Quality evaluation and control method of florfenicol sustained-release particles
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A technology of sustained-release granules and florfenicol, applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, and measuring devices, etc. Problems such as high peak concentration, to achieve the effect of ensuring consistency
Active Publication Date: 2021-08-24
SOUTH CHINA AGRI UNIV
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Problems solved by technology
The commercially available oral preparations of florfenicol, such as powder and premix, have the characteristics of fast peak time after oral administration and high peak blood concentration, especially at high blood concentration, which are easy to cause immunosuppression and embryotoxicity to the animal body, etc. side effect
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Embodiment 1
[0054] The in vitro dissolution limit determination of embodiment 1 Florfenicol sustained-release granules
[0055] 1. Test method
[0056] 1. Composition and preparation of Florfenicol sustained-release granules
[0057] The composition of the florfenicol sustained-release granules includes florfenicol raw material drug and auxiliary materials, and the auxiliary materials include monoglyceride, polyethylene glycol 4000 (PEG-4000) and starch.
[0058] In parts by weight, the present invention has prepared 9 groups of 10% Florfenicol sustained-release granules according to the formula in Table 1:
[0059] Table 1. Composition of different formulations of Florfenicol sustained-release granules
[0060]
[0061] Preparation method: Heat the monoglycerides of the above formula to 80°C in proportion and keep it warm for 5 minutes, then add florfenicol raw material, stir for 15 minutes with a JJ-1 precision small electric mixer at 100 rpm, and then After adding polyethylene gl...
Embodiment 2
[0078] Example 2 Pharmacokinetic experiments of florfenicol sustained-release granules in pigs and correlation verification analysis in vivo and in vitro
[0079] In order to verify the rationality and accuracy of the dissolution limit of the florfenicol sustained-release granules measured by the method in Example 1, the present invention carries out pharmacokinetic experiments in animals on the florfenicol sustained-release granules, and conducts in vivo and in vitro correlations. A study of gender analysis.
[0080] 1. Test method
[0081] 1. Pharmacokinetic experiment of florfenicol sustained-release granules in pigs
[0082] Get 5% florfenicol injection (5.0g florfenicol crude drug+dimethylpyrrolidone 40mL+10% propylene glycol and settle to 100mL), 10% florfenicol powder (Guangdong Foshan Zhengdian Biotechnology Co., Ltd. ), the 10% Florfenicol sustained-release granule of group 2 in the embodiment 1, with 32 landrace × large white binary mixed pigs, are randomly, averag...
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Abstract
The invention discloses a quality evaluation and control method of florfenicol sustained-release granules, which comprises the following steps of: obtaining in-vitro disintegration and release processes of florfenicol sustained-release granule medicines through a dissolution test, and establishing correlation with the in-vivo process of the medicines, so that the in-vitro dissolution limit of the medicines is formulated as follows: in simulated gastric juice, the in-vitro disintegration and release processes of the florfenicol sustained-release granules are subjected to the in-vitro disintegration and release processes of the florfenicol sustained-release granules; the cumulative release rate within 30 minutes does not exceed 20%, and the cumulative release rate within 2 hours does not exceed 50%; and in simulated intestinal juice, the cumulative release rate within 30 minutes does not exceed 25%, the cumulative release rate within 4 hours does not exceed 75%, and the cumulative release rate within 8 hours is greater than 85%. By taking the dissolution limit of the florfenicol sustained-release product as a quality standard and evaluating the in-vitro dissolution of the florfenicol sustained-release product, the product quality of preparation production is controlled, the consistency of in-vivo metabolic processes of products of different production batches is ensured, and a basis is provided for product quality control and evaluation.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a method for evaluating and controlling the quality of Florfenicol sustained-release granules. Background technique [0002] Florfenicol, also known as florfenicol, is a white or off-white crystalline powder and is a broad-spectrum antibiotic for animals. The antibacterial spectrum of florfenicol is similar to that of thiamphenicol, but its antibacterial activity is better than that of thiamphenicol. The mechanism of florfenicol is to bind to the A site on the 50S subunit of the bacterial 70S ribosome, thereby hindering the transpeptidation reaction of peptidyltransferase, so that the peptide chain cannot be extended, thereby inhibiting the synthesis of bacterial proteins. Florfenicol has a good effect on Actinobacillus pleuropneumoniae, Escherichia coli and Salmonella, but Florfenicol has embryotoxicity, so it is contraindicated in pregnant animals. Florfen...
Claims
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