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Injectio Natarii Norcantharidatis freeze-drying powder injection and its preparation method

The technology of sodium norcantharidate and sodium methylcantharidate is applied in the field of medicine and can solve the problems of inconvenient storage and transportation of medicines, and achieve the effect of convenient storage and transportation.

Inactive Publication Date: 2004-12-29
肖广常 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, domestic preparations listed with norcantharidin as the main component include norcantharidin tablets and sodium norcantharidate injections. Because sodium norcantharidate injections must be diluted with glucose in the course of intravenous application ( The local standards of chemicals have risen, the third volume of national standards (instructions for Sodium Cantharidinate Injection), and Sodium Cantharidate Injection has brought inconvenience to the storage and transportation of drugs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: sodium norcantharidate lyophilized powder injection for injection, the components are as follows, all in percent by weight:

[0021] Norcantharidin 8.714%

[0022] Sodium hydroxide 4.148%

[0023] Mannitol 87.138%

[0024] The preparation method is as follows:

[0025] Weigh 10g of norcantharidin, 10g of sodium hydroxide, add 1.5L of water for injection, heat and stir to dissolve, add 100g of mannitol and stir to dissolve, then adjust the pH value to 8.5 with 1mol / L NaOH solution, add water for injection to 2L, stir uniform. Add 0.03% charcoal for needles, stir at room temperature for 30 minutes, filter with a titanium filter stick to decarbonize, and filter through a double-layer 0.22μm microporous sterile filter. After the filtrate is divided into 2ml each, put it in a vacuum freeze dryer , lower the temperature to -40°C, freeze for 4 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the temperature to 20°C, continue t...

Embodiment 2

[0026] Embodiment 2: sodium norcantharidate lyophilized powder injection for injection, the components are as follows, all in percent by weight:

[0027] Norcantharidin 67.766%

[0028] Sodium hydroxide 32.234%

[0029] The preparation method is as follows:

[0030] Weigh 30g of norcantharidin, 14.27g of sodium hydroxide, add 0.5L of water for injection, heat and stir to dissolve, then adjust the pH value to 10 with 1mol / L NaOH solution, add water for injection to 1L, and stir well. Add 0.03% charcoal for needles, stir at room temperature for 30 minutes, filter and decarbonize with a titanium filter stick, and filter through a double-layer 0.15μm microporous sterile filter. In the dryer, cool down to -40°C, freeze for 2 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the temperature to 10°C, continue vacuuming for 10 hours, control the temperature of the partition to gradually increase to 50°C, and continue vacuuming for 10 hours , pressing...

Embodiment 3

[0031] Embodiment 3: sodium norcantharidate lyophilized powder injection for injection, the components are as follows, all in percent by weight:

[0032] Norcantharidin 5.512%

[0033] Sodium hydroxide 2.623%

[0034] Low Molecular Dextran 91.865%

[0035] The preparation method is as follows:

[0036] Weigh 30g of norcantharidin, 14.27g of sodium hydroxide, add 3.5L of water for injection, heat and stir to dissolve, then adjust the pH value to 8.0 with 1mol / L NaOH solution, add water for injection to 7L, and stir well. Add 0.03% charcoal for needles, stir at room temperature for 30 minutes, decarbonize with a titanium filter stick, filter through a double-layer 0.15μm microporous sterilizing filter, divide the filtrate into 7ml per tube, press half the stopper, and put it in vacuum freezer In the dryer, cool down to -45°C, freeze for 6 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the temperature to 20°C, continue vacuuming for 22 hours,...

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Abstract

The present invention is freeze dried demethyl sodium cantharidinate powder for injection and its preparation process, and belongs to the field of medicine technology. The freeze dried demethyl sodium cantharidinate powder for injection contains demethyl cantharidin 0.25-70 wt%, sodium hydroxide 0.1-35 wt% and excipient 0-99 wt%. The preparation process includes compounding demethyl cantharidin and sodium hydroxide in liquid compounding tank, adding injection water and heating to dissolve, adding excipient, dissolving and regulating pH value; adding proper amount of carbon for injection, stirring for 30 min for adsorption, filtering to eliminate carbon and sterilize, packing in Schering bottle, and freeze drying to obtain the freeze dried demethyl sodium cantharidinate powder for injection. The medicine is clinically used in treating liver cancer, esophagus cancer, hepatitis, etc.

Description

(1) Technical field [0001] The invention relates to sodium norcantharidate freeze-dried powder for injection and a preparation method thereof, belonging to the technical field of medicine. (2) Background technology [0002] Humans have used mylabris to treat diseases for more than 2,000 years. It is recorded in the silk book "Fifty-two Disease Prescriptions" from the Mawangdui Han Tomb and "Wuwei Han Dynasty Medical Bamboo". Yang Shiying, a famous doctor in the Southern Song Dynasty, clearly recorded in his book "Ren Jie Zhi Zhi Fang Lun" that mylabris can treat cancer, and it has been 7 centuries so far. Mylabris is the dry body of Mylabris phalerate Pall. or M. cichorii L., an insect of the family Coryneceae. It tastes pungent and hot, and returns to the liver, stomach, and kidney meridians. It is highly toxic and can cause superficial skin damage when applied externally. Taking it orally will cause reactions in various systems of the whole body. The main component of an...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/365A61P35/00
Inventor 肖广常张颖
Owner 肖广常
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