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Yunnan Manyleaf paris Rhizome extract ora disintegration tablet and its preparing process

The technology of oral disintegrating tablets and heavy building is applied in the field of preparation of Gongxuening oral disintegrating tablets, which can solve the problems of low dissolution rate, long dissolution time limit, influence on drug efficacy, etc., and achieves good taste and short disintegration time. Effect

Inactive Publication Date: 2005-10-19
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Due to preparation technology and other reasons, most oral preparations have problems such as long dissolution time, low dissolution rate, poor absorption and low bioavailability after taking, which affects the efficacy of the drug and directly affects the effect of treatment.
In addition, traditional oral preparations require a large amount of water to be taken down, which makes it difficult for patients with inconvenient water intake

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] 1. Prescription

[0039] 1. Raw materials - Chonglou 2000.0g;

[0040] 2. Filler - microcrystalline cellulose 145.0g;

[0041] Mannitol 120.0g;

[0042] 3. Disintegrant—cross-linked polyvinylpyrrolidone 36.0g;

[0043] Low-substituted hydroxypropyl cellulose 60.0g;

[0044] 4. Flavoring agent - aspartame 4.0g;

[0045] 5. Lubricant—magnesium stearate 4.5g;

[0046] A total of 2000 pieces were made

[0047] 2. Preparation method

[0048] The first step is to take Chonglou and crush it into a coarse powder, add 4 times of 70% ethanol, and extract by back distillation 3 times, the first time is 5 hours, the second time is 4 hours, the third time is 3 hours, the extracts are combined, filtered, The filtrate was decompressed and recovered ethanol to form a thick paste for later use.

[0049] The second step is to dilute the extract of Chonglou with ethanol until it has better fluidity, take the filler microcrystalline cellulose and put it into...

Embodiment 2

[0053] 1. Prescription

[0054] 1. Raw materials - Chonglou 2000.0g;

[0055] 2 filler - mannitol 110.0g;

[0056] Microcrystalline Cellulose 45.0g

[0057] 3. Coating material - Eudragit  E100 26.0g;

[0058] 4. Glidant—micronized silica gel 25.0g;

[0059] 5. Disintegrant—cross-linked polyvinylpyrrolidone 40.0g;

[0060] Low-substituted hydroxypropyl cellulose 30.0g

[0061] 6. Flavoring agent - aspartame 2.0g;

[0062] Ginseng essence 1.0g;

[0063] 7. Lubricant - magnesium stearate 3.5g;

[0064] A total of 1000 pieces were made

[0065] 2. Preparation method

[0066] The first step is to take Eudragit® E100, dissolve it with ethanol, and dilute it to 7%, and use it as a coating solution for later use.

[0067] The second step is to take Chonglou and crush it into coarse powder, add 3 to 5 times of 70% ethanol, and extract by back distillation for 3 times, the first time is 5 hours, the second time is 4 hours, and the third t...

Embodiment 3

[0070] Embodiment 3 Determination of disintegration time limit

[0071] In order to evaluate the disintegration effect of the drug in the oral cavity, the following experiments were carried out.

[0072] Take 6 50ml beakers, put them in a water bath at 37°C, add 2ml of water each, and let them stand for 10 minutes to allow the temperature to balance. Take 6 pieces of the orally disintegrating tablet preparation prepared in Example 1 above, and put each piece into a beaker , Timing, gently shake the beaker, as the criterion for judging the undisintegrated tablet core, measure the time of complete disintegration, it should disintegrate within 60 seconds. Calculate the average disintegration time of 6 tablets, and set it as the disintegration time limit. According to a similar method, the disintegration time limit of the orally disintegrating tablet prepared in Example 2 was measured and listed in Table 1 below for comparison.

[0073] Example Disintegration time limit (seconds...

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PUM

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Abstract

The present invention discloses orally disintegrating Gongxuening tablet as a kind of medicine preparation for treating menorrhagia, metrorrhagia and chronic pelvic inflammation. The medicine preparation has the functions of cooling blood, arresting bleeding, clearing away heat, eliminating wetness, dispersing blood clots and relieving pain. The present invention also relates to the preparation process of orally disintegrated Gongxuening tablet, and the preparation process includes preparing pellet, coating powder and tablet pressing.

Description

technical field [0001] The present invention relates to Gongxuening oral disintegrating tablets which have the effects of cooling blood and stopping bleeding, clearing away heat and dehumidification, dispelling blood stasis and relieving pain, and are commonly used clinically to treat diseases such as menorrhagia, uterine bleeding, and chronic pelvic inflammatory disease, and Gongxuening oral disintegrating tablets method of preparation. Background technique [0002] Gongxuening orally disintegrating tablets are orally disintegrating preparations made from Chonglou. Chonglou is the dry rhizome of Paris polyphylla Smith var.yunnanensis (Franch.) Hand.-Mazz. or Paris polyphylla Smith var.chinensis (Franch.) Hara 【1】 , Zhonglou is a rare and precious medicinal material unique to China. It is a perennial herb. 6-10 leaves in whorls, petioles 5-20mm long, thick papery leaves, lanceolate, ovate-oblong to obovate, 5-11cm long, 2-4.5cm wide. The pedicel is pulled out from the top...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61P7/04A61P15/00
Inventor 蒋海松王锦刚
Owner COSCI MED TECH CO LTD
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