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Freeze-dried HPPH powder injection preparation for injection and preparation method thereof

A technology for freeze-dried powder injection and injection, which is applied in the field of medicine, can solve the problems of the safety and effectiveness of clinical medication, the unfavorable production of water injection, and the poor stability, etc., and achieves low dark toxicity, loose preparation, and formulation. reasonable effect

Active Publication Date: 2014-08-06
SHANGHAI ARYL PHARMTECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although HPPH has a very good anti-cancer effect, its solubility in water is poor, and its stability in aqueous solution is not good. It is reported that the storage condition of the aqueous injection used in the second phase of foreign clinical research is -20 ℃, and the validity period is Therefore, the water injection is not conducive to large-scale production, and its application is also greatly restricted, and it has a certain impact on the safety and effectiveness of clinical medication.

Method used

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  • Freeze-dried HPPH powder injection preparation for injection and preparation method thereof
  • Freeze-dried HPPH powder injection preparation for injection and preparation method thereof
  • Freeze-dried HPPH powder injection preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029]

[0030] a) Move the mannitol of the prescribed amount to the batching tank equipped with 2000ml water for injection, stir and dissolve to obtain the solution ①;

[0031] b) Weigh the prescribed amount of HPPH and place it in the batching tank, add the prescribed amount of absolute ethanol, stir, add the prescribed amount of sodium carbonate solution and ELP, stir and dissolve to obtain the solution ②;

[0032] c) Add solution ② to solution ①, stir, add water for injection to 5000ml, then add phosphoric acid aqueous solution dropwise to adjust the pH of the solution to 7.0, filter and sterilize to the liquid storage tank, subpackage, semi-tampon, freeze-dry, and plug ,Package. Wherein the freeze-drying procedure is as follows:

[0033] 1) Pre-freezing: Pre-freeze the product at -40~-50°C for 3 hours to freeze the product until solid;

[0034] 2) Primary drying: After the product is pre-frozen, turn on the vacuum pump to evacuate to 20-30 Pa, raise the temperature o...

Embodiment 2

[0037]

[0038] a) Move the dextran of prescription quantity to the batching tank that 2500ml water for injection is housed, stir and dissolve to obtain solution ①;

[0039] b) Take the HPPH of the recipe quantity and put it in the batching tank, add the 96% ethanol of the recipe quantity, stir, add the sodium carbonate solution and Tween 80 of the recipe quantity, stir and dissolve to obtain the solution ②;

[0040] c) Add solution ② to solution ①, stir, add water for injection to 5000ml, then add phosphoric acid aqueous solution dropwise to adjust the pH of the solution to 6.5, filter and sterilize to the liquid storage tank, subpackage, semi-tampon, freeze-dry, and stopper ,Package. Wherein the freeze-drying procedure is as follows:

[0041] 1) Pre-freezing: Pre-freeze the product at -40~-50°C for 3.5 hours to freeze the product until solid;

[0042] 2) Primary drying: After the product is pre-frozen, turn on the vacuum pump to evacuate to 20-30 Pa, raise the temperatu...

Embodiment 3

[0045]

[0046] a) Move the prescribed amount of mannitol into a batching tank equipped with 3000ml water for injection, stir and dissolve to obtain solution ①;

[0047] b) Weighing the HPPH of the prescription quantity and placing it in the batching tank, adding 95% ethanol of the prescription quantity, stirring, adding the sodium carbonate solution and polyethylene glycol stearate 15 of the prescription quantity, stirring and dissolving to obtain the solution ②;

[0048] c) Add solution ② to solution ①, stir, add water for injection to 5000ml, add phosphoric acid aqueous solution dropwise to adjust the pH of the solution to 7.8, filter and sterilize to the liquid storage tank, sub-package, semi-tampon, freeze-dry, and stopper, Package. Wherein the freeze-drying procedure is as follows:

[0049] 1) Pre-freezing: Pre-freeze the product at -40~-50°C for 4 hours to freeze the product until solid;

[0050] 2) Primary drying: After the pre-freezing of the product, turn on the...

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Abstract

The invention relates to a freeze-dried HPPH powder injection preparation for injection and a preparation method thereof. The freeze-dried powder injection preparation contains HPPH, a cosolvent, a solubilizer, an excipient and a pH regulating agent. The freeze-dried HPPH powder injection preparation prepared in the invention can be used for treating a plurality of solid tumors like the lung cancer, the esophagus cancer, the head, face and neck cancer, the bladder cancer and the stomach cancer, and has the advantages of sponginess, good redissolvability, low moisture content, good stability, low dark toxicity and high photosensitivity.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a HPPH freeze-dried powder preparation for injection and a preparation method thereof. Background technique [0002] The anti-tumor photosensitizer HPPH is a second-generation photosensitizer. It is extracted and purified from green plants by researchers at the Roswell Park Cancer Institute in the United States. It is a semi-synthesized chlorin compound. Its structural formula is as follows: [0003] [0004] HPPH has good photodynamic activity, ideal action spectrum and good targeting, and has a high penetration rate to tumor tissues. It is clinically used in various entities such as lung cancer, esophageal cancer, head, face and neck cancer, bladder cancer, and gastric cancer. The treatment of tumors; compared with the first generation, its phototoxicity is significantly lower, it basically does not need to be protected from light, the dosage is small, and it is easy to u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K41/00A61K31/409A61K47/44A61K47/34A61P35/00
CPCA61K9/19A61K31/409A61K9/0019A61P35/00A61J3/02A61K9/143A61K9/145A61K41/0076
Inventor 冯春荣张环伟王剑桥
Owner SHANGHAI ARYL PHARMTECH CO LTD
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