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Oral suspension for treating acute lymphoblastic leukemia and preparation method thereof

A technology of acute lymphocyte and oral suspension, which is applied in the directions of non-active ingredients medical preparations, liquid delivery, pharmaceutical formulations, etc., can solve the problems of poor thixotropy, difficult to dissipate bubbles, short validity period, etc., and achieves storage conditions. The effect of low requirements and low product impurity levels

Active Publication Date: 2019-02-05
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] ②The validity period is short, and the validity period is only 1 year in the unopened state, which is not conducive to the production, sales and storage of the product;
[0021] ④ High viscosity and poor thixotropy, which is not conducive to taking;
[0022] ⑤ The bubbles generated during the shaking process are not easy to dissipate, which affects the accuracy of the dosage

Method used

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  • Oral suspension for treating acute lymphoblastic leukemia and preparation method thereof
  • Oral suspension for treating acute lymphoblastic leukemia and preparation method thereof
  • Oral suspension for treating acute lymphoblastic leukemia and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

1000

[0063] The preparation process of the prescription:

[0064] ① Measure 90% of the total prescription amount of purified water, put it in the liquid mixing tank, and heat it to 50°C;

[0065] ②The speed of the blades of the liquid mixing tank is 50rpm, and the sweetener, bacteriostat, pH regulator, and suspending agent are dissolved in sequence;

[0066] ③Mix the mercaptopurine and poloxamer evenly in the form of dry powder, then add it to the solution under item ②, and stir until evenly dispersed;

[0067] ④ Adjust the pH to 4.5±0.1, add purified water to a sufficient amount;

[0068] ⑤Fill in soda-lime glass bottles, the volume of each bottle is 103mL.

Embodiment 2

1000

[0071] The preparation process of the prescription:

[0072] ① Measure 90% of the total prescription amount of purified water, put it in the liquid mixing tank, and heat it to 50°C;

[0073] ②The speed of the blades of the liquid mixing tank is 50rpm, and the sweetener, bacteriostat, pH regulator, and suspending agent are dissolved in sequence;

[0074] ③Mix the mercaptopurine and poloxamer evenly in the form of dry powder, then add it to the solution under item ②, and stir until evenly dispersed;

[0075] ④ Adjust the pH to 4.5±0.1, add purified water to a sufficient amount;

[0076] ⑤Fill in soda-lime glass bottles, the volume of each bottle is 103mL.

Embodiment 3

1000

[0079] The preparation process of the prescription:

[0080] ① Measure 90% of the total prescription amount of purified water, put it in the liquid mixing tank, and heat it to 50°C;

[0081] ②The speed of the blades of the liquid mixing tank is 50rpm, and the sweetener, bacteriostat, pH regulator, and suspending agent are dissolved in sequence;

[0082] ③Mix the mercaptopurine and poloxamer evenly in the form of dry powder, then add it to the solution under item ②, and stir until evenly dispersed;

[0083] ④ Adjust the pH to 4.5±0.1, add purified water to a sufficient amount;

[0084] ⑤Fill in soda-lime glass bottles, the volume of each bottle is 103mL.

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Abstract

The invention relates to an oral suspension for treating acute lymphoblastic leukemia and a preparation method thereof. A mixture of poloxamer and xanthan gum is used as a compounded suspension aid, the suspension prepared by using the raw material with the granularity of 100 to 200 micrometers (D90) is good in suspension effect, good in thixotropism, convenient for administration accuracy, low inrequirement for storage environment, stable in content and impurities after the stable sampling, and good in in-vitro dissolution characteristics.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oral suspension for treating acute lymphoblastic leukemia and a preparation method thereof. Background technique [0002] Acute lymphoblastic leukemia (ALL) is a progressive malignant disease characterized by large numbers of immature white blood cells that resemble lymphoblasts. These cells can be found in the blood, bone marrow, lymph nodes, spleen and other organs. ALL accounts for 80% of acute leukemia in children, and the peak incidence is between 3 and 7 years old. ALL can also occur in adults and accounts for 20% of all adult leukemias. [0003] Mercaptopurine is used to treat acute lymphoblastic leukemia (ALL), applicable to children, adolescents and adults, and is an orphan drug for the treatment of rare diseases. Mercaptopurine has a similar chemical structure to purines and is one of the basic chemicals that make up DNA. In the body, mercaptopurines ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/36A61K47/10A61K31/52A61P35/02
CPCA61K9/0053A61K9/10A61K31/52A61K47/10A61K47/36A61P35/02
Inventor 朱亚芳谢晓燕单鹏程
Owner 南京泽恒医药技术开发有限公司