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Calcitriol sustained-release capsule and preparation method thereof

A technology of calcitriol and sustained-release capsules, which is applied in bone diseases, medical formulas, and medical preparations of non-active ingredients, etc., can solve the problems of monotonous dosage forms, poor stability of ointments and tablets, etc., and achieve reduction Dosage, stable product quality, suitable for large-scale production and application

Active Publication Date: 2014-10-01
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are mainly capsules, ointments, and tablets of calcitriol in the market in our country. The dosage forms are relatively monotonous, and because calcitriol is sensitive to light and air, the stability of ointments and tablets is not good.

Method used

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  • Calcitriol sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0021] A preparation method of calcitriol sustained-release capsules, comprising the following steps:

[0022] (1) Get a certain amount of sucrose and put it in a centrifugal granulator, and use water as a binder to prepare a blank ball core with a particle size of 50 mesh;

[0023] (2) take calcitriol, filler and binder by weight percentage, binder is made into 5% aqueous solution, calcitriol and filler are put in the powder supply chamber of centrifugal granulator, take Put an appropriate amount of blank pellet cores prepared in step (1) in a granulation pot, use the aqueous solution of the binder as the binder to prepare drug-containing pellets, dry the pellets at 60°C after being taken out of the pot, and sieve to 20 mesh for the next step coating;

[0024] (3) Dissolving the slow-release material, plasticizer, porogen, and anti-tack agent with 80% ethanol solution to make a slow-release coating solution;

[0025] (4) Spray the prepared slow-release coating solution even...

Embodiment 1～3

[0027] Preparation of Embodiment 1-3 Calcitriol Sustained Release Capsules

[0028] According to the raw and auxiliary materials in the following table, according to the above-mentioned preparation method, 2000 calcitriol sustained-release capsules were prepared in each embodiment. Among them, " / " means not used.

[0029]

[0030] Test Example 1 Determination of release rate of calcitriol sustained-release capsules obtained in Examples 1-3

[0031] According to the "Guidelines for Sustained and Controlled Release Preparations" in the appendix of the 2010 edition of the Pharmacopoeia of the People's Republic of China (Part II), 0.25% sodium lauryl sulfate was used as the release medium, and the preparations in Examples 1 to 3 were accurately weighed. An appropriate amount of calcitriol sustained-release pellets (about 100mg) was determined according to the first method of appendix XD of the 2010 edition of the Pharmacopoeia of the People's Republic of China. The peak area w...

Embodiment 4～6

[0035] The preparation of embodiment 4~6 calcitriol sustained-release capsules

[0036] According to the raw and auxiliary materials in the following table, according to the above-mentioned preparation method, 2000 calcitriol sustained-release capsules were prepared in each embodiment. The weight ratio of the slow-release material to the porogen in Example 4 is 8:1, the weight ratio of the slow-release material to the porogen in Example 5 is 7:1, and the weight ratio of the slow-release material to the porogen in Example 6 is The ratio is 6:1.

[0037]

[0038] Calcitriol Sustained-release Capsules Release Determination of Test Example 2 Examples 4-6 Gained

[0039] The measuring method is the same as that of Test Example 1. The measurement results are shown in Table 2.

[0040] Table 2 Example 4-6 Calcitriol Sustained-release Capsule Release Rate Investigation Table (Dissolution Medium: 0.25% Sodium Lauryl Sulfate)

[0041]

[0042] As can be seen ...

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Abstract

The invention discloses a calcitriol sustained-release capsule and a preparation method thereof. The calcitriol sustained-release capsule disclosed by the invention is prepared through filling a calcitriol sustained-release pellet in a capsule shell; and during preparation, the calcitriol sustained-release pellet is obtained through coating a drug-containing layer and a coating layer outside a blank pellet core and then filled in the capsule shell, thereby obtaining the calcitriol sustained-release capsule. According to the calcitriol sustained-release capsule and the preparation method of the calcitriol sustained-release capsule, the drug release is uniform, the aims of long acting and curative effect improving can be reached, and the dosage can be reduced while the same drug action is maintained, so that side effects to patients caused by drug taking are reduced; and the preparation method is simple, the quality of obtained products is stable, and thus, the method is applicable to large-scale production application.

Description

technical field [0001] The invention relates to the technical field of western medicine preparations, in particular to a calcitriol sustained-release capsule, and also relates to a preparation method of the sustained-release capsule. Background technique [0002] Calcitriol (Calcitriol), also known as Luo Calciton, is a fat-soluble sterol in vitamin D compounds. 3 The most important active form after transformation in vivo. Calcitriol was developed by Roche, Switzerland, and was approved for marketing in Switzerland in the 1970s, and was first registered in my country in the 1980s. Calcitriol can treat postmenopausal women and middle-aged and elderly osteoporosis, hypoparathyroidism, vitamin D 3 Dependent rickets, renal osteodystrophy, and renal rickets, renal bone lesions, and hypoparathyroidism caused by renal failure and other kidney diseases. With the arrival of my country's aging society, the drug market demand for calcitriol that can be used to treat osteoporosis is...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/593A61K47/32A61K47/26A61P3/02A61P19/10A61P19/08A61P5/18A61P13/12
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD