Progesterone vaginal sustained-release soft capsule and preparation method thereof

A technology of progesterone and soft capsules, which is applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of decreased curative effect, increase solubility, increase drug solubility and membrane penetration rate, and increase dissolution rate and the effect of membrane penetration rate

Inactive Publication Date: 2021-02-09
南京科宁检测科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The gel is a kind of thin semi-solid with certain fluidity, and it is easy to flow out with vaginal secretion after administration, resulting in a decline in curative effect

Method used

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  • Progesterone vaginal sustained-release soft capsule and preparation method thereof
  • Progesterone vaginal sustained-release soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Progesterone Suspension Soft Capsules (Specification: 100mg)

[0025] Prescription Dosage (g)

[0026] Progesterone 100

[0027] soybean oil 750

[0028] Gelucire 50 / 13 10

[0029] Sorbic acid 2

[0030] Beeswax 35.9

[0031] Make 1000 capsules

[0032] (1) Take 525g of soybean oil, add sorbic acid and beeswax in sequence, heat to 50°C, stir until completely dissolved, and use it as liquid A for later use.

[0033] (2) After heating and melting Gelucire 50 / 13, add 225g of prescription soybean oil and stir well. Progesterone (D 90 =7.56μm), stir quickly to disperse progesterone evenly, and use it as liquid B for later use.

[0034] (3) Add liquid A to liquid B, homogenize under high pressure at 3500 rpm for 15 minutes to obtain a uniform progesterone suspension, and the measured pH is 3.7. Then the progesterone suspension and the soft capsule glue are compressed by a pellet machine to obtain soft capsules.

Embodiment 2

[0035] Example 2 Progesterone Suspension Soft Capsules (Specification: 150mg)

[0036] Prescription Dosage (g)

[0037] Progesterone 150

[0038] soybean oil 800

[0039] Gelucire 50 / 13 15

[0040] Sorbic acid 2.2

[0041] Beeswax 50.9

[0042] Make 1000 capsules

[0043] (1) Take 560g of soybean oil, add sorbic acid and beeswax in sequence, heat to 50°C, stir until completely dissolved, and use it as liquid A for later use.

[0044] (2) After heating and melting Gelucire 50 / 13, add 240g of prescription soybean oil and stir well. Progesterone (D 90 =12.33μm), stir quickly to disperse progesterone evenly, and use it as liquid B for later use.

[0045] (3) Add liquid A to liquid B, homogenize under high pressure at 3500 rpm for 15 minutes to obtain a uniform progesterone suspension, and adjust the pH to 4.5 with sodium hydroxide solution. Then the progesterone suspension and the soft capsule glue are compressed by a pellet machine to obtain soft capsules.

Embodiment 3

[0046] Example 3 Progesterone Suspension Soft Capsules (Specification: 200mg)

[0047] Prescription Dosage (g)

[0048] Progesterone 200

[0049] soybean oil 850

[0050] Gelucire 50 / 13 20

[0051] Sorbic acid 2.2

[0052] Beeswax 68.4

[0053] Make 1000 capsules

[0054] (1) Take 595g of soybean oil, add sorbic acid and beeswax in sequence, heat to 50°C, stir until completely dissolved, and use it as liquid A for later use.

[0055] (2) After heating and melting Gelucire 50 / 13, add 255g of prescription soybean oil and stir well. Progesterone (D 90 =16.38μm), stir quickly to disperse progesterone evenly, and use it as liquid B for later use.

[0056] (3) Add liquid A to liquid B, homogenize under high pressure at 3500 rpm for 15 minutes to obtain a uniform progesterone suspension, and adjust the pH to 4.5 with sodium hydroxide solution. Then the progesterone suspension and the soft capsule glue are compressed by a pellet machine to obtain soft capsules.

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Abstract

The invention relates to a progesterone vaginal soft capsule for treating threatened abortion. Novel surfactant polyethylene glycol glyceryl stearate is utilized to enhance the stability of a progesterone vaginal suspension, and then, the vaginal suspension is wrapped in a soft capsule shell. The progesterone vaginal soft capsule has the advantages of avoiding the first-pass effect, improving thebioavailability, increasing the accuracy of administration dosage and and facilitating administration.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, in particular, the invention relates to a suspension-type progesterone vaginal soft capsule and a preparation method thereof. Background technique [0002] Progesterone is a natural progesterone secreted by the corpus luteum of the ovary, also known as progesterone and gestational hormone. It has a significant morphological effect on the endometrium stimulated by estrogen in the body and is necessary for maintaining pregnancy. Clinically, it is mainly used for the treatment of menstrual disorders, such as amenorrhea, endometrial bleeding, luteal insufficiency, threatened miscarriage and habitual miscarriage, premenstrual tension syndrome, and in hormone replacement therapy (HRT) together with estrogen Used to counteract the effects of pure estrogen on the lining. [0003] Currently commonly used progesterone dosage forms include: capsules, capsules, soft capsules, gels, suppositories, injection...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/14A61K31/57A61P15/00A61P15/06
CPCA61K9/0034A61K9/4866A61K31/57A61P15/00A61P15/06
Inventor 孙军娣
Owner 南京科宁检测科技有限公司
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