Kunjing expandable vaginal suppository, and preparation method and detection method thereof

A technology of vaginal expansive suppositories and expansive suppositories, applied in suppository delivery, measuring devices, pharmaceutical formulations, etc., which can solve the problems of patients’ discomfort, difficulty in cleaning, and easy contamination of suppositories on clothes, etc., and achieve the effect of avoiding secondary infection and preventing outflow

Active Publication Date: 2014-01-22
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

[0003] The dissolution rate of the active ingredient in the Kunjing suppository disclosed in "Ministry of Health Drug Standard Traditional Chinese Medicine Prescription" is not good, resulting in low bioavailability; CN1745763 discloses a kind of Kunjing soft capsule suppository, and the suppository is composed of Bupleurum 500g , edelweiss 500g, furazolidone 50g, appropriate amount of vaseline, liquid paraffin, and Tween 80 are made; the suppository made with liquid paraffin and Tween 80 as a mixed matrix has improved bioavailability, and the outer layer of the suppository is wrapped One layer of capsule shell made of vaseline can improve the stability of the suppository; but the capsule shell is too hard, and after being inserted into the vagina, the patient will feel uncomfortable; the Kunjing suppository disclosed above generally has fast drug release, effective The administration time is short, and there is a "peak and valley" phenomenon; the cotton sliver in the Kunjing suppository has no swelling effect, or the swelling is disordered, which greatly reduces the clinical application; the suppository is easy to pollute the clothes and is not easy to clean; the quality control method is unreliable, As a result, in the actual production process, the content, stability, and melting time between batches vary greatly

Method used

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  • Kunjing expandable vaginal suppository, and preparation method and detection method thereof
  • Kunjing expandable vaginal suppository, and preparation method and detection method thereof
  • Kunjing expandable vaginal suppository, and preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095]

[0096] Preparation:

[0097] 1) Preparation of drug-containing matrix:

[0098] a. heating and melting the glycerin gelatin in a water bath to obtain a melt;

[0099] b. Preparation of Chinese medicine extract: crush Bupleurum and edelweiss, add water and decoct three times, the first time add water is 10 times of the total weight of Bupleurum and edelweiss, decoct for 3 hours, and add water for the second time 5 times the total weight of Bupleurum and edelweiss, decoct for 2 hours, add water for the third time 1 times the total weight of Bupleurum and edelweiss, decoct for 1.5 hours, combine the decoction, filter, and concentrate the filtrate to about 200ml, Add ethanol to make the ethanol content reach 70%, let it stand, filter, recover ethanol, concentrate to thick paste, spray dry into fine powder, and obtain a Chinese medicine extract with a weight of about 6g;

[0100] c. Pulverize furazolidone, pass through a 80-mesh sieve, add the Chinese medicine extract...

Embodiment 2

[0103]

[0104] Preparation method: make 100 spherical suppositories according to the method described in Example 1, each weighing about 3.4g.

Embodiment 3

[0106]

[0107] Preparation:

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

[0109] a. poloxamer and semi-synthetic fatty acid glycerides are placed in a water bath for heating and melting to obtain a melt;

[0110] b. Preparation of Chinese medicine extract:

[0111] Ⅰ. Crush Bupleurum and edelweiss, add water and decoct three times, the first time add water is 8 times the total weight of Bupleurum and edelweiss, decoct for 3 hours, the second time add water equal to the total weight of Bupleurum and edelweiss 7 times of the total weight of bupleurum and edelweiss, decocting for 2 hours, adding water for the third time is 3 times the total weight of bupleurum and edelweiss, decocting for 1.5 hours, combining the decoction, filtering, and concentrating the filtrate to about 200ml, adding ethanol to make the ethanol-containing The amount reaches 70%, let it stand, filter, recover ethanol, concentrate to a thick paste, and spray dry into a fine powder;

[0112] Ⅱ. Cru...

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Abstract

The invention relates to a kunjing expandable vaginal suppository, and a preparation method and a detection method thereof. The expandable vaginal suppository comprises a traditional Chinese medicine extract, furazolidone, a matrix and an expansion carrier. The traditional Chinese medicine composition, furazolidone and the matrix form a drug-containing matrix, which is coated on the surface of the expansion carrier. The traditional Chinese medicine extract is mainly prepared from Radix Bupleuri and Edelweiss through extraction; and the traditional Chinese medicine extract also includes fructus kochiae and Pulsatilla. The stearic acid and sodium dextran in the drug-containing matrix can cooperate to promote absorption of the traditional Chinese medicine extract and furazolidone and improve the bioavailability of the expandable vaginal suppository; glucan can also promote the formation of the expandable vaginal suppository; and cellulose acetate prolong curative effect of the expandable vaginal suppository. The kunjing expandable vaginal suppository is an up and down double-layer expandable suppository, employs seven unique technologies, and has the beneficial effects of prevention of outflow liquid, high stability, lasting effect and prevention of secondary infection.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a Kunjing vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Kunjing Suppository, recorded in the twentieth volume of "Ministry of Health Drug Standards for Traditional Chinese Medicine Prescriptions", is prepared by adding 500g of Bupleurum bupleuri, 500g of edelweiss, 50g of furazolidone, glycerin and gelatin base to a total volume of 3000ml, stirring and heating. Make 1000 suppositories; Kunjing Suppository is a compound preparation of Chinese and Western medicine, which has the effects of clearing away heat and dampness, removing putrefaction and promoting muscle growth, and is clinically used for vaginitis, cervical erosion, and cervicitis caused by dampness and heat. [0003] The dissolution rate of the active ingredient in the Kunjing suppository disclosed in "Ministry of Health Drug Standard Traditional C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/28A61K36/71A61K9/02A61K47/44A61K47/42A61K47/38A61K47/36A61K47/34A61K47/12A61P15/00A61P15/02G01N30/02G01N33/15G01G17/00A61K31/422
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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