Compound tamsulosin and finasteride sustained release capsule and preparation method thereof

A technology of finasteride and sustained-release capsules, which is applied in the field of medicine, can solve the problems such as no literature reports or patents of compound sustained-release capsules, and achieve the effects of stable blood drug concentration, convenient administration, and long action time

Inactive Publication Date: 2010-05-12
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] After inquiry, there is no literature report or patent related to this compound sustained-release capsule.

Method used

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  • Compound tamsulosin and finasteride sustained release capsule and preparation method thereof
  • Compound tamsulosin and finasteride sustained release capsule and preparation method thereof
  • Compound tamsulosin and finasteride sustained release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Prescription A: Tamsulosin Hydrochloride 0.2mg

[0023] Finasteride 5mg

[0024] Microcrystalline Cellulose 90mg

[0025] Ethylcellulose 60mg

[0026] Polyethylene glycol 8mg

[0027] Proper amount of acetone

[0028] Preparation:

[0029] Pass tamsulosin hydrochloride and finasteride through a 100-mesh sieve, and microcrystalline cellulose through a 60-mesh sieve. After mixing the raw and auxiliary materials evenly, add an appropriate amount of purified water to make a wet soft material. 14-20 mesh diameter extruded strips about 3-5cm in length, the rotation speed of the bottom turntable is adjusted to 800-1000rpm, and the ball is rounded for 3-5 minutes. Take the medicine pellets and place them in the fluidized bed, adjust the air inlet pressure to 0.4-0.6bar, the temperature to 30-50°C, and the rotating speed to 150-200rpm, spray into the configured ethyl cellulose coating solution (the prescribed amount of ethyl cellulose Cel...

Embodiment 2

[0074] In vitro cumulative release of formulations A and E:

[0075] Table 1: Cumulative release of tamsulosin hydrochloride in vitro for prescription A

[0076] time (hours)

2

4

6

8

10

12

16

24

Release(%)

16

24

31

45

57

64

72

81

[0077] Table 2: In vitro cumulative release of prescription A finasteride

[0078] time (hours)

2

4

6

8

10

12

16

24

Release(%)

12

21

37

43

58

62

74

83

[0079] Table 3: In vitro cumulative release of tamsulosin hydrochloride for prescription E

[0080] time (hours)

2

4

6

8

10

12

16

24

Release(%)

23

31

47

59

71

80

87

94

[0081] Table 4: In vitro cumulative release of formulation E finasteride

[0082] time (hours)

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PUM

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Abstract

The invention relates to compound tamsulosin and finasteride sustained release capsules and a preparation method thereof. The compound sustained release capsule is prepared by taking tamsulosin and finasteride as medical bioactive ingredients to prepare medicine-containing pellets, coating the medicine-containing pellets by coating materials to prepare sustained release pellets, and placing the sustained release pellets into hard capsule shells. The compound tamsulosin and finasteride sustained release capsules are used for treating benign prostatic hyperplasis (BPH), can be very slowly released to maintain stable plasma concentration and longer action time, and have the advantages of less toxic and side-effects and convenient application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to compound tamsulosin and finasteride sustained-release capsules and a preparation method thereof. Background technique [0002] Benign prostatic hyperplasia (BPH) is the most common chronic disease and the most common cause of dysuria in middle-aged and elderly men. Many BPHs cause obstruction of the urethra and progressive loss of bladder function, which can lead to incomplete emptying of the bladder. It is clinically manifested as changes in urination, such as weak urination, urgency, and frequent urination. Data show that 50% of men aged 51-60 will have histological BPH, 70% over 60 years old, and 90% over 80 years old, and 25% of them need to receive various treatments. Patients generally need long-term or even life-long medication. [0003] Tamsulosin is a highly selective adrenergic receptor antagonist developed by Japan Yamanouchi Pharmaceutical Co., Ltd., which can reduc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61K31/18A61K9/52A61P13/08
Inventor 王东凯邱立朋李翔
Owner SHENYANG PHARMA UNIVERSITY
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