A Study On Preparation Of Tang Mai Ning Granule

Objective: To develop a new traditional Chinese Medicine dosage form-Tang Mai Ning Granule, which is used to cure type II diabetics who are in both Qi and Yin weakness.Methods: Orthogonal Design is adopted to optimize the technological process of the ethanol extract from the materials such as Radix Gingseng, Radix Puerariae, Radix Polygoni Multiflori according to the content of Ginsenoside-Rgl, the aqueous extract from the materials such as Radix Rehmanniae, Radix Asparagi, Fruetus Lycii according to the content of catalpol. The optimal extract process parameters of volatile oil from Rhizoma Zedoariae is obtained also by Orthogonal Design. The optimal parameter of including volatile oil with p-cyclodextrin (P-CD) is determined. The proper excipient and its ratio in the whole Granule are 6ptimized by the content of Powder Ratio and its Absorb Moisture Rate. A research on quality control of the Granule is carried out, including the quantitive control of Ginsenoside-Rgl by Thin Layer Chromatography (TLCS) and the qualitative control of the rest herbs in the Granule. The effect and the safety of the Granule are also tested by lab animal experiment.Results: The ethanol extract process is that the herbs are extracted five times with 70% ethanol for 3 hours each time. The optimal volatile oil extract process is that the herb is added 15 times herb volume water, soaked 6 hours, and heated 6 hours. The technological process of including volatile oil is that P-CD with volatile oil [5:l(g/g)]is stirred 2 hours at 40℃. The aqueous extract process is that the herbs is added 10 times volume of water, heated for 1 hour twice. The optimal excipient is lactose and dextrin. The average recovery rate of Ginsenoside-Rgl is 97.47%, RSD=1.84%.Conclusion: The optimized process is stable and feasible. The quality of the Granule can be controlled. The animal experiments prove that the Granule possesses the apparent effect of blood sugar reducing and it is safe and innocuous.