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Cnidium monnieri and rheum officinale vaginal dilation suppository as well as preparation method and detection method thereof

The technology of vaginal expansion suppository and expansion suppository, which is applied in the directions of suppository delivery, pharmaceutical formulation, material inspection, etc., can solve the problems of no expansion of cotton sliver, disordered expansion, and reduced drug bioavailability, etc., and achieves prolonged action time, The effect of avoiding secondary infection and improving compliance

Active Publication Date: 2015-03-04
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Shehuang suppository is mainly made of 1800g of Sophora flavescens, 2000g of Cnidium chinensis, 600g of rhubarb, 500g of ginseng and an appropriate amount of semi-synthetic fatty acid glycerides; the curative effect of Shehuang suppository has been clinically proven for many years, and it is widely used for secretions caused by women's vaginitis Common symptoms of gynecological diseases such as increased, peculiar smell and genital itching; but there have been some technical problems in the snake yellow suppository, for example, Chinese patent CN1530125 provides a suppository made from a Chinese medicine composition and a semi-synthetic fatty acid glyceride matrix, There are differences in the solubility of each component in the suppository, resulting in a reduction in the bioavailability of the drug; in order to improve the bioavailability and dissolution of the Chinese medicine composition, most of them are additives such as absorption enhancers, but the addition of additives will affect The properties of the matrix lead to the limitation of the application of suppositories; there is no technical scheme to improve the dissolution rate and bioavailability of suppositories by changing the properties of the traditional Chinese medicine composition of Shehuang suppositories in the prior art; in addition, Shehuang suppositories There are still the following problems to be solved: 1. The tampon in the traditional snake yellow suppository has no swelling effect, or the swelling is disordered, which greatly reduces the clinical application; 2. The quality control method is unreliable, resulting in the actual production process. The content, stability, and melting time limit vary greatly; 3. Simple mixing of multiple compound ingredients cannot exert their respective curative effects

Method used

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  • Cnidium monnieri and rheum officinale vaginal dilation suppository as well as preparation method and detection method thereof
  • Cnidium monnieri and rheum officinale vaginal dilation suppository as well as preparation method and detection method thereof
  • Cnidium monnieri and rheum officinale vaginal dilation suppository as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0106]

[0107] Preparation:

[0108] 1) Preparation of drug-containing matrix:

[0109] a. Fractionated palm oil, polyethylene glycol 1500 and polyethylene glycol 400 are placed in a water bath for heating and melting to obtain a melt;

[0110] b. Weigh the Fructus Cnidii of prescription quantity, crush, add 50% ethanol, reflux and extract twice, the amount of ethanol added for the first time is 10 times of the weight of Fructus Cnidii, reflux for 2 hours, the amount of ethanol added for the second time is the weight of Fructus Cnidii 3 times of the amount, reflux for 2 hours, filter, combine the filtrates, recover ethanol, and concentrate to a clear paste with a relative density of 1.22 at 60°C to obtain the Fructus Cnidii extract;

[0111] c. Weigh the prescribed amount of Sophora flavescens, crush it, add water to decoct twice, add 15 times the weight of Sophora flavescens for the first time, decoct for 1 hour, add 6 times the weight of Sophora flavescens for the secon...

Embodiment 2

[0117]

[0118] Preparation method: make 100 torpedo-shaped suppositories according to the method described in Example 1, each weighing about 3.9g.

Embodiment 3

[0120]

[0121] Preparation:

[0122] 1) Preparation of drug-containing matrix:

[0123] a. place the mixed fatty acid glycerides, hardened oil and glycerol tristearate in a water bath for heating and melting to obtain a melt;

[0124] b. Weigh the Fructus Cnidii of prescription quantity, crush, add 80% ethanol, reflux and extract twice, the amount of ethanol added for the first time is 5 times of the weight of Fructus Cnidii, reflux for 1 hour, the amount of ethanol added for the second time is the weight of Fructus Cnidii 5 times of the amount, reflux for 1 hour, filter, combine the filtrates, recover ethanol, and concentrate to a clear paste with a relative density of 1.26 at 70°C to obtain the Fructus Cnidii extract;

[0125] c. Weigh the prescribed amount of Sophora flavescens, crush it, add water to decoct twice, add water 10 times the weight of Sophora flavescens for the first time, decoct for 3 hours, add water 10 times the weight of Sophora flavescens for the seco...

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Abstract

The invention relates to a cnidium monnieri and rheum officinale vaginal dilation suppository as well as a preparation method and a detection method thereof. The dilation suppository mainly comprises a Chinese medicine composition, a matrix and a dilation carrier, wherein the Chinese medicine composition is prepared from radix sophorae flavescentis, cnidium monnieri, rheum officinale and ginseng through extracting; a mixture extract of the radix sophorae flavescentis and the cnidium monnieri in the dilation suppository is subjected to micronization, the particle size is controlled within a certain range, and the dissolution rate of the mixture extract is remarkably increased; hydrogenated oil and the micronized extract form a coating, so that the mixing between the micronized extract and other ingredients can be enhanced, and meanwhile, a thickening effect is achieved; a controlled release agent has the functions of prolonging the action time of the medicament on the vagina and prolonging the curative effect; meanwhile, the dilation suppository also employs seven unique advanced technologies and has the beneficial effects of preventing outflow of medicine liquor and preventing secondary infection, and is high in stability, durable in curative effect and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a snake yellow vaginal expansion suppository and a preparation method and a detection method thereof. Background technique [0002] Shehuang suppository is mainly made of 1800g of Sophora flavescens, 2000g of Cnidium chinensis, 600g of rhubarb, 500g of ginseng and an appropriate amount of semi-synthetic fatty acid glycerides; the curative effect of Shehuang suppository has been clinically proven for many years, and it is widely used for secretions caused by women's vaginitis Common symptoms of gynecological diseases such as increased, peculiar smell and genital itching; but there have been some technical problems in the snake yellow suppository, for example, Chinese patent CN1530125 provides a suppository made from a Chinese medicine composition and a semi-synthetic fatty acid glyceride matrix, There are differences in the solubility of each component in the suppository, resu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/708A61K9/02A61P15/02G01N33/15G01N5/04
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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