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Pitavastatin calcium tablet and preparation method thereof

A technology of pitavastatin calcium and tablet cores, which is applied in the field of medicine, can solve the problems of easily changing appearance, content uniformity, low content of pitavastatin calcium, and poor product stability, and achieve high dissolution rate, excellent drug properties, and stability Good results

Pending Publication Date: 2022-02-15
HAINAN HUALON PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Pitavastatin calcium has high activity and low content in the prescription, so pitavastatin calcium tablets have problems of poor product stability, low dissolution rate, easy to change appearance during storage and content uniformity

Method used

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  • Pitavastatin calcium tablet and preparation method thereof
  • Pitavastatin calcium tablet and preparation method thereof
  • Pitavastatin calcium tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] A kind of pitavastatin calcium tablet, comprises tablet core and coating layer, each component and content of its tablet core are as follows (by 1000 tablets):

[0044] components Content per 1000 tablets (g) pitavastatin calcium 2 lactose 95 magnesium aluminum silicate 2.4 hypromellose 2 Low-substituted hydroxypropyl cellulose (internal addition) 9 Low-substituted hydroxypropyl cellulose (additional) 9 Magnesium stearate 0.6

[0045] The preparation steps of pitavastatin calcium tablets are as follows:

[0046] (1): Preparation of raw and auxiliary materials: take respectively raw material pitavastatin calcium, auxiliary materials lactose, magnesium aluminum silicate, low-substituted hypromellose, hypromellose and magnesium stearate and pass through a 60-mesh sieve after pulverization, spare;

[0047] (2): the preparation of hypromellose aqueous solution: the hypromellose of 0.2kg is slowly added to the purified...

Embodiment 2

[0063] A kind of pitavastatin calcium tablet, comprises tablet core and coating layer, each component and content of its tablet core are as follows (by 1000 tablets):

[0064] components Content per 1000 tablets (g) pitavastatin calcium 2 lactose 95 Hydroxyapatite 2.4 hypromellose 2 Low-substituted hydroxypropyl cellulose (internal addition) 9 Low-substituted hydroxypropyl cellulose (additional) 9 Magnesium stearate 0.6

[0065] The difference from Example 1 is that the protective agent aluminum magnesium silicate in Example 1 is replaced by hydroxyapatite, compared to the aluminum magnesium silicate used in Example 1 as the protective agent, the present embodiment uses Hydroxyapatite is a substance with a porous structure and has a large capacity for the main drug. After it is mixed with pitavastatin calcium, it can adsorb pitavastatin calcium in the internal pores to avoid or reduce its contact with the external environ...

Embodiment 3

[0081] Pitavastatin calcium tablets were prepared according to the preparation method in Example 2 above, and the stability of the prepared pitavastatin calcium tablets was investigated in different conditions and ways. The experimental results are shown in the following table 2-5;

[0082] Wherein, the reference agent is: (trade name: Li Qingzhi, batch number 1050, manufacturer: Japan Xinghe Co., Ltd.).

[0083] Table 2 is embodiment stability investigation result

[0084]

[0085]

[0086] Table 3 is the accelerated experiment investigation result of embodiment (40 ± 2 ℃ of temperature, relative humidity 75% ± 5%)

[0087]

[0088] Table 4 is the investigation result of comparative example accelerated experiment (40 ± 2 ℃ of temperature, relative humidity 75% ± 5%)

[0089]

[0090] Table 5 is the long-term experimental investigation result of embodiment (30 ± 2 ℃ of temperature, relative humidity 60% ± 5%)

[0091]

[0092] As can be seen from the above exp...

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Abstract

The invention discloses a pitavastatin calcium tablet which comprises a tablet core and a coating layer coated outside the tablet core, and the tablet core is prepared from the following components in parts by weight: 1-3 parts of pitavastatin calcium; 90 to 100 parts of a filling agent; 2-3 parts of a protection agent; the total amount of 15-20 parts of an internally added disintegrating agent and an externally added disintegrating agent; 150 to 200 parts of an adhesive; and 2-3 parts of a lubricant. The content uniformity of the tablet can be improved, the stability and the dissolution rate of the pitavastatin calcium tablet are effectively improved, and long-term storage is facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical preparation and a preparation method thereof, in particular to pitavastatin calcium tablets and a preparation method thereof. Background technique [0002] Pitavastatin Calcium is the third-generation hydroxymethylglutaryl-CoA reductase inhibitor (HMG-CoA) successfully developed by Nissan Chemical Industry Co., Ltd. of Japan. In July 2003, Nissan Chemical Industry Co., Ltd. and Kowa Co., Ltd. jointly applied for registration in Japan, and in September, it was approved to be marketed for the treatment of hypercholesterolemia. [0003] HMG-CoA is the drug of choice for the treatment of hypercholesterolemia, and has also been praised by the pharmacological community as a "miracle in the history of modern medicine". HMG-CoA has a high and specific competitive inhibition of hydroxymethylglutaryl-CoA reductase, inhibits the synthesis of cholesterol (CH) in the liver, in...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/47A61K31/4709A61K47/38A61K47/36A61K47/32A61K47/02A61P3/06C01B25/32
CPCA61K9/2059A61K9/2054A61K9/2027A61K9/2009A61K9/2095A61K9/2866A61K31/47A61K31/4709A61P3/06C01B25/32C01B25/327
Inventor 陈益智史江永方海霞陈峙托
Owner HAINAN HUALON PHARM
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