Unit dosage type compound cantharis acid powder-injection, and its prepn. method

A technology of unit dose, cantharidinic acid powder, applied in the field of medicine, can solve the problems of increasing the probability of infusion reaction, unreasonable unit dose, waste of social wealth, etc., to increase the probability of infusion reaction, be beneficial to transportation and preservation, and reduce waste of resources. Effect

Inactive Publication Date: 2004-10-20
刘力
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In fact, when Sodium Cantharidinate Injection is used alone, 1 mg is used in one dose (Sun Weifen, et al. Chinese Journal of Hospital Pharmacy. 2001, 21 (7): 427-428), so this not only wastes 5-10 times Packaging materials are also a great waste of social wealth! Moreover, it is extremely inconvenient to use; more importantly, the unreasonable unit dosage of this drug will inevitably lead to the need to fold and open the ampoule many times during the clinical infusion process, which will increase the number of particles in the infusion, greatly increasing the risk of causing great harm. Chance of infusion reaction, which can endanger the life of the patient in severe cases

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Under clean conditions, take sodium cantharidinate 1000mg, vitamin B6 hydrochloride 25g, sodium succinate 2g, arginine 25g, 2-hydroxypropyl β-cyclodextrin 5g, sodium bisulfite 0.12 g in an appropriate amount of water for injection at 20°C, stir and dissolve; use gluconic acid and sodium hydroxide to adjust the acidity to pH=4.5, add 0.1g of activated carbon for needles, stir for 20min, filter and decarbonize with a 10μm titanium filter rod, and measure the pH value and content After passing the test, filter with a 0.45-0.8um microporous membrane, and then filter with a 0.2um-0.22um microporous membrane; sterilize and remove pyrogens, and pack them into vials according to the dosage, so that the sodium cantharidate unit in each vial The dose is 0.1 mg, the unit dose of vitamin B6 hydrochloride is 2.5 mg, add rubber stoppers, put the subpackaged vials in a freeze dryer, freeze for 2 hours, make the temperature reach -40 ° C, and make the Vacuum degree is 10Pa, ...

Embodiment 2

[0027] Example 2: Under clean conditions, take sodium cantharidate 1000mg, vitamin B6 hydrochloride 25g, disodium glycyrrhizinate 5g, lysine 50g, 2-hydroxypropyl β-cyclodextrin 5g, nicotinamide 25g, Add 0.12g of L-cysteine ​​hydrochloride in an appropriate amount of water for injection at 20°C, stir and dissolve; use glucuronic acid and sodium hydroxide to adjust the acidity to pH=4, filter through a 5μm titanium filter rod, add water for injection, and wait for the pH After the value and content are determined to be qualified, two times of ultrafiltration to sterilize, remove the pyrogen, and pack in vials according to the dose, so that the unit dose of sodium cantharidinate in each vial is 0.05 mg, and the unit dose of vitamin B6 hydrochloride is 1.25 mg. , add a rubber stopper, place the subpackaged vials in a lyophilizer, freeze for 2 hours, make the temperature reach -40°C, make the vacuum degree in the machine 10Pa, dry in a low-temperature vacuum for 30 hours, and raise ...

Embodiment 3

[0028] Example 3: Under clean conditions, take sodium cantharidinate 1000mg, vitamin B6 hydrochloride 25g, glucose 10g, disodium glycyrrhizinate 10g, arginine 15g, 2-hydroxypropyl β-cyclodextrin 5g, tobacco Add 20g of amide and 0.12g of sodium pyrosulfite to an appropriate amount of water for injection at 20°C, stir and dissolve; use hydrochloric acid and sodium hydroxide to adjust the acidity to about pH=4.5, filter and decarbonize with a 10μm titanium filter rod, add water for injection, stir well, and adjust the pH value And after the determination of content is qualified, two times of ultrafiltration sterilization, depyrogenation, are packed in vials according to dose, so that the unit dose of sodium cantharidinate in every vial is 0.5 mg, vitamin B6 hydrochloride is 12.5 mg, Add rubber stoppers, place the subpackaged vials in a lyophilizer, freeze for 2 hours, make the temperature reach -40°C, make the vacuum degree in the machine 10Pa, dry in low temperature vacuum for 30...

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PUM

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Abstract

A powder injection of compound cantharidic acid in the form of unit dosage for treating tumor contains cantharidic acid or its pharmacologically receptable salt, VB6 or its pharmacological receptable salt and optional pharmacologically receptable excipient, pH regulator, antioxidizing agent and stabilizer. Its advantages are high curative effect and high quality and stability.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a compound cantharidin acid powder injection preparation in a unit dosage form and a preparation method thereof. Background technique [0002] Chemotherapy is one of the essential means to treat tumors, but most of the chemotherapeutic drugs have limited their clinical application due to their high toxicity and side effects. Cantharidin is an anticancer drug that has been used in traditional Chinese medicine for a long time in my country. According to its effective anticancer component cantharidin, the anticancer drug—cantharidin sodium (cantharidates sodium C 10 h 12 o 5 Na 2 ), while retaining the anti-cancer effect, it has the advantages of increasing white blood cells and enhancing the immune function of the body, and has achieved good curative effect in clinical treatment of certain tumors. [0003] At present, the market has the antitumor injection that i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/365A61P35/00
Inventor 刘力
Owner 刘力
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