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Progesterone emulsion type injection and preparation method thereof

A technology of ketone emulsion and injection, which is applied in the field of progesterone emulsion type injection, can solve problems such as potential safety hazards, achieve the effects of reducing dosage, improving solubility, and alleviating adverse reactions

Pending Publication Date: 2020-06-30
JIANGSU JIAERKE PHARMA GRP CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the emulsion injection is a non-clear emulsion, once the drug is separated out, it is difficult to be observed, so there is a great safety hazard in the clinical use of the drug-loaded emulsion injection with the risk of drug precipitation

Method used

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  • Progesterone emulsion type injection and preparation method thereof
  • Progesterone emulsion type injection and preparation method thereof
  • Progesterone emulsion type injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1. Greasy solvent

[0046] In this embodiment, the oily solvent in the progesterone emulsion type injection of the present invention is provided.

[0047] The oily solvent is a mixture of injection oil and benzyl benzoate, and the mass ratio of the injection oil to the benzyl benzoate is 1:5˜5:1. Those skilled in the art will understand that the mass ratio of the oil for injection to the benzyl benzoate falls within the range of 1:5 to 5:1, that is, the oil for injection and the benzyl benzoate The ratio of the mass ratio can be any one value in 0.2 to 5. For example, the mass ratio of the injection oil to the benzyl benzoate is 1:3, 1:2.5, 1:2, 2:1, 2.5:1, 3:1, etc.

[0048] The oil for injection is at least one selected from vegetable oil for injection and medium-chain fatty acid triglyceride for injection. That is to say, the oil for injection can be vegetable oil for injection, medium-chain fatty acid triglyceride for injection, or one (or several) veg...

Embodiment 2

[0068] Embodiment 2. Progesterone emulsion type injection 1~3

[0069]In this example, 5mg:1ml, 10mg:1ml and 20mg:1ml progesterone emulsion injections 1-3 are provided. The oily solvent contained in the progesterone emulsion injection contains medium-chain fatty acid triglyceride and benzyl benzoate, wherein the mass ratio of medium-chain fatty acid triglyceride to benzyl benzoate is 2:3. The progesterone emulsion type injection also includes egg yolk lecithin for injection and glycerin as an emulsifier; wherein, the mass ratio of egg yolk lecithin for injection to the oily solvent is 12:100, and every 100 ml of the corpus luteum The ketone emulsion type injection contains 2.5 grams of said glycerol.

[0070] As an example, the specific formula of the progesterone emulsion type injection described in this embodiment is as follows.

[0071] Progesterone emulsion injection 1: specification 5mg: 1ml, formula includes: progesterone 5g, benzyl benzoate 60g, medium chain fatty aci...

Embodiment 3

[0084] Embodiment 3. Progesterone emulsion type injection 4

[0085] In this example, a 50 mg:1 ml progesterone emulsion injection 4 is provided.

[0086] The oily solvent contained in the progesterone emulsion injection 4 includes medium-chain fatty acid triglyceride and benzyl benzoate, wherein the mass ratio of medium-chain fatty acid triglyceride to benzyl benzoate is 2:3. The progesterone emulsion type injection also includes egg yolk lecithin for injection as an emulsifier, sodium oleate as a stabilizer, and glycerin; wherein, the mass ratio of egg yolk lecithin for injection to the oily solvent is 12.5 : 100, every 100 milliliters of said progesterone emulsion type injection contains said glycerin of 2.5 grams.

[0087] As an example, the specific formula of the progesterone emulsion type injection described in this embodiment is as follows.

[0088] Progesterone emulsion type injection 4: specification 50mg: 1ml, formula includes: progesterone 50g, benzyl benzoate 12...

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Abstract

A progesterone emulsion type injection comprises progesterone, an oily solvent and water for injection, wherein the oily solvent is a mixture of oil for injection and benzyl benzoate, and the mass ratio of the oil for injection to the benzyl benzoate is 1:5 to 5:1. In the progesterone emulsion type injection provided by the invention, the progesterone has excellent solubility, so that the use amount of the oily solvent can be greatly reduced, and adverse reactions caused by oil needle injection can be greatly alleviated; and at the same time, the progesterone emulsion type injection provided by the invention has a high drug encapsulation rate, and a drug is not precipitated out after long-term storage.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a progesterone emulsion type injection. Background technique [0002] Progesterone (Progesterone, also known as progesterone, progesterone) is a natural progesterone secreted by the corpus luteum of the ovary. Its chemical name is progesterone-4-ene-3,20-dione, and its molecular formula is C 21 h 30 o 2 , molecular weight 314.47, CAS number 57-83-0. Progesterone is white or off-white crystalline powder, odorless and tasteless; easily soluble in chloroform, soluble in ethanol, ether or vegetable oil, insoluble in water. [0003] The pharmacological effects of progesterone are mainly: (1) promote the secretion of endometrium in the late menstrual cycle, thicken the endometrium, facilitate the implantation of fertilized eggs, reduce the excitability of uterine muscles, and ensure the safe progress of pregnancy; (2) interact with estrogen The hormones work together to promote the growth o...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/57A61K47/14A61K47/44A61P15/00A61P15/06A61P7/04A61P15/12
CPCA61K9/0014A61K9/107A61K31/57A61K47/14A61K47/44A61P7/04A61P15/00A61P15/06A61P15/12
Inventor 赵谦翁伟宇黄建明郝越梁婷婷
Owner JIANGSU JIAERKE PHARMA GRP CORP
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