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A controlled-release pharmaceutical preparation for the treatment of locally advanced rectal cancer

A technology for controlled release of drugs and rectal cancer, applied in the field of medicine, to achieve the effect of reducing side effects and good compliance

Inactive Publication Date: 2017-12-26
QINGDAO TUMOR HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such radiation-sensitive drug carriers have not been reported

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Drug-loaded core

[0044] Capecitabine 25%

[0045] Ethylcellulose 25%

[0046] PTFE 15%

[0047] Stearyl Alcohol 12%

[0048] Chitosan 23%

[0049] Isolation layer

[0050] Stearic acid 5% by weight of pills

[0051] Talc Stearic Acid 2% by weight

[0052] coating layer

[0053] Eudragit S100 Isolation Pill Weight 5%

[0054] Triethyl citrate Eudragit S100 water dispersion weight 9%

[0055] Talc Eudragit S100 water dispersion 32% by weight

[0056]Weigh the prescribed amount of medicine and auxiliary materials through a 120-mesh sieve and mix evenly, add an appropriate amount of 35% ethanol solution to prepare a soft material, put the extruder at 32Hz to extrude strips, spheronize at a speed of 43r / min for 10min, and place in an oven at 40°C Dry for 12h. Weigh the dried drug-loaded pellets, put them in a coating pan at a temperature of 60°C, and the main engine rotates at a speed of 50r / min, add stearic acid and talcum powder in small amounts and repeatedly...

Embodiment 2

[0059] Drug-loaded core

[0060] Capecitabine 25%

[0061] Methylcellulose 30%

[0062] PTFE 15%

[0063] Stearyl Alcohol 10%

[0064] Carbomer 20%

[0065] Isolation layer

[0066] Octadecanol 7% by weight of pills

[0067] Talc Stearic Acid 2% by weight

[0068] coating layer

[0069] Eudragit S100 Isolation Pill Weight 4%

[0070] Eudragit L100 Isolation Pill Weight 3%

[0071] Triethyl citrate Coating polymer water dispersion weight 7%

[0072] Talc powder coating polymer water dispersion weight 31%

[0073] Weigh the prescribed amount of medicine and auxiliary materials through a 120-mesh sieve and mix evenly, add an appropriate amount of 35% ethanol solution to prepare a soft material, put the extruder at 32Hz to extrude strips, spheronize at a speed of 43r / min for 10min, and place in an oven at 40°C Dry for 12h. Weigh the dry drug-loaded pellets, put them in a coating pan at a temperature of 60°C, and the speed of the host machine at 50r / min, add stearyl alc...

Embodiment 3

[0075] Embodiment 3 Pharmacodynamic study

[0076] Ten patients with locally advanced rectal cancer were the study subjects, all of whom were confirmed by pathological examination. Among them, there were 4 males and 6 females, aged 46-72 years, with a median age of 54 years. It was confirmed that the local tumor was fixed and could not undergo radical resection, and there was no distant metastasis such as liver, lung, or bone. Randomly divided into two groups, 5 cases in each group.

[0077] method

[0078] The first group was given the capecitabine drug-loaded pellet preparation prepared in Example 1, based on the capecitabine dose, fixed dose, 1300mg×m -2 × d -1 , orally in 2 times. Starting from the first day of radiotherapy, 2 weeks of continuous use followed by 1 week of rest constituted a cycle. The radiotherapy adopts 15MV X-ray routine irradiation, the total pelvic radiation dose (TD) is 46-50 Gy, and the reduced-field boost dose is 20-24 Gy. The clinical target...

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Abstract

The invention relates to a controlled-release medicine preparation for treatment of local advanced rectal cancer. The controlled-release medicine preparation is prepared by using capecitabine as a medicinal effective ingredient and using a radiosensitive colon targeting drug vector, and is jointly applied with radiotherapy for treating local advanced rectal cancer, so that the treatment effect is improved, and toxic and side effects are reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a controlled-release pharmaceutical preparation for treating locally advanced rectal cancer. Background technique [0002] Colorectal cancer is one of the most common malignant tumors, with approximately one million new cases and at least half a million deaths worldwide each year. Surgical treatment is the first choice for patients with early rectal cancer, but rectal cancer has a high recurrence rate after surgical treatment alone, and a considerable number of patients are already at an advanced stage when they are discovered. [0003] For advanced patients, the curative effect of radiotherapy or chemotherapy alone is unsatisfactory, and it is necessary to study new treatment methods, especially the combined treatment of the two. However, the combined therapy of radiotherapy and chemotherapy will bring great toxic and side effects to patients, and the clinical tole...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K47/32A61K31/7068A61N5/10A61P35/00
Inventor 姚娟王志伟李春艳黄心刚徐代云韩淑红
Owner QINGDAO TUMOR HOSPITAL
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