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Paricalcitol capsule and preparation method thereof

A technology of capsules and sausages, which is applied in the field of western medicine preparations, can solve the problems of single dosage forms and poor stability, and achieve the effects of stable product quality, reduced irritation, and simple preparation process

Inactive Publication Date: 2020-03-27
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 existing 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 capsules, the enteric-coated tablets have stable quality and simple preparation process

Method used

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  • Paricalcitol capsule and preparation method thereof
  • Paricalcitol capsule and preparation method thereof
  • Paricalcitol capsule and preparation method thereof

Examples

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Embodiment 1-6

[0038] Example 1-6 Preparation of Paricalcitol Enteric-Coated Capsules

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

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

[0041] (2) Mix paricalcitol and filler evenly, and use absolute ethanol as a binder to make 20-30 mesh paricalcitol pellets for later use;

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

[0043] (4) Evenly spray the enteric coating solution prepared in step (3) on the surface of the paricalcitol pellets prepared in step (2), and dry to obtain the paricalcitol enteric pellets;

[0044] (5) Fill the paricalcitol enteric-coated pellets into the capsule shell to obtain paricalcitol enteric-coated capsules;

[0045] (6) Inspection, packaging, qualified storage.

[0046] Paricalcitol enteric-coated capsules were prepared according ...

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Abstract

The invention discloses a paricalcitol enteric-coated capsule and a preparation method thereof. The paricalcitol enteric-coated capsule is prepared by filling a capsule shell with a paricalcitol enteric-coated micropellet, the paricalcitol enteric-coated micropellet is composed of a paricalcitol micropellet and an enteric coating layer wrapping the paricalcitol micropellet, the paricalcitol micropellet includes paricalcitol, a filler and an antioxidant, the enteric coating layer includes an enteric material, a plasticizer, a pore-forming agent and a lubricant, and the paricalcitol enteric-coated capsule is prepared by wrapping the paricalcitol micropellet by the enteric coating layer and filling the capsule shell with the paricalcitol enteric-coated micropellet. The medicine provided by the invention is convenient to eat, has an ideal enteric effect, can improve the stability and bioavailability of the paricalcitol, and has a simple preparation process; and the obtained product has stable quality, and is 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 capsule, and also relates to a preparation method of the enteric-coated capsule, belonging 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. Suppleme...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K9/50A61K47/38A61K47/32A61K31/592A61P5/20
CPCA61K9/5026A61K9/5047A61K31/592A61P5/20
Inventor 臧云龙陈阳生王明刚刘晓霞孙桂玉刘振玉刘薇薛文静
Owner CP PHARMA QINGDAO CO LTD
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