Medication combination of containing finasteride and cyclodextrin or ramification

A cyclodextrin and composition technology, which is applied in the field of new pharmaceutical preparation preparation, can solve the problems of slow absorption, large individual differences in gastrointestinal absorption, and low bioavailability.

Inactive Publication Date: 2005-08-31
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is necessary to develop a finasteride preparation that absorbs more rapidly and completely, which is to improve the shortcomings of existing finasteride preparations such as low bioavailability, large individual differences in gastrointestinal absorption and slow absorption. , is of great significance and value

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Comparison of Pharmacokinetics of Inclusion Complex of Finasteride and Finasteride Cyclodextrin or Its Derivatives in Rabbits

[0011] Purpose

[0012] To find and verify a pharmaceutical composition for rapid and regular absorption of finasteride through the gastrointestinal tract, so as to develop a finasteride preparation with higher bioavailability and less individual differences in absorption.

[0013] experimental animals

[0014] Healthy rabbits, weighing 2.0-3.0Kg, male or female.

[0015] experimental method

[0016] 1. Preparation of finasteride suspension:

[0017] Pass the finasteride bulk drug through a 100-mesh sieve, and suspend it in 8% carboxymethylcellulose sodium solution.

[0018] 2. Preparation of clathrates of finasteride cyclodextrin or its derivatives:

[0019] Pass the finasteride raw material through a 100-mesh sieve, and mix it with glucosyl α-CD, β-CD, methyl β-CD, hydroxypropyl β-CD, γ-CD or methyl γ-CD according to the weight ratio of ...

Embodiment 2

[0037] Comparison of Pharmacokinetics of Inclusion Complexes of Finasteride and Finasteride Cyclodextrin or Its Derivatives in Rabbit Transdermal Absorption

[0038] Purpose

[0039] Find and verify a pharmaceutical composition that finasteride can be absorbed through the skin, so that finasteride can be developed into a pharmaceutical preparation that can be used externally to treat male pattern baldness in the future.

[0040] experimental animals

[0041] Healthy male adult rabbits, aged 6-10 months, weighing 2.0-3.0Kg.

[0042] experimental method

[0043] 1. Preparation of finasteride suspension:

[0044] Pass the finasteride bulk drug through a 100-mesh sieve, and suspend it in 8% carboxymethylcellulose sodium solution. The concentration of finasteride is 0.5mg / ml.

[0045] 2. Preparation of clathrates of finasteride cyclodextrin or its derivatives:

[0046] Pass the finasteride raw material through a 100-mesh sieve, and mix them with maltose-based α-CD, β-CD, carb...

Embodiment 3

[0065] finasteride orally disintegrating tablet

[0066] Finasteride 5g

[0067] Methyl beta-cyclodextrin 15g

[0068] Glucose 50g

[0069] Cross-linked sodium carboxymethyl starch 20g

[0070] Peppermint essence 1g

[0071] Appropriate amount of distilled water

[0072] Magnesium stearate 0.5g

[0073] Preparation Process:

[0074] Pass the main drug through a 120-mesh sieve and dimethyl β-cyclodextrin, grind and mix well, pass through a 100-mesh sieve for glucose, cross-linked sodium carboxymethyl starch, and mint essence, weigh according to the prescription, mix well, and add an appropriate amount of distilled water , granulated, dried, granulated, added with prescribed amount of magnesium stearate, mixed evenly, and compressed into tablets.

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PUM

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Abstract

A composite medicine in the form of form of dispersing tablet, oral disintegrating tablet, capsule, liniment, ointment, etc contains phenandrostamine and additional cyclodextrin or its derivative for higher biologic utilization rate.

Description

technical field [0001] The invention belongs to new preparation technology of pharmaceutical preparations. Background technique [0002] Finasteride is a competitive inhibitor of type II 5α-reductase. It can form a stable enzyme complex with 5α-reductase. The transformation of this complex is very slow, but it has no affinity for androgen. 5α-reductase is an intracellular enzyme that converts the male hormone testosterone (T) into 5α-dihydrotestosterone (DHT). Male sexual development is mediated by testosterone (T) and 5α-dihydrotestosterone (DHT). DHT controls the growth of the prostate and male pattern baldness. The development and enlargement of the prostate depends on the activity of DHT. [0003] Accumulated animal and clinical research data show that finasteride can effectively improve the symptoms of benign prostatic hyperplasia (BPH), reduce the risk of treatment failure, increase urine flow rate and reduce prostate volume. Finasteride is currently the first-line d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/568A61P13/08A61P17/14
Inventor 姚景春
Owner LUNAN PHARMA GROUP CORPORATION
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