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A kind of moxifloxacin hydrochloride pharmaceutical composition and its preparation method and application

A technology of moxifloxacin hydrochloride and a composition, applied in the field of medicine, can solve problems such as affecting the quality of life of patients, and achieve the effects of being beneficial to long-term treatment, improving compliance and safety, and reducing side effects

Active Publication Date: 2021-04-13
HARBIN ZHENBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, it seriously affects the quality of life of patients

Method used

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Examples

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preparation example Construction

[0036] In the second aspect, the embodiments of the present invention also provide a method for preparing a moxifloxacin hydrochloride pharmaceutical composition, which includes the following steps:

[0037] S1. Mix moxifloxacin hydrochloride, pregelatinized starch, microcrystalline cellulose and croscarmellose sodium evenly, add water for granulation.

[0038] It specifically includes: first crush moxifloxacin hydrochloride to 80-100 mesh, then put moxifloxacin hydrochloride, microcrystalline cellulose, pregelatinized starch and cross-linked carmellose sodium into a wet granulator, and mix for 5 -6 minutes, add an appropriate amount of purified water (the amount of purified water is 1.5-3 times the volume of the microcrystalline cellulose weight), and granulate for 1-2 minutes. Wet sizing is carried out with a oscillating granulator, and the mesh number of the sieve is 12-14 mesh. Wet granules are placed in a high-efficiency boiling dryer, preheated at an inlet air temperatu...

Embodiment 1

[0048] The present embodiment provides a kind of moxifloxacin hydrochloride pharmaceutical composition, and its preparation method is as follows:

[0049] S1, raw material preparation: 40g of moxifloxacin hydrochloride, 4g of pregelatinized starch, 10g of microcrystalline cellulose, 3g of croscarmellose sodium and 0.4g of magnesium stearate;

[0050] S2, granulation: Grinding moxifloxacin hydrochloride to 80 meshes; then placing moxifloxacin hydrochloride, pregelatinized starch, microcrystalline cellulose and croscarmellose sodium in a wet granulator, and mixing for 5 minutes, add 15ml of purified water, and granulate for 2 minutes. Wet sizing is carried out with a oscillating granulator, and the mesh number of the sieve is 12 mesh. Wet granules are placed in a high-efficiency fluidized dryer, and the dryer is preheated for 10 minutes with wind at a temperature of 70°C, and then dried at room temperature. Control particle moisture between 1.5% and 6.5%. The dried granules a...

Embodiment 2

[0052] The present embodiment provides a kind of moxifloxacin hydrochloride pharmaceutical composition, and its preparation method is as follows:

[0053] S1. Raw material preparation: 96g of moxifloxacin hydrochloride, 9.6g of pregelatinized starch, 28g of microcrystalline cellulose, 7g of croscarmellose sodium, 1.8g of magnesium stearate, 4g of gastric soluble film coating premix .

[0054] S2, granulation: crush moxifloxacin hydrochloride to 100 meshes; then place moxifloxacin hydrochloride, pregelatinized starch, microcrystalline cellulose and cross-linked carmellose sodium in a wet granulator, mix 6 minutes, add 20ml of purified water, and granulate for 1 minute. Wet sizing is carried out with a oscillating granulator, and the mesh number of the sieve is 14 mesh. Wet granules are placed in a high-efficiency fluidized dryer, and the dryer is preheated for 15 minutes with wind at a temperature of 60°C, and then dried at room temperature. Control particle moisture between...

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Abstract

The invention relates to the technical field of medicine, and provides a moxifloxacin hydrochloride pharmaceutical composition, a preparation method and application thereof. The moxifloxacin hydrochloride pharmaceutical composition comprises, in parts by weight, 40-50 parts of moxifloxacin hydrochloride, 4-5 parts of pregelatinized starch, 10-15 parts of microcrystalline cellulose, cross-linked carboxymethyl 3-4 parts of cellulose sodium and 0.3-1 part of magnesium stearate; the preparation method comprises mixing moxifloxacin hydrochloride, pregelatinized starch, microcrystalline cellulose and cross-linked carboxymethyl cellulose sodium, adding water Granulate, then add magnesium stearate, mix well and make capsules or tablets. In this example, by limiting the content of the components, the drug can be released slowly in the body, reducing the direct stimulation of moxifloxacin hydrochloride to the gastrointestinal tract, thereby reducing its side effects, especially the occurrence of severe gastrointestinal reactions, and improving the quality of the patients. The compliance and safety of medication make it easier for patients to tolerate and benefit long-term treatment.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a moxifloxacin hydrochloride pharmaceutical composition and a preparation method and application thereof. Background technique [0002] Moxifloxacin hydrochloride is a broad-spectrum and 8-methoxyfluoroquinolone antibacterial drug with antibacterial activity, but very large doses of moxifloxacin hydrochloride can cause diarrhea in individual patients. When diarrhea exceeds 5 times a day or bloody diarrhea occurs, it is generally necessary to reduce the dose of the drug or stop the chemical drug immediately and treat it in time. Generally, after the drug is stopped, the treatment will be difficult to proceed smoothly, thereby affecting the curative effect of the treatment. [0003] The main cause of diarrhea in patients receiving chemical drugs is due to the direct inhibition or destruction of intestinal mucosal cells by the drugs, and it is also related to many other factors su...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4709A61K47/42A61K47/36A61K47/38A61K47/12A61P31/04
CPCA61K31/4709A61K47/12A61K47/36A61K47/38A61K47/42A61P31/04
Inventor 方同华韩冰崔玉海徐秀杰
Owner HARBIN ZHENBAO PHARMA
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