收藏切换
Study on the compatibility of human fibrinogen with inner packaging materials
收藏切换
PDF
Fan HUANG1, 2, *, Zhi-Hua DENG1, 2, Yi HUANG1, 2, Li-Ling ZHANG1, 2
Laboratory Testing | 2024, 2(9) : 119 - 121
Less
收藏切换
Laboratory Testing | 2024, 2(9): 119-121
Evaluation and Analysis
Study on the compatibility of human fibrinogen with inner packaging materials
Full
Fan HUANG1, 2, *, Zhi-Hua DENG1, 2, Yi HUANG1, 2, Li-Ling ZHANG1, 2
Affiliations
  • 1 Guangdong Danxia Bio-pharmaceutical Co., Ltd. Shaoguan 512029 China
  • 2 Guangdong Plasma Protein Engineering Technology Research Center Shaoguan 512029 China
Outline
收藏切换

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.

human fibrinogen  /  internal packaging materials  /  compatibility
Fan HUANG, Zhi-Hua DENG, Yi HUANG, Li-Ling ZHANG. Study on the compatibility of human fibrinogen with inner packaging materials[J]. Laboratory Testing, 2024 , 2 (9) : 119 -121 .
Year 2024 volume 2 Issue 9
PDF
28
13
Cite this Article
BibTeX
Article Info
  • Online Date:2025-07-29
Article Data
Affiliations
History
Affiliations
    1 Guangdong Danxia Bio-pharmaceutical Co., Ltd. Shaoguan 512029 China
    2 Guangdong Plasma Protein Engineering Technology Research Center Shaoguan 512029 China

Corresponding:

*HUANG Fan, Master, Engineer, Guangdong Danxia Bio-pharmaceutical Co., Ltd., Shaoguan 512029, China. E-mail:
References
Share
https://castjournals.cast.org.cn/joweb/sysjc/EN/
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT