Moxifloxacin hydrochloride medicine composition as well as preparation method and application thereof

A technology of moxifloxacin hydrochloride and its composition, which is applied in the field of medicine, can solve problems affecting the quality of life of patients, and achieve the effects of long-term treatment, improvement of compliance and safety, and maintenance of blood drug concentration

Active Publication Date: 2018-12-21
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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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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PUM

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Abstract

The invention relates to the technical field of medicines and provides a moxifloxacin hydrochloride medicine composition as well as a preparation method and application thereof. The moxifloxacin hydrochloride medicine composition comprises the following components in parts by weight: 40-50 parts of moxifloxacin hydrochloride, 4-5 parts of pregelatinized starch, 10-15 parts of microcrystalline cellulose, 3-4 parts of croscarmellose sodium and 0.3-1 part of magnesium stearate. The preparation method comprises the following steps: uniformly mixing the moxifloxacin hydrochloride, the pregelatinized starch, the microcrystalline cellulose and the croscarmellose sodium, adding water for pelletizing, further adding the magnesium stearate, and uniformly mixing, thereby obtaining capsules or tablets. According to the embodiment of the invention, contents of components are limited, medicines are slowly released in bodies; direct irritation of the moxifloxacin hydrochloride to gastrointestinal tracts can be alleviated; side effects, particularly serious gastrointestinal tract reactions, can be reduced; the compliance and the security of medicine taking can be improved for patients; patients can tolerate the composition; long-term treatment can be facilitated.

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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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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