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Rosuvastatin calcium sustained-release preparation and preparation method thereof

A technology for rosuvastatin calcium and sustained-release preparations, applied in the field of sustained-release preparations of rosuvastatin calcium and its preparation, capable of solving problems such as rhabdomyolysis, liver toxicity, headache and flu-like symptoms

Inactive Publication Date: 2010-11-24
BEIJING HONGWAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, adverse reactions such as rhabdomyolysis, proteinuria, nephropathy, renal failure, hepatotoxicity, pharyngitis, headache and flu-like symptoms may occur at larger doses (10-40mg).

Method used

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  • Rosuvastatin calcium sustained-release preparation and preparation method thereof
  • Rosuvastatin calcium sustained-release preparation and preparation method thereof
  • Rosuvastatin calcium sustained-release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Example 1: Rosuvastatin Calcium Hydrophilic Gel Matrix Sustained Release Tablets

[0014] Prescription composition:

[0015] Rosuvastatin Calcium 5.2mg

[0016] Hypromellose K4M 72mg

[0017] Lactose 82mg

[0018] 10% polyvinylpyrrolidone appropriate amount

[0019] 60% ethanol appropriate amount

[0020] Magnesium Stearate 1.6mg

[0021]

[0022] Tablet weight 160mg

[0023] Preparation process: crush rosuvastatin calcium into a 80-mesh sieve, mix evenly with hypromellose K4M and lactose, moisten with 10% polyvinylpyrrolidone and 60% ethanol, and then granulate, dry at 50°C and then granulate. Add magnesium stearate, mix evenly, and press into tablets.

[0024] Release test: In order to investigate the in vitro release characteristics of rosuvastatin calcium sustained-release tablets, according to the Chinese Pharmacopoeia in 2010 two appendix XC, the first method (basket method), with 900ml of water as the dissolution medium, the...

Embodiment 2

[0028] Example 2: Rosuvastatin Calcium Hydrophilic Gel Matrix Sustained Release Tablets

[0029] Prescription composition:

[0030] Rosuvastatin Calcium 5.2mg

[0031] Hypromellose K15M 64mg

[0032] Microcrystalline Cellulose 90mg

[0033] 10% polyvinylpyrrolidone appropriate amount

[0034] 60% ethanol appropriate amount

[0035] Magnesium Stearate 1.6mg

[0036]

[0037] Tablet weight 160mg

[0038] Preparation process: crush rosuvastatin calcium into a 80-mesh sieve, mix evenly with hypromellose K15M and microcrystalline cellulose, moisten with 10% polyvinylpyrrolidone and 60% ethanol, and granulate, dry at 50°C Whole grains, add magnesium stearate, mix evenly, compress into tablets, and obtain.

[0039] Release test: test method is the same as embodiment 1

[0040] The experimental results are shown in Table 2

[0041] Table 2

[0042]

[0043]

Embodiment 3

[0044] Example 3: Rosuvastatin Calcium Hydrophilic Gel Matrix Sustained Release Tablets

[0045] Prescription composition:

[0046] Rosuvastatin Calcium 5.2mg

[0047] Sodium Alginate 58mg

[0048] Microcrystalline Cellulose 96mg

[0049] 10% polyvinylpyrrolidone appropriate amount

[0050] 60% ethanol appropriate amount

[0051] Magnesium Stearate 1.6mg

[0052]

[0053] Tablet weight 160mg

[0054] Preparation process: crush rosuvastatin calcium into a 80-mesh sieve, mix it evenly with sodium alginate and microcrystalline cellulose, moisten it with 10% polyvinylpyrrolidone and 60% ethanol, and then granulate it, dry it at 50°C, and granulate it. Add magnesium stearate, mix evenly, and press into tablets.

[0055] Release test: test method is the same as embodiment 1

[0056] The experimental results are shown in Table 3

[0057] table 3

[0058]

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Abstract

The invention relates to a rosuvastatin calcium sustained-release preparation and a preparation method thereof. The rosuvastatin calcium sustained-release preparation basically contains 5 to 10mg of rosuvastatin calcium, and the balance of sustained-release framework material and other pharmaceutical excipients. The preparation method is simple; and all the materials are proportioned and the preparation is prepared by the preparation method for common tablets, granules or capsules. The rosuvastatin calcium sustained-release preparation prepared by the method avoids adverse reactions such as rhabdomyolysis, proteinuria, nephrosis, kidney failure, hepatotoxicity and the like caused by overdosage of medicaments; meanwhile, due blood concentration and time for treating diseases after the medicaments are taken can be maintained, and the peak valley phenomenon of the blood concentration is effectively avoided.

Description

technical field [0001] The invention relates to a drug sustained-release preparation, in particular to a sustained-release preparation of rosuvastatin calcium and a preparation method thereof. Background technique [0002] In recent years, diseases of the cardiovascular system have ranked among the top three causes of death in my country. Atherosclerosis is the main pathological basis of cardiovascular and cerebrovascular diseases. Prevention and treatment of atherosclerosis is an important measure to prevent and treat cardiovascular and cerebrovascular diseases. Some blood lipids or lipoproteins are higher than the normal range and become hyperlipidemia. It is generally believed that hyperlipidemia can promote the formation and development of atherosclerotic lesions. Epidemiological survey The plasma levels of total cholesterol (TC) and low-density lipoprotein (LDL) are closely related to the morbidity and mortality of coronary heart disease and cerebrovascular disease. Th...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/505A61K9/16A61K9/52A61K9/22A61P9/10A61P3/06
Inventor 王艳皎张志芳谢晓东毕华
Owner BEIJING HONGWAN PHARMA TECH
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