Dripping pill made from red rice and its preparing method

A technology of red yeast rice and dropping pills, which is applied in the field of dropping pills for the treatment of hyperlipidemia and its preparation, can solve the problems of difficulty in obtaining new drug certificates and production approval documents, affecting the accuracy of drug dosage, and increasing the cost of medication for patients, so as to improve bioavailability The effect of high degree, drug safety and high rounding rate

Active Publication Date: 2007-01-24
BEIJING WBL PEKING UNIV BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] When utilizing solid dispersion technology to prepare drop pills, many factors such as the nature of the drug, the type of matrix and its mixing ratio with the drug, the condensing agent and its temperature, and the dripping speed all affect the molding and quality of the drop pills. The drop pill preparation prepared by the preparation method disclosed in the technology has only about 60% of qualified products in its roundness rate in the test, and the qualified rate of pill weight difference only reaches 50%~58%. It is quite different from the quality index of the drop p

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0027] Experimental example 1 Study on boiling drying conditions of red yeast rice extraction process

[0028] After extracting red yeast rice with 75% ethanol, according to the material temperature is 40-60 ℃, 60-80 ℃, 80-100 ℃, the spray speed is 20-25 liters / hour, 25-35 liters / hour, 35-40 liters / hour The result is that when the temperature of the material is 40-60°C, the temperature of the material is too low, the powder is not easy to dry, and it is easy to agglomerate. The liquid spraying speed is 20-25 liters / hour, the liquid spraying speed is low, the flow rate is small, and the efficiency is affected. The liquid spraying speed is 35-40 liters / hour, the liquid spraying speed is fast, the powder is not easy to dry completely, and it is easy to agglomerate. When the material temperature is 80-100°C, the material temperature is too high, which may cause the decomposition of active ingredients in red yeast rice. Therefore, the conditions of material temperature of 60-80°C...

experiment example 2

[0029] Experimental example 2 The screening experiment of dripping pill raw material of the present invention

[0030] The screening results were evaluated with hardness, roundness, dissolution time limit, yield, and 7-day stability as indicators, and the raw materials of the test dropping pills were screened at the same time. According to different applicable groups of people and the compliance of taking medicine thereof, two specifications of preparations are designed, the first specification is a drop pill (or small pill) of 75mg / pill, and the second specification is a drop pill (or small pill) of 375mg / pill. Daimaru), the results are shown in the table below.

[0031]

[0032]

[0033] The results showed that using PEG alone 10000 and PEG 6000 And S_40 as the matrix, no matter the main: auxiliary = 1:1.0, 1:1.5 or 1:2.0, the drop pill formability is relatively poor (low integral), especially in liquid paraffin. The best molding effect is to use PEG a...

experiment example 3

[0034] Experimental example 3 Optimum process condition screening experiment

[0035] Three kinds of factors such as the ratio of medicine and substrate in the small drop pill of the present invention and big drop pill development, medicinal liquid temperature, coolant temperature are investigated respectively with orthogonal test method, and every factor gets three levels; , Dissolution time limit, and yield are used as the evaluation indicators of the basic performance of this product. Set the scoring standard for evaluation, and do statistical analysis to find out the best process conditions, see the table below:

[0036]

Level

factor

Red Yeast Extract: PEG 4000 (A)

Liquid temperature ℃ (B)

Coolant temperature °C (10cm below the liquid surface) (C)

1

2

3

1.0∶1.3

1.0∶1.4

1.0∶1.5

70±2

75±2

80±2

10±2

15±2

20±2

[0037]

Group No

column number

1

...

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PUM

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Abstract

The present invention relates to a kind of dripping pill for treating hyperlipemia and its preparation process. The dripping pill is prepared with red rice extract and polyglycol in the weight ratio of 1 to 1-3 as material. The red rice extract is prepared through the following steps: extracting red rice with 75 % concentration ethanol solution, filtering and concentrating the filtrate to obtain concentrate of density 0.9-1.1; crushing small amount of red rice; spraying the concentrate to the red rice powder and fluid-bed drying; and grinding to obtain the red rice extract. The dripping pill of the present invention has the features of high bioavailability, fast medicine release, quick acting, etc.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to a drop pill made from red yeast rice for treating hyperlipidemia and a preparation method thereof. Background technique [0002] Due to the preparation technology and other reasons, the oral preparations of most drugs, especially the oral preparations of traditional Chinese medicine, have problems such as long dissolution time, low dissolution rate, poor absorption, hepatic and intestinal first-pass effect and low bioavailability after taking. , thus affecting the efficacy of the drug, and directly affecting the therapeutic effect. In addition, conventional oral dosage forms, such as tablets, capsules, granules (infusions), etc., due to the granulation process in the preparation process, will generate relatively large dust pollution, which will cause health damage to the staff to a certain extent. Harm, but also cause some pollution to the environment. Furthermore, the production...

Claims

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Application Information

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IPC IPC(8): A61K36/06A61K9/20A61P3/06
Inventor 段震文曲韵智
Owner BEIJING WBL PEKING UNIV BIOTECH
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