Full
Outline
To optimize the preparation process of Qiwei Chanshen Capsules (QCC) and conduct quality standard research.
Using the comprehensive scores of molding rate, drying weight loss, moisture absorption rate, solid density and angle of repose as characteristic index, the preparation technology of QCC was optimized using Box-Behnken design-response surface method combined with G1-entropy weight method with regard to the factors such as drug dosage, wetting agent (ethanol) concentration and drying time. Moisture, volume difference, disintegration time limit were checked. TLC method was used for qualitative identification. HPLC wavelength switching method was used to simultaneously determine the contents of 3 components with anti-tumor effect, such as epicatechin, camptothecin, and ginsenoside Rb1.
The best preparation process was as following: the dosage ratio of drug to adjuvant was 1∶1.15, the wetting agent (ethanol) concentration was 91%, and drying time was 117 min. The moisture, volume difference and disintegration time limit of the capsule were in line with Chinese Pharmacopoeia. TLC identification is highly specific. The linear ranges of the 3 components with anti-tumor effect were 0.52~16.74 μg·mL-1 (r=0.999 6), 0.68~21.68 μg·mL-1 (r=0.999 9), 6.70~214.49 μg·mL-1 (r=0.999 7), respectively. RSDs of precision, stability and reproducibility tests were lower than 3%. The average recoveries were 97.11% (RSD=1.73%, n=6), 99.33% (RSD=1.68%, n=6), 99.18% (RSD=2.21%, n=6), respectively. The content of them were 0.158 8, 0.196 7, 3.091 3 mg·g-1.
The preparation process of QCC is stable and feasible. The quality control method is comprehensive and systematic.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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