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Novel metformin hydrochloride solid medicinal preparation and preparation method thereof

A technology of metformin hydrochloride and solid pharmaceutical preparation, which is applied in the field of new solid pharmaceutical preparation of metformin hydrochloride and its preparation field, can solve the problems of increasing the occurrence of adverse reactions, being difficult to improve bioavailability, discounting the treatment effect, etc., and reducing the occurrence of adverse reactions. , increase bioavailability, exert therapeutic effect

Inactive Publication Date: 2015-10-21
CHENGDU ZHIJIAXIN MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing dosage forms have great limitations in human body absorption, either oral common preparations and sustained-release preparations are absorbed in the human stomach, or enteric-coated preparations are absorbed in the human intestinal tract
The disintegration speed of the dosage form of the existing medicine is too fast. Due to the limited absorption capacity of the human body and the fact that the medicine can only be absorbed in one part of the stomach or intestinal tract, the medicine cannot be fully absorbed, and the therapeutic effect will be greatly reduced. To reach the therapeutic concentration, it is necessary to increase the dose of the drug taken, or shorten the cycle of taking the drug, which directly increases the probability and severity of adverse reactions
[0004] The existing metformin hydrochloride research direction is to delay the release of metformin hydrochloride and use various slow-release agents to realize the slow release of metformin hydrochloride in the human body, thereby improving its bioavailability. However, metformin hydrochloride is only available in the stomach of the human body. and intestinal absorption, and these two organs are relatively active in the human body, so while the drug release is delayed, a large amount of drug is also lost, and it is also difficult to improve its bioavailability

Method used

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  • Novel metformin hydrochloride solid medicinal preparation and preparation method thereof
  • Novel metformin hydrochloride solid medicinal preparation and preparation method thereof
  • Novel metformin hydrochloride solid medicinal preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The preparation method of a novel metformin hydrochloride solid pharmaceutical preparation of the present embodiment is prepared by a known method in the pharmaceutical industry, and the specific dosage of each component is shown in Table 1 below:

[0029] Table I

[0030]

[0031]

[0032] The specific preparation method is preparation, after mixing metformin hydrochloride, calcium hydrogen phosphate, sodium carboxymethyl cellulose, and low-substituted hydroxypropyl cellulose evenly, adding to an aqueous solution of polyvinylpyrrolidone K90, and stirring to make a soft material.

[0033] The soft material is made into wet granules through 18 sieves, and the wet granules are dried in an environment of 50-60°C until the moisture content of the wet granules is 3%-5%, then add micro-powdered silica gel and mix evenly, press 0.2g / tablet Formed into tablets, this is the plain tablet to be coated.

[0034] Add stomach-soluble polymethacrylate, enteric-coated polymethac...

Embodiment 2

[0037] The preparation method of a novel metformin hydrochloride solid pharmaceutical preparation of this embodiment is prepared by a known method in the pharmaceutical industry, and the specific dosage of each component is shown in Table 2 below:

[0038] Table II

[0039]

[0040] Concrete preparation method is with embodiment 1, and concrete coating parameter is:

[0041] Tablet bed temperature: 25-35°C; air outlet temperature: 33-40°C; liquid spray speed: 3-6g / min / kg, that is, 2.4-5g / min; coating weight gain: 15%.

Embodiment 3

[0043] The preparation method of a novel metformin hydrochloride solid pharmaceutical preparation of this embodiment is prepared by a known method in the pharmaceutical industry, and the specific dosage of each component is shown in Table 3 below:

[0044] Table three

[0045]

[0046] Concrete preparation method is the same as above-mentioned embodiment, and concrete coating parameter is:

[0047] Tablet bed temperature: 25-35°C; air outlet temperature: 33-40°C, liquid spray speed: 3-6g / min / kg, ie 3.75-7.5g / min, coating weight gain: 10%.

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Abstract

The invention discloses a novel metformin hydrochloride solid medicinal preparation and a preparation method thereof. The novel metformin hydrochloride solid medicinal preparation comprises, by weight, 300-800 parts of metformin hydrochloride as a main drug of a tablet core, 100-500 parts of auxiliary materials and 100-300 parts of coating materials, wherein the auxiliary materials comprise a filling agent, a disintegrating agent, a bonding agent and a lubricating agent, and the coating materials comprise 5-60 parts of gastric-soluble type polymethacrylate and 80-240 parts of enteric-soluble type polymethacrylate. The specific preparation method comprises the following steps that 1, after the main drug is mixed with the filling agent and the disintegrating agent, the bonding agent is added into the mixture, and a soft material is prepared; 2, the soft material is sieved to form granules, and the granules are dried; 3, after drying, the lubricating agent is added into the dried granules and mixed to be uniform, the tablet cores are formed through pressing; 4, coating is performed, the weight is increased by 5%-20%, and then the novel metformin hydrochloride solid medicinal preparation is obtained. The novel metformin hydrochloride solid medicinal preparation has the advantages that the limitation that existing listed preparations can only be absorbed in the stomach or the intestinal canal is overcome, the medicinal preparation is released in a balanced mode in a certain time, the medicinal preparation is absorbed continuously and stably, the medicinal preparation concentration in the blood is maintained for a long time, so that the optimal treatment effect is achieved, the treatment effect of the medicinal preparation is fully played, and meanwhile the untoward effect is reduced.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a novel solid pharmaceutical preparation of metformin hydrochloride and a preparation method thereof. Background technique [0002] Metformin hydrochloride is a safe, effective and market-affirmed drug for treating diabetes. The first choice is for type 2 diabetes that is ineffective in simple diet control and physical exercise, especially obese type 2 diabetes; for type 1 or type 2 diabetes, the drug can be used in combination with insulin, which can enhance the hypoglycemic effect of insulin, thereby reducing insulin Dosage to prevent hypoglycemia; the drug can also be used in combination with sulfonylurea oral hypoglycemic drugs, which has a synergistic effect. [0003] Metformin hydrochloride is mainly taken orally, and then absorbed in the patient's stomach, so its dosage forms include common preparations, sustained-release preparations, enteric-coated preparation...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K31/155A61K47/32A61K47/38A61P3/10
Inventor 朱德其王海
Owner CHENGDU ZHIJIAXIN MEDICAL TECH CO LTD
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