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Liquid drug preparations

A technology of liquid preparations and drugs, which is applied in the direction of drug combination, drug delivery, and pharmaceutical formulations, etc.

Inactive Publication Date: 2004-07-07
HISAMITSU PHARM CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to solve the above problems, the inventors of the present invention conducted in-depth research on the composition and additives of fudosteine ​​liquid preparations, and found that fudosteine ​​is easy to change color under neutral conditions, but does not change color under certain acidic conditions. Easy to change color and there is no problem of precipitation

Method used

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  • Liquid drug preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Studies on the effect of pH on liquid formulations of fudosteine:

[0024] Adjust the pH of the aqueous solution containing 8 g of fudosteine ​​with an appropriate amount of phosphoric acid or sodium hydroxide, and adjust the pH to 2-7 respectively as shown in Table 1. Purified water was added to bring the total amount of each solution to 100 ml, thereby obtaining fudosteine ​​liquid preparations with different pH values. The liquid preparation was stored at 70° C. for 7 days, and the residual rate of fudosteine ​​in the solution and whether there was discoloration and precipitation were detected. The content of fudosteine ​​was quantitatively analyzed by high performance liquid chromatography (HPLC), thereby calculating the residual rate of fudosteine. Visually inspect for discoloration and precipitation, and evaluate the results according to the following criteria. The results are shown in Table 1.

[0025] Discoloration Evaluation Criteria:

[0026] comment conte...

Embodiment 2

[0040] Study on the Types of pH Regulators for Fudosteine ​​Liquid Preparations

[0041] An aqueous solution containing 8 g of fudosteine ​​was adjusted to pH 3.5 by adding various acids as shown in Table 2. Purified water was added to bring the total amount of each solution to 100 ml, whereby a fudosteine ​​liquid preparation was obtained. This liquid preparation was stored at 70°C for 7 days, and the presence or absence of discoloration was evaluated in the same manner as in Example 1. The results are shown in Table 2.

[0042] (result)

[0043] Analysis value

[0044] The results confirmed that both inorganic acids and organic acids can be used in the pharmaceutical liquid formulations of the present invention. In addition, the pH of each solution was hardly changed by the acid after 7 days, that is, the change in pH was within the allowable error range.

Embodiment 3

[0046] Studies on types of sweeteners used in liquid formulations of fudosteine:

[0047] An aqueous solution containing 8 g of fudosteine ​​and 20 g of the sweeteners shown in Table 3 was adjusted to pH 3.5 by adding phosphoric acid. Purified water was added to bring the total amount of each solution to 100 ml, whereby a fudosteine ​​liquid preparation was obtained. This liquid preparation was stored at 70°C for 7 days, and the presence or absence of discoloration was evaluated in the same manner as in Example 1. The results are shown in Table 3.

[0048] (result)

[0049] Analysis value

Survival rate (%)

discoloration

Refined white sugar

90.5

++

Glucose

78.8

++

fructose

90.7

++

isomerized sugar

90.8

++

D-sorbose

100.7

-

D-Mannitol

99.3

-

Xylitol

100.3

-

Erythritol

99.5

...

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PUM

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Abstract

Liquid drug preparations characterized by containing fudostein and an acid together with a sweetener such as sugar alcohol, trehalose or a sweetener having a high degree of sweetness. These liquid drug preparations are fudostein-containing liquid drug preparations which are free from color change or sedimentation upon prolonged storage and can be easily taken.

Description

technical field [0001] The present invention relates to a pharmaceutical liquid preparation containing fudosteine, and more particularly, the present invention relates to a pharmaceutical liquid preparation which, although containing fudosteine, does not change color and Produces a precipitate and is effective as an expectorant. Background technique [0002] Fudosteine ​​is a general term for S-(3-hydroxypropyl)-L-cysteine ​​represented by the following formula (I), and it is a drug having an expectorant effect (Japanese Patent Publication No. 7-88352). [0003] [0004] Patients with chronic bronchitis or bronchial asthma have increased mucus secretion in the respiratory tract due to the hypertrophy of the submucosal gland of the respiratory tract or the excessive formation of goblet cells. When they are ill, the sputum is difficult to cough up due to the excessive secretion of mucin. Therefore, these patients Symptoms include sputum stagnation in the terminal airway an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/00A61K31/198A61K39/35A61K45/06A61K47/02A61K47/10A61K47/12A61K47/24A61K47/26A61K47/42A61P11/00A61P11/06A61P11/10
CPCA61K31/198A61K47/02A61K39/35A61K47/12A61K47/26A61K45/06A61K9/0095A61P11/00A61P11/06A61P11/10A61K2300/00A61K9/08
Inventor 大杉智彦伏见升成村田豊金子哲男今森胜美
Owner HISAMITSU PHARM CO INC
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