Isosulfan blue injection for lymphatic tracing and preparation method thereof

A technology of isothiocyanate and injection, which is applied in the field of pharmaceutical preparations, can solve problems such as poor absorption, inconsistent success rate, and outlining the scope of lesions, so as to achieve no accumulation and residue, rapid elimination of injection sites, and non-diffusion in tissue spaces Effect

Active Publication Date: 2017-01-04
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, existing studies have shown that MB is not well absorbed in the lymphatic vessels. The success rate of sentinel lymph node biopsy for breast cancer using MB as a dye is inconsistent, some are above 90%, and some are only 69%. Methylene blue exists in a dissolved state, and the interstitial space and bloo

Method used

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  • Isosulfan blue injection for lymphatic tracing and preparation method thereof
  • Isosulfan blue injection for lymphatic tracing and preparation method thereof
  • Isosulfan blue injection for lymphatic tracing and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: the preparation of isosulfur blue injection

[0032] 1.1 Prescription:

[0033]

[0034] 1.2 Preparation process

[0035] 1) Concentrated preparation: Weigh the prescribed amount of disodium hydrogen phosphate, potassium dihydrogen phosphate and sodium chloride, add 80% of the prescribed amount of water for injection, stir for about 15 minutes to dissolve, then add the prescribed amount of medicine, stir for about 20 minutes to dissolve , put in 0.1% activated carbon for needles, stir and adsorb at 40°C for 10min.

[0036]2) Dilute formulation: the concentrated formulation is filtered through a 3 μm carbon rod and then transferred to the dilute formulation tank, rinsed and combined with the rinse solution. Add water for injection until the volume of the medicinal solution in the dilute tank reaches the specified amount, then stir for about 10 minutes. After filtering through a 0.22μm microporous membrane, foreign matter can be seen in the inspection....

Embodiment 2

[0038] Embodiment 2: the preparation of isosulfur blue injection

[0039] 2.1 Prescription:

[0040]

[0041] 2.2 Preparation process

[0042] 1) Concentrated preparation: Weigh the prescribed amount of disodium hydrogen phosphate, potassium dihydrogen phosphate and sodium chloride, add 80% of the prescribed amount of water for injection, stir for about 15 minutes to dissolve, then add the prescribed amount of medicine, stir for about 20 minutes to dissolve , put in 0.1% activated carbon for needles, stir and adsorb at 40°C for 10min.

[0043] 2) Dilute formulation: the concentrated formulation is filtered through a 3 μm carbon rod and then transferred to the dilute formulation tank, rinsed and combined with the rinse solution. Add water for injection until the volume of the medicinal solution in the dilute tank reaches the specified amount, then stir for about 10 minutes. After filtering through a 0.22μm microporous membrane, foreign matter can be seen in the inspection...

Embodiment 3

[0045] Embodiment 3: the preparation of isosulfur blue injection

[0046] 3.1 Prescription:

[0047]

[0048] 3.2 Preparation process

[0049] 1) Concentrated preparation: Weigh the prescribed amount of disodium hydrogen phosphate, potassium dihydrogen phosphate and sodium chloride, add 80% of the prescribed amount of water for injection, stir for about 15 minutes to dissolve, then add the prescribed amount of medicine, stir for about 20 minutes to dissolve , put in 0.1% activated carbon for needles, and stir and adsorb at 50°C for 20min.

[0050] 2) Dilute formulation: the concentrated formulation is filtered through a 3 μm carbon rod and then transferred to the dilute formulation tank, rinsed and combined with the rinse solution. Add water for injection until the volume of the medicinal solution in the dilute tank reaches the specified amount, then stir for about 10 minutes. After filtering through a 0.22μm microporous membrane, foreign matter can be seen in the inspec...

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PUM

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Abstract

The invention provides an isosulfan blue injection having efficient lymphaffinity and a preparation method thereof. Accordingly, the effects of efficient lymphatic drainage and uptake are achieved by adopting different types and dosages of osmotic pressure adjusting agents. The osmotic pressure adjusting agents are one or combinations of sodium chloride and glucose. The isosulfan blue injection has the advantages that the defects of tissue space dispersion, low lymph uptake ratio and poor dyeing effect after water soluble dyes undergo hypodermic injection of a clinic tumor sentinel lymphatic positioning operation are overcome, the lymph gland can be accurately positioned without other auxiliary equipment, the isosulfan blue injection is non-radioactive, simple, convenient and visual, can achieve the purpose of lymphatic tracing and is a technical method having development prospect and a clinical application value.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to isosulfur blue injection for lymphatic tracing and a preparation method thereof. Background technique [0002] Malignant tumor is a common disease that seriously endangers human health. There are 8 million new cancer patients every year in the world. According to a research report released by the International Cancer Research Center of the World Health Organization, according to the current incidence of cancer The incidence rate will increase by 50% compared with the present, and the number of new cancer patients worldwide will reach 15 million people every year. The sentinel lymph node (SLN) is the first station lymph node that first receives lymphatic drainage from the tumor area and where tumor metastasis occurs first. If there is no metastasis in the sentinel lymph node, the possibility of metastasis to other lymph nodes in the region is very small, and...

Claims

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Application Information

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IPC IPC(8): A61K49/00
Inventor 王淑君何蕊
Owner SHENYANG PHARMA UNIVERSITY
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