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Clopidogrel hydrogen sulfate tablets and preparation method thereof

A technology of clopidogrel bisulfate tablets and clopidogrel bisulfate, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. Wet process is not feasible and other problems, to achieve the effect of easy operation, simple process, and inhibition of the production of clopidogrel acid

Inactive Publication Date: 2013-03-27
HARBIN PHARMA GROUP TECH CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The industrialization of some existing prescriptions is not feasible, and the wet process is not feasible, resulting in a significant increase in related substances A and C. Some formulations have complex ingredients, and some prescriptions have significantly increased related substances A and C after long-term stability inspections. Quality Standard Requirements

Method used

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  • Clopidogrel hydrogen sulfate tablets and preparation method thereof
  • Clopidogrel hydrogen sulfate tablets and preparation method thereof
  • Clopidogrel hydrogen sulfate tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Prescription for Clopidogrel Bisulfate Tablets:

[0046] Specifications: 75mg (calculated as clopidogrel), tablet weight 300mg, the prescription is as follows:

[0047] Table 1 Prescription of Clopidogrel Bisulfate Tablets 1

[0048] Plain tablet ingredients

Proportion

1000 prescription quantity (g)

Clopidogrel bisulfate API

32.62％

97.86 (dried to pure)

lactose

57.88％

173.64

Hydroxypropyl Methyl Cellulose E501v

3％

9

Low-substituted hydroxypropyl cellulose

4％

12

Sodium dodecyl sulfate

2％

6

silica

0.5％

1.5

total

100％

1000 pieces

[0049] Clopidogrel bisulfate tablet preparation process

[0050] (1) Various auxiliary materials are passed through a 60-mesh sieve, and the bulk drug of clopidogrel bisulfate is passed through a 120-mesh sieve for subsequent use;

[0051] (2) Weigh 9 g of hydroxypropyl methylcellulose, 12 g...

Embodiment 2

[0057] Prescription for Clopidogrel Bisulfate Tablets:

[0058] Specifications: 75mg (calculated as clopidogrel), tablet weight 300mg, the prescription is as follows:

[0059] Table 2 Clopidogrel bisulfate tablet prescription 2

[0060] Plain tablet ingredients

Proportion

1000 prescription quantity (g)

Clopidogrel bisulfate API

32.62％

97.86 (dried to pure)

lactose

56.13％

168.39

Hydroxypropyl Methyl Cellulose E501v

3％

9

Low-substituted hydroxypropyl cellulose

5％

15

Sodium dodecyl sulfate

3％

9

silica

0.25％

0.75

total

100％

1000 pieces

[0061] Clopidogrel bisulfate tablet preparation process

[0062] (1) Various auxiliary materials are passed through a 60-mesh sieve, and the bulk drug of clopidogrel bisulfate is passed through a 120-mesh sieve for subsequent use;

[0063] (2) Take by weighing 9g of hydroxypropyl methylcellulo...

Embodiment 3

[0069] Clopidogrel Bisulfate Prescription

[0070] Specifications: 75mg (calculated as clopidogrel), tablet weight 300mg, the prescription is as follows:

[0071] Table 3 Prescription of Clopidogrel Bisulfate Tablets 3

[0072] Plain tablet ingredients

Proportion

1000 prescription quantity (g)

Clopidogrel bisulfate API

32.62％

97.86 (dried to pure)

lactose

55.18％

165.54

Hydroxypropyl Methyl Cellulose E501v

2％

6

Low-substituted hydroxypropyl cellulose

6％

18

Sodium dodecyl sulfate

4％

12

silica

0.2％

0.6

total

100％

1000 pieces

[0073] Clopidogrel bisulfate tablet preparation process

[0074] (1) Various auxiliary materials are passed through a 60-mesh sieve, and the bulk drug of clopidogrel bisulfate is passed through a 120-mesh sieve for subsequent use;

[0075] (2) Weigh 6g of hydroxypropyl methylcellulose, 18g of hydroxypro...

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PUM

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Abstract

The invention relates to clopidogrel hydrogen sulfate tablets and a preparation method thereof. The preparation is composed of: an active component of clopidogrel hydrogen sulfate, a filling material, a diluent, an adhesive, a disintegrating agent, a lubricant, and a flow aid. The preparation method provided by the invention can satisfy production requirements of tablet industrialization. With the method, medicine quality is controllable. The prepared clopidogrel hydrogen sulfate tablets satisfy quality standard requirements of United States Pharmacopoeia USP 32 version. The stability of the medicine is ensured, and the medicine can be stored for more than 2 years under room temperature.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a clopidogrel bisulfate tablet and a preparation method thereof. Background technique [0002] With the aging population, changes in diet and environment, changes in lifestyle, and intensified social competition pressure, the number of patients with cardiovascular and cerebrovascular diseases continues to increase, and the market demand continues to expand. Clopidogrel bisulfate tablets were first successfully developed in 1986 by the French company SANOFI. It was first launched in the United States in March 1998 under the trade name: Plavix. Then it entered the markets of Europe, Canada, Australia, Singapore and other countries. In 2001, France's Sanofi Santa Dela Fort obtained the import approval from China. In August 2002, Shenzhen Xinlitai Pharmaceutical Co., Ltd. was approved to produce clopidogrel bisulfate and its tablets. Clopidogrel bisulfate tablets are characterized by the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/30A61K31/4365A61K47/20A61K47/26A61K47/04A61K47/38A61P7/02
Inventor 王忠安文静孙照英陈玉军李郑武苏宏健张玉华曹翊婕高晶刘宇庭宋紫玉
Owner HARBIN PHARMA GROUP TECH CENT
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