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Paracetamol solid oral preparation and preparation method thereof

A technology of paricalcitol and fillers, which is applied in the field of western medicine preparations, can solve the problems of poor stability and single dosage form, and achieve the effects of stable product quality, high product quality stability, and simple preparation process

Inactive Publication Date: 2020-04-14
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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 controlled-release granules, the controlled-release capsules have stable quality, uniform drug release, and simple preparation process

Method used

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  • Paracetamol solid oral preparation and preparation method thereof
  • Paracetamol solid oral preparation and preparation method thereof
  • Paracetamol solid oral preparation and preparation method thereof

Examples

Experimental program
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Embodiment 1-5

[0030] Example 1-5 Preparation of Paricalcitol Controlled-Release Granules

[0031] A preparation method of paricalcitol controlled-release granules, comprising the following steps:

[0032] (1) Weigh each raw and auxiliary material according to the prescription amount;

[0033] (2) Mix paricalcitol, filler and antioxidant evenly, and use absolute ethanol as a binder to make 20-24 mesh immediate-release granule cores for later use;

[0034] (3) Dissolve the controlled release material, plasticizer and anti-sticking agent with 80% ethanol to make a controlled release coating solution;

[0035] (4) uniformly spraying the prepared controlled-release coating liquid on the surface of the immediate-release granule core prepared in step (2), and drying to obtain paricalcitol controlled-release granules;

[0036] (5) Inspection, packaging, and qualified storage.

[0037] According to the raw and auxiliary materials in the prescription (1000 bags) in the following table 1, and accor...

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Abstract

The invention discloses a paracetamol controlled-release granule and a preparation method thereof. The paracetamol controlled-release granule is composed of a quick-release granule core and a controlled-release coating layer coating the quick-release granule core, the quick-release granule core is composed of paracetamol, a filler and an antioxidant, the controlled-release coating layer is composed of a controlled-release material, a plasticizer and an anti-sticking agent, and the quick-release particle core is coated with the controlled-release coating layer during preparation. The medicine solves the problems of single paracetamol dosage form, poor oral preparation stability and the like in the market, achieves the purposes of long acting and curative effect increase, can reduce the dosage and reduce the side effects while maintaining the same efficacy, and is simple in preparation process, stable in quality of the obtained product and suitable for large-scale production.

Description

technical field [0001] The invention relates to a western medicine preparation technology, in particular to a controlled-release granule of paricalcitol, and also relates to a preparation method of the controlled-release 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 low blood calcium and magnesium and high blood phosphorus. Parathyroid hormone, compensatory maintenance of normal serum calcium and phosphorus. The disease is more common in vitamin D deficiency, severe renal insufficiency, osteomalacia, pregnant or breastfeeding women. [0003] The biologically active form of vitamin D, calcitriol, plays a key role in a series of physiological functions such as calcium balance, hormone secretion, and cell proliferation and differentiation in the body. Calcitriol supplementation has become an important ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/592A61K47/32A61K47/14A61P5/20
CPCA61K9/5015A61K9/5026A61K31/592A61P5/20
Inventor 刘薇陈阳生王明刚臧云龙刘晓霞孙桂玉王清亭牛建兴耿立朵
Owner CP PHARMA QINGDAO CO LTD