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Progesterone injection and method for preparing the same

A progesterone and injection technology, applied in the field of progesterone injection and its preparation, can solve the problems such as the sterilization temperature cannot be higher than 105 DEG C, the solubility problem of progesterone cannot be solved, the sterilization time cannot be longer than 15 minutes, and the like, To achieve the effect of reducing local injection irritation and allergic side effects, reducing hemolysis and histamine release, and improving drug efficacy and safety

Inactive Publication Date: 2011-07-06
曲靖平和安康医药保健有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing non-progesterone submicron emulsion preparations cannot withstand high temperature for a long time, the sterilization temperature cannot be higher than 105°C, and the sterilization time cannot be longer than 15 minutes. Therefore, the preparation environment requires a high degree of sterility, and the cost of maintaining a sterile environment is high. The existing non-progesterone submicron emulsion preparations have poor stability, large and uneven particle size, and long-term storage is likely to cause stratification of the preparation
[0004] Since progesterone is completely insoluble in water, making an aqueous solution preparation is a very difficult technology in the preparation process, and the solubility problem of progesterone cannot be solved with conventional solubilizers

Method used

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  • Progesterone injection and method for preparing the same
  • Progesterone injection and method for preparing the same
  • Progesterone injection and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1: preparation content is the progesterone submicron emulsion of 0.5% (being 5mg / ml)

[0043] Prescription 1 Progesterone 5g

[0044] Soybean oil (injection grade) 180g

[0045] Polyethylene glycol 15-hydroxystearate 18g

[0046] Soy Lecithin (Injection Grade) 2g

[0047] Glycerin (injection grade) 2g

[0048] Oleic acid 5g

[0049] Vitamin E 0.3g

[0050] Water for injection to 1000ml

[0051] Dissolve 5g of progesterone in 180g of soybean oil, vitamin E and 5g of oleic acid as the oil phase, stir continuously and heat to 70°C, add 18g of polyethylene glycol 15-hydroxystearate (solutol HS15), 2g of soybean lecithin, Disperse 2g of glycerin in water as the water phase, heat it to 70°C with constant stirring, slowly add the oil phase to the water phase, stir at high speed with a high-speed disperser for 8 minutes (rotation speed 20,000 rpm) to prepare colostrum, and use high-pressure Homogenize with a homogenizer (pressure 65MPa, temperature 75°C) for 7...

Embodiment 2

[0054] The preparation content is the progesterone submicron emulsion of 1% (being 10mg / ml)

[0055] Prescription 2 Progesterone 10g

[0056] Soybean oil (injection grade) 180g

[0057] Polyethylene glycol 15-hydroxystearate 18g

[0058] Soy Lecithin (Injection Grade) 2g

[0059] Glycerin (injection grade) 2g

[0060] Oleic acid 5g

[0061] Ascorbic acid 0.1g

[0062] Water for injection to 1000ml

[0063] 10g of progesterone was dissolved in 180g of soybean oil and 5g of oleic acid as the oil phase, and heated to 70°C with constant stirring, 18g of polyethylene glycol 15-hydroxystearate (solutol HS15), 2g of soybean lecithin, 2g of glycerin, Ascorbic acid is dispersed in water as the water phase, heated to 70°C with constant stirring, the oil phase is slowly added to the water phase, and the colostrum is prepared after 8 minutes of high-speed stirring with a high-speed disperser (rotation speed 20000 rpm), and the colostrum is homogenized with high pressure After homog...

Embodiment 3

[0066] Preparation content is the progesterone submicron emulsion of 2% (being 20mg / ml)

[0067] Prescription 3 Progesterone 20g

[0068] Soybean oil (injection grade) 180g

[0069] Polyethylene glycol 15-hydroxystearate 18g

[0070] Soy Lecithin (Injection Grade) 2g

[0071] Glycerin (injection grade) 2g

[0072] Oleic acid 5g

[0073] Hexasodium Phytate 0.5g

[0074] Water for injection to 1000ml

[0075] Dissolve 20g of progesterone in 180g of soybean oil and 5g of oleic acid as the oil phase, stir continuously and heat to 70°C, add 18g of polyethylene glycol 15-hydroxystearate (solutol HS15), 2g of soybean lecithin, 2g of glycerin, Disperse hexasodium phytate in water as the water phase, heat it to 70°C with constant stirring, slowly add the oil phase to the water phase, stir at high speed with a high-speed disperser for 8 minutes (speed 20,000 rpm) to prepare colostrum, and mix the colostrum Homogenize with a high-pressure homogenizer (pressure 65MPa, temperature 7...

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Abstract

The invention provides a progesterone injection and the preparation method, which solves the problems of strong pungency, inconvenient use with prior progesterone injection, the problems of low stability and poor quality with prior progesterone micoremulsion, and the problems of high cost with asepsis preparation process. The weight percentage of the progesterone injection is: 0.5 to 2 percent ofprogesterone, 15 to 35 percent of oil for injection, 1 to 12 percent of emulsifier, 0.1 to 1 percent of assistant emulsifier, 0.2 to 2 percent of stabilizer, 0.01 to 2.5 percent of zntioxidant and allowance of water.

Description

Technical field: [0001] The invention relates to a progesterone injection and a preparation method thereof. Background technique: [0002] Progesterone is a natural progestin, insoluble in water, soluble in organic solvents such as ethanol. Progesterone is a commonly used sex hormone drug, which can regulate hormone balance. Progesterone has the general effect of progesterone. It is widely used in clinical practice, mainly for menstrual disorders, such as amenorrhea and functional uterine bleeding, luteal phase insufficiency, aura Treatment of miscarriage and recurrent miscarriage, premenstrual tension syndrome, and estrogen cycles against the effects of pure estrogen on the endometrium. [0003] Progesterone (Progesterone / Progetin) is a fat-soluble substance that is insoluble in water. It absorbs a small amount after oral administration and is quickly metabolized and inactivated by the liver. Therefore, only oil solution injections can be used clinically. When the injecti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/57A61K9/107A61K47/34A61K47/44A61P15/08A61P15/00A61K47/14
Inventor 张为群杨放
Owner 曲靖平和安康医药保健有限公司
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