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Misoprostol medicine combination used in mouths

A misoprostol, intraoral technology, applied in the field of medicine, can solve the problem of not being used for prevention or treatment, etc., and achieve the effects of improving compliance, convenient taking, and good taste

Inactive Publication Date: 2013-01-16
天津市聚星康华医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Misoprostol vaginal tablets (25 μg per tablet) for cervical ripening are currently in clinical trials, and there is no suitable specification for the prevention or treatment of postpartum hemorrhage

Method used

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  • Misoprostol medicine combination used in mouths
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  • Misoprostol medicine combination used in mouths

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Preparation of Misoprostol Sublingual Tablets (1000 Tablets Quantity)

[0030]

[0031]Preparation method: Pretreat misoprostol-hypromellose mixture, mannitol, lactose, croscarmellose sodium, aspartame and magnesium stearate through a 100-mesh sieve; The processed raw materials and auxiliary materials are evenly mixed; the content of the above mixture is detected, the weight of the tablet is calculated, and the finished product is obtained by 8mm shallow punching.

[0032] Measured according to the disintegration time limit inspection method stipulated in the second appendix XA of the 2010 edition of "Pharmacopoeia of the People's Republic of China", the results are shown in Table 1.

[0033] The dissolution time limit of table 1 misoprostol sublingual tablet (n=6)

[0034]

Embodiment 2

[0036] Preparation of Misoprostol Chewable Tablets (1000 Tablets Quantity)

[0037]

[0038] Preparation method: use part of xylitol, pregelatinized starch, cross-linked polyvinylpyrrolidone, and stevioside with polyvinylpyrrolidone aqueous solution as a binder to make soft materials, granulate with a 16-mesh sieve, dry at 60°C, and granulate. Fully mix with misoprostol-hypromellose mixture and part of the xylitol mixture, and mix evenly with magnesium stearate and talcum powder; detect the content of the above mixture, calculate the tablet weight, and 10mm shallow punched tablet to obtain the finished product.

Embodiment 3

[0040] Preparation of misoprostol orally disintegrating tablets (quantity of 1000 tablets)

[0041]

[0042]

[0043] Preparation method: pretreat mannitol, low-substituted hydroxypropyl cellulose, and hydroxypropyl methylcellulose through a 80-mesh sieve, mix to make soft materials, granulate with a 16-mesh sieve, dry at 60°C, granulate, and mix with rice Mix the soprostol-hypromellose mixture, part of the mannitol mixture, and magnesium stearate evenly; detect the content of the above mixture, calculate the tablet weight, and obtain a finished product by pressing a 6.5mm flat punched tablet.

[0044] The method for measuring the disintegration time limit of misoprostol orally disintegrating tablets is as follows: take six 10mL small beakers, add 2mL of water at a constant temperature to 37°C, put 1 tablet of this product in each, and place it statically for 1 minute. Disintegrate within 1 minute, shake gently, and pass through a 24-mesh sieve (if necessary, wash with n...

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PUM

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Abstract

The invention discloses a misoprostol medicine combination used in mouths. The misoprostol medicine combination can be used in mouths and is good in taste, can be dissolved, disintegrated and dispersed in the mouths without water drinking or can be disintegrated and dispersed by aid of mouth chewing and then be absorbed or swallowed in the mouths. The misoprostol medicine combination can be sublingual tablets, chewable tablets, mouth lozenges, mouth disintegrating tablets, mouth film agents and dropping pills, and preferably be the sublingual tablets, the chewable tablets, the mouth disintegrating tablets and the mouth lozenges. The medicine combination can be used for promoting uterine contraction and preventing and treating postpartum hemorrhage. The medicine combination is simple in dosing method, safe, efficient, capable of being accepted by people easily, simple in preparation process and suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing misoprostol used in the oral cavity, which can be used to promote uterine contraction and prevent and treat postpartum hemorrhage. The invention belongs to the technical field of medicine. Background technique [0002] Postpartum hemorrhage is one of the most common serious complications in obstetrics and is the leading cause of maternal death in my country. Among the four major causes of postpartum hemorrhage, uterine atony bleeding takes the first place, with an incidence rate of 50%-75%, accounting for about 2 / 3 of postpartum hemorrhage. Reducing maternal mortality is a fundamental health goal in many developing countries. The United Nations' fifth Millennium Development Goal focuses on reducing maternal mortality by three quarters by 2015. However, the interventions recommended to reduce these rates are either unavailable or too expensive to afford in many low-resource settings. M...

Claims

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Application Information

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IPC IPC(8): A61K31/5575A61K9/20A61K9/70A61P15/04
Inventor 赵伟王伟平王红霞李化淋
Owner 天津市聚星康华医药科技有限公司
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