Megestrol acetate nanocrystalline oral mixed suspension as well as preparation method and application thereof

A technology of megestrol acetate and oral suspension, which is applied in the field of medicine and can solve the problems of great post-suffering pain and long-term stability to be improved

Active Publication Date: 2020-11-10
ACADEMY OF MILITARY MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is aggregation in the nanocrystalline suspension, the long-term stability of the preparation needs to be improved, and the aftertaste is very bitter.

Method used

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  • Megestrol acetate nanocrystalline oral mixed suspension as well as preparation method and application thereof
  • Megestrol acetate nanocrystalline oral mixed suspension as well as preparation method and application thereof
  • Megestrol acetate nanocrystalline oral mixed suspension as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Example 1 Preparation of Megestrol Acetate Nanocrystalline Oral Suspension

[0075] The composition of megestrol acetate nanocrystalline oral suspension is shown in Table 1.

[0076] Table 1

[0077] components Dosage (g) Megestrol Acetate (MA) 120.2 HPMC (E5) 24 Docusate Sodium (DOSS) 1.2 sodium benzoate 1.9 Sodium citrate dihydrate 1.8 Citric Acid Monohydrate 4 sucrose 144.2 Lemon Spice GLR101378 1.5 Lemon Spice GLR101340 0.5 water 700.7

[0078] The preparation method of embodiment 1 comprises the following steps:

[0079] Weigh 24g of HPMC E5 and add appropriate amount of water, heat to 75°C, stir until clear and transparent, let stand at room temperature, and set aside. Weigh 1.2g of DOSS, add an appropriate amount of water, stir until dissolved, add 1.9g of sodium benzoate, 1.8g of sodium citrate dihydrate and 4g of citric acid monohydrate, stir until dissolved, and prepare a mixed solu...

Embodiment 2-4

[0087] The preparation of embodiment 2-4 megestrol acetate nanocrystal oral suspension

[0088] The composition of embodiment 2-4 megestrol acetate nanocrystal oral suspension is shown in Table 3.

[0089] table 3

[0090] components Dosage (g) megestrol acetate 346.8 HPMC E5 69.2 Docusate Sodium (DOSS) 3.46 sodium benzoate 5.48 Sodium citrate dihydrate 5.19 Citric Acid Monohydrate 11.54 sucrose 416.0 Lemon Spice GLR101378 4.33 Lemon Spice GLR101340 1.44 water 2021.5

[0091] The preparation method of embodiment 2-4 comprises the steps:

[0092] Weigh 69.28g HPMC E5 and add appropriate amount of water, heat to 80°C, stir until clear and transparent, let stand at room temperature, and set aside. Weigh 3.46g DOSS, add appropriate amount of water, stir until dissolved, add 5.48g sodium benzoate, 5.19g sodium citrate dihydrate and 11.54g citric acid monohydrate, stir until dissolved, and prepare a mixed so...

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Abstract

The invention provides a megestrol acetate nanocrystal oral mixed suspension. The particle size of megestrol acetate nanocrystal in the oral mixed suspension is less than or equal to 600nm, the polydispersity index (PdI) is less than or equal to 0.3, the Zeta electric potential is less than or equal to 10mv, and the oral mixed suspension also contains a space protective agent, a charge stabilizer,a preservative, a buffer agent, a corrigent and a sweetening agent with the content of 10-20% (w / w). According to the megestrol acetate nanocrystalline oral mixed suspension disclosed by the invention, the drug dissolution speed is increased, so that the biological availability is improved. The particle size distribution is uniform, aggregation and layering phenomena are avoided, and the stability is good. The megestrol acetate nanocrystal oral mixed suspension is good in mouth feel, sour and sweet in taste, small in bitter taste after being tasted and lasting in sweetness, and is suitable for patients who have difficulty in swallowing large-volume liquid and have to take medicines due to poor appetite, the appetite of anorexia patients is improved, and the medication compliance of the patients is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a megestrol acetate nanometer oral suspension, a preparation method thereof and an application thereof. Background technique [0002] AIDS (AIDS) is a major infectious disease manifested by immunodeficiency caused by infection with human immunodeficiency virus (HIV). HIV infection can impair metabolic and nutritional status, leading to cachexia characterized by anorexia and weight loss. Cachexia is an important factor leading to poor prognosis of HIV-infected patients and AIDS patients. It not only makes patients more prone to opportunistic infections and other complications, but also accelerates the development of the disease and affects the effect of antiviral therapy. In addition to AIDS, many other diseases, such as tumors, chronic obstructive pulmonary disease, rheumatoid arthritis, severe trauma, etc., can also cause cachexia. Improving cachexia can not only ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/57A61P1/14A61P35/00A61P37/02A61P43/00
CPCA61K31/57A61K9/0095A61K9/10A61K47/38A61P37/02A61P1/14A61P35/00A61P43/00
Inventor 郑爱萍张慧李蒙王增明孟萌高静高翔刘楠
Owner ACADEMY OF MILITARY MEDICAL SCI
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