Full
Outline
To optimize the dry granulation process of Shufeng Jiedu (SFJD) Capsules placebo based on the similarity of the dosage form characteristic attributes and visual characteristic attributes.
The technological parameters including horizontal speeds, rotate speed of roller and pressure rollers were screened by single factor experiment as well as L9(34) orthogonal experiment, taking particle formation rate, friability, value of chromatism and comprehensive in granulation process as indexes, and then, the optimum process was verified. On this basis, the physical properties of content particles were determined respectively, including angle of repose, loose and tap bulk density, moisture content and disintegration time, to evaluate the consistency of characteristic attributes of dosage form between the formed placebo and SFJD Capsules; and the chromatism value of the particles was determined to evaluate the consistency of visual characteristic attributes.
The optimized process parameters were as follows: horizontal speed 34 r·min-1, press roll speed 6 r·min-1 and press roll pressure 1.2×106 Pa. Through the process validation of three batches, it was shown that the particle forming rate of SFJD Capsules placebo prepared under the optimum process was between 73.67% and 75.87%, the friability was between 45.50% and 46.39%, the chromatism value was between 2.34 and 4.11. In the granule state, the dosage form characteristic properties as well as visual characteristic properties of placebo were consistent with those of the test preparation.
The optimized dry granulation preparation technology is feasible, reasonable and stable, which produces good flakes continuously and granules with color uniformity, suitable rigidity and good formability. And both the dosage form characteristic properties and visual characteristics properties of the placebo are consistent with the contents of SFJD Capsules.
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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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