脾氨肽口服冻干粉多肽含量检测数据
收藏浙江省数据知识产权登记平台2024-01-11 更新2024-05-08 收录
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脾氨肽口服冻干粉,为免疫体调节剂。用于治疗细胞免疫功能低下、免疫缺陷和自身免疫功能紊乱性疾病,主要成份为多肽,多肽的含量是指多肽在其中的质量百分比,由于多肽冻干粉末中不仅仅包含多肽,还包含有一些非肽的组分,如水,溶剂、盐等,所以多肽含量的检测尤为重要,检验人员严格按照检验操作规程进行检验和完成相关的记录,为本企业及同行业企业的多肽含量检验提供依据。1、按照紫外线分光光度法,分别测得浓度C1、C2、C3,再按照以下公式来得出多肽含量,
多肽含量C1%=浓度C1*容量瓶含量/2000*100%
多肽含量C2%=浓度C2*容量瓶含量/2000*100%
多肽含量C3%=浓度C3*容量瓶含量/2000*100%
2、按照药典的相关规定,每瓶含脾氨肽以多肽计算应为标示量的82.0%-120.0%,三次多肽含量都符合这个标准,方为合格,数据中采用IF函数来判定。
Spleen Aminopeptide Oral Lyophilized Powder is an immunomodulator. It is used for treating diseases associated with cellular immune hypofunction, immunodeficiency and autoimmune disorders. Its main active component is polypeptides. The polypeptide content refers to the mass percentage of polypeptides in the preparation. Since the lyophilized powder not only contains polypeptides but also non-peptide components such as water, solvents and salts, the detection of polypeptide content is particularly critical. Inspectors shall conduct tests and complete relevant records strictly in accordance with the standard test operating procedures, which provides a reference for polypeptide content detection of this enterprise and other enterprises in the same industry.
1. The ultraviolet spectrophotometry is adopted to measure the concentrations C1, C2 and C3 respectively, and the polypeptide content is calculated via the following formulas:
Polypeptide content C1% = (Concentration C1 × Volumetric flask volume) / 2000 × 100%
Polypeptide content C2% = (Concentration C2 × Volumetric flask volume) / 2000 × 100%
Polypeptide content C3% = (Concentration C3 × Volumetric flask volume) / 2000 × 100%
2. In accordance with the relevant provisions of the Chinese Pharmacopoeia, the content of spleen aminopeptide per bottle, calculated as polypeptides, shall be 82.0% to 120.0% of the labeled amount. A sample is qualified only when all three polypeptide content test results meet this standard. The IF function is used for the qualification judgment in this dataset.
提供机构:
浙江丰安生物制药有限公司
创建时间:
2023-11-20
搜集汇总
数据集介绍

特点
该数据集记录了脾氨肽口服冻干粉的多肽含量检测数据,包含批号、容量瓶容量、浓度及多肽含量等关键信息,适用于免疫调节剂的质量控制和检验。
以上内容由遇见数据集搜集并总结生成



