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Dihydroartemisinin piperaquine phosphate tablets and preparation process thereof

A technology of dihydroartemisinin and piperaquine, which is applied in the field of dihydroartemisinin-piperaquine tablets and their preparation, can solve the problems of easy discoloration of piperaquine phosphate and the inability of plain tablets to guarantee the stability of medicines, and achieves one-sided bright and clean , less impurities, the effect of overcoming the problem of discoloration

Inactive Publication Date: 2011-03-16
贝克诺顿(浙江)制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Dihydroartemisinin-piperaquine tablets are compound preparations composed of dihydroartemisinin and piperaquine phosphate. However, because piperaquine phosphate is unstable when exposed to light and easy to change color, after being made into tablets, it will disappear within 24 hours. Then it turns red, so the stability of the plain tablet cannot be guaranteed

Method used

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  • Dihydroartemisinin piperaquine phosphate tablets and preparation process thereof
  • Dihydroartemisinin piperaquine phosphate tablets and preparation process thereof
  • Dihydroartemisinin piperaquine phosphate tablets and preparation process thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0040] Prepare according to the following formula:

[0041] Dihydroartemisinin (Chongqing Huali Wulingshan Pharmaceutical Co., Ltd.)

40.0g

[0042] Piperaquine Phosphate (Zhuhai Rundu Mintong Pharmaceutical Co., Ltd.)

320.0g

Corn starch (Haiyan Liuhe Starch Chemical Co., Ltd.)

70.6g

Dextrin (Haiyan Liuhe Starch Chemical Co., Ltd.)

17.7g

Hypromellose (Huzhou Zhanwang Pharmaceutical Co., Ltd.)

2.9g

Sodium carboxymethyl starch (Huzhou Zhanwang Pharmaceutical Co., Ltd.)

212g

Magnesium stearate (Huzhou Zhanwang Pharmaceutical Co., Ltd.)

2.18g

Opadry (Shanghai Colorcon Coating Technology Co., Ltd.)

13.4g

production

1000 pieces

[0043] Grind 40g of double artemisinin and 320g of piperaquine phosphate with a 100-mesh sieve and pass through a 100-mesh steel sieve, requiring all to pass through a 100-mesh sieve; 70.6g of corn starch, 17.7g of dextrin, 2.9g of hypr...

Embodiment 2

[0052] 40g of bisartemisinin and 320g of piperaquine phosphate were crushed with a 100-mesh sieve and passed through a 100-mesh steel sieve, requiring all to pass through a 100-mesh sieve; 80.9g of corn starch, 22.8g of dextrin, 2.9g of hypromellose, hard Magnesium fatty acid 3.5g and sodium carboxymethyl starch 8.6g pass through a 60-mesh steel sieve respectively for later use.

[0053] The hypromellose is dissolved in an ethanol solution with a concentration of 50% by mass, and stirred until dissolved to form a binder with a concentration of 8% by mass.

[0054] Add the above-mentioned piperaquine phosphate, dihydroartemisinin, starch, dextrin and carboxymethyl starch sodium after sieving into the wet granulator, add hypromellose binder to make soft material, pass through a 14-mesh sieve, Get wet granules.

[0055] The wet granules are dried in an explosion-proof boiling dryer, and the material temperature is controlled at 40-50°C to obtain dry granules.

[0056] The dry...

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Abstract

The invention discloses dihydroartemisinin piperaquine phosphate tablets. The dihydroartemisinin piperaquine phosphate tablets comprise the following raw materials in part by weight: 40 parts of dihydroartemisinin, 320 parts of piperaquine phosphate, 60 to 90 parts of starch, 10 to 25 parts of dextrin, 2 to 8 parts of hydroxypropyl methylcellulose, 20 to 80 parts of sodium carboxy-methyl starch, 2.5 to 3.0 parts of magnesium stearate and 12 to 18 parts of opadry. The invention also discloses a preparation method for the dihydroartemisinin piperaquine phosphate tablets. The preparation method comprises the following steps of: preparing materials, crushing, sieving, preparing a bonding agent, mixing and pelleting, drying, mixing and tabletting, and coating. The dihydroartemisinin piperaquine phosphate tablets have good stability and long storage time and are difficult to discolor.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a dihydroartemisinin-piperaquine tablet and a preparation process thereof. Background technique [0002] Dihydroartemisinin-piperaquine tablet is a compound preparation composed of dihydroartemisinin and piperaquine phosphate. Dihydroartemisinin, a derivative of artemisinin, is the active substance of artemisinin in the body. It has a strong killing effect on Plasmodium asexuals, and can quickly kill Plasmodium, thereby controlling symptoms. Plasmodium is not easy to develop drug resistance to dihydroartemisinin. Piperaquine phosphate is a 4-aminoquinoline antimalarial drug. The antimalarial effect is similar to that of chloroquine, and it affects the ultrastructure of erythrocyst schizonts of Plasmodium. It can mainly make the food bubble membrane and mitochondria of trophozoites swell, leading to the destruction of their physiological functions, thereby killing the malaria parasite. Pi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K31/357A61K9/28A61P33/06
Inventor 逮春明
Owner 贝克诺顿(浙江)制药有限公司
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