08（50℃）;powdered extract prepared by spray drying method, and mixed with appropriate excipient to prepare granules by dry granulation. Conclusion. In 3 batches of validation testes, the enzyme activity of a-Amylase was 55. 37U（RSD： 3.85%, n= 3）. The technology is stable and feasible.