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Paricalcitol enteric-coated granules

A technology of paricalcitol and alcohol intestine, which is applied in the field of medicine, can solve the problems of poor stability and single dosage form, and achieve the effects of stable product quality, reduced stimulation, improved stability and bioavailability

Inactive Publication Date: 2020-08-07
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to overcome the problems of single dosage form and poor stability of paricalcitol, and develop an oral solid preparation with high stability, convenient administration and simple preparation process, the present invention screens auxiliary materials and process optimization through a large number of tests, and provides a Paricalcitol enteric-coated granules, the enteric-coated granules have stable quality and simple preparation process

Method used

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  • Paricalcitol enteric-coated granules
  • Paricalcitol enteric-coated granules
  • Paricalcitol enteric-coated granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0038] Example 1-6 Preparation of Paricalcitol enteric-coated granules

[0039] A preparation method of Paricalcitol enteric-coated granules, comprising the following steps:

[0040] (1) Weigh each raw and auxiliary material according to the prescription quantity;

[0041] (2) Mix paricalcitol, fillers, antioxidants and disintegrants evenly, use absolute ethanol as a binder, and granulate with a 20-24 mesh sieve to obtain paricalcitol immediate-release granule cores ;

[0042] (3) Dissolve enteric-coated materials, plasticizers and lubricants with 80% ethanol to make enteric-coated liquid;

[0043] (4) Spray the enteric-coated solution prepared in step (3) evenly on the surface of the Paricalcitol immediate-release granules prepared in step (2), and dry to obtain the paricalcitol enteric-coated granules;

[0044] (5) Inspection, packaging, qualified storage.

[0045] Paricalcitol enteric-coated granules were prepared according to the raw and auxiliary materials in the pres...

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Abstract

The invention discloses paricalcitol enteric-coated granules and a preparation method thereof. The paricalcitol enteric-coated granule is composed of a paricalcitol quick-release granule core and an enteric coating layer coating the paricalcitol quick-release granule core, wherein the quick-release granule core comprises paricalcitol, a filling agent, an antioxidant and a disintegrating agent, theenteric coating layer comprises an enteric material, a plasticizer and a lubricant, and the paricalcitol quick-release granule core is coated with the enteric coating layer during preparation, so that the paricalcitol quick-release granule is obtained. The stability and bioavailability of paricalcitol can be improved, irritation of the medicine to gastric mucosa is reduced, the preparation process is simple, and the obtained product is stable in quality and suitable for large-scale production.

Description

technical field [0001] The invention relates to a western medicine preparation technology, in particular to a paricalcitol enteric-coated granule, which belongs to the technical field of medicine. Background technique [0002] Secondary hyperparathyroidism (SHPT) is due to the existence of factors that stimulate the parathyroid glands in the body, especially hypocalcemia, magnesium and hyperphosphatemia, the glands are stimulated to proliferate, hypertrophy, and secrete too much Parathyroid hormone, compensatory maintenance of blood calcium, phosphorus normal. This disease is more common in vitamin D deficiency, severe renal insufficiency, osteomalacia, pregnant or lactating women. [0003] Calcitriol, the biologically active form of vitamin D, plays a key role in a series of physiological functions such as calcium balance, hormone secretion, and cell proliferation and differentiation in the body. Supplementing calcitriol has become an important approach in the clinical tr...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K31/592A61K47/38A61K47/32A61P5/20
CPCA61K9/5026A61K9/5042A61K9/5047A61K31/592A61P5/20
Inventor 陈阳生臧云龙孙桂玉刘晓霞王明刚王清亭张怀征刘薇马庆童
Owner CP PHARMA QINGDAO CO LTD