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Pharmaceutical composition containing paricalcitol

A technology for paricalcitol and a composition is applied in the field of soft capsule pharmaceutical compositions containing paricalcitol and the preparation thereof, and can solve the problems of poor disintegration uniformity, poor dissolution, and soft capsules of paricalcitol. Problems such as long disintegration time of capsules

Inactive Publication Date: 2017-03-08
CHENGDU GUOHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to overcome the long disintegration time of Paricalcitol soft capsules in the prior art, especially the problems of delayed disintegration, poor disintegration uniformity and poor dissolution rate during long-term storage, the present invention provides the following technical solutions :

Method used

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  • Pharmaceutical composition containing paricalcitol
  • Pharmaceutical composition containing paricalcitol
  • Pharmaceutical composition containing paricalcitol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090] Follow the prescription below:

[0091]

[0092] [1] Type A gelatin was purchased from Rousselot 200 AH type gelatin.

[0093] Preparation process: Add BHT and Paricalcitol into absolute ethanol, stir to dissolve, add medium-chain triglycerides in equal amounts and stir to mix evenly.

[0094] Grind and disperse titanium dioxide and yellow iron oxide with some water to obtain a pigment suspension; after heating up to 60-70°C, add gelatin and pigment suspension in sequence, wash the adhered materials in the container with remaining water and put them into the solution; Keep the temperature of the glue solution at 60-70°C, stir and vacuumize to remove air bubbles; measure the viscosity of the glue solution, it should be 8000-30000mPa·s, and keep the glue solution at 50-60°C after removing air bubbles for later use.

[0095] Adjust the temperature of the plastic box, the temperature of the spray body, and the thickness of the rubber in the range of 0.6-0.9mm, and press...

Embodiment 2

[0097] Follow the prescription below:

[0098]

[0099] [1] Type A gelatin was purchased from Rousselot type 200FG gelatin.

[0100] The preparation method is the same as in Example 1. Finally dry to the target rubber moisture of 19%.

Embodiment 3

[0102] Follow the prescription below:

[0103]

[0104] [1] Type A gelatin was purchased from Rousselot 180PS type gelatin.

[0105] The preparation method is the same as in Example 1. Finally dry until the target rubber moisture is 9%.

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Abstract

The invention relates to a soft capsule pharmaceutical composition containing paricalcitol. The prescription is characterized in that a content consists of the paricalcitol, absolute ethyl alcohol, BHT and MCT, and a rubber shell consists of dried gelatin, glycerol, titanium dioxide and yellow ferric oxide, wherein in the content, the weight ratio of the paricalcitol to the absolute ethyl alcohol is at 1 to (600-800), the weight ratio of the paricalcitol to the BHT is at 1 to (8.5-15), and the weight ratio of the paricalcitol to the MCT is at 1 to (71000-80000); in the rubber shell, the weight ratio of the various components is at 1 to (0.3-0.8) to (0.005-0.04) to (0.001-0.008) of the dried gelatin to the glycerol to the titanium dioxide to the yellow ferric oxide; and the adopted gelatin is type A gelatin. In addition, the invention also discloses a preparation method of the soft capsule. The paricalcitol soft capsule provided by the invention can get disintegrated and dissolved rapidly, and the paricalcitol soft capsule is good in disintegrating stability and high in disintegrating uniformity in a long-term storage process; and the preparation method is simple and applicable to large-scale industrial production.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a soft capsule pharmaceutical composition containing paricalcitol and a preparation method thereof. Background technique [0002] Paricalcitol, also known as 19-nor-1,25-(OH) 2 - Vitamin D 2 or 19-nor-1,25-dihydroxyvitamin D 2 , is a synthetic, selective, third-generation bioactive vitamin D 2 Analogue, for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage V chronic kidney disease. Although the structure of the drug is similar to that of calcitriol, compared with calcitriol, it can inhibit parathyroid hormone faster and longer, and has little effect on calcium, phosphorus and calcium-phosphorus product, so persistent Hypercalcemia, and the drug is also more effective than calcitriol in reducing aortic calcification and improving bone quality, and can reduce patient mortality, hospitalization frequency and length of hospitalization. [0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/592A61K47/44A61K47/10A61K47/14A61P5/20
Inventor 蒋代财郭礼新郭晖
Owner CHENGDU GUOHONG PHARMA
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