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Antitumor composition inhalation powder aerosols and preparation method thereof

A technology for inhaling powder mist and composition, which is applied in the field of pharmaceutical preparations, can solve the problems of low bioavailability, insufficient anticancer efficacy, and large toxic and side effects of VCR, so as to improve the deposition rate, avoid the first-pass effect of the liver, and improve The effect of bioavailability

Active Publication Date: 2020-04-28
ZHUHAI RESPROLY PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In general, the prior art generally has the problems of insufficient anticancer efficacy, large toxic and side effects of VCR and low bioavailability

Method used

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  • Antitumor composition inhalation powder aerosols and preparation method thereof
  • Antitumor composition inhalation powder aerosols and preparation method thereof
  • Antitumor composition inhalation powder aerosols and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The experimental materials and methods used in the embodiments are as follows:

[0041] Experimental cells: human T lymphocyte leukemia cells (Jurkat), human breast cancer cells (MCF-7), retinoblastoma cell line (HXO-Rb44).

[0042] Growth medium: RPMI-1640 medium (containing 10% FBS+1% PS).

[0043] Culture environment: 37°C, 5% CO 2 Saturated humidity incubator.

[0044] Human T-lymphoblastic leukemia cells (Jurkat), human breast cancer cells (MCF-7), and retinoblastoma cell lines (HXO-Rb44) in logarithmic growth phase with good morphology were washed once with PBS buffer, added Digest with 0.25% trypsin digestion solution and gently pipette to form a single cell suspension. Pipette 20 μl of cell suspension to a cell counting plate for cell counting. The above cell suspension was divided into 1×10 cells 4 The density of cells / well was inoculated in 96-well plate, and each group was set up with 5 duplicate holes, at 37°C, 5% CO 2 Cultured in a saturated humidity ...

Embodiment 2

[0054] The NOD-SCID mice were randomly divided into a control group (plus normal saline), a VCR group, a nimodipine group and a VCR-nimodipine combined action group, with 10 mice in each group. Give mice a dose of 7.5Gy 60 After 5 days of whole-body irradiation with Coγ-rays, human T-lymphoblastic leukemia cells (Jurkat) in logarithmic growth phase and in good shape were taken, washed with PBS buffer three times, digested with 0.25% trypsin digestion solution, and gently pipetted to make the cells If it falls off, add 12ml RPMI-1640 medium, transfer the suspension to a 15ml centrifuge tube, and centrifuge at 1000rpm for 5min. The supernatant was discarded, and the pelleted cells were washed and diluted with sterile saline. Take 40 μl of cell suspension for microscopic examination and counting to make a concentration of 1×10 6 tumor cell suspension per ml, inject 0.2ml / monkey into the tail vein. The mice were observed for leukemia symptoms after being inoculated with Jurkat ...

Embodiment 3

[0060] (a) Get 3.0g VCR and 25g nimodipine to carry out ultra-fine jet pulverization respectively, set injection pressure 7bar, pulverize pressure 5bar, feed rate 0.4g / min, obtain the VCR of micronization (D10=1.29 μ m, D50=3.62 μm, D90=6.49 μm, NLT96.44%<10 μm) and nimodipine (D10=1.48 μm, D50=3.75 μm, D90=6.76 μm, NLT96.12%<10 μm). VCR 0.8g (micropowder), nimodipine 12g (micropowder), mannitol 50g and leucine 0.4g were mixed, the mixed sample was placed in a high-speed mixing granulator, the stirring speed was set at 1300rpm, and the mixing was finished after 20min, statically After standing for 1 h, the obtained dry powder mixture was filled into No. 3 dark-colored vegetable capsules in aliquots.

[0061] (b) get 3.0g VCR and 0.03g leucine to mix, get 25g nimodipine and 0.25g leucine to mix, above-mentioned two mixtures are carried out ultra-micro jet pulverization respectively according to the parameter of embodiment 3 step (a), Micronized VCR mixture (D10=1.13 μm, D50=3....

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Abstract

The invention discloses antitumor composition inhalation powder aerosols. The antitumor composition inhalation powder aerosols consist of the following raw materials in parts by weight of 100-500 parts of vincristine sulfate, 500-30000 parts of nimodipine, 2500-40000 parts of carriers and 2-2000 parts of additives, wherein the particle diameter of the vincristine sulfate and the nimodipine is D10=0.2-1.5 [mu]m, D50=1.0-4.0 [mu]m and D90=2.5-8.0 [mu]m, and NLT98% is smaller than 10 [mu]m; the particle diameter of the carriers is D10=2-40 [mu]m, D50=10-110 [mu]m and D90=50-180 [mu]m; and at least 98% of the particle diameter of additional particles of the additives is lower than 50 [mu]m by weight. The invention also provides a preparation method of the antitumor composition inhalation powder aerosols. The preparation method comprises the following steps of performing micronizing treatment on the vincristine sulfate, the nimodipine and the additives; performing particle diameter treatment on the carriers and the additives; performing dispersal adjustment and control on micronized medicines; mixing the micronized medicines with carrier particles and the additives to obtain mixtures; and stuffing the mixtures in No. 3 deep-color plant capsules with a minor-quantity capsule stuffing agent to obtain powder aerosol capsules. The antitumor composition inhalation powder aerosols disclosed by the invention can reinforce cancer resisting treatment effects, alleviate toxic and side effects of VCR and increase biological availability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an anti-tumor composition inhalation powder, especially an anti-tumor composition inhalation powder and a preparation method thereof. Background technique [0002] Tumor is a new organism formed by abnormal proliferation of tissue cells at the gene level due to the loss of normal regulation of growth by tissue cells under the action of various carcinogenic factors, and has become a common chronic disease. Tumors are generally divided into benign and malignant. According to the report of the World Health Organization, there were 18.1 million new cancer cases and 9.6 million deaths worldwide in 2018, further increasing the global cancer burden. Before the age of 75, the cumulative risk of developing cancer is 21.4%, the risk of dying from cancer is 17.7%, and the five-year survival rate, that is, the number of people who are still alive after 5 years of illness...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K47/10A61K9/14A61K31/475A61P35/00A61K31/4422
CPCA61K31/475A61K31/4422A61K9/0075A61K9/145A61P35/00A61K2300/00
Inventor 陈永奇陈浩璇胡芳
Owner ZHUHAI RESPROLY PHARM TECH CO LTD
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