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Outline
Taking Huoling Shengji Granules (HLG) placebo as an example, the quality standards of TCM placebo was discussed using similarity, applicability, controllability and safety as the basic attributes.
On the basis of the quality standards of HLG granule, that of its simulated preparation HLG granule placebo were studied. Besides similarity, the quality control items that embody the other three attributes were established. Artificial evaluation was used to establish the similarity control between the placebo and the tested preparation. Thin layer chromatography (TLC) method was used for the qualitative examination of Atractylodes rhizome, Poria cocos and Astragalus membranaceus. HPLC was used to detect loganin and icariin in limited quantities to establish the applicability and controllability of placebo. The safety of placebo was assessed by numerical statistics of acceptable daily intake (ADI) values of components in the prescription.
Using the method of artificial evaluation and scoring, the similarity between the placebo and the tested preparation was 0.992 5. In TLC, the HLG placebo had no corresponding spots or shallower spots compared to the 10% of the tested preparations and the tested preparation. In HPLC, the content in HLG placebo was lower than that of 10% tested preparations. In addition, the amounts of food additives were within the safe range. In terms of similarity, applicability, controllability and safety, the HLG placebo met the requirements of placebo quality standards.
The quality standard of HLG granule placebo can provide an empirical basis for the formulation of TCM placebo industry standards.
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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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