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Oral solution containing alfacalcidol

A technology of alfacalcidol and oral solution, applied in the field of medicine, can solve problems such as difficulty and poor stability of alfacalcidol

Inactive Publication Date: 2006-10-18
YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Alfacalcidol is known to be less stable and it is very difficult to make an aqueous oral solution

Method used

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  • Oral solution containing alfacalcidol
  • Oral solution containing alfacalcidol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] prescription:

[0059] Alfacalcidol 25μg

[0060] Citrate (monohydrate) 500mg

[0061] water to 100ml

[0062] Preparation method: take citric acid, add appropriate amount of water to dissolve, add prescribed amount of alfacalcidol (prepared into a concentrated solution of 50 μg / ml), add water to the full amount, and pack the liquid medicine in glass bottles, seal it tightly, Instantly.

[0063] The liquid tastes good.

[0064] The pH value of the medicinal solution is 2.36.

[0065] After 6 months at a constant temperature of 30°C, the residual rate of the main component = 95.1%.

Embodiment 2

[0067] prescription:

[0068] Alfacalcidol 25μg

[0069] Tartaric acid 500mg

[0070] water to 100ml

[0071] Preparation method: take tartaric acid, add appropriate amount of water to dissolve, add prescribed amount of alfacalcidol (pre-prepared to a concentrated solution of 50 μg / ml), add water to the full amount, divide the liquid medicine into glass bottles, seal it tightly, and obtain .

[0072] The liquid tastes good.

[0073] The pH value of the medicinal solution is 2.67.

[0074] After 6 months of constant temperature storage at 30°C, the residual rate of the main component = 94.6%.

Embodiment 3

[0076] prescription:

[0077] Alfacalcidol 50μg

[0078] Malic acid 250mg

[0079] water to 100ml

[0080] Preparation method: take malic acid, add appropriate amount of water to dissolve, add prescribed amount of alfacalcidol (pre-prepared to a concentrated solution of 50 μg / ml), add water to the full amount, and pack the medicinal solution in glass bottles, and seal it tightly, that is, have to.

[0081] The liquid tastes good.

[0082] The pH value of the medicinal solution is 3.32.

[0083] After 6 months of constant temperature storage at 30°C, the residual rate of the main component = 92.4%.

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Abstract

The present invention relates to medicine technology, and is especially one kind of oral solution containing alfacalcidol. The oral solution contains: alfacalcidol in therapeutically effective amount, therapeutically acceptable organic acid supplementary material in such amount as to regulate the pH value of the or al solution to 2.0-4.0, and water. The oral solution containing alfacalcidol has high stability.

Description

【Technical field】 [0001] The invention belongs to the technical field of medicine and relates to an oral solution, in particular to an oral solution containing alfacalcidol. 【Background technique】 [0002] Osteoporosis and other diseases related to the regulation of calcium metabolism are known as a "silent epidemic", which has increasingly become a serious disease that endangers public health. It is a common and easily overlooked bone metabolic disease. Causes of osteoporosis include endocrine effects, vitamin D deficiency, calcium deficiency, hyperthyroidism, certain drugs (corticosteroids, heparin, phenobarbital, methotrexate, phenytoin, and methotrexate) etc.) induce drug-induced osteoporosis and many other reasons. Among them, the reduction of calcium absorption and the decrease of intestinal calcium absorption function are the most important reasons as the body ages. In addition, patients with diabetes, kidney disease, gastrointestinal disease, bone tumors, and sever...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/59A61K47/12A61P19/10
Inventor 石和鹏李俊领宋志涛周津梅姜爱萍李薇
Owner YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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