Stabilization method of dibutyl hydroxytoluene
A technology of dibutyl hydroxytoluene and liquid preparations, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of thermal stability decline and dibutyl hydroxytoluene stability. There are no problems such as research, to achieve the effect of inhibiting the decline of content and maintaining the antioxidant effect
Active Publication Date: 2019-09-03
SENJU PHARMA CO LTD
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Problems solved by technology
However, in Patent Document 1, focusing on the stability of pranoprofen and / or its salt, there is no study on the stability of dibutylhydroxytoluene
In addition, it has been reported that in an aqueous composition containing pranoprofen and / or a salt thereof and dibutylhydroxytoluene, the thermal stability decreases, but yellowing can be suppressed by further blending a sulfonamide (see Patent Document 2)
However, in Patent Document 2, attention is also paid to the inhibition of yellowing of the aqueous composition, and there is no study on the stability of dibutylhydroxytoluene itself.
Method used
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preparation example 1
[0179] Eye drops having the compositions shown in Table 8 were prepared according to a conventional method. Each eye drop was accommodated in an eye drop container in which a polybutylene terephthalate nozzle was attached to a polyethylene terephthalate container main body.
[0180] [Table 8]
[0181]
[0182] Symbol Description
[0183] 1 Container body
[0184] 2 injection part
[0185] 3 cover
[0186] 4 Internal space of the drawer
[0187] 5 Wall surface of the inner space of the extraction part
[0188] 6 The wall surface of the cover facing the spout of the spout.
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The objective of the present invention is to provide a technique for increasing the thermal stability of dibutylhydroxytoluene and suppressing a decrease in the content thereof over time in a liquid drug that includes dibutylhydroxytoluene and pranoprofen and / or a salt thereof. By mixing, into the liquid drug that includes dibutylhydroxytoluene and pranoprofen and / or a salt thereof, at least one item selected from the group consisting of a chondroitin sulfate ester, aspartic acid, alginic acid, an alginic acid derivative, pharmaceutically acceptable salts of these, cyanocobalamin, panthenol, a tocopherol, and a tocopherol derivative, and by employing a resin including polybutylene terephthalate as a resin that constitutes an inner wall surface (such as the wall surface of an interior space in a spout portion and / or a lid wall surface facing a spout opening in the spout portion) of an accommodating container, the thermal stability of the dibutylhydroxytoluene in the liquid drug can be increased, adsorption of the dibutylhydroxytoluene to the container can be suppressed, and a decrease in the dibutylhydroxytoluene content over time can be suppressed.
Description
technical field [0001] The present invention relates to a product capable of stably maintaining dibutylhydroxytoluene in a liquid formulation containing dibutylhydroxytoluene and pranoprofen and / or a salt thereof. Furthermore, this invention relates to the stabilization method of the liquid preparation containing dibutylhydroxytoluene, and pranoprofen and / or its salt. Background technique [0002] In recent years, preparations having various effects have been developed in the fields of medicine, food, cosmetics and the like. In these formulations, in order to prevent the oxidation of the components contained, it is required to incorporate an antioxidant. [0003] Conventionally, dibutylhydroxytoluene (BHT) has been known as a representative compound of the fat-soluble antioxidant. Butylated hydroxyanisole and the like are also known as fat-soluble antioxidants, but dibutyl hydroxytoluene has a stronger antioxidant effect than other fat-soluble antioxidants, and is widely u...
Claims
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IPC IPC(8): A61K31/436A61J1/05A61K9/08A61K47/04A61K47/10A61K47/16A61K47/18A61K47/22A61K47/24A61K47/36A61P27/02
CPCA61F9/0008A61J1/05A61K9/0048A61K9/08A61K31/437A61K47/10A61K47/16A61K47/18A61K47/183A61K47/20A61K47/22A61K47/24A61K47/36A61J1/1418A61P27/02A61P29/00A61J1/00A61K31/436
Inventor 根本夫规子松久敬一
Owner SENJU PHARMA CO LTD




