Preparation method of long-acting hydrochloric ceftiofur injection

A technology of ceftiofur hydrochloride and injection, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve problems such as inconvenience in veterinary treatment and incompatibility in treating animals

Active Publication Date: 2017-01-11
上海公谊药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the maintenance time of the effective blood drug concentration of the above-mentioned preparations mostly between 24-32 hours, daily injections a

Method used

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  • Preparation method of long-acting hydrochloric ceftiofur injection
  • Preparation method of long-acting hydrochloric ceftiofur injection

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Experimental program
Comparison scheme
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Embodiment Construction

[0014] 1. Instruments and reagents

[0015] Colloid mill (Shanghai Donghua High Pressure Homogenizer Factory); Agilent 1100 high performance liquid chromatography; AG285 electronic analytical balance (Swiss Mettler Toledo Instrument Co., Ltd.); Ceftiofur reference substance (China Veterinary Drug Control Institute) , batch number: K0330702); Siban-80 (Shanghai Shenyu Pharmaceutical Chemical Co., Ltd.); lecithin (Shanghai Aikang Fine Chemical Co., Ltd.); soybean oil for injection (Tianyu Camellia Oil Development Co., Ltd.).

[0016] 2. Methods and results

[0017] 2.1 Prescription and process

[0018] 2.1.1 Prescription Composition

[0019] Ceftiofur hydrochloride 5kg, Span-80 (wetting agent) 0.5L, lecithin (suspending agent) 0.5L, soybean oil for injection (solvent) to 50L.

[0020] 2.1.2 Process

[0021] During the production process, all open surfaces in contact with the liquid medicine, such as preparation, filtration, and pipelines, should be treated as follows: prepar...

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Abstract

The invention discloses a preparation method of a long-acting hydrochloric ceftiofur injection. The preparation method is characterized by including: using soybean oil as a solvent, heating the soybean oil to 140-150 DEG C, holding the temperature for 60min for sterilizing, and cooling to room temperature; dissolving or dispersing 0.5-2.0wt% of and 0.5-1.5wt% of according to prescription amounts in 70-80% of the sterilized solvent; guiding into a colloid mill for grinding, adding 10.2-10.8wt% of hydrochloric ceftiofur according to a prescription amount after grinding is finished, adopting a mode of alternating circulating grinding and non-circulating grinding for grinding, checking whether particle fineness reaches 2.5-5.0um or not, stopping grinding after requirements are met, and adding the sterilized solvent to the prescription amount to obtain an intermediate product; testing ceftiofur content and product character of the intermediate product, after passing needle drawing experiment, filling, externally packing, warehousing, and obtaining the injection after passing tests of content, sterility, granularity and related matter. Results show that when consumption of and is 1%, production process and product quality of the injection are stable.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of long-acting ceftiofur hydrochloride injection. Background technique [0002] Ceftiofur (Ceftiofur), also known as Saidefu, was first synthesized by Bernard Labeeuw et al. in 1984. It was the first third-generation cephalosporin antibiotic dedicated to livestock and poultry; The company (Pharmacia & Upjohn) makes it into a suspension of sodium salt freeze-dried powder and hydrochloride (trade name Naxcel, Excenel) for the treatment of animal diseases. [0003] Ceftiofur is absorbed quickly and has high bioavailability; it has a high binding rate with proteins in the body, forming a stock bactericidal effect, with a long half-life and long-lasting drug effect; compared with other antibiotics, the uniqueness of this drug lies in the content of the drug in infected tissues It is 2 to 4 times higher than that in non-infected tissues, show...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/44A61K47/24A61K47/26A61K31/546A61P31/04
CPCA61K9/0019A61K9/08A61K31/546A61K47/24A61K47/26A61K47/44
Inventor 廖雪玲徐玉明顾岳明
Owner 上海公谊药业有限公司
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