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A kind of stable rosuvastatin calcium capsule and preparation method thereof

A technology of rosuvastatin calcium and capsules, which is applied in the field of stable rosuvastatin calcium capsules and its preparation, can solve the problems of increasing product manufacturing costs, cumbersome operations, and increasing risks of drug bioequivalence, and achieves Increased stability, simple operation effect

Active Publication Date: 2021-06-18
CHINA MEHECO SANYANG PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Chinese patent CN105147636A discloses rosuvastatin calcium capsules and a preparation method thereof. The preparation method uses organic solvents such as dichloromethane and / or chloroform, and requires a freeze-drying process to remove the organic solvent. The operation is cumbersome and not suitable for industrial production.
At present, most of the formulations of rosuvastatin calcium on the domestic market are coated tablets. Since such tablets require granulation, pressurization, coating and other processes, the production process is cumbersome and increases the manufacturing cost of the product.
In addition, the reference preparation developed by AstraZeneca can be prescribed as a tablet, while the present invention is a capsule. Usually, changing the dosage form will significantly increase the risk of bioequivalence of the drug

Method used

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  • A kind of stable rosuvastatin calcium capsule and preparation method thereof
  • A kind of stable rosuvastatin calcium capsule and preparation method thereof
  • A kind of stable rosuvastatin calcium capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1 The capsule shell adopts: 1# gelatin hollow capsule produced by Henan Chengxin Pharmaceutical Capsule Co., Ltd., batch number 160702;

Embodiment 2

[0050] Embodiment 2 The capsule shell adopts: 1# gelatin hollow capsule produced by Shanxi Guangsheng Capsule Co., Ltd., batch number 117010872;

Embodiment 3

[0051] Example 3 The capsule shell is used: 1# gelatin hollow capsule produced by Suzhou Capsule Co., Ltd., batch number 12861855.

[0052] Screening and inspection of important excipients

[0053] 1, the screening of stabilizer (calcium carbonate) (prescription and preparation process are the same as embodiment 2, only change light calcium carbonate crystal form)

[0054] After the raw material medicine is micronized, the texture is lighter. In order to make the mixing uniform, the use of heavy calcium carbonate was abandoned after investigation, and the light calcium carbonate with a very small particle size (average particle size 1 μm-3 μm) was selected for investigation. A variety of light calcium carbonate with different crystal forms (only the following three types are listed now: spherical calcium carbonate, flake calcium carbonate, and spindle calcium carbonate) were studied, and the dissolution behavior of the prepared samples in two dissolution media was determined. ...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and specifically discloses a stable rosuvastatin calcium capsule and a preparation method thereof. The capsule contains spherical light calcium carbonate as a stabilizer, and the parts by weight of each component are as follows: Vastatin calcium 1.0 parts, spherical light calcium carbonate 1.0-2.0 parts, spray-dried lactose 20-25 parts, micropowder silica gel 0.10-0.15 parts, sodium stearyl fumarate 0.20-0.25 parts. The rosuvastatin calcium capsule of the present invention includes a main drug, a stabilizer, a filler, a glidant and a lubricant, and the dosage of each component is strictly controlled so that the main drug and auxiliary materials complement each other and act synergistically. The rosuvastatin calcium capsule obtained in the present invention has high stability, fast dissolution rate, consistent bioequivalence in vivo with the reference preparation, controllable product quality, simple preparation method, and is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a stable rosuvastatin calcium capsule and a preparation method thereof. Background technique [0002] Cardiovascular disease, also known as circulatory system disease, is a series of diseases involving the circulatory system. The circulatory system refers to the organs and tissues that transport blood in the human body, mainly including the heart and blood vessels (arteries, veins, microvessels), which can be subdivided into acute and chronic, and are generally related to arteriosclerosis. These diseases all have similar etiology, pathogenesis and treatment methods. Statins are the most commonly used clinically for the treatment of atherosclerosis, primary hyperlipidemia, familial hypercholesterolemia, mixed lipidemia (type IIb) and similar diseases. Most people tolerate statins well, usually only 0.5% to 2.0% of cases have elevated liver transaminases; they...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/02A61K47/26A61K47/04A61K47/12A61K31/505A61P3/06
CPCA61K9/485A61K9/4858A61K31/505A61P3/06
Inventor 王玲玲陈海刚黄琨傅超婷熊景辉宋光文王玉娟杨若婧
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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