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Orally administered enteric-coated composition of calcitonin and preparation method thereof

A technology of composition and calcitonin, which is applied in the direction of drug combination, pharmaceutical formula, medical preparations of non-active ingredients, etc., can solve the problem that the bioavailability and effectiveness of the drug need to be further improved, the bioavailability is not ideal, and the safety It can achieve the effects of high drug bioavailability, long duration of drug effect and simple preparation method

Inactive Publication Date: 2007-05-23
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this method needs to use a new diketopiperazine compound self-made by the author as the enteric-coated carrier material. The disadvantages are: firstly, this auxiliary material is not currently sold in the market; secondly, because it is a new auxiliary material, its safety is not yet available. It has not been proven, and the drug is directly used in the human body, and its safety and effectiveness are equally important; again, the bioavailability and effectiveness of the drug need to be further improved
[0006] The administration methods and preparations of the above-mentioned prior art often require complex process conditions and numerous adjuvants, and their bioavailability is not ideal

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Take salmon calcitonin 10mg, citric acid fine powder 200mg, mix calcitonin and citric acid evenly, fill into No. 2 common enteric-coated empty capsules (manufactured by Guangdong Chaozhou Medicinal Capsule Factory) and get final product.

Embodiment 2

[0036] Take 200mg of citric acid and 20mg of fine starch powder, pass through 80 mesh sieve, mix well, add 17% starch slurry to make soft material, pass through 20 mesh sieve to granulate, dry at 70°C, mix salmon calcitonin 5mg with granule, fill Enter No. 2 common enteric-coated empty capsules.

Embodiment 3

[0038] Take 10ml of sterilized distilled water and stir, add 800mg of citric acid, add 1M dilute hydrochloric acid to adjust the pH to 4.4, add 48mg of salmon calcitonin, dissolve, freeze-dry, the conditions are: temperature -40°C, pre-freezing time is 24 hours, vacuum The degree is 0.1kPa. Then put it in a jet mill and pulverize to a particle size of 1-5 μm, and fill it into No. 2 ordinary enteric-coated hollow capsules.

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PUM

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Abstract

The invention relates to an oral enteric soluble composite of calcimar, and relative production, wherein it adds citrate, salicylic acid and sodium cholate into calcimar, to improve the adsorption of calcimar in intestinal tract. And its effect is higher than injection.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oral enteric-coated composition of calcitonin and a preparation method thereof. Background technique [0002] Osteoporosis is a worldwide public health problem. Osteoporosis is divided into three categories: the first category is primary osteoporosis, and this category is divided into two types, i.e. type I (postmenopausal osteoporosis). osteoporosis) and type II (senile osteoporosis). This is a kind of "physiological" degenerative disease that occurs with the growth of age or after women's menopause. It is one of the most common diseases in the middle-aged and elderly people and the focus of current prevention and treatment; the second type is secondary osteoporosis Osteoporosis is osteoporosis induced by other diseases or drugs. When the inducement is eliminated, osteoporosis can be significantly improved; the third type is idiopathic osteoporosis, which is common...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/23A61K9/48A61K9/16A61K9/20A61K47/12A61K47/28A61P19/10
Inventor 陈西敬吴磊卢琴
Owner CHINA PHARM UNIV