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Finasteride and doxazosin compound controlled release capsule and use thereof

A technology of doxazosin and finasteride, which is applied in the field of medicine, can solve problems such as unovercome adverse reactions of combined medication and increased toxicity of drugs, so as to reduce the time of taking medicine, reduce toxic and side effects, and improve compliance Effect

Inactive Publication Date: 2011-05-18
NAT INST OF PHARMA R & D CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ordinary compound preparations have demonstrated the mutual synergy of the two drugs in terms of therapeutic effects, however, the adverse reactions of the combined drug have not been overcome, and the toxic and side effects of the drug on the human body have increased.

Method used

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  • Finasteride and doxazosin compound controlled release capsule and use thereof
  • Finasteride and doxazosin compound controlled release capsule and use thereof
  • Finasteride and doxazosin compound controlled release capsule and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: Preparation of finasteride immediate-release pellets

[0026] Finasteride micropellet coating preparation process: mix the drug, binder, co-solvent and organic solvent in the formula (according to the formula) to make a coating solution; the above-mentioned coating solution will be used to coat the blank in a fluidized bed Sugar pellet core coating. During coating, the drug content of finasteride in the pellets can be controlled at 1-60 wt%.

[0027] Here, the drug is finasteride; the binder can be selected from starch slurry, methylcellulose, hydroxypropylcellulose, hypromellose, ethylcellulose, povidone, gelatin, polyethylene glycol, etc. One or more of them are mixed; when the degree of drug solubility is not enough, a cosolvent can be added, and the cosolvent is selected from sodium lauryl sulfate, Tween, Span, phospholipids, polyoxyethylene poly One or more mixtures of oxypropylene copolymer, glyceryl stearate, sucrose fatty acid ester, etc.; the or...

Embodiment 2

[0052] Embodiment 2, the preparation of doxazosin sustained-release pellets

[0053] Coating preparation process of doxazosin sustained-release pellets: firstly mix the drug with fillers and binders, then perform wet granulation, then extrude and spheronize to prepare drug pellets. After the drug pellets are dried, use a fluidized bed to The coating solution is used for coating, and the weight gain of the coating is 5-17%. The doxazosin drug contained in the pellets can be controlled in an amount of 1-60 wt%.

[0054] Here, the drug in the drug pellets is doxazosin or its pharmaceutically acceptable salt, and the pharmaceutically acceptable salt can be hydrochloride, sulfate, mesylate, maleate, preferably doxazosin mesylate; filling The agent is selected from one or more of lactose, mannitol, xylitol, sorbitol, powdered sugar, dextrin, starch, pregelatinized starch, microcrystalline cellulose, inorganic salts, etc., and the binder is selected from One or more of starch slurr...

Embodiment 3

[0123] Example 3: Preparation of Finasteride Doxazosin Controlled Release Capsules

[0124] The two kinds of micropills prepared in Examples 1 and 2 were respectively mixed uniformly according to the amount of the two kinds of medicines according to the combination method in Table 1, and then packed into empty capsules, and the loading amount of each capsule was 100 mg.

[0125] Table 1: Finasteride-doxazosin compound controlled-release capsules

[0126]

[0127] Experimental part

[0128] Experiment 1. The effect of finasteride doxazosin with different ratios on benign prostatic hyperplasia

[0129] 80 adult SD male rats, weighing 70-110g. They were randomly divided into 8 groups according to Table 2. Except the normal group, the rats in the other 7 groups were castrated respectively: the rats were anesthetized by intraperitoneal injection of 3.0% chloral hydrate (10ml / kg), underwent aseptic surgery through the scrotum, and removed both testes. Start medication 7 day...

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Abstract

The invention discloses a finasteride-doxazosin controlled-release capsule, and belongs to the technical field of medicines. Common micro pills of finasteride and slow release micro pills of doxazosin are mixed and encapsulated to prepare the controlled-release capsule, wherein the weight ratio of the finasteride medicine to the doxazosin medicine in the capsule is 1:0.625-2.5. The composite capsule preparation utilizes high molecular polymers as auxiliary materials of the controlled-release preparation, the finasteride as the common micro pill and the doxazosin as the slow release micro pill; tests verify that: effective constituents of the two medicines not only can be mutually cooperated to achieve better curative effects, but also can stably release the medicines, avoid the differencebetween blood concentration at wave crest and wave hollow, and reduce toxic and side effects of the medicines on human body are reduced; moreover, the controlled-release capsule can also reduce the medicine taking time of a patient and improve compliance of taking medicines. The finasteride-doxazosin controlled-release capsule can be used as a medicine to treat hypertension and benign hyperplasiaof prostate.

Description

Technical field: [0001] The invention belongs to the technical field of medicines, and relates to a drug preparation for treating hypertension and benign prostatic hyperplasia, in particular to a capsule preparation compounded by finasteride and doxazosin with controlled release capability. Background technique: [0002] Benign prostatic hyperplasia is a common senile disease in men. The main reason is the increase in age and the existence of functional testicles. The urinary obstruction caused by two main reasons: one is the testosterone produced by the testis, and the function of α1 reductase Under the action, it is transformed into dihydrotestosterone, which acts on the prostate to make the prostate hyperplasia. The protruding gland protrudes into the bladder, compressing the urethra and causing mechanical obstruction of the bladder outlet. On the other hand, the bladder neck, posterior urethra, prostatic body, and capsule are rich in α-receptors. Due to the stimulation ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/58A61K31/517A61P9/12A61P13/08
Inventor 孙从新郑礼郑少辉孙宇章王爱玲黄圆圆赵志惠邢东东郭旻彤
Owner NAT INST OF PHARMA R & D CO LTD
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