Objective This study aims to conduct a compatibility testbetween human fibrinogen and inner packaging materials throughaccelerated testing, explore the stability of drugs, determine whetherinner packaging materials have an impact on product quality, and providenecessary information for formulation design, packaging, transportation,and storage. Methods Conduct accelerated testing using 3 batches of testsamples, and place them upright and inverted at a temperature of $\left({{25}\pm 2}\right){}^{\circ }\mathrm{C}$ for6months. During the experimental period, samples were taken at theend of the third and sixth months respectively, and tested according tothe accelerated stability key inspection items (appearance, vacuumdegree, reconstitution time, visible foreign matter, osmotic pressuremolar concentration, stability test, moisture, $\mathrm{{pH}}$ value, purity, total amountof human fibrinogen, coagulation activity, arginine hydrochloride,citrate ions, sterility test), and compared with the results of Month 0. Results After being stored at ${\left({25}\pm 2\right)}^{\circ }\mathrm{C}$ for6months, the relevant migration products met the requirements, andthere were no significant changes in the activity indicators. Otherbiochemical detection indicators met the requirements of the ChinesePharmacopoeia (2020 edition, Part III), and there were no significantdifferences in the changes of the detection results of each indicator. Conclusion The selected packaging system has no adverse effects on thequality of human fibrinogen, and the drug quality in the selectedpackaging container is stable and controllable, which can maintain itssafety and effectiveness in use. The inner packaging material has nosignificant impact on the quality of the formulation and has goodcompatibility.
| 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 |