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Isosulfur blue injection for lymphatic tracing and preparation method thereof

An isosulfan blue and injection technology, applied in the field of pharmaceutical preparations, can solve problems such as poor absorption, inconsistent success rates, and outline the scope of lesions, and achieve rapid elimination at the injection site, no accumulation and residue, and no dispersion in tissue spaces. Effect

Active Publication Date: 2019-11-08
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 blood vessels are widely stained and diffused, which cannot effectively outline the lesion range and affect the observation of the surgical field; and the methylene blue is eliminated quickly, and the maintenance time of blue staining is short, so it is not necessary to use it during the operation. locate lymph nodes

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1: Preparation of isosulfan blue injection

[0031] 1.1 Prescription:

[0032]

[0033] 1.2 Preparation process

[0034] 1) Concentration: Weigh the prescription amount of disodium hydrogen phosphate, potassium dihydrogen phosphate and sodium chloride, add 80% of the prescription amount of water for injection, stir for about 15 minutes to dissolve, then add the prescription amount of medicine, stir for about 20 minutes to dissolve , Put in 0.1% activated carbon for needle, stir and absorb at 40℃ for 10min.

[0035] 2) Dilute preparation: the concentrated preparation is filtered by a 3μm carbon rod and transferred to the dilute preparation tank, rinsed and combined with the rinse solution. After adding water for injection until the volume of the liquid medicine in the dilute mixing tank reaches the specified amount, stir for about 10 minutes. It is filtered through a 0.22μm microporous filter membrane to detect visible foreign matter.

[0036] 3) Sterilization: Nitrogen...

Embodiment 2

[0037] Example 2: Preparation of isosulfan blue injection

[0038] 2.1 Prescription:

[0039]

[0040] 2.2 Preparation process

[0041] 1) Concentration: Weigh the prescription amount of disodium hydrogen phosphate, potassium dihydrogen phosphate and sodium chloride, add 80% of the prescription amount of water for injection, stir for about 15 minutes to dissolve, then add the prescription amount of medicine, stir for about 20 minutes to dissolve , Put in 0.1% activated carbon for needle, stir and absorb at 40℃ for 10min.

[0042] 2) Dilute preparation: the concentrated preparation is filtered by a 3μm carbon rod and transferred to the dilute preparation tank, rinsed and combined with the rinse solution. After adding water for injection until the volume of the liquid medicine in the dilute mixing tank reaches the specified amount, stir for about 10 minutes. It is filtered through a 0.22μm microporous filter membrane to detect visible foreign matter.

[0043] 3) Sterilization: Nitrogen...

Embodiment 3

[0044] Example 3: Preparation of isosulfan blue injection

[0045] 3.1 Prescription:

[0046]

[0047] 3.2 Preparation process

[0048] 1) Concentration: Weigh the prescription amount of disodium hydrogen phosphate, potassium dihydrogen phosphate and sodium chloride, add 80% of the prescription amount of water for injection, stir for about 15 minutes to dissolve, then add the prescription amount of medicine, stir for about 20 minutes to dissolve , Put in 0.1% activated carbon for needle, stir and absorb at 50℃ for 20min.

[0049] 2) Dilute preparation: the concentrated preparation is filtered by a 3μm carbon rod and transferred to the dilute preparation tank, rinsed and combined with the rinse solution. After adding water for injection until the volume of the liquid medicine in the dilute mixing tank reaches the specified amount, stir for about 10 minutes. It is filtered through a 0.22μm microporous filter membrane to detect visible foreign matter.

[0050] 3) Sterilization: Nitrogen...

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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 particularly relates to isosulfan blue injection for lymphatic tracing and a preparation method thereof. Background technique [0002] Malignant tumors are a common disease that seriously endangers human health. There are 8 million new cancer patients worldwide each year. A research report released by the International Center for Cancer Research of the World Health Organization recently stated that according to the current trend of cancer incidence, cancer worldwide in 2020 The incidence rate will increase by 50% compared with the present, and the number of new cancer patients worldwide will reach 15 million every year. The sentinel lymph node (SLN) is the first lymph node to receive lymphatic drainage from the tumor area and the first to have tumor metastasis. If the sentinel lymph node has no metastasis, the possibility of other lymph nodes in the area is very small, and the scope of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K49/00
Inventor 王淑君何蕊
Owner SHENYANG PHARMA UNIVERSITY