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Minodronic acid tablet and preparation process thereof

A technology of minodronic acid tablets and minodronic acid monohydrate, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of unfavorable coating and easy splitting , poor tablet stability and other issues, to achieve the effects of good fluidity and compressibility, improved content uniformity, and easy operation

Active Publication Date: 2015-03-25
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Minodronic acid has temperature sensitivity, on the basis of prior art, the present invention adopts the method for powder direct compression to prepare a kind of minodronic acid sheet, overcomes the problem of temperature sensitivity, but finds in the preparation process, The minodronic acid tablet is easily broken when the powder is directly compressed, which is unfavorable for coating. At the same time, the tablet after coating also has the problem of poor stability. For this reason, the present invention adds a polymer material in the formula Polylactic acid, at the same time, a small amount of polylactic acid is added to the coating material, which eliminates the problems of splits and unstable coated tablets, meets the quality standards, and meets the technical requirements of powder direct compression

Method used

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  • Minodronic acid tablet and preparation process thereof
  • Minodronic acid tablet and preparation process thereof
  • Minodronic acid tablet and preparation process thereof

Examples

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Effect test

Embodiment 1

[0038] Per 1000 tablets, the weight composition of each component of the tablet core is: minodronic acid monohydrate 1g, spray-dried Flowlac100 lactose 80g, cornstarch 12g, polylactic acid 10g, hydroxypropyl cellulose 6g, magnesium stearate 1g,

[0039] Coating solution: use Opadry 20 g, polylactic acid 5 g dissolved in 200 g of 80% (v / v) ethanol for coating.

[0040] Preparation method, the steps are as follows:

[0041] 1) The minodronic acid monohydrate raw material is passed through a 160-mesh sieve; the spray-dried Flowlac100 lactose, corn starch, hydroxypropyl cellulose, and magnesium stearate are respectively passed through a 60-mesh sieve.

[0042] 2) Minodronic acid raw materials, direct-compressed lactose, corn starch, polylactic acid, and hydroxypropyl cellulose were mixed in a three-dimensional motion mixer for 30 minutes, then magnesium stearate was added and mixed for 5 minutes, and the mixed material Add a high-speed rotary tablet press to compress the tablets,...

Embodiment 2

[0044] Per 1000, the weight of each component of the tablet core consists of: minodronic acid monohydrate 1g, spray-dried Flowlac100 lactose 70g, cornstarch 12g, polylactic acid 10g, hydroxypropyl cellulose 6g, magnesium stearate 1g, The above-mentioned components are coated with film coating after tableting, and the film coating solution is prepared from the following materials: Opadry 20g,

[0045] 5 g of polylactic acid was dissolved in 200 g of 80% ethanol, and mixed uniformly.

[0046] Preparation method, the steps are as follows:

[0047]1) The minodronic acid monohydrate raw material is passed through a 160-mesh sieve; the spray-dried Flowlac100 lactose, corn starch, hydroxypropyl cellulose, and magnesium stearate are respectively passed through a 60-mesh sieve.

[0048] 2) Minodronic acid raw materials, direct-compressed lactose, cornstarch, polylactic acid, and hydroxypropyl cellulose were mixed in a three-dimensional motion mixer for 30 minutes, then magnesium stear...

Embodiment 3

[0050] Every 1000 tablets, the weight of each component of the tablet core consists of: minodronic acid monohydrate 2g, spray-dried Flowlac100 lactose 59.5g, cornstarch 15g, polylactic acid 12g, hydroxypropyl cellulose 10g, magnesium stearate 1.5 g. The above-mentioned components were compressed into tablets and coated with a film coating, and the film coating liquid was prepared from the following materials: 20 g of Opadry, 5 g of polylactic acid dissolved in 200 g of 80% ethanol, and mixed uniformly.

[0051] Preparation method, the steps are as follows:

[0052] 1) The minodronic acid monohydrate raw material is passed through a 160-mesh sieve; the spray-dried Flowlac100 lactose, corn starch, hydroxypropyl cellulose, and magnesium stearate are respectively passed through a 60-mesh sieve.

[0053] 2) Minodronic acid raw materials, direct-compressed lactose, cornstarch, polylactic acid, and hydroxypropyl cellulose were mixed in a three-dimensional motion mixer for 30 minutes,...

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Abstract

The invention relates to a minodronic acid tablet and a preparation process thereof. According to the preparation process, a direct tabletting method is used, Flowac100 type spray-dried lactose is used as a filling agent and polylactic acid is added at the same time, so that the prepared minodronic acid tablet is uniform in content and favorable to release; and compared with the prior art, the direct tabletting method is capable of solving the problem that the minodronic acid tablets obtained via powder direct tableting are easy to crack and not good for coating, so that the medicine quality is ensured.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a minodronic acid tablet and a preparation method thereof. Background technique [0002] Osteoporosis is now considered by the World Health Organization to be the second major health problem after cardiovascular disease. Statistics show that among the population over 60 years old in my country, the prevalence rate of osteoporosis is more than 30%. my country's existing elderly population is nearly 200 million, and there are at least 60 million osteoporosis patients. In recent years, the incidence of osteoporosis has also shown an overall upward trend, most of which are elderly people over the age of 50, while postmenopausal women and elderly people over the age of 70, the risk of the disease increases every 5 years. will double. [0003] Minodronic acid is a third-generation nitrogen-containing aromatic heterocyclic bisphosphonate, which is mainly used for...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/675A61K47/34A61P19/10A61K47/26A61K47/36A61K47/38
Inventor 袁淑杰杨新春王淼李郑武王忠高晶李金花崔琳曲学伟赵金龙
Owner 哈药集团股份有限公司
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