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A preparation method of 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: 2018-04-20
QINGDAO CENT 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] Pill core

[0044] Capecitabine 25%

[0045] Ethyl cellulose 25%

[0046] PTFE 15%

[0047] Stearyl alcohol 12%

[0048] Chitosan 23%

[0049] Isolation layer

[0050] Stearic acid 5% weight of pill

[0051] Talc 2% by weight of stearic acid

[0052] Coating layer

[0053] Youtech S100 Isolation Pill Weight 5%

[0054] Triethyl Citrate Eudragit S100 Water Dispersible Body Weight 9%

[0055] Talcum powder Eudragit S100 water dispersible body weight 32%

[0056] Weigh the prescription drug and auxiliary materials through a 120-mesh sieve and mix them evenly, add an appropriate amount of 35% ethanol solution to prepare the soft material, set the extruder 32Hz to extrude the strips, the spheronizer rotates at 43r / min, spheronizes for 10min, and puts in a 40℃ oven Dry for 12h. Weigh the dry drug-loaded pellets and place them in a coating pan at a temperature of 60°C and a host rotating speed of 50r / min. Add the prescribed amount of stearic acid and talc in small quantities and stir continuo...

Embodiment 2

[0059] Pill core

[0060] Capecitabine 25%

[0061] Methyl cellulose 30%

[0062] PTFE 15%

[0063] Stearyl alcohol 10%

[0064] Carbomer 20%

[0065] Isolation layer

[0066] Stearyl alcohol 7% by weight of pill

[0067] Talc 2% by weight of stearic acid

[0068] Coating layer

[0069] Eudragit S100 Isolation Pill Weight 4%

[0070] Eudragit L100 isolation pill weight 3%

[0071] Triethyl citrate coating polymer water dispersion body weight 7%

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

[0073] Weigh the prescription drug and auxiliary materials through a 120-mesh sieve and mix them evenly, add an appropriate amount of 35% ethanol solution to prepare the soft material, set the extruder 32Hz to extrude the strips, the spheronizer rotates at 43r / min, spheronizes for 10min, and puts in a 40℃ oven Dry for 12h. Weigh the dry drug-loaded pellets and place them in a coating pan at a temperature of 60°C and a host rotating speed of 50r / min. Add the prescription amount of steary...

Embodiment 3

[0075] Example 3 Pharmacodynamic study

[0076] Ten patients with locally advanced rectal cancer were the research objects, all of which were diagnosed by pathological examination. Among them, there were 4 males and 6 females, aged 46-72 years old, with a median age of 54 years. It was confirmed that local tumor fixation could not be radical resection, and there was no distant metastasis to liver, lung, bone, etc. Randomly divided into two groups, 5 cases in each group.

[0077] method

[0078] The first group was administered with the capecitabine pill preparation prepared in Example 1, based on the dose of capecitabine, a fixed dose, 1300 mg×m -2 ×d -1 , Oral in 2 times. Starting from the first day of radiotherapy, a period of 1 week after continuous use for 2 weeks is a cycle. The radiotherapy uses 15MV X-ray conventional radiation, the total pelvic radiation dose (TD) is 46-50 Gy, and the reduced field increase is 20-24 Gy. The clinical target area is jointly confirmed by th...

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Abstract

The invention relates to a method for preparing 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 a radiosensitive colon-targeted drug carrier, is jointly applied with radiotherapy for treating local advanced rectal cancer, so that the treatment effect can be improved, and toxic and side effects are reduced.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a preparation method of a controlled-release pharmaceutical preparation for the treatment of locally advanced rectal cancer. Background technique [0002] Colorectal cancer is one of the most common malignant tumors. There are approximately one million new cases worldwide each year, and at least half a million patients die. Surgical treatment is the first choice for patients with early rectal cancer, but rectal cancer has a higher recurrence rate after surgical treatment alone, and a considerable number of patients are already at an advanced stage when discovered. [0003] For advanced patients, the efficacy of radiotherapy or chemotherapy alone is not ideal, and it is necessary to study new treatment methods, especially the combination of the two. However, the combined therapy of radiotherapy and chemotherapy will bring greater toxic and side effects to patients, and poor ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K9/36A61K47/38A61K47/32A61K31/7068A61P35/00
Inventor 马宝花乔蕾张来香王宏韩淑红梁华
Owner QINGDAO CENT HOSPITAL
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