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Compound tamsulosin and finasteride controlled release tablet and preparation method

A technology of finasteride and controlled-release tablets, which is applied in the field of medicine, can solve the problems of no literature reports or patents on compound controlled-release tablets, and achieve the effects of small fluctuations in blood drug concentration, improved curative effect, and improved compliance

Inactive Publication Date: 2014-06-25
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 controlled-release tablet.

Method used

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  • Compound tamsulosin and finasteride controlled release tablet and preparation method
  • Compound tamsulosin and finasteride controlled release tablet and preparation method
  • Compound tamsulosin and finasteride controlled release tablet and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Prescription A: 1. Tablet core ingredients

[0038] Tamsulosin Hydrochloride 0.2mg

[0039] Finasteride 5mg

[0040] Lactose 100mg

[0041] Starch 75mg

[0042] Hypromellose 10mg.

[0043] Magnesium Stearate 5mg

[0044] 2. Semi-permeable membrane coating solution

[0045] Cellulose acetate 40mg

[0046] Polyethylene glycol 8mg

[0047] Proper amount of acetone

[0048] Preparation:

[0049] 1. Sieve and mix the prescribed amount of tamsulosin, finasteride and fillers, make soft materials with binders, granulate, dry, granulate, add lubricants or glidants, mix well, and press to form Chips.

[0050] 2. Dissolve the prescribed amount of cellulose acetate and polyethylene glycol in 500ml of acetone to make a semi-permeable membrane coating solution. After coating the tablet core, use a laser to punch at least one small hole on the tablet. The aperture is controlled at 0.1 mm-1.0mm, and then w...

Embodiment 2

[0117] Table 1: Cumulative release of tamsulosin hydrochloride in vitro for prescription A

[0118] time (hours)

2

4

6

8

12

24

Release(%)

18.2

35.7

47.4

66.3

80.6

88.5

[0119] Table 2: In vitro cumulative release of prescription A finasteride

[0120] time (hours)

2

4

6

8

12

24

Release(%)

19.7

38.2

49.0

69.5

75.1

86.9

[0121] Table 3: In vitro cumulative release of tamsulosin hydrochloride for prescription D

[0122] time (hours)

2

4

6

8

12

24

Release(%)

17.6

33.9

50.2

68.4

79.3

91.4

[0123] Table 4: In vitro cumulative release of prescription D finasteride

[0124] time (hours)

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Abstract

The invention belongs to the technical field of medicine, relating to a compound tamsulosin and finasteride controlled release tablet and a preparation method, and comprising two main active substances of tamsulosin and finasteride; the unit dosage of the tamsulosin is 0.01mg to 10mg, the unit dosage of the finasteride is 1mg to 50mg, and the weight ratio of the tamsulosin and finasteride is 1:1 to 1:100. The preparation method comprises the following steps: firstly pressing a tablet core, then coating a layer of insoluble semipermeable membrane on the tablet core, and punching at least one small hole on the semipermeable membrane to lead the active substances to be released from the semipermeable membrane. The compound controlled release tablet is used for curing benign prostatic hyperplasia, leading the concentration fluctuation of the blood and the drugs to be small, reducing the side effect, improving the curative effect, being taken for one time everyday and improving compliance of patients.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a compound tamsulosin and finasteride controlled-release tablet 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 redu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/58A61K31/18A61K9/32A61P13/08
Inventor 王东凯邱立朋李翔
Owner SHENYANG PHARMA UNIVERSITY