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Palmatine vaginal swelling bolt as well as preparation method and detection method thereof

A technique for vaginal expansive suppositories and detection methods, applied in suppository delivery, pharmaceutical formulations, material inspection products, etc., can solve the problems of suppository deterioration, easy to pollute clothes, and slow dissolution of palmetine, so as to prevent outflow and avoid secondary Effect of infection

Active Publication Date: 2014-04-23
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 existing palmatine preparations include palmatine tablets, capsules and suppositories. Because suppositories overcome the gastrointestinal side effects of tablets and capsules, palmatine suppositories have been widely used; new drug standardization volume 64 included Huangtengsu suppository is clinically used for candidal vulvovaginal disease; it is made of Huangtengsu and a water-soluble base, but the water-soluble base is irritating to the vagina; and Huangtengin dissolves slowly in water , Caking is prone to occur during the dissolution process, and redissolution is difficult, resulting in low bioavailability and poor targeting of suppositories, and cannot fully exert the efficacy of palmetine; and the prepared suppositories deteriorate and deform, seriously affecting the absorption of drugs. This leads to inconvenient transportation and storage; moreover, the common patellogenin suppository is not easy to clean and easily contaminates clothes; the active ingredient has a small contact surface with the human body, resulting in insufficient absorption and failure to exert the best curative effect of the prescription.

Method used

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  • Palmatine vaginal swelling bolt as well as preparation method and detection method thereof
  • Palmatine vaginal swelling bolt as well as preparation method and detection method thereof
  • Palmatine vaginal swelling bolt as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092]

[0093] Preparation:

[0094] 1) Preparation of drug-containing matrix:

[0095] a. placing hardened oil and semi-synthetic palm oil ester in a water bath for heating and melting to obtain a melt;

[0096] b. Carry out micronization treatment of palmatine twice by jet pulverization method, the pulverization pressure is 7bar, and the obtained particle size is d 0.9 12 μm of palmatine;

[0097] c. adding the palmatine in step b to the melt in step a, and mixing evenly to obtain a drug-containing matrix;

[0098] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 bullet-shaped suppositories, each weighing about 3.2g.

Embodiment 2

[0100]

[0101] Preparation:

[0102] 1) Preparation of drug-containing matrix:

[0103] a. placing semi-synthetic fatty acid glycerides and semi-synthetic litsea cubeba in a water bath for heating and melting to obtain a melt;

[0104] b. Carry out micronization treatment of palmatine twice by jet pulverization method, the pulverization pressure is 7bar, and the obtained particle size is d 0.9 12 μm of palmatine;

[0105] c. mix the palmatine in step b with glyceryl xylitol monostearate and karaya gum evenly to prepare the mixture;

[0106] d. Add the mixture of step c to the melt of step a, and mix evenly to obtain a drug-containing matrix;

[0107] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 egg-shaped suppositories, each weighing about 2.2g.

Embodiment 3

[0109]

[0110] Preparation method: make 100 torpedo-shaped suppositories by the method of embodiment 2, each weighing about 5.0 g .

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Abstract

The invention relates to a palmatine vaginal swelling bolt as well as a preparation method and a detection method thereof. The swelling bolt comprises a medicated substrate formed by micronized palmatine and a substrate, and an expansion carrier, wherein the medicated substrate also comprises xylitol anhydride glycerol monostearate, karaya gum, sorbitol lauric acid ester, myristyl alcohol and spherical saccharose. The palmatine vaginal swelling bolt disclosed by the invention is high in stability, significant in curative effect, not easy to deform, and free of rancidity, and the provided palmatine vaginal swelling bolt adopts six original leading technologies, and has the beneficial effects that the soup is prevented from flowing out, the palmatine vaginal swelling bolt is quick to take effect, secondary infection is prevented and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, and in particular relates to a palmetine vaginal expansion suppository and a preparation method and a detection method thereof. Background technique [0002] Phytophthalin is an alkaloid extracted from the stem of Phyllostachys vine Fibraurea recisa Pierre. The main component is tetrandrine hydrochloride, which has the function of clearing away heat and detoxifying. It is used for gynecological inflammation, bacillary dysentery, enteritis, respiratory tract and urinary tract tract infection, surgical infection, conjunctivitis, etc.; palmatine itself is odorless, bitter, soluble in hot water, slightly soluble in water. [0003] The existing palmatine preparations include palmatine tablets, capsules and suppositories. Because suppositories overcome the gastrointestinal side effects of tablets and capsules, palmatine suppositories have been widely used; new drug standardization volume 64 include...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K31/4375A61K47/26A61K47/44A61K47/36A61P15/02A61P31/10G01N33/15G01N5/04
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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