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Composite hydrochloric acid lysozyme vagina tablet and preparation method thereof

A technology of lysozyme hydrochloride and compound hydrochloric acid, which is applied in the field of medicine, can solve the problems of undescribed and high potency, and achieve the effects of enhancing local defense, improving metabolism, and improving local circulation disorders

Active Publication Date: 2016-07-13
SHANDONG SBOND PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above patents provide a drug suppository for lysozyme to treat gynecological vaginitis very well. The disadvantages are (1) the preparation method of this patent is that lysozyme dissolves at 55°C, and the marine lysozyme has an optimum temperature range of 5-50°C. ℃, the stability is better, and its titer is the highest; (2) Because lysozyme hydrochloride has good stability between pH 4.0 and 6.0, the process does not describe the pH in the preparation process
So far, the application of compound lysozyme hydrochloride vaginal tablets containing lysozyme hydrochloride and sucrose in the treatment of gynecological vaginitis has not been reported

Method used

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  • Composite hydrochloric acid lysozyme vagina tablet and preparation method thereof
  • Composite hydrochloric acid lysozyme vagina tablet and preparation method thereof
  • Composite hydrochloric acid lysozyme vagina tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0034] A preparation method of compound lysozyme hydrochloride vaginal tablet, comprising the steps of:

[0035] (1) Pulverize sucrose and pass through a 100-120 mesh sieve; pulverize lactose and pass through a 80-100 mesh sieve; sterilize sucrose, lactose and magnesium stearate at a temperature of 40-60°C respectively: sucrose, The sterilization pressure of lactose is controlled at 20-30Kpa, and the time is 6-7h; the sterilization pressure of magnesium stearate is controlled at 35-50Kpa, and the time is 3-4h, and it is used for standby;

[0036] (2) Weigh hydrochloric acid lysozyme according to the proportion, add purified water to dissolve, adjust the pH to 4.0-6.0 with 2-10% (W / W) hydrochloric acid, filter and sterilize the obtained lysozyme with a 0.1-0.22 μm filter membrane The feed liquid is transported to the sterilized tank and kept at room temperature for standby;

[0037] (3) Weigh and mix mannitol and purified water according to the proportion, continue to heat up ...

experiment example 1

[0087] Experimental example 1, sucrose and auxiliary material sterilization experiment

[0088] See Table 1 for the comparison of different ethylene oxide sterilization pressures and times on the sterilization effects of sucrose and magnesium stearate.

[0089] Table 1 Comparison of sterilizing effects of sucrose and magnesium stearate

[0090]

[0091] It can be analyzed from Table 1 that:

[0092] 1. Under the conditions of ethylene oxide sterilization pressure of 10-20Kpa and time of 3-6 hours, the sterility test of sucrose, lactose and magnesium stearate did not meet the requirements;

[0093] 2. Under the conditions of ethylene oxide sterilization pressure of 20-30Kpa and time of 3-4 hours, the sterility test of sucrose, lactose and magnesium stearate did not meet the requirements;

[0094] 3. Under the conditions of ethylene oxide sterilization pressure 20-30Kpa, time 6h, sucrose, lactose sterility inspection, meet the regulations. But the sterility test of magnesium...

experiment example 2

[0097] Experimental example 2, mannitol sterilization experiment

[0098] The comparison of different high-temperature sterilization temperatures and times on the high-temperature sterilization effect of mannitol is shown in Table 2:

[0099] Table 2 Comparison of mannitol high temperature sterilization effect

[0100]

[0101] It can be analyzed from Table 2 that:

[0102] 1. Under the conditions of high-temperature sterilization at 121-126°C and 15-30 minutes, the sterility test does not meet the requirements;

[0103] 2. The high temperature sterilization temperature is 131℃, the time is 15min, and the sterility test does not meet the requirements;

[0104] 3. The high temperature sterilization temperature is 131~136℃, the time is 20~30min, and the sterility inspection meets the regulations;

[0105] Test results: Mannitol was sterilized at high temperature by controlling the temperature at 131-136°C and the time at 20-30 minutes.

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Abstract

The invention discloses a composite hydrochloric acid lysozyme vagina tablet and a preparation method thereof. The composite hydrochloric acid lysozyme vagina tablet comprises active components and auxiliary materials, wherein the active components are hydrochloric acid lysozyme and cane sugar; the weight percentage of the hydrochloric acid lysozyme in the composite hydrochloric acid lysozyme vagina tablet is 2-11%; the weight percentage of the cane sugar in the composite hydrochloric acid lysozyme vagina tablet is 38-72%; the auxiliary materials are any acceptable auxiliary materials essential for preparation of a hydrochloric acid lysozyme vagina tablet, including a freeze-dried powder framework agent, an adhesive agent, a filling agent, a lubricating agent and / or other additives which are very well known in the field. The composite hydrochloric acid lysozyme vagina tablet is relatively good in bacterium inhibition and sterilization effect, and has an inhibition function on staphylococcus albus, blastomyces albican escherichia coli, staphylococcus aureus, beta hemolytic streptococcus and the like.

Description

technical field [0001] The invention relates to a vaginal tablet and a preparation method thereof, in particular to a compound lysozyme hydrochloride vaginal tablet containing lysozyme hydrochloride and sucrose and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Due to the special anatomical and physiological characteristics of women's vagina, they are most susceptible to infection by various pathogens, which can cause vaginal inflammation and other vaginal diseases. If not actively treated, it may cause other gynecological diseases and adverse maternal perinatal outcomes. Among the various pathogens that cause vaginitis, Candida albicans ranks first, and the infection rate is very high, accounting for almost 1 / 2 of vaginitis patients. It is currently the main pathogen of vaginitis in women. Other pathogens, Compared with the past, the infection rate of Trichomonas, Gram-positive bacteria, and Gram-negative bacteria h...

Claims

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Application Information

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IPC IPC(8): A61K38/47A61K9/20A61K47/26A61P15/02A61P29/00A61P31/04A61P31/10A61K31/7016
CPCA61K38/47A61K9/0034A61K9/2018A61K31/7016C12Y302/01017A61K2300/00Y02A50/30
Inventor 乔敏袁武杰
Owner SHANDONG SBOND PHARMA
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