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High-dispersity composition of low-dose drugs and preparation method of high-dispersity composition

A low-dose, composition technology, applied in the low-dose pharmaceutical composition and its preparation, the low-dose pharmaceutical composition and its preparation field, can solve the problems such as the application of twin-screw extrusion technology that has not been reported yet

Active Publication Date: 2018-09-14
NANJING HERON PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The application of twin-screw extrusion technology in the preparation of low-dose drug compositions and formulations has not been reported in the prior art

Method used

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  • High-dispersity composition of low-dose drugs and preparation method of high-dispersity composition
  • High-dispersity composition of low-dose drugs and preparation method of high-dispersity composition
  • High-dispersity composition of low-dose drugs and preparation method of high-dispersity composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Preparation of Embodiment 1 Alfacalcidol Tablets, Small Test Process

[0084] 1. Prescription

[0085]

[0086] 2. The preparation method specifically comprises the following steps:

[0087] 1) dissolving the crude drug alfacalcidol in absolute ethanol to make a solution;

[0088] 2) Weigh the prescribed amount of anhydrous lactose, povidone, and propyl gallate in a wet mixing granulator, and the mixing time is greater than or equal to 5 minutes to make dry powder;

[0089] 3) Add the dry powder obtained in the above step 2) into the solid feeder, and after the solution obtained in the above step 1) is connected to the extruder through a low-pulse peristaltic pump, control the granulation temperature of the twin-screw extruder at 20-25 Between ℃, adjust the feeding speed of dry powder to 1.0-2.0kg / hr, the speed of peristaltic pump to 2rpm-4rpm, and the speed of twin-screw to 100rpm-200rpm, and the above-mentioned dry powder and solution enter the twin-screw extrude...

Embodiment 2

[0093] Example 2 Preparation of Alfacalcidol Tablets, Pilot Test Process

[0094] 1. Prescription

[0095]

[0096] 2. The preparation method specifically comprises the following steps:

[0097] 1) dissolving the crude drug alfacalcidol in absolute ethanol to make a solution;

[0098] 2) Weigh the prescribed amount of anhydrous lactose, povidone, and propyl gallate in a wet mixing granulator, and the mixing time is greater than or equal to 5 minutes to make dry powder;

[0099] 3) Add the dry powder obtained in the above step 2) into the solid feeder, and after the solution obtained in the above step 1) is connected to the extruder through a low-pulse peristaltic pump, control the granulation temperature of the twin-screw extruder at 20-25 Between ℃, adjust the feeding speed of dry powder to 2.0-3.0kg / hr, the speed of peristaltic pump to 4rpm-8rpm, and the speed of twin-screw to 300rpm-400rpm, and the above-mentioned dry powder and solution enter the twin-screw extruder w...

Embodiment 3 comparative Embodiment 1

[0103] Example 3 Comparative Example 1 CN104739793A discloses a kind of alfacalcidol tablet and its preparation method, adopts traditional wet granulation, according to the preparation method of Example 1 in the text, uses the same prescription of the present invention, obtains comparative example 1 Alpha tablets. The process description is as follows: Weigh the raw and auxiliary materials of the prescription amount, pass through 80 mesh sieves respectively for standby; configure the adhesive solution; Soft material; after granulating with a 40-mesh sieve, dry at 50°C for 30 minutes, pass through a 20-mesh sieve for granulation, add magnesium stearate, mix evenly, and press into tablets.

[0104] Example 4 Comparative Example 2 CN1196677A discloses a preparation method of a very low-dose solid dosage form of medicine, using high-speed shear mixing granulation technology, according to the preparation method in the text, using the same prescription of the present invention, to o...

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Abstract

The invention discloses a high-dispersity composition of low-dose drugs and a preparation method of the high-dispersity composition, aiming to solve the problem that existing preparation methods for the low-dose drugs cannot meet requirements on content uniformity and influences of parameter change amplification in the production process on physicochemical properties of the low-dose drugs are remarkable. The high-dispersity composition and the preparation method thereof have the advantages that the low-dose drugs are prepared by the twin-screw extrusion technology for the first time; Vitamin Danalogue drugs, glucocorticoid drugs, antipsychotics, antipyretic and analgesic drugs and other low-dose drugs are screened as research objects; preparation of solid preparations through a twin-screwextruder is studied deeply; the content uniformity meets requirements of the pharmacopeia.

Description

technical field [0001] The invention relates to a low-dose pharmaceutical composition and a preparation method thereof, in particular to a highly dispersed low-dose pharmaceutical composition and a preparation method thereof, belonging to the technical field of pharmaceutical preparation. Background technique [0002] Low-dose pharmaceutical preparations refer to solid pharmaceutical preparations such as tablets, capsules, granules, and sprays with a single labeled dose of no more than 1 mg. Due to its extremely low unit drug content, it is extremely vulnerable to loss and pollution during the production process; therefore, it requires highly sensitive analytical methods and extremely fine pre-treatment methods in the preparation process, and obtains a good recovery rate; in addition, the final The content uniformity of the product and the stability requirements of the product in production and storage are relatively high. For low-dose pharmaceutical preparations, its formu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61J3/00A61K31/59
CPCA61J3/00A61K9/1682A61K31/59
Inventor 包玉胜马冲陶莉袁晓丽郑慧娟闵涛
Owner NANJING HERON PHARM CO LTD
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