Full
Outline
To investigate the influencing factors of weight control level of meclofenoxate hydrochloride for injection, and establish the quality control method based on laser diffraction particle size analysis.
The sources of APIs, types of packaging equipment and debugging methods of preparations from different companies were investigated by telephone survey. The crystal form was determined by powder X-ray diffraction. Laser diffraction particle size analysis was used to determine the particle size and particle size distribution, and the diameter was calculated.
For the meclofenoxate hydrochloride for injection produced by direct packing of API, the excessive spans of API and improper bugging methods of packaging equipment were the direct causes of product non-conformity. There was a positive correlation between the span and the RSD value of weight.
This study reasonably explained the reasons for the unqualified weight and content of meclofenac hydrochloride injection and proposed a practical method for the improvement of the production process of the enterprise and a scientific and feasible control acceptance method for the bulk drug used in the packaging, which provides a strong technical support for improving the quality of medicines and reducing the risk of clinical medication.
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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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