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Nimustine sustained-release implantation agent for curing entity tumour

A slow-release implant, nimustine technology, applied in the field of medicine, can solve the problems of heavy toxic reaction, easy burst release, short drug release cycle, etc.

Inactive Publication Date: 2008-05-14
JINAN SHUAIHUA PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing sustained-release agents use polyesters (polyesters) such as PLA and PLGA as sustained-release carriers, which have a short drug release cycle and have poor effects on tumor cells entering the dormant phase. Therefore, the effect on residual tumor cells The effect is poor, easy to burst release, so the toxicity is serious

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081] Put the weighed sustained-release auxiliary material (molecular weight is 15000-25000PLGA, 50:50) and sustained-release regulator (mannitol) into different containers respectively, then add a certain amount of organic solvent to dissolve and mix well (to fully dissolve as Accurate) and then add different weights of nimustine, shake again and then vacuum dry to remove the organic solvent. The dried solid sustained-release implant was immediately shaped to obtain the following sustained-release implant:

[0082] (A) 1% Nimustine, containing 1mg Nimustine, 99mg PLGA

[0083] (a) 1% nimustine, containing 1mg nimustine, 95mg PLGA, 4mg mannitol;

[0084] (B) 5% nimustine, containing 5mg nimustine, 95mg PLGA;

[0085] (b) 5% nimustine, containing 5mg nimustine, 91mg PLGA, 4mg mannitol;

[0086] (C) 10% nimustine, containing 10mg nimustine, 90mg PLGA;

[0087] (c) 10% nimustine, containing 10mg nimustine, 80mg PLGA, 10mg mannitol;

[0088] (D) 15% nimustine, containing 15m...

Embodiment 2

[0093] 10 sustained-release implants in Example 1 were put into the dissolution apparatus respectively to measure the drug cumulative release amount (%) at different times, and it was found that in the sustained-release implants (A), (B), (C ), (D) and (E) five nimustine sustained-release implants without a sustained-release modulator (mannitol) had obvious burst release phenomenon, and the burst release phenomenon mostly occurred on the 1218th day, accounting for about 4060% of the total drug content, while (a), (b), (c), (d) and (e) etc. contain the sustained-release modifier (mannitol) of nimustine sustained-release implants. The release phenomenon is obviously not obvious, and the drug is released slowly for 24 weeks.

Embodiment 3

[0095]Put the weighed sustained-release auxiliary material (PLGA with a molecular weight of 20000-30000, 75:25) and the sustained-release regulator (mannitol) into different containers respectively, then add a certain amount of organic solvent to dissolve and mix (to fully Dissolution prevails) and then add different weights of nimustine, shake again and then vacuum dry to remove the organic solvent. The dried solid sustained-release implant was immediately shaped to obtain the following sustained-release implant:

[0096] (A) 1% Nimustine, containing 1mg Nimustine, 99mg PLGA

[0097] (a) 1% nimustine, containing 1 mg nimustine, 95 mg PLGA and 4 mg sorbitol;

[0098] (B) 5% nimustine, containing 5mg nimustine, 95mg PLGA;

[0099] (b) 5% nimustine, containing 5 mg nimustine, 91 mg PLGA and 4 mg sorbitol;

[0100] (C) 10% nimustine, containing 10mg nimustine, 90mg PLGA;

[0101] (c) 10% nimustine, containing 10mg nimustine, 80mg PLGA and 10% sorbitol;

[0102] (D) 15% nimus...

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Abstract

The invention relates to a slow-release implant agent of nimustine, which is characterized in comprising amounts of nimustine, slow-release excipients and releasing regulatory agents in the slow-release implant agent. The excipients comprise macromolecules which are biologically compatible and degradable, mainly PLA and PLGA. The releasing regulatory agents are selected from one or more items from mannitol, sorbitol, xylitol, oligosaccharide, chitin, potassium salt, sodium salt, hyaluronic acid, collagen, chondroitin, gelatin and albumin. The slow-release implant agent slowly releases nimustine on the local tumor in the process of degradation and absorption, so the argent can evidently reduce the systemic toxicity and simultaneously apply to the effective drug concentration control on the local tumor. Therefore, the argent can be applied separately or combined with the non-surgical treatments such as chemotherapy drug and radiotherapy, which can also be widely used for tumor treatment of different phases, not only selectively improving the drug concentration on local tumor but also reinforcing the therapeutic effect of non-surgical treatments such as chemotherapy drug and radiotherapy.

Description

(1) Technical field [0001] The invention relates to a nimustine sustained-release implant for treating solid tumors, belonging to the technical field of medicines. (2) Background technology [0002] Although the research on cancer has made great progress, its mortality rate is still in the forefront of various common causes of death. In my country, about 1.6 million people suffer from cancer every year, and nearly 1.3 million people die of cancer, accounting for one-fifth of the total death toll. The incidence of cancer is increasing year by year and tends to be younger. Statistics show that in less than 20 years, the incidence of cancer in my country has increased by 69%, and the mortality rate has increased by 29.4%. According to the latest statistics from the World Health Organization, the global cancer incidence rate will increase by 50% by 2020, and the number of patients will increase to 15 million. Therefore, exploring an effective method or drug for treating cancer...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/505A61K47/34A61P35/00
Inventor 孙娟姜俊敏
Owner JINAN SHUAIHUA PHARMA TECH
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