Study On Preparation Technology And Quality Standard Of Thymalfasin For Injection

Thymalfasin(T?1)exists as a factor that regulates immunity,and its structure is composed of 28 amino acids linked.It has a strong promoting effect on differentiation of mature T lymphocytes,and it can also stimulate the secretion of interferon and various lymphokines.Thymalfasin for injection is often used clinically to treat chronic hepatitis B and C.It is also frequently used in diseases such as cancer,immunodeficiency and infection,and it has unmatched clinical practical value.And the market is very promising.Unfortunately,because of its expensive price,imported Thymalfasin for injection(Patheon Italia S.p.A;product name:ZADAXIN)has not formed a scale of drug use in China.At present,there are eight domestic pharmaceutical manufacturers listed on the sale,but the quality of listed drugs varies.According to the National Development[2015]No.44 document,injection of thymalfasin method for the new consistency of the evaluation is listed companies must carry out a work,has been listed on the sale of pharmaceutical production enterprises sooner completion of the work will be the sooner the national policy support,for example,in the tender procurement,clinical application,brochures and label labeling,health insurance reimbursement and other aspects of policy support,will also reallocate market share.Therefore,this subject is in accordance with the requirements of consistency evaluation of thymalfasin injection about preparation process,quality standards and stability on the study,to promote the quality of the product and improve the efficacy of reference.In the preparation process research,reference is made to the prescription excipients of the original research drug,according to the conventional production process of the injection,the compatibility of the raw and auxiliary materials,the amount of phosphate,the pH of the solution,the amount of activated carbon,the stability of the intermediate solution,and the freeze-drying parameters are selected.The prescription and preparation process of the thymus gland for injection was determined,and three batches of pilot samples were successfully prepared on the production line.In the quality standard study,the quality of the three batches of pilot samples was investigated with reference to the registration standards for imported thymus drugs for injection,and the characteristics,identification,pH,and solution of the three batches of pilot samples and the original research drug(ZADAXIN)were performed.The comparison of the clarity and the quality of color,moisture,related substances,content uniformity,content,etc.,proves that the three batches of pilot samples are consistent with the quality of original research drug,and at the same time,the methodological verification of the relevant substances and contents is carried out,including the linear range inspection.Accuracy test,repeatability test,solution stability test,recovery test,and sample determination.The experimental results show that the method used is accurate,sensitive,reproducible,and reliable.The quality standard of the product is established.Three batches of pilot test samples in the stability study have now completed accelerated 6-month and 6-month long-term stability inspections.The test results show that the unknown impurities in the substances are slightly increased,but all within the standard limits;appearance traits,other There were no significant changes in impurities and content;three batches of pilot test samples for bacterial endotoxin and sterility in the months of 0,6 months of acceleration,and 6 months of long-term compliance with the regulations.According to the influencing factor test and the results of the stability test,combined with the storage conditions and the validity period in the manual,the storage condition of the product is defined as:shading,airtight,and stored at 2-8?;the valid period is 24 months.Long-term stay samples continue to be investigated.In this paper,the thymalfasin injection for the new prescription and preparation process,quality standards,quality control and stability and other aspects of a detailed study,through the three batches of pilot samples and the original drug series of quality comparison shows,pilot samples and the original research drug quality consistent with the State Food and Drug Administration to achieve the consistency of the requirements of the assessment,for the current domestic T?1 injection production of pharmaceutical companies to provide a certain reference.