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Medicine composition containing ergometrine and oxytocin analogue and preparation method

A technology of ergometrine and its composition, which is applied in the field of medicine, can solve problems such as unacceptable, inconvenient clinical use, and limited clinical application, and achieve the effect of reducing the production of related substances and increasing stability

Active Publication Date: 2012-07-18
WUHAN DOCAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to this process, the production cost is high, and it is difficult to accept clinically
[0020] In addition, compound oxytocin and ergometrine aqueous injections are very unstable, and they have high requirements for storage conditions: even products produced by filter sterilization processes should be protected from light, stored and transported at 2-8°C, which is It brings great inconvenience to clinical use, and the limited production and transportation costs limit the clinical application of this product for water injection

Method used

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  • Medicine composition containing ergometrine and oxytocin analogue and preparation method
  • Medicine composition containing ergometrine and oxytocin analogue and preparation method
  • Medicine composition containing ergometrine and oxytocin analogue and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Comparison of content and stability of related substances in the pharmaceutical composition of compound oxytocin for injection and its analogs and pharmaceutically acceptable salt of ergometrine and ergometrine oxytocin injection

[0051] The test article and reference article:

[0052] Foreign reference substance: Syntometrine injection (ergometrine oxytocin injection), 10IU / ml / bottle, provided by Zuellig Pharma and produced by Novartis;

[0053] Test product A: Ergonovine Oxytocin Injection, imitating the prescription of foreign Syntometrine Injection, without antioxidant, produced by sterile filtration process, without high temperature sterilization, made by Nanjing Xianyu Technology Co., Ltd.;

[0054] Test product B: Ergonovine Oxytocin Injection, imitating the prescription of foreign Syntometrine Injection, does not contain antioxidants, and is sterilized at high temperature, provided by Nanjing Xianyu Technology Co., Ltd.;

[0055] Test product C: ergonovine oxy...

Embodiment 2

[0094] Compound ergometrine oxytocin for injection

[0095] (1) Prescription

[0096]

[0097] (2) Preparation process

[0098] Weigh the prescribed amount of mannitol, add 4 / 5 of the amount of water for injection, and stir to completely dissolve.

[0099] Use 1.0mol / L hydrochloric acid to adjust the pH value between 3-8, then add water for injection to make the volume to 1000ml.

[0100] Add 0.5 to 1 g of activated carbon, stir for 15 minutes, filter and remove carbon, add the prescribed amount of oxytocin, ergometrine besylate, sodium bisulfite and cysteine, and filter to sterilize with a 0.22um filter membrane.

[0101] Determination of the content of the main drug in the intermediate to determine the loading.

[0102] Freeze-dried, plugged and capped.

Embodiment 3

[0104] Compound Carbetocin Ergometrine Maleate for Injection

[0105] (1) Prescription

[0106]

[0107]

[0108] (2) Preparation process

[0109] Weigh the prescribed amount of dextran and glycine, add 90% of the total amount of water for injection, stir and dissolve with a 78HW-1 digital constant temperature magnetic stirrer to obtain solution (1).

[0110] Weigh 0.1% (W / V) activated carbon, add it to the above liquid (1) and stir for 15 minutes, decarbonize through an hourglass filter, and fine filter with a 0.22um filter membrane.

[0111] Take the combined antioxidant sodium metabisulfite and citric acid in the prescribed amount, slowly add them to 5% water for injection, stir to dissolve, and obtain the solution (2).

[0112] Take the prescribed amount of ergonovine and carbetocin and slowly add to (2), while stirring to completely dissolve.

[0113] Add the solution (2) into the solution (1), stir evenly, and adjust the pH to 4-6. Dilute to the mark with water...

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PUM

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Abstract

The invention relates to a medicine composition, which is characterized by consisting of oxytocin analogue, ergometrine or salt acceptable in pharmacy, a carrier acceptable in preparation process or excipient, antioxygen, a potential of hydrogen (pH)conditioning agent, solubilizer and other auxiliary materials. The medicine composition is used for prevention and cure of postpartum hemorrhage caused by uterine contraction and atony and active management at the third stage of childbirth and is contribute to postpartum functional recovery. The ergometrine and the oxytocin analogue are combined to increase the curative effect and reduce the untoward effect. The dosage form is a freeze-drying mode or a sterile split package mode, high temperature sterilization is avoided in the preparation process, the medicines are stored in a solid state, the integrated antioxygen is added, impurities are decreased, the medicine composition is stable, and storage and transportation at the room temperature are facilitated.

Description

technical field [0001] The invention relates to the prevention and treatment of postpartum hemorrhage caused by uterine atony, active management of the third stage of childbirth and a pharmaceutical composition helpful for postpartum functional recovery, belonging to the technical field of medicine. Background technique [0002] Oxytocin is mainly used clinically for induction of labor, antepartum uterine atony, postpartum hemorrhage and incomplete uterine involution. [0003] Oxytocin can indirectly stimulate the contraction of uterine smooth muscle, simulating the uterine contraction of normal childbirth, resulting in cervical dilatation, and the uterine response to oxytocin gradually increases during pregnancy and reaches its peak at full term. It can also stimulate the contraction of the smooth muscle of the mammary gland, which helps the milk to be discharged from the breast, but does not increase the milk secretion of the mammary gland. [0004] The special anatomical...

Claims

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Application Information

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IPC IPC(8): A61K38/11A61P15/04A61P15/00A61K31/437A61K38/095
Inventor 吴琦李明
Owner WUHAN DOCAN PHARMA
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