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In-situ gelling chemotherapy immune medicine composition and preparation method thereof

A chemoimmune and composition technology, applied in the field of tumor treatment drugs, can solve problems such as single administration mode, limited application, etc., and achieve the effects of ensuring water dispersibility and stability, avoiding pH changes, and improving stability problems.

Pending Publication Date: 2022-07-01
SUZHOU INNOVATIVE BIOMATERIALS & PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although it has a certain immune stimulating function, its single administration method limits the application of imiquimod in the treatment of various tumors in the body

Method used

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  • In-situ gelling chemotherapy immune medicine composition and preparation method thereof
  • In-situ gelling chemotherapy immune medicine composition and preparation method thereof
  • In-situ gelling chemotherapy immune medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A1

[0046] The preparation method of the first composition:

[0047] S1: Weigh a certain amount of the solid of the fat-soluble immune adjuvant imiquimod R837 and carry out jet pulverization treatment, and the pulverization pressure is 6-10 bar to obtain micron-scale imiquimod R837. Proportion 1: (0.025~5) Weigh micron-sized fat-soluble immune adjuvant imiquimod R837 and surfactant poloxamer 188, preferably 2g R837, add an appropriate amount of poloxamer 188 (0.05g, 0.3g g, 0.6g, 1g, 2g, 4g, 6g, 8g, 10g), add 200ml of water for injection, and stir at 100-500rpm for 0.5-2 hours to obtain a suspension. Homogenize the above suspension under high pressure for 2-4 times under the pressure of 750-1200bar, suck the suspension with a peristaltic pump and fill it into 10ml ampoules, each bottle is 6ml, for a total of 30 bottles. After melting and sealing, a micron suspension is obtained, which is sterilized by moist heat at 105°C to 150°C for 15-20 minutes.

[0048] The preparation metho...

Embodiment A2

[0058] The preparation method of the first composition:

[0059] S1: Weigh a certain amount of the fat-soluble immune adjuvant Resiquimod R848 solid and carry out jet pulverization treatment, and the pulverization pressure is 6-10 bar to obtain micron-scale Resiquimod R848. Weigh micron-sized fat-soluble immune adjuvant Resiquimod R848 and surfactant poloxamer 407, preferably 0.2g R848, according to the ratio 1:(0.025~5), add an appropriate amount of poloxamer 407 (0.005g, 0.05g, 0.1g, 0.2g, 0.4g, 0.8g, 1g), add 200ml of water for injection, and stir at 100-500rpm for 0.5-2 hours to obtain a suspension. Homogenize the above suspension under high pressure for 2-4 times under the pressure of 750-1200bar, suck the suspension with a peristaltic pump and fill it into 10ml ampoules, each bottle is 6ml, for a total of 30 bottles. After melting and sealing, a micron suspension is obtained, which is sterilized by moist heat at 105°C to 150°C for 15-20 minutes.

[0060] The preparatio...

Embodiment B

[0069] Instructions for the use of the three-component mixed liquid and lyophilized preparations.

[0070] Use scheme 1: The freeze-dried powder injection of the composition of the second and third types of components in the above example A1 is added to the suspension of the first component composition and mixed evenly, and the drug is administered by clinical intervention and direct puncture. In the method, the composition solution is directly injected into the tumor site of the patient, and multi-point injection is adopted during injection to ensure that the composition solution evenly fills the entire tumor.

[0071] After the composition is injected into the tumor, firstly, when the alginate in the third composition encounters calcium ions in the organism tissue or the gel-forming excipients in the fourth composition, it will rapidly gel to form a porous network The combined structure enables the other three types of components mixed in alginate to be released slowly, ther...

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Abstract

The invention discloses an in-situ gelling chemotherapy immune pharmaceutical composition, which comprises a first composition, a second composition and a third composition, the first composition comprises a fat-soluble immunologic adjuvant and a surfactant, the second composition comprises a carboxylic acid ligand-containing platinum chemotherapy drug capable of causing immunogenic death and a protective filler, and the third composition comprises a carboxylic acid ligand-containing platinum chemotherapy drug capable of causing immunogenic death and a carboxylic acid ligand-containing platinum chemotherapy drug capable of causing immunogenic death and a carboxylic acid ligand-containing platinum chemotherapy drug capable of causing immunogenic death. The third composition is prepared from soluble alginate, a protective filling agent and a pH (Potential of Hydrogen) regulator. The invention provides a composition with better stability, which can better generate a synergistic anticancer effect, reduce side effects, reduce the metastasis probability and recurrence probability of cancers, and inhibit the growth of distal metastatic tumors and reduce the recurrence probability of tumors through immunoreaction while effectively killing in-situ tumors. The invention further discloses a preparation method of the in-situ gelling chemotherapy immune composition, and the product system is good in stability and easy to store for a long time.

Description

technical field [0001] The invention relates to the field of tumor therapeutic drugs, in particular to an in-situ gel-forming chemo-immune composition and a preparation method thereof. Background technique [0002] Chemotherapy is one of the main treatment methods for the clinical treatment of tumors at present. For those tumors that have the tendency to metastasize or have already metastasized, chemotherapy is the main treatment method. However, the commonly used chemotherapy modes in clinic are systemic administration, which does not have good selectivity to the lesion site, and also has toxic and side effects on normal organs. How to inhibit tumor metastasis and prevent its recurrence while performing local treatment has always been a global problem. In addition, the operability of drug production, as well as the sterilization and storage stability of drug products are also difficult problems. [0003] Although tumor immunotherapy represented by immune checkpoint blockad...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K47/36A61K47/56A61K47/10A61K47/24A61P35/00A61P35/04
CPCA61K45/06A61K47/36A61K47/56A61K47/10A61K47/24A61P35/00A61P35/04
Inventor 刘庄许欢张瑞
Owner SUZHOU INNOVATIVE BIOMATERIALS & PHARM CO LTD
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