搅拌速度和搅拌时间对克林霉素 Hcl 乙硫异烟肼和 ich Q1a (r2) 稳定性试验表征的影响

IF 1.4 4区医学 Q4 PHARMACOLOGY & PHARMACY

FARMACIA Pub Date : 2023-10-26 DOI:10.31925/farmacia.2023.5.10

E. F. Apriani

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引用次数: 0

摘要

盐酸克林霉素是一种生物利用度有限的抗生素，其生物利用度为使用剂量的 0.7% 至 12.9%。乙糖体给药系统可以提高盐酸克林霉素的生物利用度。然而，在生产过程中，搅拌的速度和时间是影响乙硫体特性的关键因素。本研究采用 2 2 因式设计法，通过改变搅拌速度（7 600 转/分钟和 15 000 转/分钟）和搅拌时间（15 分钟和 30 分钟），优化盐酸克林霉素乙素体配方。对乙硫柳配方进行了表征，包括夹带效率、粒度、多分散指数和电位 Zeta。根据 ICH Q1A (R2) 标准对最佳配方进行了稳定性测试。在搅拌速度为 7 600 rpm、搅拌时间为 15 分钟的条件下，获得了最佳配方，其夹带效率为 72.38 ± 0.36%，粒度为 270.80 ± 8.69 nm，多分散指数为 0.111 ± 0.032，Zeta 电位为 -31.21 ± 0.82 mV。ICH Q1A (R2) 稳定性测试结果表明，活性物质的释放模型遵循阶 0，活化能为 4.232 cal/mol，动力学常数为 9.897/day，在 25 ± 2°C/60 ± 5% RH 下的保质期为 7.293 天，在 25 ± 2°C/60 ± 5% RH 下的保质期为 8.247 天。

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EFFECT OF STIRRING SPEED AND STIRRING TIME ON CHARACTERIZATION OF CLINDAMYCIN HCL ETHOSOMAL AND ICH Q1A (R2) STABILITY TEST

Clindamycin HCl is an antibiotic with limited bioavailability ranging from 0.7% to 12.9% of the applied dose. The ethosomal delivery system can increase the bioavailability of clindamycin HCl. However, in the manufacturing process, the speed and time of stirring are essential factors that affect the characterization of the resulting ethosomes. This study aims to optimize the clindamycin HCl ethosomal formula by varying the stirring speed (7,600 and 15,000 rpm) and stirring time (15 and 30 minutes) using ultra-turrax with a 2 2 factorial design method. The ethosomal formula was characterized including entrapment efficiency, particle size, polydispersity index and potential zeta. The optimum formula was tested for stability according to the ICH Q1A (R2) standard. The optimum formula was obtained at a stirring speed of 7,600 rpm and a stirring time of 15 minutes with an entrapment efficiency percentage of 72.38 ± 0.36%, a particle size of 270.80 ± 8.69 nm, a polydispersity index of 0.111 ± 0.032 and a potential zeta of -31.21 ± 0.82 mV. The results of the ICH Q1A (R2) stability test showed that the release model of the active substance followed order 0, the activation energy was 4.232 cal/mol, the kinetic constant was 9.897/day with a shelf life of 7.293 days at 25 ± 2°C/60 ± 5% RH and 8.247 days at

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来源期刊

FARMACIA 医学-药学

CiteScore

2.40

自引率

50.00%

发文量

审稿时长

6-12 weeks

期刊介绍： FARMACIA publishes original research papers, invited topical reviews and editorial commentaries and news, with emphasis on conceptual novelty and scientific quality. Main research areas are focused on: pharmacology, toxicology, medicinal chemistry, biopharmacy, drug design, drug delivery, personalized medicine, nanostructures, nutraceuticals, biochemistry and biotechnology. Manuscripts submitted to the Journal are only accepted after the peer review precess. The papers should have not been published in any other journal. The recommendations of the Declaration of Helsinki, for humans, and the International guidelines as accepted principles for the use of experimental animals should be followed.