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Progesterone suspension long-acting injection as well as preparation method thereof and progesterone suspension powder needle for injection

A progesterone and injection technology, applied in the field of medicine, can solve the problems of unfavorable injection site tissue health, long half-life of oily progesterone, inconvenient injection of progesterone, etc., so as to improve bioavailability, improve bioavailability, and reduce administration effect of times

Active Publication Date: 2017-09-26
上海赛增医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And oily progesterone has a long half-life, and it usually takes several weeks to recover
Long-term high-frequency injections will also cause other symptoms such as induration at the injection site, which is not conducive to the health of the tissue at the injection site
The patients are all pregnant women, and it is extremely inconvenient to inject progesterone every day, and the presence of oil solvent in progesterone injection can easily cause problems such as muscle hardening and pain

Method used

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  • Progesterone suspension long-acting injection as well as preparation method thereof and progesterone suspension powder needle for injection
  • Progesterone suspension long-acting injection as well as preparation method thereof and progesterone suspension powder needle for injection
  • Progesterone suspension long-acting injection as well as preparation method thereof and progesterone suspension powder needle for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Preparation of progesterone suspension injection (wet grinding method)

[0056] Prescription (100 sticks):

[0057]

[0058] Preparation Process:

[0059] (1) Prepare grinding media, dissolve 3 g of polyethylene glycol 4000, 0.3 g of Tween 80 and 2.7 g of sodium chloride in 300 mL of water for injection, stir until completely dissolved, and use as grinding media.

[0060] (2) Pour 200mL of zirconia grinding beads into the grinding chamber, disperse 15g of progesterone in 150mL of grinding media, pour into the chamber, and transfer the remaining drug with the remaining media.

[0061] (3) Circular grinding at 1500 rpm for 10 min to obtain a progesterone suspension, which was dispensed into prefilled syringes under aseptic conditions to prepare 100 prefilled injections.

Embodiment 2

[0063] Preparation of progesterone suspension injection (wet grinding method)

[0064] Prescription (100 sticks):

[0065]

[0066] Preparation Process:

[0067] (1) Prepare grinding medium, dissolve 1.35g sodium carboxymethylcellulose, 0.15g Tween 80 and 2.7g sodium chloride in 300mL water for injection, stir until completely dissolved, and use as grinding medium.

[0068] (2) Pour 200 mL of zirconia grinding beads into the grinding chamber, disperse 7.5 g of progesterone in 150 mL of grinding media, pour into the chamber, and transfer the remaining drug with the remaining media.

[0069] (3) Circular grinding at 1500 rpm for 10 min, the obtained progesterone suspension was filled into prefilled syringes under aseptic conditions, and 100 prefilled injections were prepared.

Embodiment 3

[0071] Preparation of Progesterone Suspension Injection (Microfluidic Method)

[0072] Prescription (100 sticks):

[0073]

[0074] Preparation Process:

[0075] (1) Weigh 15 g of progesterone, add 3 g of povidone, 0.3 g of Tween 80, add 300 mL of water for injection, and stir evenly to obtain an initial suspension.

[0076] (2) Put the primary suspension into the micro-fluidizer, circulate once under the pressure of 10000psi, and circulate three times under the pressure of 20000psi, carry out micronization treatment, obtain progesterone suspension with uniform particle size.

[0077] (3) The obtained progesterone suspension was aseptically filled into prefilled syringes to prepare 100 prefilled injections.

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Abstract

The invention relates to the technical field of medicines and discloses a progesterone suspension long-acting injection as well as a preparation method thereof and a progesterone suspension powder needle for injection, which are used for luteal support in threatened abortion and assisted reproduction. In the embodiment of the invention, through micron-crystallization and nano-crystallization, a number of stabilizing agents are added, so that a progesterone suspension or a freeze-dried powder needle and the like is prepared, and the progesterone suspension or the freeze-dried powder needle is used for muscle or subcutaneous injection. According to the suspension, the problem of administration of insoluble medicines is solved, accessories are less, and the drug loading capacity is large, so that the bioavailability can be remarkably improved, the one-week or longer slow-release effect is achieved, and administration times are decreased; in addition, the biocompatibility is good, the irritation is small, and the compliance of patients is improved. In the preparation method disclosed by the invention, a media milling method, a solvent replacement-high pressure homogenization method or a microjet method and the like can be adopted. The preparation disclosed by the invention is simple and controllable in preparation processes, so that industrial production can be realized.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a new dosage form of progesterone, in particular to a progesterone suspension long-acting injection and a preparation method thereof, and a progesterone suspension injection powder injection. Background technique [0002] Progesterone, also known as progesterone, is a white or slightly yellow crystalline powder with a melting point of 127-131°C, odorless, stable in air, dextrorotatory, insoluble in water, soluble in ethanol, ether, and chloroform , acetone, dioxane and concentrated sulfuric acid. The chemical name of progesterone is: Pregn-4-ene-3,20-dione, molecular formula: C 21 h 30 o 2 , molecular weight: 314.47, the structural formula is as follows: [0003] [0004] Progesterone is a natural progesterone secreted by the corpus luteum of the ovary and is an important hormone for maintaining pregnancy. Progesterone has many functions during pregnancy, inc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K9/16A61K9/19A61K31/57A61K47/10A61K47/26A61K47/38A61K47/22A61P15/06A61P15/00A61P7/04
CPCA61K9/0002A61K9/0019A61K9/10A61K9/1641A61K9/1652A61K9/19A61K31/57A61K47/10A61K47/22A61K47/26A61K47/38
Inventor 金磊唐星张士权徐万国彭飞王世曼
Owner 上海赛增医疗科技有限公司
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