Minodronic acid medicinal composition and preparation method thereof

A minodronic acid and composition technology, applied in the field of minodronic acid pharmaceutical composition and its preparation, can solve the problems of difficult uniform mixing, poor patient compliance, easy aggregation, etc., and achieve improved content uniformity and quality control Effect

Inactive Publication Date: 2014-07-16
Yung Shin Pharm Ind (Kunshan) Co Ltd
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It began to be used in the treatment of OP in the mid-1970s, but long-term use can prevent normal bone tissue calcification and increase the incidence of fractures
[0010] In the pharmaceutical composition disclosed in patent CN102078323A, a certain amount of alkaline auxiliary material sodium carbonate is added as a stabilizer and solubilizer to improve its dissolution rate. However, sodium carbonate is strong in alkalinity and has a destructive effect on gastric acid, resulting in poor patient compliance.
[0011] Patents CN102114025A and CN102204923A disclose the micronization of minodronic acid raw materials to improve the dissolution rate of minodronic acid, and patent CN103565771A adopts a preparation method of micronizing minodronic acid monohydrate and water-soluble auxiliary materials according to a certain ratio to promote The dissolution of the drug, but after the raw material is micronized, it is easier to aggregate, it is difficult to mix evenly, and it is easy to cause uneven content

Method used

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  • Minodronic acid medicinal composition and preparation method thereof
  • Minodronic acid medicinal composition and preparation method thereof
  • Minodronic acid medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1: Investigation on the appropriate ratio and dosage of lactose and starch in the filler

[0036] Table 1 Prescription Screening-Investigation of Filler Ratio Screening Process

[0037]

[0038] Note: the starch in the binder starch slurry accounts for 15% by mass of the total starch in the minodronic acid pharmaceutical composition, and the starch in the binder starch slurry accounts for 8% by mass of water.

[0039] As shown in Table 1, four groups of minodronic acid pharmaceutical compositions were prepared according to prescriptions 1, 2, 3 and 4, and their quality was inspected, and the results are shown in Table 2.

[0040] Table 2 Prescription Screening - Results of Investigation of Filler Ratio

[0041]

[0042] Result analysis: the main difference between prescription 1, prescription 2, prescription 3 and prescription 4 is the proportion of lactose and starch used in fillers. The proportions of lactose used in prescriptions 1, 2, 3 and 4 are 90%,...

Embodiment 2

[0043] Embodiment 2: the investigation of adhesive

[0044] On the basis of prescription 2, combined with the common use of excipients, the analysis of the original research product, the excipients that may be used as binders in the prescription are hydroxypropyl cellulose and starch, and different varieties and concentrations of hydroxypropyl cellulose and starch are investigated. The effect of starch slurry as a binder on product quality. Select different concentrations of starch slurry and hydroxypropyl cellulose as the binder, and the starch or hydroxypropyl cellulose in the binder starch slurry accounts for 15% by mass of the total starch in the minodronic acid pharmaceutical composition %,as shown in Table 3.

[0045] Table 3 Prescription Screening - Investigation of Adhesive Use Single Factor

[0046]

[0047]

[0048] The inspection results are shown in Table 4.

[0049] Table 4 Prescription Screening - Results of Adhesive Use Single Factor Investigation

[0...

Embodiment 3

[0053] Embodiment 3: the dosage investigation of lubricant magnesium stearate

[0054] On the basis of prescription 8, investigate the usage dosage of lubricant magnesium stearate, investigate according to the commonly used amount of magnesium stearate in preparation as lubricant 1%, 3%. The specific formula is shown in Table 5.

[0055] Table 5 Prescription Screening-Lubricant Use Single Factor Investigation

[0056]

[0057] Table 6 Prescription Screening - Results of Lubricant Use Single Factor Investigation

[0058]

[0059] Result analysis: Prescription 10 adopts the wet tableting process, 8% starch slurry is used as a binder, and the amount of lubricant used is 3%. The disintegration time limit is relatively small, and prescription 8 is still selected to continue the research.

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PUM

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Abstract

The invention belongs to the technical field of pharmacy, and relates to a minodronic acid medicinal composition and a preparation method thereof, in particular to a tablet consisting of a crystal form E minodronic acid monohydrate, a filling agent, a bonding agent, a lubricating agent, a disintegrating agent, a coating agent and other acceptable medicinal auxiliary materials. Active components account for 1 percent of the total weight of the minodronic acid tablet prepared by using the method. By mixing through a method for equivalently adding auxiliary materials, the content uniformity of the tablet can be increased effectively, so that the minodronic acid tablet is safe, effective and controllable in quality.

Description

technical field [0001] The invention relates to a minodronic acid pharmaceutical composition and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] Osteoporosis (OP) is a systemic skeletal disease caused by a variety of reasons. It is a systemic bone disease characterized by decreased bone strength and increased risk of fracture. Fractures are prone to occur due to increased bone fragility. Bone strength depends primarily on two factors: bone mineral density and bone quality. Factors affecting bone quality include bone microarchitecture, bone turnover, damage accumulation (such as microfractures), and bone mineralization status. Decreased bone strength makes bones prone to fracture when subjected to external forces. With the extension of human life span, the problem of aging has brought new problems to human health. Osteoporosis and the fractures it causes rank seventh among current common diseases, seriously threaten...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/26A61K47/36A61K47/12A61K47/18A61K31/675A61P19/10
Inventor 刘佳林维政
Owner Yung Shin Pharm Ind (Kunshan) Co Ltd
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