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Medicine composite for treating osteoporosis and preparation method thereof

A technology for osteoporosis and composition, which is applied in the field of pharmaceutical preparations and can solve the problems of lack of response and increase of bone

Inactive Publication Date: 2015-12-23
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the combined dosage forms of bisphosphonates or calcitonin and calcium or vitamin D have appeared on the market, but as far as teriparatide is concerned, there has not been a corresponding combined dosage form that can enhance bone synthesis. There is a functional complementarity with anti-bone resorption drugs in the treatment of osteoporosis. The former increases bone formation and the latter reduces bone loss. Therefore, teriparatide is now combined with bisphosphonates or calcitonin Combination dosage forms of estrogen-like or estrogen-like drugs can prevent and treat osteoporosis from both positive and negative aspects, which is convenient for clinical use

Method used

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  • Medicine composite for treating osteoporosis and preparation method thereof
  • Medicine composite for treating osteoporosis and preparation method thereof
  • Medicine composite for treating osteoporosis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Teriparatide 600mg, alendronate sodium 300g, mannitol 300g, appropriate amount of hydrochloric acid buffer.

[0022] The preparation process is as follows: accurately weigh the main drug in the prescribed amount, add appropriate amount of water for injection to dissolve; add the prescribed amount of mannitol and hydrochloric acid buffer to the above solution in turn, and adjust the pH to 7.0; Filter through a microporous membrane, set the volume to 2400ml, pack into 1000 tubes, press the plug, take out the box, tie the cover, and after passing the inspection, label and pack to obtain the composition injection.

[0023] Therapeutic effect of the composition injection prepared in Example 1 on the osteoporosis rat model.

[0024] Experimental animals: 40 SD female rats, weighing about 200g, used 1% cellulose solution to add retinoic acid to adjust to an appropriate concentration, and administered 80mg / kg / d for 20 days, once a day, to form osteoporosis rats Model.

[0025...

Embodiment 2

[0030] Teriparatide 120mg, risedronate sodium 30g, glucose 3000mg, appropriate amount of hydrochloric acid buffer.

[0031] The preparation process is as follows: accurately weigh the main drug in the prescribed amount, add appropriate amount of water for injection to dissolve; add the prescribed amount of mannitol and hydrochloric acid buffer to the above solution in turn, and adjust the pH to 6.5; Filter through a microporous membrane, set the volume to 2400ml, pack into 1000 tubes, press the plug, take out the box, tie the cover, and after passing the inspection, label and pack to obtain the composition injection.

[0032] The therapeutic effect of the composition injection prepared in Example 2 on the osteoporosis rat model.

[0033] Experimental animals: 40 SD female rats, weighing about 200g, used 1% cellulose solution to add retinoic acid to adjust to an appropriate concentration, and administered 80mg / kg / d for 20 days, once a day, to form osteoporosis rats Model.

[...

Embodiment 3

[0039] Teriparatide 900mg, zoledronate sodium 4g, mannitol 3000mg, hydrochloric acid buffer in proper amount.

[0040] The preparation process is as follows: accurately weigh the main drug in the prescribed amount, add appropriate amount of water for injection to dissolve; add the prescribed amount of mannitol and hydrochloric acid buffer to the above solution in turn, and adjust the pH to 6.5; Filter through a microporous membrane, set the volume to 2400ml, pack into 1000 tubes, press the plug, take out the box, tie the cover, and after passing the inspection, label and pack to obtain the composition injection.

[0041] The therapeutic effect of the composition injection prepared in Example 3 on the osteoporosis rat model.

[0042]Experimental animals: 40 SD female rats, weighing about 200g, used 1% cellulose solution to add retinoic acid to adjust to an appropriate concentration, and administered 80mg / kg / d for 20 days, once a day, to form osteoporosis rats Model.

[0043] ...

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Abstract

The invention relates to a medicine composite injection for treating osteoporosis and a preparation method thereof. In particular, active constituents of the injection comprise one or more constituents out of teriparatide combined with bisphosphonate series, calcitonin series and estrogen, and besides, pH regulating agents and excipient with the amount acceptable to pharmacy are added. According to the preparation method, the preparation process is investigated, the rat urinary calcium content, the blood calcium conent, the serum phosphate content and the thighbone mineral matter content further serve as indexes, the treatment effect of the injection on osteoporosis model rats is further investigated, the prepared composite injection is remarkable in effect, and the practical significance is achieved.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition injection for treating osteoporosis and a preparation method thereof. Background technique: [0002] Osteoporosis (Osteoporosis, OP) is a metabolic bone disease that causes bone loss and bone quality decline due to various reasons, resulting in increased bone fragility until fracture occurs. Osteoporosis can be divided into primary and secondary types. Type I primary osteoporosis occurs in postmenopausal women, and type II primary osteoporosis occurs in the elderly. According to survey data, there are about 84 million patients with osteoporosis in my country, and it is estimated that the number will increase to 220 million by the middle of the 21st century, resulting in 1.3-1.6 million fractures. The risk of fractures caused by osteoporosis seriously affects the psychosomatic and quality of life of patients. Osteoporosis often has no signif...

Claims

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Application Information

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IPC IPC(8): A61K45/00A61K38/29A61P19/10A61K38/23A61K31/663A61K31/565
Inventor 姚志勇李新宇刘自成黄盛治曹演威黄秋霞
Owner SHENZHEN JYMED TECH
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