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Oxygen-carrying blood substitute preparations

A blood substitute and oxygen-carrying technology, which is applied in the direction of blood diseases, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of increasing production costs and achieve the effect of avoiding cost increases

Inactive Publication Date: 2008-09-17
NIPRO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This will inevitably increase the production cost

Method used

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  • Oxygen-carrying blood substitute preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Example 1. Stability of liposomal dispersions containing L-Cys in glass vials

[0073] 10 mL glass vials (24 mm cylinder diameter, 40 mm height and 12.5 mm aperture) were filled with the sample solutions prepared in step 2 containing 0.7 nM, 1.4 mM or 2.8 mM L-Cys and were capped with rubber stoppers and aluminum caps seal. The filling process is carried out in an atmosphere with an oxygen concentration of less than 0.1%. Each vial was stored at 25°C for 6 months. The stability of hemoglobin encapsulated in liposomes was determined at days 2, 7, 28 and 6 months as percent methemoglobin (% Met) using the method described above. The results are shown in Table 1 below.

[0074] Table 1. % Met of liposome-coated hemoglobin in glass vials

[0075]

[0076] As shown in Table 1, %Met remained essentially unchanged after 6 months of storage at 25°C.

Embodiment 2

[0077] Example 2. Under hypoxia (O 2 <0.3%) Stability of liposome dispersions in plastic bags

[0078] A 50 ml sample of the liposome dispersion containing 2.8 mM L-Cys prepared in Part II was packaged and sealed in a polypropylene (HFB tablet, Nipro Corporation) in an atmosphere with an oxygen concentration of less than 0.3%. ) into a rectangular (8 × 10 cm) bag. Packed bags further with oxygen absorber (AGELESS TM, Mitsubishi Gas Chemical Co., Ltd.) are packaged together in an oxygen-impermeable outer envelope (TECHBARRIER TM , Mitsubishi Plastics, Inc.). The resulting product was stored at a temperature of 40°C and a relative humidity of 75% or a temperature of 25°C and a relative humidity of 60%. Methemoglobin levels (Met%) were determined in duplicate (n=2) over time. The results are shown in Table 2 below.

[0079] Table 2.O 2 %Met of liposome-coated hemoglobin in plastic bags packed at < 0.3%

[0080]

[0081] As shown in Table 2, the % Met of the liposome di...

Embodiment 3

[0082] Example 3. Under hypoxia (O 2 <3%) Stability of liposome dispersions in plastic bags packed

[0083] Example 2 was repeated, except that the packaging operation was carried out in an atmosphere with an oxygen concentration of 3%. The results are shown in Table 3 below.

[0084] Table 3.O 2 %Met of liposome-coated hemoglobin in plastic bags packaged at <3%

[0085]

[0086] As shown in Table 3, the %Met of the liposome dispersion samples in the binary package did not increase when stored at 40°C, 75% RH for 1 month or at 25°C, 60% RH for 12 months.

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Abstract

An oxygen-carrying blood substitute preparation stable upon storage is provided. The preparation comprises an oxygen-carrying substance capable of reversibly binding and releasing oxygen in vivo and an amount of a physiologically tolerable reducing agent effective for preventing at least partially irreversible oxidation of said oxygen-carrying substance. Preferably the oxygen-carrying substance is a hemoglobin-based substance in the form of a liposome encapsulating hemoglobin.

Description

Field of Invention [0001] The present invention involves an oxygen blood substitution preparation that contains oxygen -loaded in vivo that can be combined with and released oxygen in the body. This preparation is used in the field of pharmaceuticals. For example, as a patient with a blood volume after blood loss after blood substitutes, a reduced blood capacity after blood loss provides oxygen for local ischemia and tumor tissues, as a injection solution for preserving natural organs, and as cell culture as cell culture 's medium. Background technique [0002] The ideal of the oxygen blood substitutes is the ideal of these hemoglobin groups (composition) or pyrine-metal complex base groups, which contains as low as possible high-speed rail hemoglobin or equivalent. The main reason for the level of high -speed rail hemoglobin and its equivalent objects is self -oxidation during the production process and / or storage. Therefore, someone tries to use an inert gas to transmit ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/42A61K38/41A61K47/20A61P7/08A61J1/10
CPCA61K38/41A61K47/183A61K38/42A61K47/24A61K9/1271A61K47/12A61K9/1272A61K9/0026A61K47/20A61P7/00A61P7/08
Inventor 甲斐俊哉西田诚司片山直久堀伸明真锅宜久须贺裕子
Owner NIPRO CORP
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