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Spirolactone composition, preparation and preparation method

A technology of spironolactone and composition, which is applied in the field of pharmaceutical preparations, can solve the problems of reducing drug efficacy, cumbersome preparation process, and oxidation of raw materials, and achieve the effects of promoting improvement, uniform tablet composition, and facilitating dissolution

Pending Publication Date: 2022-07-29
上海金不换兰考制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the hot-melt extrusion process adopted in this method needs to ensure that the raw materials are fully mixed and uniform. Before the preparation, the raw materials need to be crushed, sieved, mixed, etc., and they need to be crushed again after the hot-melt extrusion. During the melt extrusion process, some raw materials will be oxidized in a high temperature environment, reducing the efficacy of the drug

Method used

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  • Spirolactone composition, preparation and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A kind of spironolactone composition preparation, its raw material is composed as follows:

[0029] Spironolactone 20.0g

[0030] Sodium Stearoyl Lactate 1.0g

[0031] Sucrose Acetate Isobutyrate 80g

[0032] Preparation:

[0033] 1) Sodium stearoyl lactylate is dispersed in deionized water at 50°C, and the consumption of deionized water is 100 g;

[0034] 2) adding spironolactone and sucrose acetate isobutyrate to the mixed solution in 1), mixing uniformly, and after the spironolactone is completely dissolved, the spironolactone composition preparation slurry is obtained;

[0035] 3) 10g of povidone was added to the slurry obtained in 2), mixed uniformly, and after the binder was completely dissolved, it was used as a wet granulation binder solution;

[0036] 4) 100g of calcium sulfate dihydrate was used as a filler, added to the granulator together with the wet granulation binder solution in 3) to carry out wet granulation, followed by drying and dry granulation a...

Embodiment 2

[0038] A kind of spironolactone composition preparation, its raw material is composed as follows:

[0039] Spironolactone 20.0g

[0040] Sodium Stearoyl Lactate 2.0g

[0041] Sucrose Acetate Isobutyrate 70g

[0042] The preparation method is the same as that of Example 1, and the dosage of the binder and lubricant is the same as that of Example 1, the dosage of calcium sulfate dihydrate is 110 g, and the dosage of deionized water is 110 g.

Embodiment 3

[0044] A kind of spironolactone composition preparation, its raw material is composed as follows:

[0045] Spironolactone 20.0g

[0046] Sodium Stearoyl Lactate 3.0g

[0047] Sucrose Acetate Isobutyrate 60g

[0048] The preparation method is the same as that of Example 1, and the dosage of the adhesive and lubricant is the same as that of Example 1, the dosage of calcium sulfate dihydrate is 120 g, and the dosage of deionized water is 120 g.

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Abstract

The invention discloses a spirolactone composition, and relates to the technical field of pharmaceutical preparations, the spirolactone composition comprises spirolactone, sodium stearoyl lactylate, sucrose acetate isobutyrate and other pharmaceutically acceptable auxiliary materials, the weight ratio of the spirolactone to the sodium stearoyl lactylate is 1: (0.1-0.8), and the weight ratio of the spirolactone to the sucrose acetate isobutyrate is 1: (1.5-4). According to the spirolactone composition disclosed by the invention, through the synergistic effect of the sodium stearoyl lactylate and the sucrose acetate isobutyrate, the spirolactone forms a stable emulsion in water, so that the in-vitro dissolution of the spirolactone is promoted, and the in-vitro dissolution effect of the spirolactone is improved. The invention further provides a preparation method of the spirolactone composition preparation, and the spirolactone composition can be conveniently used as a medicine.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a spironolactone composition, a preparation and a preparation method. Background technique [0002] Spironolactone (CAS No. 52-01-7) is an aldosterone receptor antagonist that can compete with aldosterone for binding to the mineralocorticoid receptor (MR), making the formation of aldosterone-receptor complexes difficult, and can be used to inhibit the pathology of aldosterone effect. Clinically, studies have shown that spironolactone can be used for the treatment of hypertension, chronic kidney disease, diabetes and other diseases. In the treatment of diabetes, spironolactone can enhance the therapeutic effect of ACEI or ARB drugs and reduce the level of urinary protein. [0003] Spironolactone has extremely poor water solubility and cannot be directly dissolved in water. The solubility in hydrochloric acid solution of pH 1.2 is 28.4 μg·ml -1 (Zang Yu et al....

Claims

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Application Information

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IPC IPC(8): A61K31/585A61K47/12A61K47/26A61K9/20A61P3/10A61P9/12A61P13/12
CPCA61K31/585A61K47/12A61K47/26A61K9/2018A61K9/2013A61K9/2095A61P9/12A61P13/12A61P3/10
Inventor 张旭康建党李尚
Owner 上海金不换兰考制药有限公司
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