一种高含量 (30%) 稳定的多西环林酸盐饮用水溶液用于肉:制备,稳定性和生物等价性
Ziyao Liu1, Xiaojun Jiao1, Linhua Xie1
1Guangdong Key Laboratory for Veterinary Drug Development and Safety Evaluation, College of Veterinary Medicine, South China Agricultural University, Guangzhou, China.
Frontiers in veterinary science
|January 23, 2026
概括
为解决商业配方中的可溶性和稳定性问题,开发了一种新的稳定的多西环林酸盐 (DOX·HCl) 溶液用于饮用水. 这种含量高的DOX·HCl溶液被证明与 brojlers中现有的产品具有生物等价性.
科学领域:
- 兽医药物学 兽医药物学
- 动物健康 动物健康
- 制药配方 制药配方 制药配方
背景情况:
- 商用多西环林饮用水配方在密集畜牧业中往往表现出不良的溶解性,稳定性和分布.
- 这些局限性要求开发改进的配方,以提供有效的牲畜和家禽药物.
研究的目的:
- 开发和评估一种稳定,高含量的多克西环林酸盐 (DOX·HCl) 溶液,用于饮用水.
- 与商业产品相比,评估新型DOX·HCl溶液在肉中的物理化学稳定性和生物等价性.
主要方法:
- 使用高温测试和单因素选,制备了30% (w/v) 的DOX·HCl溶液.
- 质量评估包括含量测定,稀释性,稀释稳定性,混合性能和稳定性研究 (影响因素,加速,长期).
- 一个随机的,并行的,盲目的生物等价性研究在肉中进行.
主要成果:
- 30%的DOX·HCl溶液的试点规模批量成功制造,并在稀释后24小时表现出良好的稳定性.
- 长期稳定性研究表明,使用期限超过24个月.
- 肉的药理动力学参数与商业产品相比没有显著差异,90%的CI值处于生物等效范围 (80-125%).
结论:
- 30%的DOX·HCl溶液是一种稳定,工业可扩展的饮用水缩物,具有已证明的生物等价性.
- 这种配方为牲畜和家禽药物提供了方便和可靠的替代品,特别是在高密度养殖系统中.
相关概念视频
Body Water Content and Fluid Compartments
4.0K
Life's biochemical processes occur within aqueous solutions. Solutes are substances that are dissolved within these solutions. The human body contains a variety of solutes, which can differ across various body parts. These can encompass proteins—such as those responsible for clotting and carbohydrate transport—as well as electrolytes. In medicine, an electrolyte is often described as a mineral ion derived from a salt possessing an electric charge. Examples include sodium ions...
4.0K
Bioequivalence: Overview
1.9K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.9K
RNA Stability
35.7K
Intact DNA strands can be found in fossils, while scientists sometimes struggle to keep RNA intact under laboratory conditions. The structural variations between RNA and DNA underlie the differences in their stability and longevity. Because DNA is double-stranded, it is inherently more stable. The single-stranded structure of RNA is less stable but also more flexible and can form weak internal bonds. Additionally, most RNAs in the cell are relatively short, while DNA can be up to 250 million...
35.7K
Nuclear Stability
23.0K
Protons and neutrons, collectively called nucleons, are packed together tightly in a nucleus. With a radius of about 10−15 meters, a nucleus is quite small compared to the radius of the entire atom, which is about 10−10 meters. Nuclei are extremely dense compared to bulk matter, averaging 1.8 × 1014 grams per cubic centimeter. If the earth’s density were equal to the average nuclear density, the earth’s radius would be only about 200 meters.
To hold positively charged protons together...
To hold positively charged protons together...
23.0K
Bioequivalence studies: Biowaivers
237
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
237
Equivalence: In Vitro and In Vivo Bioequivalence
219
Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.
219


