Study On New Production Technological Process Of Tongluo Shenggu Capsule

Osteonecrosis of femoral head (ONFH) was a pertinacious illness, because whole mechanism has not obtained and there is no a better therapy on it. "TongLuoShengGu Capsule" was a new national drug and industrialized developed for treating ONFH, it could activate the blood and eliminate the stagnant, tonify the kidney and strengthen the bone, relieve the swelling and remove the pain. The capsule have been used to cure the ONFH for ten years and got confirmed effect.Pigeon pea leaves was the main raw material of the "TongLuoShengGu Capsule", and was extracted by decoction and heat water reflux extraction in the traditional extraction. In the present study, the yields of total flavonoids and vitexin have used as index to optimize microwave-assisted extraction (MAE) parameters and MAE was compared with heat water reflux extraction. Those studies can provide strong supports for improve the curative effect of "TongLuoShengGu Capsule" and utilizing resource of pigeon pea. The results as follow:A RP-HPLC method for determination of vitexin and the colorimetric assays for total flavonoids were developed and as follow:The chromatographic column was Diamonsil C18V (5μm,250 mm×4.6 mm I.D.), mobile phase was methanol-water-formic acid (35:64.9:0.1, v/v/v), flow rate was 1 mL/min, injection volume 10μL, PAD at 338.7 nm, and column temperature:35℃.Three colorimetric assays were compared to determine the total flavonoids with vitexin and rutin as control in pigeon pea leaves. The results indicated that Al(NO)3 colorimetric assay was most appropriate for the determination of total flavonoids with rutin as control. The content of the total flavonoids in pigeon pea leaves was 9.14 mg/g DW.The microwave-assisted water extraction of flavonoids from pigeon pea leaves was optimized, and the optimum extraction parameters were as follows:Apparatus power,500 W; Material particle size,50 mesh; Extraction time,5 min; Extraction temperature,65℃; Ratio of liquid/solid,20:1 (mL/g); Extraction cycles,3 times. Under the above optimum conditions, the yield of the total flavonoids and vitexin were 12.47 and 0.49 mg/g DW, respectively. from pigeon pea leaves, with extraction ratio of 91.8% and 82.7%, respectively.The microwave-assisted water extraction and the heat water reflux extraction were compared to yield of flavonoids, the results indicate that show the yield of total flavonoids and vitexin over 29.6% and 50.0% than reflux extraction, respectively. But the time of microwave-assisted water extraction is only 1/12 of reflux extraction.Preparation Process of raw material for "TongLuoShengGu Capsule" was modified and content of the effective components were increased in this study, it provides strong support for improve the curative effect to ONFH.