Sex hormone micro-nano human body injection emulsion containing TPGS, and preparation method thereof

A micro-nano-emulsion and sex hormone technology, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, emulsion delivery, etc., to achieve the effects of avoiding cardiovascular diseases, reducing production costs, and shortening the course of treatment

Inactive Publication Date: 2014-02-19
杭州伟智生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a kind of sex hormone micro-nano human body injection emulsion containing TPGS, the micro-nano human body injection emulsion solves the defects of current sex hormone drugs, and has the characteristics of high safety and stability of intravenous injection; another object of the present invention is to provide Preparation method of micronano human body injection emulsion containing TPGS sex hormone

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Get 0.7 grams of median chain triglycerides (MCT oil) and 100 mg of progesterone, heat to 45 degrees under normal pressure, mix and dissolve; get 5 grams of vitamin E polyethylene glycol 1000 succinate and add it, Continue stirring until completely dissolved. 244.2 grams of purified water was added dropwise to the above lysate and stirred until a transparent microemulsion solution was formed; the microemulsion solution was recently passed through a 0.22M CM filter to eliminate particulate material and microorganisms; the product was packaged and sealed for use.

[0035] Analyze the results by ion experiments:

[0036]Add 5% glucose injection into 25 ml of the solution prepared in Example 1 until the final volume is 100 ml. Stir in a water bath at 50 degrees; because the total weight of the micro-nano emulsion prepared in Example 1 is 250 grams, which contains 100 mg of progesterone, so the 100 ml solution that adds 5% glucose injection contains 10 mg of progesterone k...

Embodiment 2

[0041] Get 0.7 grams of median chain triglycerides (MCT oil) and 100 mg of progesterone, heat to 45 degrees under normal pressure, mix and dissolve; get 5 grams of vitamin E polyethylene glycol 1000 succinate and add it, Continue stirring until completely dissolved. 244.2 grams of glucose injection was added dropwise to the above lysate, stirred until a transparent microemulsion solution was formed; recently the microemulsion solution was passed through a 0.22M CM filter to eliminate particulate material and microorganisms; the product was packaged and sealed for use.

[0042] Analyze the results by ion experiments:

[0043] Add 5% glucose injection into 25 ml of the solution prepared in Example 2 until the final volume is 100 ml. Stir in a 50-degree water bath; since the total weight of the micro-nano emulsion prepared in Example 2 is 250 grams, which contains 100 mg of progesterone, so the 100 ml solution that adds 5% glucose injection contains 10 mg of progesterone ketone...

Embodiment 3

[0048] Get 0.7 grams of median chain triglycerides (MCT oil) and 100 mg of progesterone, heat to 45 degrees under normal pressure, mix and dissolve; get 5 grams of vitamin E polyethylene glycol 1000 succinate and add it, Continue stirring until completely dissolved. 244.2 grams of saline injection (0.9% NaCl aqueous solution) was added dropwise to the above lysate and stirred until a transparent microemulsion solution was formed; the microemulsion solution was recently passed through a 0.22M C M filter to eliminate particulate material and microorganisms; product packaging Sealed and ready to use.

[0049] Analyze the results by ion experiments:

[0050] Add 5% glucose injection into 25 ml of the solution prepared in Example 3 until the final volume is 100 ml. Stir in a 50-degree water bath; since the total weight of the micro-nano emulsion prepared in Example 3 is 250 grams, which contains 100 mg of progesterone, so the 100 ml solution that adds 5% glucose injection contain...

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Abstract

The invention belongs to the field of bioscience and bio-pharmaceutical technology, and specifically relates to a sex hormone micro-nano human body injection emulsion containing TPGS, and a preparation method thereof. Particle size of 90% particles in the sex hormone micro-nano human body injection emulsion is no more than 200nm, and average particle size of the sex hormone micro-nano human body injection emulsion is no more than 180nm, and sex hormone and TPGS are the effective components of the sex hormone micro-nano human body injection emulsion. Beneficial effects of the sex hormone micro-nano human body injection emulsion are that: the sex hormone micro-nano human body injection emulsion contains no obvious lipid components, and is capable of reducing occurrence rate of hyperlipidaemia and microorganism infection; tween is replaced by TPGS, so that influences on intravenous injection caused by antihypertensive effect and slight hemolysis effect of tween are avoided, and cardiovascular diseases induced by tween are avoided; and TPGS comprises hydrophilic PEG chains and hydrophobic vitamin E chains, and the hydrophobic vitamin E chains are capable of inserting into hydrophobic layers of sex hormone, so as to obtain sex hormone preparations coated by PEG, and increase stability of sex hormone.

Description

technical field [0001] The invention belongs to the technical fields of life science and biopharmaceuticals, and in particular relates to a sex hormone micro-nano human body injection emulsion containing TPGS and a preparation method thereof. Background technique [0002] Sex hormone refers to a steroid hormone synthesized by human gonads, placenta, adrenal cortex and other tissues; it can promote the maturation of sexual organs, the development of secondary sexual characteristics and maintain sexual function. The human ovaries mainly secrete two sex hormones - estrogen and progesterone, and the testes mainly secrete androgens mainly testosterone. [0003] Sex hormones are produced by endocrine cells, and there are two types of human endocrine cells: gregarious and scattered. Groups form endocrine gland organs, such as pituitary gland, thyroid gland, parathyroid gland, adrenal gland, pancreatic islets, ovary and testis; scattered ones include gastrointestinal hormone cells ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K45/00A61K47/34A61P5/24
Inventor 严伟琪李建雄
Owner 杭州伟智生物医药科技有限公司
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