Objective: To determine the optimal preparation conditions for Huangmai granules. Methods: Using single factor screening method and orthogonal design method, the extraction process and granulation process were optimized. Results:The optimal preparation process was as follows:the medicinal materials in the prescription were extracted 3 times with 8-fold amount of water with 2h for each time. The water extract was combined followed by vacuum concentration, and then dried to obtain dry extract. The powder of dry extract was evenly mixed with dextrin at appropriate amount, and the wet granules were prepared with the 40% ethanol followed by drying and size stabilization to obtain the products. Conclusion:The selected preparation process is scientific, reasonable and sta-ble, and suitable for the industrial production.

Objective:To prepare the placebos of Sicao Tongmai capsules to provide the reference for the placebo preparation in clinical trials of traditional Chinese medicines. Methods: Taking the placebo preparation of Sicao Tongmai capsules as the example, the appearance, color and smell of the placebo were assessed by the scoring method and an electronic nose. Results:The appearance, color and taste of the placebo were in line with those of the drug powder, while there was difference in smell. The simulated clinical ex-periments showed that the placebo was difficult to be unblinded. Conclusion:The placebo can be used in TCM clinical trials, howev-er, the production technology should be further improved and modified.

Objective: To establish the preparation method of the placebos for Shenbawei capsules and objectively evaluate the simulation effects. Methods:Using the placebos for Shenbawei capsules as the example, a blind trial was used to assess and score the appearance, color and smell of the placebos. Results: The placebos were basically the same in the appearance, color and taste with the testing drugs. The results of the clinical trial simulation showed that the placebos were difficult to be unblinded. Conclusion:The placebos can be used in the clinical trial for Shenbawei capsules.

OBJECTIVE:To establish a method for the quality control of Huangmai granules and provide reference for the qual-ity control. METHODS:TLC was conducted to identify the Leguminosae in Huangmai granules and HPLC was used to determine the contents of icariin,hyperin and stilbene glycoside in Huangmai granules. RESULTS:The spots on TLC plates were clear with good reproducibility. The results of HPLC showed that the linear range was 9.969-319.0 μg/ml(r=0.999 9) for icariin , 12.3-196.8 μg/ml(r=0.999 9)for hyperin and 12.64-202.2 μg/ml(r=0.999 8)for stilbene glycoside;RSDs of precision,stability and reproducibility tests were all no more than 2.92%;the average recoveries were respectively 95.44%(RSD=1.46%,n=6), 101.06%(RSD=1.90%,n=6)and 100.51%(RSD=1.73%,n=6). CONCLUSIONS:The method is simple,reproducible,accu-rate and reliable,and can be used for the quality control of Huangmai granules.

Objective: To investigate the stability of icariin, 2,3,5,4'-tetrahydroxy-stilbene-2-O-β-D-glucoside and hyperoside in Huangmai mixture.Methods: TLC was used to identify astrogaloside IV and Morindae officinalis Radix, and HPLC was used to determine the contents of icariin, 2,3,5,4'-retrahydroxy-stilbene-2-O-β-D-glucoside and hyperoside.The stability of Huangmai mixture under the conditions of accelerated testing and long-term testing was assessed.Results: Astrogaloside IV, Morindae officinalis Radix and icariin showed good stability during the accelerated testing and long-term testing.The contents of 2,3,5,4'-tetrahydroxy-stilbene-2-O-β-D-glucoside and hyperoside declined quickly during the stability testing.Conclusion: Hyperoside and 2,3,5,4'-retrahydroxy-stilbene-2-O-β-D-glucoside are unstable in Huangmai mixture.A novel solid dosage form of Huangmai should be developed to obtain better stability.