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Vitamin D analog preparation and preparation method thereof

A technology for vitamins and analogs, which is applied in the preparation of pharmaceutical preparations, vitamin D analog preparations and their preparation fields, can solve problems such as the application of twin-screw extrusion technology that has not yet been reported

Active Publication Date: 2018-08-21
NANJING HERON PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, the application of twin-screw extrusion technology in the preparation of vitamin D analog compositions and preparations thereof has not been reported

Method used

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  • Vitamin D analog preparation and preparation method thereof
  • Vitamin D analog preparation and preparation method thereof
  • Vitamin D analog preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Preparation of Embodiment 1 Alfacalcidol Tablets, Small Test Process

[0066] 1. Prescription

[0067]

[0068]

[0069] 2. The preparation method specifically comprises the following steps:

[0070] 1) dissolving the raw material alfacalcidol in absolute ethanol, then adding the prescribed amount of Tween and stirring to dissolve to make a solution;

[0071] 2) Weigh the prescription 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;

[0072] 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...

Embodiment 2

[0076] Preparation of Embodiment 2 Alfacalcidol Tablets, Pilot Test Process

[0077] 1. Prescription

[0078]

[0079]

[0080] 2. The preparation method specifically comprises the following steps:

[0081] 1) Dissolve the raw material alfacalcidol in absolute ethanol, then add the prescribed amount of Tween and stir to dissolve to make a solution; 2) Weigh the prescribed amount of anhydrous lactose, povidone, and propyl gallate in wet In the method mixing granulator, the mixing time is greater than or equal to 5 minutes, and made into dry powder;

[0082] 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...

Embodiment 3

[0086] Preparation of Embodiment 3 Alfacalcidol Tablets, Small Test Process

[0087] 1. Prescription

[0088]

[0089]

[0090] 2. The preparation method specifically comprises the following steps:

[0091] 1) dissolving the crude drug alfacalcidol in absolute ethanol to make a solution;

[0092] 2) Weigh the prescription 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;

[0093] 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...

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Abstract

The invention discloses a vitamin D analog preparation and a preparation method thereof. The invention aims to solve the problems that a conventional preparation method of vitamin D analog has difficulty in meeting the uniformity requirement and during the granulation process, drugs are converted and degraded easily. For the first time, a double screw extrusion technology is used to prepare a solid preparation of vitamin D analog. Various vitamin D analogs are taken as model drugs, on the basis that a preparation technology of solid preparations is deeply researched, alfacalcidol, eldecalcitol, or calcitriol is chosen to prepare the solid preparation by using a double screw extruding machine; the uniformity meets the pharmacopeia requirements; the drug stability is obviously enhanced, andthe drug quality is greatly improved.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical preparation, in particular to a vitamin D analog preparation and a preparation method thereof, and belongs to the technical field of pharmaceutical preparation. Background technique [0002] Calciferol is a derivative of vitamin D. Vitamin D (vitamin D) is a sterol derivative with anti-rickets effect, also known as anti-rickets vitamin. At present, vitamin D analogues that have been marketed worldwide are mainly used for the treatment of osteoporosis, secondary hyperparathyroidism (SHPT) and psoriasis in patients with renal dialysis. Another anti-cancer indication is in clinical research abroad. Among them, vitamin D structural analog drugs, such as: calcifediol, calcitriol, alfacalcidol, idecalcitol, docecalcitol, maxacalcitol, paricalcitol, Fluoccidol, tacalcitol, and calcipotriol, as low-dose drugs, are usually granulated by high-speed stirring wet method in the preparation process....

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K47/32A61K47/38A61K31/593A61P19/08
CPCA61P19/08A61K9/1635A61K9/1652A61K9/1682A61K31/593
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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