Mitoxantrone composition and preparation method thereof

A technology of mitoxantrone and composition, applied in the field of mitoxantrone composition, can solve problems such as inability to prepare pharmaceutical preparations, dispersion of pharmaceutical components, uncertain dosage, etc., to reduce system exposure level, enhance effect, The effect of reducing toxic side effects

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

Such a heterogeneous system is directly injected into the tumor, although a considerable therapeutic effect can still be obtained, but it cannot be prepared as a standardized pharmaceutical preparation, and the direct use will also have the problem of uncertain dosage, and it will be stored for a period of time (more than about 6 Hours), each drug component will agglomerate and cannot be dispersed in aqueous solution, making it completely unusable

Method used

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  • Mitoxantrone composition and preparation method thereof
  • Mitoxantrone composition and preparation method thereof
  • Mitoxantrone composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A

[0039] Example A: Preparation of Formulations

[0040] figure 1 It is a schematic diagram of the preparation and use steps of the mitoxantrone pharmaceutical composition.

Embodiment A1

[0041] Example A1: Preparation of the first composition:

[0042] A certain amount of the immune adjuvant imiquimod R837 solid is weighed and subjected to jet pulverization, and the pulverization pressure is 6-10 bar to obtain micron-scale imiquimod R837. Proportion 1: (0.025~5) Weigh the micron-scale immune adjuvant imiquimod R837 and the surfactant poloxamer 188, preferably 2g R837, add an appropriate amount of poloxamer 188 (0.05g, 0.3g, 0.6g, 1g, 2g, 4g, 6g, 8g, 10g), add 100mL 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 at 750-1200ba for 2-4 times, suck the suspension with a peristaltic pump and fill it into 10mL ampoule bottles, 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.

[0043] Poloxamer 188 is a new type of polymer nonionic surfactant. It h...

Embodiment A2

[0065] A certain amount of immune adjuvant Resiquimod (R848) solid is weighed and subjected to jet pulverization, and the pulverization pressure is 6-10 bar to obtain micron-scale Resiquimod (R848).

[0066] Proportion 1: (0.025~5) Weigh the micron-sized immune adjuvant Resiquimod (R848) and the surfactant Poloxamer 407, preferably 0.2g R848, add an appropriate amount of Poloxamer 407 (0.005g, 0.01 g, 0.2 g, 0.4 g, 0.8 g, 1 g), add 200 mL of water for injection, and stir at 100-500 rpm for 0.5-2 hours to obtain a suspension.

[0067] The above suspension is homogenized under high pressure at 750-1200bar for 2-4 times to obtain the suspension, and the suspension is sucked by a peristaltic pump and filled into 10mL ampoule bottles, each bottle of 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.

[0068] Poloxamer 407 is a new type of polymer nonionic surfactant, whi...

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Abstract

The invention discloses a mitoxantrone pharmaceutical composition which comprises a first composition and a second composition, the first composition comprises composite particles formed by an immunologic adjuvant and a solubilizer, and the second composition comprises mitoxantrone hydrochloride or mitoxantrone lactate, soluble alginate, a pH regulator and an excipient, by improving the dosage form combination, the compatibility problem of the mitoxantrone-containing chemotherapeutic drug and the soluble alginate auxiliary material is solved, and the invention also provides a preparation method of the mitoxantrone composition.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations for treating tumors, in particular to a mitoxantrone composition and a preparation method. Background technique [0002] Chemotherapy, surgical resection, or radiation therapy are the most commonly used cancer treatment strategies. 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 suppress tumor metastasis and prevent its recurrence at the same time of local treatment has always been a problem that plagues the world. However, there are many problems in the transformation of many drugs from laboratory verification...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/136A61K45/06A61K47/36A61K47/10A61K9/08A61P35/00A61P35/04A61L2/04
CPCA61K31/136A61K45/06A61K47/36A61K47/10A61K9/0019A61K9/08A61P35/00A61P35/04A61L2/0023A61L2202/21A61K2300/00A61L2/04A61K39/39
Inventor 刘庄许欢张瑞
Owner SUZHOU INNOVATIVE BIOMATERIALS & PHARM CO LTD
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