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Fuyanping vaginal dilation suppository as well as preparation method and detection method thereof

A technology for vaginal expansion suppositories and detection methods, which are applied in the directions of suppository delivery, pharmaceutical formulations, material testing products, etc., can solve the problems of poor solubility, difficult cleaning, and splintering of traditional Chinese medicine compositions, achieve fast drug release speed, and avoid secondary infection. , the effect of increasing stability

Active Publication Date: 2014-01-08
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] At present, Fuyanping preparations commonly used clinically include Fuyanping Capsules, Fuyanping Vaginal Effervescent Tablets, Fuyanping Suppositories and other dosage forms. Among them, Fuyanping Vaginal Effervescent Tablets have a quick onset of action and can directly reach the effect of the lesion, but It has the technical problems of sticking, punching and lobes in the preparation process, which limits the application of Fuyanping vaginal effervescent tablets; the capsules dissolve slowly and have low bioavailability; the Fuyanping suppository has been widely used
[0004] Fuyanping suppository is recorded in the 77th volume of "New Drug Standards"; CN1745765 discloses Fuyanping suppository made of a traditional Chinese medicine composition composed of 9 raw materials such as Sophora flavescens and bitter wood, and semi-synthetic fatty acid ester; And disclose the capsule suppository that is made by auxiliary materials such as described Chinese medicine composition and liquid paraffin, Tween 80; The bioavailability of suppository disclosed in CN1745765 and capsule suppository is low; Traditional Chinese medicine composition, seabuckthorn seed oil and mixed fatty acid glycerides are made into suppositories. In the suppository, seabuckthorn seed oil is not conducive to molding, and the solubility of the traditional Chinese medicine composition is poor, and the bioavailability of the suppository is still very high. Low; CN1559577 discloses a kind of preparation method of Fuyanping capsule suppository and suppository, described method still does not overcome the low technical problem of traditional suppository bioavailability; And the tampon in the above-mentioned disclosed Fuyanping suppository has no swelling effect , or expansion disorder, which greatly reduces the clinical application; suppositories are easy to contaminate clothes and are not easy to clean; quality control methods are unreliable, resulting in large variations in batch-to-batch content, stability, and melting time in the actual production process

Method used

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  • Fuyanping vaginal dilation suppository as well as preparation method and detection method thereof
  • Fuyanping vaginal dilation suppository as well as preparation method and detection method thereof
  • Fuyanping vaginal dilation suppository as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117]

[0118] Preparation:

[0119] 1) Preparation of drug-containing matrix:

[0120] a. Putting Poloxamer, Tween 65 and glycerol triabietate in a water bath for heating and melting to obtain a melt;

[0121] b. the preparation of Chinese medicine composition:

[0122] I. Take the Sophora flavescens and bitter wood of prescription quantity, pulverize, decoct in water three times, the amount of water that adds for the first time is 10 times of the total weight of Sophora flavescens and bitter wood, decocts 3h, the amount of water that adds for the second time is Sophora flavescens and bitter wood 5 times the total weight of bitter wood, decoct for 2 hours, add water for the third time 3 times the total weight of flavescens and bitter wood, decoct for 1.5 hours, combine the decoction liquid, filter, concentrate the filtrate to a thick paste, and spray dry it into powder;

[0123] II. Take the Fructus Cnidii of prescription quantity, pulverize, add 75% ethanol and reflux...

Embodiment 2

[0129]

[0130] Preparation:

[0131] 1) Preparation of drug-containing matrix:

[0132] a. placing polyoxyethylene monostearate and glycerol trilaurate in a water bath for heating and melting to obtain a melt;

[0133] b. the preparation of Chinese medicine composition:

[0134] I. Take the Sophora flavescens and bitter wood of prescription quantity, pulverize, decoct in water three times, the amount of water that adds for the first time is 10 times of the total weight of Sophora flavescens and bitter wood, decocts 3h, the amount of water that adds for the second time is Sophora flavescens and bitter wood 5 times the total weight of bitter wood, decoct for 2 hours, add water for the third time 3 times the total weight of flavescens and bitter wood, decoct for 1.5 hours, combine the decoction liquid, filter, concentrate the filtrate to a thick paste, and spray dry it into powder;

[0135] II. Take the Fructus Cnidii of prescription quantity, pulverize, add 75% ethanol an...

Embodiment 3

[0142]

[0143] Preparation method: Prepare 100 torpedo-shaped suppositories according to the method described in Example 2, each weighing about 5.0 g.

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Abstract

The invention relates to a Fuyanping vaginal dilation suppository as well as a preparation method and a detection method thereof. The dilation suppository comprises a medicine-containing matrix formed by a Chinese medicine composition and a matrix, and a dilation carrier; the Chinese medicine composition comprises nine raw medicinal materials, such as radix sophorae flavescentis and quassia, and in addition, cockscomb and loofah sponge are also added in the Chinese medicine composition, thus the prepared Fuyanping vaginal dilation suppository has good curative effects on gynecological diseases, such as trichomonas vaginitis; the Chinese medicine composition, polyoxyethylene 40 hydrogenated castor oil, potassium stearate and glycol monooleate are prepared into a medicine-containing emulsion, so that the solubility of the Chinese medicine composition can be improved, and further the bioavailability of the Fuyanping vaginal dilation suppository can be improved; the dilation suppository is prepared into a hollow dilation suppository, so that the stability is improved; meglumine also has the capability of improving the stability of the medicine-containing emulsion; in addition, the Fuyanping vaginal dilation suppository adopts six unique leading 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 Fuyanping vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Fuyanping preparation composed of sophora flavescens, cnidium fruit, bitter wood, dried alum, nacre powder, borneol, menthol, berberine hydrochloride and boric acid has the effects of clearing away heat and detoxification, drying dampness and stopping belt, killing insects and relieving itching, It is generally used for leukorrhea, vulva itching, excessive leukorrhea, yellowish smell, and genital itching caused by hot and humid betting; vaginitis and vulvitis caused by trichomonas, mold, and bacteria see the above symptoms. [0003] At present, Fuyanping preparations commonly used clinically include Fuyanping Capsules, Fuyanping Vaginal Effervescent Tablets, Fuyanping Suppositories and other dosage forms. Among them, Fuyanping Vaginal Effervescent Tab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/489A61K47/14A61K47/44A61K47/34A61K47/42A61K47/26A61K9/02A61P15/02A61P15/00A61P31/02A61P33/02G01N33/15G01N5/04A61K31/045A61K31/4375A61K33/06A61K35/56A61K33/22A61K35/618A61K47/10
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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