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Shandong Binzhou Zhiyuan Biotechnology Co., Ltd.
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Gliomas originate from the ectoderm and are the most common primary tumors of the nervous system, accounting for more than 50% of intracranial primary tumors. Although surgical treatment has significantly improved the survival of patients with glioma, drug therapy is still one of the important means for the treatment of glioma because of the difficulty in radical treatment. According to the 2012 NCCN guidelines, chemotherapy should be adopted except for low-grade, complete resection of gliomas without high-risk factors. Temozolamide, as a new imidazolium tetrazine alkylating agent, easily enters the blood-brain barrier, and its concentration in brain tissue can reach 30%-40% of the blood concentration. It has been widely used in the chemotherapy of central nervous system tumors, especially malignant glioma, and has become a "milestone" in the progress of glioma chemotherapy. It has become a first-line chemotherapeutic drug for malignant glioma. Temozolamide has low solubility (about 3mg/ml) and poor stability in aqueous solution, which makes it difficult to develop intravenous injection. The original research company disclosed a pharmaceutical preparation in the patent CN 03804363. The technical scheme has successfully realized the solubilization of temozolomide in aqueous solution and made intravenous injection possible. However, there are some problems, such as slow dissolution rate and re-dissolution rate, long time of liquid mixing and re-dissolution, and high impurity content, which cause potential safety hazards to patients. Because of the high content of impurities, the appearance of the original developer is light pink powder, while the low content of impurities in Temozolomide freeze-dried powder is white powder. In addition, crystallization is easy to precipitate in the process of liquid mixing. If the temporary storage time of solution exceeds 8 hours, it needs to be filtered again, which brings great trouble to GMP production. The present invention uses glycine and sulfobutyl beta cyclodextrin sodium as solvents, which can remarkably improve the dissolution rate without adding organic solvent, reduce the time of temozolomide existing in solution state in industrial production, and reduce the level of related substances. At the same time, the resolving speed and stability during storage can be improved.
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Shandong Binzhou Zhiyuan Biotechnology Co., Ltd.
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Cyclodextrin and its derivatives can be used as a green food additive - Knowledge - Shandong Binzhou Zhiyuan Biotechnology Co.,Ltd
With the improvement of consumption levels and the yearning for green life, people are increasingly demanding green foods. Natural food additives with excellent comprehensive performance have become the darling of the industry. Naturally occurring additives have a number of disadvantages, mainly due to their high volatility and poor solubility in water, which limits their use. The inclusion of the beta-cyclodextrin derivative in the additive is well solved, such as the inclusion of hydroxypropyl beta-cyclodextrin on the inclusion of Litsea cubeba oil, peppermint oil, curcumin, etc. Very good role. The modification of food additives with β-cyclodextrin derivatives can significantly improve their performance, making them widely used in more functional foods and other aspects of the food industry.
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Shandong Binzhou Zhiyuan Biotechnology Co., Ltd.
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Oxaliplatin is the first Cyclohexanediamine platinum anticancer drug to enter the market. It has the characteristics of clear anticancer effect, low toxicity, and obvious inhibition on colorectal cancer cell lines and cisplatin resistant cell lines. The combination of oxaliplatin with 5-fluorouracil and folic acid has been used as the first-line drug in the treatment of colorectal cancer, and widely used in the treatment of gastric cancer, ovarian cancer and so on. However, oxaliplatin is slightly soluble in water and has poor stability in water. It can react with water molecules to form diamine cyclohexaneplatinum dihydrate, and its aqueous solution will gradually oxidize to dihydroxyoxaliplatin in the presence of oxygen.
It is found that when hydroxypropyl betacyl dextrin is selected as the stabilizer of oxaliplatin aqueous solution, the total amount of related substances measured according to the detection method of oxaliplatin for injection in USP can not increase more than 0.25% within 24 hours after the preparation of the solution. Compared with the current oxaliplatin aqueous solution prepared according to the existing technology, it has the advantages of providing its stability. It has obvious advantages, while hydroxypropyl beta cyclodextrin, as a skeleton agent, can be used in the lyophilized preparation of oxaliplatin. The quality of the finished product, especially the related substances, is better than the products on the market.
Shandong Binzhou Zhiyuan Biotechnology Co., Ltd. is a scientific and technological company focusing on the application, development and innovation of cyclodextrin and cyclodextrin derivatives. The company has strong technical force and close cooperation with Shandong University, Chinese Academy of Sciences and other first-class universities and scientific research institutes at home and abroad. It is a professional R & D and production enterprise with the largest variety and the most complete specifications in the cyclodextrin industry in China. Hydroxypropyl beta cyclodextrin and sulfobutyl ether beta cyclodextrin sodium salt are our two main products with complete qualification, and they have been registered on CDE, welcome to discuss.
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Pharma Sources Insight June 2024: Globalization on the Go
