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OBJECTIVE To evaluate the quality consistency for the different qualities of Chinese medicine preparation (PCM) with the same raw material? and develop a method for measuring dissolution rate of Ginkgo biloba leaves tablets(GLT) as a model by flow-through cell(FTC) method. METHODS A closed-loop flow tank system was adopted, the GLT were placed in the circulating tank which was preloaded with glass beads, taking 150 mL water as the dissolution medium, with the flow rate of 8 mL·min-1, the temperature was (37±0.5) ℃, the pulse frequency was 0 Hz, and sampling 3 mL each at 30, 60, 120, 180 and 240 min, respectively, at the same time, 3 mL of preheated fresh dissolution medium were replenished. HPLC analysis was conducted to determine the contents and cumulative dissolution rates of five ingredients (manghaslin, clitorin, rutin, nicotiflorin and narcissoside), and corresponding dissolution curves were plotted. Nine batches of markerted GLT from three manufactures were determined, and their similarity factors and dissolution models were fitted. RESULTS The contents of five flavonoids glycosides in GLT from the same specification of different manufacturers were consistent, but their cumulative dissolution rates in 4 hours were from 10% to 90% within different batches from different manufacturers, and most of them were lower than the conventional standard of 70%. It indicates that although the raw materials are same, different production processes details may lead to great differences in marketed product qualities and clinical efficacy. Therefore, to ensure the effectiveness and consistency of the quality of PCM, it is very important to carry out dissolution rate inspection in PCM quality standard. CONCLUSION The established FTC dissolution test method can distinguish the dissolution behavior of samples from different manufacturers, which could reflect the influences of technology and prescription on product quality, which has important practical value for regulating medicinal production.
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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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