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Solid preparation containing finasteride and preparation method thereof

A technology for finasteride and finasteride tablets, which is applied in the direction of medical preparations without active ingredients, medical preparations containing active ingredients, pill delivery, etc., to improve content uniformity and avoid causing harm to production personnel Impairment, solubility-increasing effects

Active Publication Date: 2017-04-05
BEIJING HANMI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although poloxamer is considered non-hemolytic, non-skin irritating, and less toxic, there are reports in the literature (new excipients-poloxamer 108 toxicity and general pharmacology research, Ma Kongchen, etc., Journal of Shenyang Pharmaceutical University, 1993( 55) 105-109), according to the results of the subacute toxicity test of poloxamer 108 in dogs, it was found that turbidity and swelling of dog liver cells could be observed with low doses of poloxamer

Method used

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  • Solid preparation containing finasteride and preparation method thereof
  • Solid preparation containing finasteride and preparation method thereof
  • Solid preparation containing finasteride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] 1. Prescription (1000 tablets)

[0047]

[0048]

[0049] Finasteride: provided by Hubei Gedian Renfu Pharmaceutical Co., Ltd., batch number: 061007

[0050] 2. Preparation method:

[0051] 1) Pass the excipients pregelatinized starch, lactose, sodium carboxymethyl starch, colloidal silicon dioxide and magnesium stearate through a 40-mesh sieve.

[0052] 2) Pour 95% ethanol into a clean stainless steel container, start the RW 28 Basic mixer (IKA Guangzhou Yike Laboratory Technology Co., Ltd.), then slowly add povidone K-30 and finasteride, and continue stirring until Dissolve completely, seal the container, and set aside.

[0053] 3) Put the sieved pregelatinized starch and lactose in a GHL250 wet granulator (purchased from Harbin Nano Pharmaceutical and Chemical Equipment Co., Ltd.), and mix for 3 minutes (stirring speed 130±30rpm, cutter speed: low speed) , add the solution obtained in the above step 2) to the mixed material, granulate for 3 minutes, shovel d...

Embodiment 2

[0111] Embodiment 2: compound preparation

[0112] In this example, finasteride was compressed into a plain tablet with a diameter of 5-5.5 mm according to the same preparation method as in Example 1, and then packed in the same capsule with the tamsulosin active ingredient to form a fixed-dose tablet. compound.

[0113] 1. Prescription of finasteride tablets

[0114]

[0115] 2. Tamsulosin sustained-release pellets

[0116]

[0117]

[0118] 3. Preparation method

[0119] 1) Preparation of finasteride tablets: referring to the same preparation method as in Example 1, according to the dosage of the above-mentioned finasteride tablet prescription, press into finasteride tablets with a diameter of 5-5.5 mm.

[0120] 2) Preparation of tamsulosin sustained-release pellets: according to the dosage of tamsulosin sustained-release pellets mentioned above, tamsulosin hydrochloride was mixed with the skeleton material hydroxypropyl methylcellulose, and then mixed with the p...

Embodiment 3

[0123] Prescription for finasteride

[0124]

[0125] The preparation method is the same as in Example 1.

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Abstract

The invention provides a solid preparation including finasteride. The solid preparation contains finasteride and polyvinylpyrrolidone K30, and a weight ratio of finasteride to polyvinylpyrrolidone K30 is in a range of 0.5: 3 to 10: 3. The invention further provides a composite preparation including the solid preparation and a preparation method for the solid preparation.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a solid preparation containing finasteride and a preparation method thereof. Background technique [0002] Benign prostatic hyperplasia (BPH) is one of the most common chronic diseases in middle-aged and older men. Men with benign prostatic hyperplasia account for about 20% of elderly men. Many benign prostatic hyperplasias cause urethral obstruction and gradual loss of bladder function, which are often manifested clinically as changes in urination, such as frequent urination, urgency, inability to urinate, dribbling, hematuria, and urinary retention, which seriously affect the quality of life of patients. [0003] Finasteride is a 4-aza steroid compound with the structural formula: [0004] [0005] Finasteride is a specific inhibitor of type II 5ɑ-reductase, an intracellular enzyme involved in the metabolism of testosterone to dihydrotestosterone. Benign prostatic hyperplasia depe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/58A61K47/32A61K47/36A61P13/08A61P17/14A61K31/18A61K31/517
Inventor 陈海建王书典杨慧君成仁基万英
Owner BEIJING HANMI PHARMA CO LTD