Fuyanping vaginal expansion suppository and its preparation method and detection method

The technology of vaginal expansion suppository and expansion suppository is applied in the directions of suppository delivery, pharmaceutical formulations, material inspection products, etc., which 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: 2016-04-20
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 expansion suppository and its preparation method and detection method
  • Fuyanping vaginal expansion suppository and its preparation method and detection method
  • Fuyanping vaginal expansion suppository and its preparation method and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109]

[0110] Preparation:

[0111] 1) Preparation of drug-containing matrix:

[0112] a. Putting Poloxamer, Tween 65 and glycerol triabietate in a water bath for heating and melting to obtain a melt;

[0113] b. the preparation of Chinese medicine composition:

[0114] Ⅰ. Weigh the Sophora flavescens and Bitterwood in the prescribed amount, crush them, and decoct them in water three times. The amount of water added for the first time is 10 times of the total weight of Sophora Sophorae and Bitterwood, and boiled for 3 hours. The amount of water added for the second time is 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;

[0115] Ⅱ. Take the Fructus Cnidii of prescription quantity, pulverize, add 75% ethanol and reflux to extract twice, the am...

Embodiment 2

[0121]

[0122] Preparation:

[0123] 1) Preparation of drug-containing matrix:

[0124] a. placing polyoxyethylene monostearate and glycerol trilaurate in a water bath for heating and melting to obtain a melt;

[0125] b. the preparation of Chinese medicine composition:

[0126] Ⅰ. Weigh the Sophora flavescens and Bitterwood in the prescribed amount, crush them, and decoct them in water three times. The amount of water added for the first time is 10 times of the total weight of Sophora Sophorae and Bitterwood, and boiled for 3 hours. The amount of water added for the second time is 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;

[0127] Ⅱ. Take the Fructus Cnidii of prescription quantity, pulverize, add 75% ethanol and reflux to extract twice...

Embodiment 3

[0134]

[0135] 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 expansion suppository and a preparation method and a detection method thereof. The expansion suppository includes a drug-containing matrix and an expansion carrier formed by a Chinese medicine composition and a matrix; the Chinese medicine composition includes Sophora flavescens, bitter wood, etc. 9 raw materials, and cockscomb and loofah are also added in the Chinese medicine composition, and the Fuyanping vaginal expansion suppository made has a good curative effect on gynecological diseases such as trichomonal vaginitis; the Chinese medicine composition The drug-containing microemulsion is made with polyoxyethylene 40 hydrogenated castor oil, potassium stearate and ethylene glycol monooleate, which can improve the solubility of the traditional Chinese medicine composition, thereby improving the bioavailability of Fuyanping vaginal expansion suppository; Making the expansion plug into a hollow expansion plug can improve its stability; the meglumine can also improve the stability of the drug-containing microemulsion; and the Fuyanping vaginal expansion plug adopts six original leading technologies, which can prevent The medicinal liquid flows out, has high stability, long-lasting curative effect, and prevents secondary infection and other beneficial effects.

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