Application of thalidomide to preparation of pharmaceutical composition for improving liver function damage of patients with thalassemia

A technology for thalassemia and thalidomide, applied in pharmaceutical compositions, the field of thalidomide

Active Publication Date: 2020-07-07
梧州市工人医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, thalidomide has been used in the treatment of Kaposi sarcoma, ovarian cancer, malignant melanoma, etc., ...

Method used

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  • Application of thalidomide to preparation of pharmaceutical composition for improving liver function damage of patients with thalassemia
  • Application of thalidomide to preparation of pharmaceutical composition for improving liver function damage of patients with thalassemia
  • Application of thalidomide to preparation of pharmaceutical composition for improving liver function damage of patients with thalassemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Preparation of capsules:

[0032] Thalidomide is provided by Changzhou Pharmaceutical Factory of Shanghai Pharmaceutical Group, and the preparation method of Thalidomide capsules is as follows:

[0033] 1) Take 100g of thalidomide, micronize it, and pass through a 200-mesh sieve to obtain thalidomide fine powder;

[0034] 2) Put 50g of poloxamer 237 in a suitable container, put it in a water bath at 49°C-50°C and heat it to a molten liquid state, add 100g of thalidomide fine powder, stir quickly and fully at 49°C-50°C until mixed Evenly, let it stand to remove air bubbles, spread the mixture into a thin layer and put it in a -5°C refrigerator for rapid cooling. After the mixture is completely solidified, take it out and pulverize it, and dry it in a vacuum dryer at 35°C for 24 hours, and pulverize it through a 100-mesh sieve to obtain Thalidomide solid dispersion;

[0035] 3) Add 82g of microcrystalline cellulose, 10g of lactose, 8g of sodium carboxymethyl starch, and...

Embodiment 2

[0036] Embodiment 2: the preparation of thalidomide intravenous injection:

[0037] Thalidomide is provided by Changzhou Pharmaceutical Factory of Shanghai Pharmaceutical Group, and the preparation method of Thalidomide intravenous injection is as follows:

[0038] 1) Place co-solvent ethylenediamine in water for injection cooled to room temperature, and mix well;

[0039] 2) Measure thalidomide and co-solvent ethylenediamine according to the mass ratio of thalidomide and co-solvent ethylenediamine as 1:0.23, place thalidomide in co-solvent ethylenediamine solution, stir until completely dissolved;

[0040] 3) Weigh hydroxypropyl-β-cyclodextrin according to the mass ratio of thalidomide to hydroxypropyl-β-cyclodextrin as 1:2.5, and add hydroxypropyl-β-cyclodextrin to step (2 ) in the prepared solution, stirred until completely dissolved;

[0041] 4) Add water for injection to the full amount;

[0042] 5) filling and sealing the medicinal solution in a brown ampoule;

[00...

experiment example

[0045] 1. Method

[0046] From May 2018 to July 2019, a total of 100 participants were enrolled in 6 centers in South China, and randomly received thalidomide (Example 1) (group A, N=49) or Placebo (Group B, N=50) treatment. A total of 99 patients have completed. Patients were followed for a median of 156.56 days (range, 16 to 360 days), and 99 people were included in the final analysis.

[0047] 2. Usage:

[0048] The test drug was started at 100 mg / day, taken after dinner. For patients who can tolerate it, the dose is increased to 150 mg per day after 3 days. If necessary, the dose should be adjusted according to adverse reactions.

[0049] 3. Research objectives

[0050] The main observation goal is the change of hemoglobin level from baseline to week 12. The observation goals include comparing blood transfusion volume, change of HbF level, red blood cell lifespan, liver and kidney function myocardial enzymes, and evaluating safety at the end of follow-up.

[0051] 4...

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Abstract

The invention discloses application of thalidomide to preparation of a pharmaceutical composition for improving liver function damage of patients with thalassemia. Biochemical indexes of patients during treatment show that the aspartate aminotransferase (AST) level representing a liver function in a thalidomide group is significantly reduced after 8 weeks of treatment by monitoring liver functiontests of the patients during a follow-up visit; the AST level in a placebo group is significantly increased, and the AST level of the thalidomide group is significantly lower than that of the placebogroup (32.7 VS 44.1, P=0.021). By 12 weeks, the advantage of reduction of the AST level in the thalidomide group is further expanded (28.8 VS 44.0, P=0.008), and it is indicated that the thalidomide can effectively improve the liver function levels of the patients with thalassemia, and suggests that the thalidomide has a good therapeutic effect on liver function damage of the patients with the thalassemia.

Description

【Technical field】 [0001] The invention relates to the technical field of medicine and pharmacy, in particular to the application of thalidomide in the preparation of a pharmaceutical composition for improving liver function damage of thalassemia patients. 【Background technique】 [0002] Thalassemia (thalassemia, thalassemia) is a group of inherited hemolytic anemia diseases. Anemia or pathological condition caused by the absence or insufficient synthesis of one or more globin chains in hemoglobin due to inherited genetic defects. Due to the complexity and diversity of gene defects, the type, quantity and clinical symptoms of the lack of globin chains are highly variable, so they are named and classified according to the type and degree of lack of globin chains. Thalassemia is a genetic disease with the highest incidence rate in the world, widely distributed in countries bordering the Mediterranean Sea (Italy, Greece), the Middle East, Central Asia, India, Pakistan, Myanmar,...

Claims

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Application Information

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IPC IPC(8): A61K31/454A61P1/16
CPCA61K31/454A61P1/16
Inventor 陈江明蔡宁李金燕黄兰胡美玲周美光
Owner 梧州市工人医院
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