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Heat clearing tablet and preparation method thereof

The technology of Qinghuo tablet and rhubarb is applied in the field of Qinghuo tablet and its preparation, which can solve the problems of inconvenient taking, many spots, low yield, etc., and achieves the improvement of quality and stability, the expansion of drug population, and the simple preparation process. Effect

Active Publication Date: 2014-02-19
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Sugar-coated tablets have the following disadvantages: large tablets, inconvenient to take, not suitable for diabetics, large dust production, long coating time, low degree of automation, large side effects, poor quality of tablets
The disintegration time limit of the prepared tablet is long, there are many spots, the tablet is heavy, the output is small, and the yield is low, and taking 6 tablets each time still brings inconvenience to the patient
[0010] Menthol is dissolved in absolute ethanol and added to the powder for mixing. During the post-production process, there will be many pinholes and wrinkled skin on the surface of the tablet, which will seriously affect the appearance quality of the finished product and the firmness of the coating layer.

Method used

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  • Heat clearing tablet and preparation method thereof
  • Heat clearing tablet and preparation method thereof
  • Heat clearing tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 Investigation of Rhubarb Extraction Technology

[0036] (1) Investigation on the powder yield of rhubarb: the improved process rhubarb was first crushed into coarse powder, and then extracted with ethanol under reflux, and the powder yield of rhubarb crushed into coarse powder was investigated, as shown in Table 1. The results showed that the powder extraction rate of rhubarb was above 97.5%.

[0037] Table 1 Powder extraction rate of rhubarb

[0038] Number of trials

1

2

3

Amount of medicinal materials (kg)

10

10

10

Amount of fine powder (kg)

9.82

9.78

9.80

Powder yield (%)

98.2

97.8

98.0

[0039] (2) Screening of ethanol reflux extraction conditions: the selected ethanol concentration, ethanol dosage, and reflux extraction time are the three factors investigated, each factor is taken at three levels, and the total content of emodin and chrysophanol ...

Embodiment 2

[0054] Example 2 Investigation of Folium Folium Water Decoction Process

[0055] When Folium Folium was decocted with water in the original production process, only the number of decoctions and decoction time were given, and the multiple of water addition was not given. The yield of the extract was used as the index to investigate the influence of different water additions on the yield of the extract.

[0056] Table 5 Effects of different water decoction conditions on the yield of extract

[0057] condition

[0058] The results showed that the extract yields of condition 1 and 2 were close, and the extract yield of condition 3 was low. Considering water saving, energy saving and time saving, the selected condition 2 is the water extraction condition.

Embodiment 3

[0059] Embodiment 3 Menthol inclusion process

[0060] Dissolve menthol with 10 times the amount of ethyl acetate, take 8 times the amount of β-cyclodextrin, dissolve it in the tank with 20 times the amount of purified water, and pour hot water into the jacket of the tank to make the solution temperature in the tank Keep at 38-42°C, start the stirring, slowly add the menthol solution, and keep stirring for 1 hour after the addition is complete. Pass ice-salt water into the jacket, keep the temperature of the mixed solution at 0-5°C, let it stand for 24 hours, filter the precipitate, and dry it at 50-60°C for 2 hours to control the loss on drying to ≤4.0%.

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Abstract

The invention relates to a heat clearing tablet and a preparation method thereof. The preparation method includes steps of taking follum isatidis, rheum officinale, gypsum fibrosum and menthol crystals as active pharmaceutical ingredients and then extracting, granulating, tabletting and coating films, and particularly, treating the follum isatidis by ethanol in a reflux extraction process to obtain extracts, granulating the extracts to obtain granules, preparing the menthol crystals into an inclusion compound, and then mixing the inclusion compound with the granules. Since the follum isatidis is subjected to reflux extraction by the ethanol, the disintegration time of the tablet is short, the appearance of the tablet is good, usage of materials for granulating is reduced while active ingredients keep constant, the output is increased while cost is lowered, and convenience is brought to patients as dosage can be reduced along with increase of effective contents of the tablet. Further, as the inclusion compound is prepared by the menthol crystals and beta-cyclodextrin, the tablet is smooth and flat while the yield is increased. Quality and stability of the film-coated heat-clearing tablet are improved, the preparation method is simple, the production period is shortened, quality controllability is high, detailed production parameters are provided, and thus a basis is provided for large-scale production.

Description

technical field [0001] The invention relates to the field of preparation technology of traditional Chinese medicines, in particular to a Qinghuo tablet and a preparation method thereof. Background technique [0002] Qinghuo tablets prepared according to the standards issued by the Ministry of Health have the functions of clearing heat, purging fire and laxative. It is one of the commonly used Chinese patent medicines in clinical practice. It has definite curative effect and no obvious toxic and side effects reports. . [0003] Ministry of Health Drug Standard WS 3 -The prescription, process and brief description of Qinghuo Tablet given by B-0414-90 are as follows: [0004] Prescription: Folium Folium 400g, Rhubarb 100g, Gypsum 50g, Menthol 0.65g. [0005] Preparation method: the above four flavors, rhubarb and gypsum are crushed into fine powder, and sieved; Folium Folium is boiled twice with water, the first time is 2 hours, the second time is 1 hour, the decoction is co...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/855A61K36/708A61K9/28A61K47/40A61P1/10A61K33/06A61K31/045
Inventor 马其胜张勇尹群孙鹏朱学娟李保琴
Owner 蚌埠丰原涂山制药有限公司
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