Biological self-assembly nanometer crystal injection agent with lympha targeted function and preparation method

A technology of lymphatic targeting and injection, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, and drug combinations, etc.

Active Publication Date: 2017-09-12
SHENZHEN CHINA RESOURCES JIUCHUANG MEDICAL & PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are no pharmaceutical preparations of mitoxantrone and its salts that have been marketed and have lymphatic targeting function at home and abroad

Method used

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  • Biological self-assembly nanometer crystal injection agent with lympha targeted function and preparation method
  • Biological self-assembly nanometer crystal injection agent with lympha targeted function and preparation method
  • Biological self-assembly nanometer crystal injection agent with lympha targeted function and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] The prescription and dosage of 1,000 vials of small water needle bioself-assembled nanocrystal injection are as follows:

[0043]

[0044] Weigh an appropriate amount of raw and auxiliary materials, add 70% of the prescribed amount of water for injection into the concentrated preparation tank, add the prescribed amount of auxiliary materials, stir for about 15 minutes to dissolve, then add mitoxantrone hydrochloride, and stir for about 20 minutes to dissolve.

[0045] The concentration of mitoxantrone hydrochloride in the small water needle type biological self-assembled nanocrystal injection prepared by the prescription process is 0.58%, the measured pH value is 3.5, and the osmotic pressure is 196mmol / Kg. The particle size of self-assembled nanocrystals under mesenchymal biological conditions is 50nm. After subcutaneous interstitial administration, the metastatic primary lymph nodes are visible dark blue, and the secondary and tertiary lymph nodes are visible light...

Embodiment 2

[0047] The prescription and dosage of 1,000 vials of small water needle bioself-assembled nanocrystal injection are as follows:

[0048]

[0049] Weigh an appropriate amount of raw and auxiliary materials, add 70% of the prescribed amount of water for injection into the concentrated preparation tank, add the prescribed amount of auxiliary materials, stir for about 15 minutes to dissolve, then add mitoxantrone hydrochloride, stir for about 20 minutes to dissolve, and put in activated carbon , Stir and adsorb at 40-60°C for 20 minutes. The concentrated solution is filtered through a 3μm stainless steel pleated filter element and then transferred to the dilution tank, and water for injection is added to the total amount of the solution, and stirred for 10 minutes. The liquid medicine is filtered through two serially connected sterile filters (0.22 μm in pore size), and sealed aseptically.

[0050] The concentration of mitoxantrone hydrochloride in the small water needle type ...

Embodiment 3

[0052] The prescription and dosage of 1,000 vials of small water needle bioself-assembled nanocrystal injection are as follows:

[0053]

[0054] Weigh an appropriate amount of raw and auxiliary materials, add 70% of the prescribed amount of water for injection into the concentrated preparation tank, add the prescribed amount of auxiliary materials, stir for about 15 minutes to dissolve, then add mitoxantrone oxalate, stir for about 20 minutes to dissolve, and put in activated carbon , Stir and adsorb at 40-60°C for 20 minutes. The concentrated solution is filtered through a 3μm stainless steel pleated filter element and then transferred to the dilution tank, and water for injection is added to the total amount of the solution, and stirred for 10 minutes. The liquid medicine is filtered through two serially connected sterile filters (0.22 μm in pore size), and sealed aseptically.

[0055] The concentration of mitoxantrone oxalate in the small water needle type biological s...

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Abstract

The invention discloses a biological self-assembly nanometer crystal injection agent composition with a lympha targeted function and an administration mode for targeting a lymphatic system by using a biological self-assembly nanometer crystal injection agent. A recipe composition is prepared from 0.05 to 5 percent of mitoxantrone and mitoxantrone salt, 0.1 to 10 percent of osmotic pressure regulating agents, 0.001 to 0.1 percent of buffer agents, 0.01 to 0.1 percent of antioxidants, 0.05 to 1 percent of adsorbents and 0 to 20 percent of filling agents. The administration mode is interstitial injection; after the passive lymphatic system targeting, the lymph gland can generate the macroscopic blue color. The problems of poor in vitro and vivo physical and chemical property, poor storage stability, preparation flow process complexity and high cost of the micro particle preparation with the lympha targeted function are solved.

Description

technical field [0001] The invention relates to the design and preparation of a new dosage form with a lymphatic targeting function, and provides a prescription composition and a preparation method of an in vivo self-assembled nanocrystal injection. Background technique [0002] Lymphatic metastasis is one of the important factors affecting the prognosis of malignant tumors. Tumor cells can enter the lymphatic system and spread in the early stage, and enter non-affiliated lymph nodes or lymph nodes far away from the primary tumor through lymphatic collateral circulation, forming so-called skip metastasis, which limits the application of surgery. The sensitivity of regional lymph nodes to radiotherapy is lower than that of primary lesions, and the curative effect of systemic chemotherapy on metastatic lymph nodes is not good, because conventional chemotherapy drugs are not easily transported to lymph nodes. Since the curative effect of treating lymph node metastases directly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/19A61K47/12A61K47/18A61K47/26A61K47/36A61K31/136A61P35/04
CPCA61K47/12A61K47/183A61K47/26A61K47/36A61K9/0019A61K9/08A61K9/19A61K31/136A61P35/04A61P7/00A61K9/51A61K9/5192A61K47/10A61K47/14B82Y5/00
Inventor 刘珺叶田田张丹
Owner SHENZHEN CHINA RESOURCES JIUCHUANG MEDICAL & PHARMA CO LTD
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