Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Vitamin D analog preparation and preparation method thereof

A technology of vitamins and analogs, applied in the preparation of pharmaceutical preparations, vitamin D analog preparations and the fields of preparation thereof, can solve problems such as the application of twin-screw extrusion technology that has not yet been reported, and achieve uniformity, cost reduction, and fewer processes. Effect

Active Publication Date: 2022-05-03
NANJING HERON PHARM CO LTD
View PDF6 Cites 0 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • 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...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention discloses a vitamin D analog preparation and a preparation method thereof. In order to solve the defects in the existing methods of preparing vitamin D analog drugs, which are difficult to meet the requirements of content uniformity, and the drug is easy to degrade and transform during the granulation process, the twin-screw extrusion technology is used for the first time to prepare vitamin D analogs. solid preparations. On the basis of extensively using various vitamin D analogues as model drugs and in-depth research on the preparation process of their solid preparations, alfacalcidol, idecalcitol or calcitriol are preferably processed through a twin-screw extruder. The solid preparation is prepared, and its content uniformity meets the requirements of the Pharmacopoeia, the stability of the drug is significantly improved, and the quality of the drug 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com