阅读说明：本技术 一种甲硝唑维b6组合物 (Metronidazole vitamin B6 composition ) 是由 张明涛 于华静 刘斐 于 2020-07-30 设计创作，主要内容包括：本发明涉及一种甲硝唑维B6组合物,属于制药技术领域。本发明所述甲硝唑维B6复方片组合物,单位剂量的组合物中含有：甲硝唑维200mg,维B6 20mg,枸橼酸钠7-16mg,预胶化淀粉60-100mg,气相二氧化硅40-80mg,聚维酮K30 8-15mg,羟丙纤维素的加入量为聚维酮K30的0.8-1.6倍。本发明提供了一种稳定的甲硝唑维B6复方片组合物,为临床提供了质量优秀的药品。(The invention relates to a metronidazole vitamin B6 composition, and belongs to the technical field of pharmacy. The metronidazole vitamin B6 compound tablet composition disclosed by the invention contains the following components in unit dose: 200mg of metronidazole, 620mg mg of vitamin B, 7-16mg of sodium citrate, 60-100mg of pregelatinized starch, 40-80mg of fumed silica, 308-15 mg of povidone K and 0.8-1.6 times of the addition amount of hydroxypropyl cellulose of the povidone K30. The invention provides a stable metronidazole vitamin B6 compound tablet composition, which provides a medicine with excellent quality for clinic.)

1. The metronidazole vitamin B6 compound tablet composition is characterized in that a unit dose of the composition contains: 200mg of metronidazole, 620mg of vitamin B, 7-16mg of sodium citrate, 60-100mg of pregelatinized starch, 40-80mg of fumed silica, 308-15 mg of povidone K and a certain amount of hydroxypropyl cellulose, wherein the addition amount of the hydroxypropyl cellulose is 0.8-1.6 times of that of the povidone K30.

2. The metronidazole vitamin B6 compound tablet composition of claim 1, wherein the unit dose of the composition comprises: 200mg of metronidazole, 620mg of vitamin B, 10-15mg of sodium citrate, 70-88mg of pregelatinized starch, 47-70mg of fumed silica, 3010-14 mg of povidone K and a certain amount of hydroxypropyl cellulose, wherein the addition amount of the hydroxypropyl cellulose is 1.0-1.4 times of that of the povidone K30.

3. The metronidazole vitamin B6 compound tablet composition of claim 1, wherein the unit dose of the composition comprises: 200mg of metronidazole, 620mg of vitamin B, 12-14mg of sodium citrate, 76-85mg of pregelatinized starch, 52-66mg of fumed silica, 3010-14 mg of povidone K and a certain amount of hydroxypropyl cellulose, wherein the addition amount of the hydroxypropyl cellulose is 1.15-1.3 times of that of the povidone K30.

4. The preparation method of the metronidazole vitamin B6 compound tablet composition as claimed in claim 1, which is characterized by comprising the following steps:

step 1, sieving vitamin B6 with a 100-mesh sieve, and sieving other raw and auxiliary materials with a 80-mesh sieve;

step 2, preparing an adhesive solution by using 40% ethanol water solution as a solvent, firstly dissolving povidone K30 with the prescription amount in 40% ethanol water solution to prepare 10% solution, then adding hydroxypropyl cellulose with the prescription amount, and stirring for dissolving;

step 3, uniformly mixing vitamin B6 in a prescription amount, fumed silica in a third prescription amount, pregelatinized starch in a third prescription amount and sodium citrate in a second prescription amount, placing the mixture in a granulator, spraying one third of the adhesive solution prepared in the step 2, and granulating;

step 4, adding the metronidazole vitamin, the rest sodium citrate, the pregelatinized starch, the fumed silica and the sodium citrate in the prescription amount, uniformly mixing, spraying the rest adhesive solution, granulating and finishing;

and 5, tabletting.

Technical Field

The invention relates to a metronidazole vitamin B6 composition, and belongs to the technical field of pharmacy.

Background

Metronidazole is an anti-infective drug. Can be used for treating various anaerobic infections, such as septicemia, endocarditis, empyema, lung abscess, abdominal cavity infection, gynecological infection, bone and joint infection, and periodontal infection, and has wide clinical application. However, after metronidazole is taken, 15-30% of patients have symptoms of nausea, vomiting, inappetence, abdominal pain and the like of the digestive system; the compliance of clinical use is influenced, some patients are reluctant to continue taking the medicine due to adverse reaction problems, and particularly patients with superficial gastritis are very resistant to metronidazole treatment for related diseases.

In order to solve the serious adverse reactions, the applicant registers and claims a metronidazole VB6 compound tablet and obtains production batch pieces, the appearance of the metronidazole tablet solves the problems of nausea, vomiting and the like of a digestive system of a patient after taking the metronidazole tablet, and the metronidazole tablet is approved by the patient and medical service workers and becomes a first-line medicament for treating anaerobic bacteria. In the research and development process, if the prescription composition is not proper, the dissolution of metronidazole in the compound preparation is reduced along with the prolonging of time, and meanwhile, the condition that related substances of the metronidazole are in a rising trend influences the clinical use effect of the medicine. .

Disclosure of Invention

The purpose of the invention is as follows: provides stable and excellent metronidazole VB6 compound tablets and a production process, and improves the production yield.

In the research, a certain amount of sodium citrate added can avoid the degradation problem of the metronidazole vitamin B6 compound preparation in storage.

The technical scheme of the invention is as follows:

a metronidazole vitamin B6 compound tablet composition, unit dose composition contains: 200mg of metronidazole, 620mg mg of vitamin B, 7-16mg of sodium citrate, 60-100mg of pregelatinized starch, 40-80mg of fumed silica, 308-15 mg of povidone K and 0.8-1.6 times of the addition amount of hydroxypropyl cellulose of the povidone K30.

In the technical scheme of the invention, the povidone K30 and the hydroxypropyl cellulose are jointly used, so that the problem of reduced metronidazole dissolution in the storage process is solved, and analysis shows that the metronidazole dissolution is possibly the joint action of the two binders, a certain hardness is maintained for the tablet, a certain protective film is formed, and the problems of easy moisture absorption, unstable light and the like of the vitamin B6 in the compound tablet are avoided.

If the addition amount of the hydroxypropyl cellulose is less than 0.8 time of that of the povidone K30, the problem of reduction of metronidazole dissolution in the storage process cannot be solved. If the addition amount of the hydroxypropyl cellulose is less than 2 times of that of the povidone K30, the dissolution rate of metronidazole is influenced, and the dissolution rate of the active ingredients is estimated to be influenced by the fact that the addition amount of the adhesive is too high.

In the technical scheme of the invention, the introduction of a proper amount of sodium citrate solves the problem of the stability of metronidazole related substances in the storage process of the metronidazole VB6 compound tablets.

Preferably, the metronidazole vitamin B6 compound tablet composition disclosed by the invention contains the following components in unit dose: 200mg of metronidazole, 620mg of vitamin B, 10-15mg of sodium citrate, 70-88mg of pregelatinized starch, 47-70mg of fumed silica, 3010-14 mg of povidone K, and the addition amount of hydroxypropyl cellulose is 1.0-1.4 times of that of povidone K30.

Preferably, the metronidazole vitamin B6 compound tablet composition disclosed by the invention contains the following components in unit dose: 200mg of metronidazole, 620mg of vitamin B, 12-14mg of sodium citrate, 76-85mg of pregelatinized starch, 52-66mg of fumed silica, 3010-14 mg of povidone K, and the addition amount of hydroxypropyl cellulose is 1.15-1.3 times of that of povidone K30.

The preparation method of the metronidazole vitamin B6 compound tablet composition comprises the following steps:

step 1, sieving vitamin B6 with a 100-mesh sieve, and sieving other raw and auxiliary materials with a 80-mesh sieve;

step 2, preparing an adhesive solution by using 40% ethanol water solution as a solvent, firstly dissolving povidone K30 with the prescription amount in 40% ethanol water solution to prepare 10% solution, then adding hydroxypropyl cellulose with the prescription amount, and stirring for dissolving;

step 3, uniformly mixing vitamin B6 in a prescription amount, fumed silica in a third prescription amount, pregelatinized starch in a third prescription amount and sodium citrate in a second prescription amount, placing the mixture in a granulator, spraying one third of the adhesive solution prepared in the step 2, and granulating;

step 4, adding the metronidazole vitamin, the rest sodium citrate, the pregelatinized starch, the fumed silica and the sodium citrate in the prescription amount, uniformly mixing, spraying the rest adhesive solution, granulating and finishing;

and 5, tabletting.

The preparation method of the invention can solve the content uniformity problem of vitamin B6 by granulating in steps.

Has the advantages that: the invention provides a stable metronidazole vitamin B6 compound tablet composition, which provides a medicine with excellent quality for clinic.

Example 1, 200g of metronidazole vitamin, 620 g of vitamin B620 g, 7g of sodium citrate, 100g of pregelatinized starch, 40g of fumed silica, 308 g of povidone K308 g and 12.8g of hydroxypropyl cellulose, and 1000 tablets are prepared according to the preparation method of the technical scheme.