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A kind of Xianglian granule, Xianglian preparation and its preparation method and application

A technology of granules and preparations, applied in the field of Xianglian granules and its preparation, can solve the problems of large loss of active ingredients, long time, high temperature, etc., and achieve the effect of increasing the content of active ingredients, reducing waste, and improving the content

Active Publication Date: 2021-10-22
HUBEI XIANGLIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the standard preparation method of the National Pharmacopoeia is to dry the woody extract and Yuhuanglian extract respectively, then make dry paste powder, and then granulate with auxiliary materials. During the drying process of the extract, the time is long, the temperature is high, and After granulating with auxiliary materials, it needs to be heated and dried again, which will cause a large loss of active ingredients

Method used

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  • A kind of Xianglian granule, Xianglian preparation and its preparation method and application
  • A kind of Xianglian granule, Xianglian preparation and its preparation method and application
  • A kind of Xianglian granule, Xianglian preparation and its preparation method and application

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Experimental program
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Effect test

preparation example

[0077]

[0078] (1) Preparation of Woody Extract

[0079] 1) Extraction of woody fragrance: Put the prepared woody fragrance (1st tank time) into the tank, put 2400L (5 times the amount) of drinking water into the extraction tank through the pipeline; soak for 30 minutes, pass in steam (control steam 0.1 ~0.25MPa), reflux extraction after boiling, collect the light yellow woody volatile oil, the volatile oil should not be less than 720g, label it, store it, and reserve it; after filtering the extract, put it into the liquid storage tank through the pipeline, mark it, and set it aside .

[0080] 2) Concentration of the extract of Cinnamomum sinensis: the extract is input into a double-effect concentrator through a pipeline for concentration under reduced pressure, the steam pressure is 0.1-0.2MPa, the vacuum degree of control I effect is 0.05-0.06MPa, and the temperature is about 70-80°C. Control the vacuum degree of the II effect at 0.06-0.07MPa, the temperature is about 6...

Embodiment 1

[0089] 154kg Yuhuanglian extract, 43kg woody extract and 59.1kg purified water in the above preparation example were mixed and stirred for 10 minutes until uniform to form a mixed extract slurry, set aside, set the fan frequency of the boiling granulator to 35Hz, and the air inlet The temperature is 65°C, the material temperature is 40°C, and the exhaust air temperature is 40°C. Inhale 46.6kg of starch into the boiling granulator through negative pressure, seal it, and dry it for 10-20 minutes first, then spray the mixed extract slurry into the boiling granulator, dry while spraying, and put all the above mixed extract slurry into the boiling granulator. Spray into the boiling granulator for 132 minutes until the mixed extract slurry is sprayed, and continue to dry for 20-30 minutes to obtain a granular mixture; cool the granular mixture with cold air for 5 minutes, spray 180g with 1000ml 95 The volatile oil diluted with % ethanol was used to obtain the granular Cyperus granul...

Embodiment 2

[0092] The 180kg Xianglian granules and 3.6kg magnesium stearate prepared in the above-mentioned embodiment 1 are all transferred to the motion mixer through a vacuum feeder, and the mixing operation is carried out. After mixing for 20 minutes, stop the machine, collect the granules in a stainless steel bucket, and weigh them. Heavy, affix the intermediate product label, enter the intermediate station of the preparation workshop, and set aside.

[0093] Tablet test: install a tablet die (13mm special-shaped die), hopper and add granules. According to the marked amount of 0.3g / tablet, the tablet weight difference limit is controlled at ±4%. According to this requirement, the speed of the tablet press is 14-30rpm. Test the tablet, check the weight and appearance of the plain tablet.

[0094] Tablet compression: After the tablet to be tested meets the requirements, perform the tablet compression operation. Collect the plain flakes in a stainless steel turnover bucket. During th...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to Xianglian granules, Xianglian tablets, their preparation method and application. The invention provides a Xianglian granule, which is characterized in that the weight content of Yuhuanglian containing berberine hydrochloride C20H17NO4·HCl should not be less than 6.0%. The invention also provides the preparation method and application of the Xianglian granule. For example, the active ingredient content of the Xianglian tablets prepared by using the Xianglian granules provided by the invention is significantly increased. In every 0.3g of Xianglian Tablets, the amount of Yuhuanglian (calculated as berberine hydrochloride C20H17NO4 HCl) is more than 18.0mg, which is higher than the existing standard, which is conducive to further improving and improving the therapeutic effect, and avoiding repeated repeated use of patients. Inconvenience from taking medication. The preparation method of the xianglian granule of the invention is simple and convenient, and can be made into dry granules at one time, which reduces the heating temperature of medicines, shortens the heating time, improves the content of active ingredients, and increases the product yield.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to Xianglian granules, a preparation method and application thereof. Background technique [0002] In the production process of preparations, both traditional Chinese medicine preparations and western medicine preparations inevitably involve the granulation process. The preparation process of traditional Chinese medicine tablets is usually: material selection-removal of impurities-extraction-concentration-drying-granulation-granulation-compression Tablet-coating-aluminum-plastic packaging-outer packaging, among which, granulation is to mix the powder or extract with a certain proportion of excipients, and use water and ethanol as wetting agents to form the required number of granules. The granulation process or The granulation process is a very important link. In order to improve the quality of the finished granules and ensure the clinical efficacy, p...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/718A61K9/16A61K9/30A61P31/04A61P1/12A61P1/00A61P7/04A61P29/00G01N30/02G01N30/06
CPCA61K9/1652A61K9/282A61K36/285A61K36/718G01N30/02G01N30/06A61K2300/00Y02A50/30
Inventor 郑瑞隆王程陈孟辉王永波朱彬
Owner HUBEI XIANGLIAN PHARMA
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