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Tamsulosin and finasteride compound sustained release tablets and preparation method thereof

A technology of compound sustained-release tablets and finasteride, which is applied in the direction of pharmaceutical formulations, amide active ingredients, medical preparations containing active ingredients, etc., can solve the problems of no literature reports or patents on compound sustained-release tablets, and achieve maintenance Plasma drug concentration, good synergistic effect, and the effect of increasing cell apoptosis

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 tablet.

Method used

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  • Tamsulosin and finasteride compound sustained release tablets and preparation method thereof
  • Tamsulosin and finasteride compound sustained release tablets and preparation method thereof
  • Tamsulosin and finasteride compound sustained release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Prescription A: Tamsulosin Hydrochloride 0.2mg

[0022] Finasteride 5mg

[0023] HPMC 16mg

[0024] Lactose 90mg

[0025] Magnesium Stearate 8mg

[0026] Appropriate amount of adhesive

[0027] Preparation process: Pass tamsulosin hydrochloride, finasteride and HPMC through a 80-mesh sieve, mix evenly with lactose and an appropriate amount of binder, make a soft material, granulate with a 24-mesh sieve, dry, granulate with a 20-mesh sieve, add Magnesium stearate is mixed evenly and then compressed into tablets.

[0028] Prescription B: Tamsulosin Hydrochloride 0.4mg

[0029] Finasteride 5mg

[0030] HPMC 16mg

[0031] Lactose 90mg

[0032] Magnesium Stearate 8mg

[0033] Appropriate amount of adhesive

[0034] The preparation process is the same as prescription A.

[0035] Prescription C: Tamsulosin Hydrochloride 0.2mg

[0036] Finasteride 5mg

[0037] Ethylcellulose 12mg

...

Embodiment 2

[0078] Cumulative release of formulations A and C:

[0079] Table 1: Cumulative release of tamsulosin hydrochloride in vitro for prescription A

[0080] time (hours)

2

4

6

8

10

12

16

24

Release(%)

16

27

38

45

56

62

76

84

[0081] Table 2: In vitro cumulative release of prescription A finasteride

[0082] time (hours)

2

4

6

8

10

12

16

24

Release(%)

12

24

33

46

57

68

76

81

[0083] Table 3: In vitro cumulative release of tamsulosin hydrochloride for prescription C

[0084] time (hours)

2

4

6

8

10

12

16

24

Release(%)

14

23

31

48

53

69

74

85

[0085] Table 4: In vitro cumulative release of prescription C finasteride

[0086] time (hours)

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PUM

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Abstract

The invention relates to compound sustained release tablets taking tamsulosin and finasteride as medicinal active ingredients, wherein the tamsulosin can also exist in the form of other pharmaceutically acceptable salts. The preparation also comprises one or more pharmaceutically acceptable sustained release carriers and auxiliary materials consisting of conventional preparations besides main components. The compound sustained release tablets have the advantages of good therapeutic effect, fewer side effects, and safe and reliable use, can maintain steadier blood drug concentration and longer action time due to the sustained release of the medicament, and can be used for the treatment of benign prostatic hyperplasia (BPH).

Description

technical field [0001] The invention relates to a compound slow-release tablet of tamsulosin and finasteride and a preparation method thereof. The slow-release tablet is used for treating benign prostatic hyperplasia (BPH). 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 Pharmaceut...

Claims

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Application Information

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IPC IPC(8): A61K31/58A61K31/18A61K9/22A61P13/08
Inventor 王东凯邱立朋李翔
Owner SHENYANG PHARMA UNIVERSITY
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