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A kind of lysozyme hydrochloride vaginal tablet and its preparation method and application

A technology of lysozyme hydrochloride and vaginal tablets, which is applied in the field of medicine, can solve the problems of high potency and undescribed, and achieve the effects of decomposing pus, improving mucopolysaccharide metabolism, and enhancing curative effect

Active Publication Date: 2020-07-17
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 lysozyme hydrochloride vaginal tablets in the treatment of gynecological vaginitis has not been reported

Method used

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  • A kind of lysozyme hydrochloride vaginal tablet and its preparation method and application
  • A kind of lysozyme hydrochloride vaginal tablet and its preparation method and application
  • A kind of lysozyme hydrochloride vaginal tablet and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0033] A preparation method of lysozyme hydrochloride vaginal tablet, comprising the steps of:

[0034] (1) Grinding the lactose and passing through a 80-100 mesh sieve;

[0035] (2) Weigh hydrochloric acid lysozyme according to the proportion, add purified water to dissolve, adjust pH to 4.0-6.0 with 2-10% (W / W) hydrochloric acid, filter and sterilize with 0.1-0.22 μm filter membrane, and lyse the obtained hydrochloric acid The enzyme feed solution is transported to the sterilized tank and kept at room temperature for standby;

[0036] (3) Sterilize lactose and magnesium stearate separately at a temperature of 40-60°C, control the sterilization pressure of lactose at 20-30Kpa, and the time of 6-7h; control the sterilization pressure of magnesium stearate at 35-50Kpa , the time is 3~4h, standby;

[0037] (4) Weigh mannitol according to the proportion, raise the temperature to 131-136° C., and keep the temperature for 20-30 minutes for sterilization; transport it to a sterili...

experiment example 1

[0080] Experimental Example 1, Lactose and Magnesium Stearate Sterilization Experiment

[0081] See Table 1 for the comparison of different ethylene oxide sterilization pressures and times on the sterilization effects of lactose and magnesium stearate.

[0082] Table 1 Comparison of sterilization effects of lactose and magnesium stearate

[0083]

[0084] It can be analyzed from Table 1 that:

[0085] 1. Under the conditions of ethylene oxide sterilization pressure of 10-20Kpa and time of 3-6 hours, the sterility test of lactose and magnesium stearate did not meet the requirements.

[0086] 2. Under the conditions of ethylene oxide sterilization pressure of 20-30Kpa and time of 3-4 hours, lactose and magnesium stearate sterility test did not meet the requirements.

[0087] 3. Under the conditions of ethylene oxide sterilization pressure of 20-30Kpa and time of 6 hours, the sterility test of lactose meets the regulations. But the sterility test of magnesium stearate did n...

experiment example 2

[0090] Experimental example 2, mannitol sterilization experiment

[0091] The comparison of different high-temperature sterilization temperatures and times on the high-temperature sterilization effect of mannitol is shown in Table 2:

[0092] Table 2 Comparison of high temperature sterilization effects of mannitol

[0093]

[0094] It can be analyzed from Table 2 that:

[0095] 1. Under the conditions of high-temperature sterilization at 121-126°C and 15-30 minutes, the sterility test does not meet the requirements;

[0096] 2. The high temperature sterilization temperature is 131℃, the time is 15min, and the sterility test does not meet the requirements;

[0097] 3. The high temperature sterilization temperature is 131~136℃, the time is 20~30min, and the sterility inspection meets the regulations;

[0098] 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 lysozyme hydrochloride vaginal tablets, and a preparation method and application thereof. The vaginal tablets comprise an active ingredient and auxiliary materials; the active ingredient is lysozyme hydrochloride which accounts for 25 to 48 percent by weight in the lysozyme hydrochloride vaginal tablets. The auxiliary materials are any acceptable auxiliary materials required for preparing the lysozyme hydrochloride vaginal tablets, and comprise a freeze-dried powder skeleton agent, a bonding agent, a filling agent, a lubricating agent and / or other additives. The lysozyme hydrochloride vaginal tablets have a good bacterium inhibiting or killing effect, and have a strong killing effect on staphylococcus aureus belonging to gram-positive bacteria and Escherichia coli of the gram-positive bacteria.

Description

technical field [0001] The invention relates to a vaginal tablet and a preparation method thereof, in particular to a lysozyme hydrochloride vaginal tablet, a preparation method and application thereof, and belongs 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 has increased significantly. On the othe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/47A61K9/20A61K47/26A61P15/02A61P29/00A61P31/04A61P31/10
CPCA61K9/0034A61K9/2018A61K9/2095A61K38/47C12Y302/01017Y02A50/30
Inventor 乔敏袁武杰
Owner SHANDONG SBOND PHARMA
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