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Solid dispersoid containing progestational hormone, preparation method thereof and composite comprising same

A solid dispersion, progesterone technology, used in the field of medicine

Inactive Publication Date: 2011-04-20
上海市生物医药技术研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical field is in urgent need of new technology, which has its unique important role and advantages in improving the absorption and delivery of drugs, improving the bioavailability of preparations, and ensuring the effectiveness, safety and reliability of medication, such as the type of carrier to choose More, the preparation process is simple and easy, and does not involve the evaluation of inclusion efficiency

Method used

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  • Solid dispersoid containing progestational hormone, preparation method thereof and composite comprising same
  • Solid dispersoid containing progestational hormone, preparation method thereof and composite comprising same
  • Solid dispersoid containing progestational hormone, preparation method thereof and composite comprising same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Take 1000 pieces as an example:

[0034] Gestodene (Beijing Zizhu Pharmaceutical Co., Ltd.) 75mg

[0035] PVP (PLASDON K-29 / 32, American ISP Company) 3.75g

[0036] Ethinylestradiol (Shanghai Pharmaceutical Group Co., Ltd.) 30mg

[0037] Calcium Carbonate (Shanghai Daewoo Biochemical Co., Ltd.) 63g

[0038] Cross-linked PVP (Polyplasdone XL or XL-10, American ISP company, 12g

[0039] Mw=10,000-300,000)

[0040] Magnesium stearate [China Pharmaceutical (Group) Shanghai Chemical Reagent Company] 1g

[0041] Dissolve Gestodene and PVP in 50 mL of ethanol at the same time, or dissolve them in ethanol separately and mix well. Remove the solvent by vacuum drying to obtain about 3.75 g of solid dispersion.

[0042] Pulverize the above solid dispersion, pass through a 60-mesh sieve, mix evenly with ethinyl estradiol and calcium carbonate, granulate with 75% ethanol aqueous solution, dry (45°C), add cross-linked PVP and magnesium stearate for granulation, and tablet. Get ...

Embodiment 2

[0044] Take 1000 pieces as an example:

[0045] Gestodene (Beijing Zizhu Pharmaceutical Co., Ltd.) 60mg

[0046] Ethinylestradiol (Shanghai Pharmaceutical Group Co., Ltd.) 20mg

[0047] PVP (PLASDON K-29 / 32, American ISP Company) 3g

[0048] Low-substituted hydroxypropyl methylcellulose (Huzhou Zhanwang Tianming Pharmaceutical Co., Ltd.) 12g

[0049] Compressible starch (Starch 1500, American Colorcon company) 63g

[0050] Talc powder (Dandong Medicinal Talc Powder Factory) 0.5g

[0051] Magnesium stearate (Anhui Shanhe Pharmaceutical Excipients Co., Ltd.) 0.5g

[0052] Dissolve Gestodene and PVP in 40 mL of ethanol at the same time, or dissolve in ethanol separately and mix well, and remove the solvent by vacuum drying (vacuum condition is less than 20 mmHg) to obtain about 3 grams of solid dispersion.

[0053] Crush the above solid dispersion, pass through a 60-mesh sieve, mix evenly with ethinyl estradiol, low-substituted hydroxypropylmethylcellulose (L-HPC) and compress...

Embodiment 3

[0055] Take 1000 pieces as an example:

[0056] Gestodene (Beijing Zizhu Pharmaceutical Co., Ltd.) 60mg

[0057] PVP (K30, Hainan Nanhang Pharmaceutical Co., Ltd.) 6g

[0058] Ethinylestradiol (Shanghai Xinyi Pharmaceutical Co., Ltd.) 20mg

[0059] Calcium carbonate (Shandong Liaocheng Anxin Pharmaceutical Excipients Co., Ltd.) 60g

[0060] Cross-linked PVP (Hainan Nanhang Pharmaceutical Co., Ltd.) 12g

[0061] Magnesium stearate (Shandong Liaocheng Ahua Pharmaceutical Co., Ltd.) 1g

[0062] Dissolve Gestodene and PVP in 50 mL of ethanol at the same time, or dissolve them in ethanol separately and mix well. Remove the solvent by vacuum drying (vacuum degree less than 20 mmHg) to obtain about 6 grams of solid dispersion.

[0063] Pulverize the above solid dispersion, pass through a 60-mesh sieve, mix evenly with ethinyl estradiol and calcium carbonate, granulate with 75% ethanol aqueous solution, dry (45°C), add cross-linked PVP and magnesium stearate for granulation, and t...

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Abstract

The invention relates to a solid dispersoid comprising progestational hormone and at least one water-soluble carrier material, wherein the progestational hormone is dispersed into the water-soluble carrier material, and the weight ratio of the progestational hormone to the water-soluble carrier material is 1:0.3-300. The solid dispersoid has the advantages of higher dissolution rate and bioavailability, good content uniformity degree, high physical stability and high chemical stability. The invention also relates to a preparation method of the solid dispersoid and a composite comprising the solid dispersoid.

Description

technical field [0001] The present invention generally relates to the field of medical technology, specifically, the present invention relates to a solid dispersion containing a progestin and a preparation method thereof, and the present invention also relates to a composition comprising the composition of the solid dispersion. Background technique [0002] Progestogens are commonly used as part of formulations commonly used in birth control pills or hormone replacement therapy. However, the synergistic effect of estrogen and progesterone can reduce the dose of estrogen and progesterone without changing the curative effect. The application of the compound preparation composed of the two is becoming more and more extensive. [0003] In oral solid dosage forms with natural or synthetically derived steroid hormones as active pharmaceutical ingredients, the doses of these ingredients are usually very low, within the range of 0.010-0.500 mg. Therefore, the problem of content uni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/14A61K9/16A61K9/20A61K9/48A61K9/50A61K45/06A61K45/08A61K31/567A61K31/57A61K31/585A61K47/10A61K47/14A61K47/26A61K47/32A61K47/34A61K47/36A61K47/42A61P5/30A61P15/18
Inventor 陈海林陈良康俸灵林陈建兴余丽宁
Owner 上海市生物医药技术研究院
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