CN109364242A - A kind of compound bromelain ointment and its manufacturing method - Google Patents
A kind of compound bromelain ointment and its manufacturing method Download PDFInfo
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- CN109364242A CN109364242A CN201811457175.XA CN201811457175A CN109364242A CN 109364242 A CN109364242 A CN 109364242A CN 201811457175 A CN201811457175 A CN 201811457175A CN 109364242 A CN109364242 A CN 109364242A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/4873—Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/07—Retinol compounds, e.g. vitamin A
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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Abstract
The invention discloses a kind of compound bromelain ointment and its manufacturing method, formula includes: bromelain 30-40%, lysozyme 3-7%, vitamin A 0.1%, matrix 20%-50%, water 12.9%-46.9% according to mass percent；Formula of the invention accelerates the nature decrustation time by bromelain, lysozyme increases the bactericidal mechanism of specificity and the sterilizing ability of wide spectrum, it can effectively prevent and control surface of a wound stadium decrustationis infection conditions, vitamin A facilitates mature collage synthesis, epithelium regeneration and vascularization；Deep II degree and III degree surface of a wound decrustation so that ointment can be used for burning, and have the function of controlling trauma surface infestation and inflammation, the dermatoplastic time is carried out to accelerate depth II degree and III degree fire victim；Manufacturing method is designed according to the physicochemical characteristics of formula, can play drug effect to the greatest extent.
Description
Technical field
The present invention relates to the externally applied drug field for deep burn, especially a kind of compound bromelain ointment and its system
Make method.
Background technique
I degree and the burn of shallow II degree are clinically known as superficial burns, deep II degree and the burn of III degree are classified as depth and burnt
Wound.Invention, which is directed to, is used for deep burn.Will form on deep burn wound one layer of pale asphyxia, yellow-white, coke yellow or
It is the necrotic tissue of black, as eschar.If not infecting, deep ii degree burn and small area depth III burn wound are in 17-20
After it, fully recover under scab.The eschar for the deep II degree surface of a wound and III the degree burn obviously infected started from health tissues separation in 2-3 weeks
Decrustation, decrustation time are longer.And a large amount of necrotic tissue liquefaction at this time, as the decrustation time extends, infection is aggravated, it may occur that
Eschar breaking-in period septicemia.Therefore, necrotic tissue is removed early and carries out the basic method that skin-grafting is effective control infection.
Currently, common exposure method, wound surface smearing anti-infectives, and dry eschar and keep dry, reduce exudation, to subtract
Light bacterium intrusion, then physics removes eschar in batches, removes necrotic tissue, makes skin graft.The method causes larger pain to patient
Hardship, or the completion that needs to perform the operation are complex, not very ideal；The medicine decrustation time for treating deep burn in the market is long, nothing
Method prevention and control surface of a wound stadium decrustationis infection conditions, the present invention need to solve such problems；
Lysozyme is a kind of alkaline globulin, molecule neutral and alkali amino acid, amide residues and aromatic amine, sour ratio compared with
Height, the activity centre of enzyme are aspartic acid and glutamic acid
Lysozyme is a kind of hydrolase for being acting exclusively on microorganism wall, claims packet muramidase or N- acetyl murein
Endohydrolase, it exclusively acts on the β -1 in peptide polysaccharide molecule between -acetylmuramic acid and N-acetylglucosamine,
4 keys are allowed to loose and lose the protective effect to cell to destroy the cell wall of bacterium, finally make bacterolysis death
The cell wall of gram-positive bacteria can be directly destroyed, and have the function that sterilization, this is primarily due to gram-positive bacterium
Cell wall mainly be made of murein and phosphoric acid matter, the glycoprotein that wherein murein is made of heteroglycan and polypeptide, this
Kind polysaccharide is exactly by the of β -1,4 key joint between -acetylmuramic acid and N-acetylglucosamine to certain gram-negatives
Property bacterium, such as Escherichia coli, salmonella typhi, the destruction lysozyme that also will receive lysozyme can be protected in breast milk
Baby is from a kind of effective component of virus infection, it can keep its activated state by alimentary canal, and lysozyme can also make
Escherichia coli are reduced in baby intestinal, are promoted the increase of Bifidobacterium, can also be promoted the digestion and absorption of protein.
Bromelain is also known as bromelain.Its selective hydrolysis basic amino acid (such as arginine) or aromatic amino acid
Peptide chain on the carboxyl side of (such as phenylalanine, tyrosine), selective hydrolysis fibrin can decompose muscle fibre, and to fibre
Fibrillarin original work are with faint.It can be used for beer clarification, medicinal aid digestion and anti-inflammation detumescence.
According to the two enzyme viabilities, it is used cooperatively in the externally applied drug field of deep burn, there is researching value.
Summary of the invention
To solve the deficiencies in the prior art, the purpose of the present invention is to provide a kind of compound bromelain ointment and its systems
Method is made, formula accelerates the nature decrustation time by bromelain, and lysozyme increases specific bactericidal mechanism and wide spectrum
Sterilizing ability, can effectively prevent and control surface of a wound stadium decrustationis infection conditions, and vitamin A facilitates collage synthesis maturation, epithelium
Regeneration and vascularization；Deep II degree and III degree surface of a wound decrustation so that ointment can be used for burning, and there is control surface of a wound sense
The effect of dye and inflammation carries out the dermatoplastic time to accelerate depth II degree and III degree fire victim.
In order to achieve the above objectives, the present invention adopts the following technical scheme that:
A kind of compound bromelain ointment includes: bromelain 30-40%, lysozyme 3- according to mass percent
7%, matrix 20%-50%, water 12.9%-46.9%.
A kind of compound bromelain ointment above-mentioned, includes: bromelain 30-40% according to mass percent, molten
Bacterium enzyme 3-7%, vitamin A 0.1%, matrix 20%-50%, water 12.9%-46.9%.
A kind of compound bromelain ointment above-mentioned, matrix is vaseline.
A kind of compound bromelain ointment above-mentioned, bromelain 40%, lysozyme 5%, vitamin A 0.1% are all
Intellectual circle 39.9%, water 15%.
A kind of compound bromelain ointment above-mentioned, stability maintenance 6 months of compound bromelain ointment.
A kind of manufacturing method of compound bromelain ointment, includes the following steps:
Step 1 prepares raw material according to formula；Formula includes: bromelain 30-40% according to mass percent, molten
Bacterium enzyme 3-7%, vitamin A 0.1%, matrix 20%-50%, water 12.9%-46.9%；
Step 2 sterilizes to raw material；Bromelain uses radiation sterilization, and 100 ± 2 DEG C of matrix sterilize 60 ± 5 minutes；
Water after sterilizing is heated to 80 DEG C, vitamin A is added after mixing evenly, adds matrix, sufficiently stirs by step 3
It mixes uniformly, after temperature is lower than 37 degrees Celsius, lysozyme and bromelain is added, stirs evenly.
A kind of manufacturing method of compound bromelain ointment above-mentioned, matrix is vaseline.
A kind of manufacturing method of compound bromelain ointment above-mentioned, radiation sterilization are used with radioactive isotope60Co
The gamma-rays of radiation, dosage are (1.5-5.0) * 104Gy。
The invention has the beneficial effects that:
Formula of the invention accelerates the nature decrustation time by bromelain；
Lysozyme increases the bactericidal mechanism of specificity and the sterilizing ability of wide spectrum, can effectively prevent and control surface of a wound decrustation
Phase infection conditions；
Vitamin A facilitates mature collage synthesis, epithelium regeneration and vascularization；
Ointment can be used for burning deep II degree and III degree surface of a wound decrustation, and have the function of controlling trauma surface infestation and inflammation,
The dermatoplastic time is carried out to accelerate depth II degree and III degree fire victim；
Manufacturing method is designed according to the physicochemical characteristics of formula, can play drug effect to the greatest extent；
Compound bromelain stability in illumination, hot test, accelerated test is qualified, and in long-term storage conditions
Under, stability 6 months are good.
Specific embodiment
Below in conjunction with detailed description of the invention by specific embodiments.
A kind of compound bromelain ointment, which is characterized in that according to mass percent include: bromelain 30-
40%, lysozyme 3-7%, vitamin A 0.1%, matrix 20%-50%, water 12.9%-46.9%.Lysozyme has specificity
Bactericidal mechanism and broad-spectrum bactericidal capacity, the main component for the lysozyme that the present invention uses are staphylococcus lysozymes, can cut off and cause a disease
β-Isosorbide-5-Nitrae glycosidic linkage in bacterium whole cell peptidoglycan structure, multiple broken wall bactericidal mechanism enable to meet lysozyme kill rapidly it is pathogenic
Bacterium, including kill a variety of pairs of drug resistant drug-fast bacterias of antibiotic.And this is as protein, can drain with human metabolism, it will not
Generate any toxic side effect.Part fire victim's self-healing ability is weaker, and easily the case where immunoloregulation function disorder occurs, is added
The ingredient of vitamin A not only facilitates mature collage synthesis, epithelium regeneration and vascularization, can also improve caused by manufacturer and exempt from
Epidemic disease function inhibitio.
It should be understood that bromelain, lysozyme that the present invention uses are produced by our company, vitamin A is purchased from Zhejiang
Jiang Xin and at limited liability company, the matrix vaseline of selection is purchased from Jiangsu Hua Shen pharmaceutcal corporation, Ltd；But where essence produces
Raw material all on the present invention do not influence, all within the scope of the present invention.
A kind of manufacturing method of compound bromelain ointment, includes the following steps:
Step 1 prepares raw material according to formula；Formula includes: bromelain 30-40% according to mass percent, molten
Bacterium enzyme 3-7%, vitamin A 0.1%, matrix 20%-50%, water 12.9%-46.9%；
Step 2 sterilizes to raw material；Bromelain uses radiation sterilization, with radioactive isotope60The γ of Co radiation
Ray, dosage are (1.5-5.0) * 104Gy, 100 ± 2 DEG C of matrix sterilize 60 ± 5 minutes；
Water after sterilizing is heated to 80 DEG C by step 3, and vitamin A is added and stirs evenly, adds matrix, is sufficiently stirred
Uniformly, lysozyme and bromelain is added after temperature is lower than 37 degrees Celsius, stirs evenly；Operating process should keep nothing
Bacterium operation.
Experimental verification part:
Experiment one, the research of separation and its decrustation effect of bromelain；
It is refined using the bromelain raw material that the country meets the national drug standards, and determines best process for refining item
Part.Use PEG4000 and PEG400 as matrix, ratio 1:3 prepares bromelain ointment, and bromelain concentration is
6.25%, ointment potency is 50,000 U/g.Influence factor experiment and Acceleration study show that the bromelain of preparation engages in improper stability
It meets the requirements.It is positive control, matrix as negative control using moist exposed burn cream, prepared by research purification bromelain raw material
Ointment and the ointment of non-refined material preparation scald decrustation effect to cavy cavy III degree, observe the 10th day incrustation rate and average
Decrustation number of days, as a result refining bromelain, to prepare ointment decrustation effect consistent with moist exposed burn cream, and respectively 10.9 ± 1.79
It and 10.5 ± 1.71 days；It is better than and does not refine bromelain ointment, 12.8 ± 1.81 days；The two decrustation effect is better than feminine gender
Control group, 16.3 ± 1.34 days, pathology slice display ointment group and positive controls after decrustation did not had significant difference.
Interpretation of result: experiments have shown that low concentration bromelain is bad to decrustation function and effect.
Experiment two, the research of bromelin decrustation effect；
1. the outer solute effect observation of proteasome
The skin for taking the thermal burns such as people, pig, dog and rabbit or mustard gas to damage, degree of injury are depth II-III degree, are cut into big
Small identical lump in the abdomen weighs in the solution that 100mg. does not have as 5ml containing various concentration, 37 DEG C of heat preservations, observes crust dissolution in 48 hours
Situation is completely dissolved the time.
The molten scab effect of protease
Analysis of experimental results: thus experiment is it is found that bromelain has outside outstanding proteasome compared to other strains
Solute effect.
2. bromelain acts on the decrustation of rabbit, porcine skin mustard gas deep lesions
With mustard gas infected rabbits and pig, depth II degree wound is established.With each concentration bromelain ointment of each substrate preparation,
Start to add medicine within seven days, secondary daily, wrapping is fixed.Observe decrustation time and skin graft survival rate.
As a result such as following table, show the enzyme preparation decrustation effect that four kinds of different substrates are configured to.The all scholars of 20% bromelain
Woods ointment be averaged the decrustation time be 21.3 hours, cold cream preparation be 28.5 hours, other two matrix decrustation effect is poor.Vaseline pair
It is up to 7-10 days according to the decrustation time, significant difference.34 pieces of surface of a wound of pig, 50% bromelain Ointment in Treatment, average decrustation time
It is 22.5 hours, vaseline control group is 6.3 days, consistent with the result of rabbit.
Self-skin transplant is carried out after decrustation, rabbit the livabitity of skin grafts is 6/7, and pig skin-grafting success rate is 50%, and loser is more
Because after animal activity skin graft vault it is bad caused by.
The decrustation effect that the bromelain that different substrates are prepared damages rabbit mustard gas
| Bromelain % | Matrix | Surface of a wound number | Decrustation time h |
| 0 | Vaseline | 9 | 168-240 |
| 5 | Vaseline | 6 | 49.3 |
| 20 | Vaseline | 12 | 21.3±13.3 |
| 20 | Cold cream | 11 | 28.5±13.5 |
| 20 | Vaseline+lanolin | 6 | 46±11.8 |
| 20 | Hydrous ointment | 8 | 45±16.6 |
Analysis of experimental results: according to the experimental results, 20% bromelain and matrix: the formula of vaseline has optimal
Decrustation effect；And in the case where all using 20% bromelain, the decrustation effect of vaseline is selected most in each matrix
It is good, so matrix is preferably vaseline.
Experiment three: bromelain optimal concentration test experiments；
(1) animal model
Cavy, back depilation are selected, coin is placed at guinea pig back with 15 minutes in 100 DEG C of boiling water, after taking-up by anesthesia
Dry rapidly, guinea pig back place it is for 12 seconds cause III degree scald, 4 wounds of every guinea pig back, sub-cage rearing.
(2) experimental group
Modeling cavy is taken, is randomly divided into 6 groups, every group 10, i.e. 30% experimental group, 35% experimental group, 40% experimental group, yin
Property control group, matrix control group and moist exposed burn cream group.Experimental group is compound bromelain ointment, and negative control is not made to locate
Reason, Matrix controls are the ointment containing sterile water and vaseline, and moist exposed burn cream is outsourcing product.
(3) experimental implementation
Embodiment 1 is prepared respectively, and embodiment 2, it is respectively 30%, 35% and that embodiment 3, which corresponds to bromelain concentration,
40% ointment.
Embodiment 1:30% bromelain, 5% lysozyme, 0.1% vitamin A, matrix 47.2%, water 17.7%；
Embodiment 2:35% bromelain, 5% lysozyme, 0.1% vitamin A, matrix 43.6%, water 16.4%；
Embodiment 3:40% bromelain, 5% lysozyme, 0.1% vitamin A, matrix 40.0%, water 14.9%.
After cavy modeling, thick scab is administered after being formed, and ointment is applied on the surface of a wound, and wrapping is fixed, secondary daily.
(4) result
The decrustation time: the results show that 30%, 35% and 40% experimental group is respectively 17.8 ± 9.1 hours, 17.1 ± 6.9
Hour and 16.3 ± 7.4 can decrustation, hence it is evident that earlier than negative control group, matrix group and moist exposed burn cream.
| Group | Decrustation time h |
| Negative control | 306.2±29.3 |
| Matrix controls | 251.6±31.6 |
| 30% experimental group | 17.8±9.1 |
| 35% experimental group | 17.1±6.9 |
| 40% experimental group | 16.3±7.4 |
| Moist exposed burn cream | 233.7±26.4 |
Interpretation of result, short using the formula universal decrustation time of the invention, the shortest time is 40% experimental group.
Experiment four: the compliance test result of lysozyme control infection:
Embodiment 4:40% bromelain, 3% lysozyme, 0.1% vitamin A, matrix 34.8%, water 22.1%；
Embodiment 5:40% bromelain, 7% lysozyme, 0.1% vitamin A, matrix 32.3%, water 20.6%.
Wound inflammation reaction:
When implementing experiment three, the surface of a wound is divided into negative and positive.The positive surface of a wound is to have purulent secretion, 2cm around the surface of a wound
There is the obviously acute inflammatory reactions symptom such as red, swollen, hot in range；2cm range is not without purulent secretion, around the surface of a wound for the negative surface of a wound
There are the types inflammatory reaction symptoms such as obvious redness, heat.
The results show that experimental group positive surface of a wound quantity is far below other groups, illustrate this product to infection control and inflammation
Control has positive effect, and 5% and 7% lysozyme is most to wound inflammation reaction negative, positive minimum, is better than other groups, considers
To cost and side reaction situation, it is believed that 5% concentration lysozyme is optimal concentration.In conjunction with experiment three as a result, illustrating reality
The formula for applying example 3 is optimum embodiment.
Optimum embodiment are as follows: formula includes: bromelain 40%, lysozyme 5%, vitamin A according to mass percent
0.1%, vaseline 40%, water 14.9%.
Experiment five: compound bromelain enzyme stability；
Compound bromelain stability in illumination, hot test, accelerated test is qualified, and in long-term storage conditions
Under, stability 6 months are good.
Exposure experiments to light and high temperature test result
Accelerated stability result
Long-time stability result
Analysis of experimental results: compound bromelain stability in illumination, hot test, accelerated test is qualified, and
Under long-term storage conditions, stability 6 months good.
Formula of the invention accelerates the nature decrustation time by bromelain；Lysozyme increases the bactericidal mechanism of specificity
With the sterilizing ability of wide spectrum, it can effectively prevent and control surface of a wound stadium decrustationis infection conditions；Vitamin A facilitate collage synthesis at
Ripe, epithelium regeneration and vascularization；Ointment can be used for burning deep II degree and III degree surface of a wound decrustation, and have control surface of a wound sense
The effect of dye and inflammation carries out the dermatoplastic time to accelerate depth II degree and III degree fire victim；Manufacturing method is according to formula
Physicochemical characteristics design, drug effect can be played to the greatest extent；Compound bromelain is in illumination, hot test, acceleration
Stability is qualified in test, and under long-term storage conditions, and stability 6 months good.
The basic principles, main features and advantages of the invention have been shown and described above.The technical staff of the industry should
Understand, the above embodiments do not limit the invention in any form, all obtained by the way of equivalent substitution or equivalent transformation
Technical solution is fallen within the scope of protection of the present invention.
Claims (8)
1. a kind of compound bromelain ointment, which is characterized in that it according to mass percent include: bromelain 30-40%,
Lysozyme 3-7%, matrix 20%-50%, water 12.9%-46.9%.
2. a kind of compound bromelain ointment according to claim 1, which is characterized in that according to mass percent packet
It includes: bromelain 30-40%, lysozyme 3-7%, vitamin A 0.1%, matrix 20%-50%, water 12.9%-46.9%.
3. a kind of compound bromelain ointment according to claim 1 or 2, which is characterized in that the matrix is all scholars
Woods.
4. a kind of compound bromelain ointment according to claim 3, which is characterized in that bromelain 40%, it is molten
Bacterium enzyme 5%, vitamin A 0.1%, vaseline 39.9%, water 15%.
5. a kind of compound bromelain ointment according to claim 1, which is characterized in that the compound bromelain
The stability maintenance of ointment 6 months.
6. a kind of manufacturing method of compound bromelain ointment, which comprises the steps of:
Step 1 prepares raw material according to formula；Formula includes: bromelain 30-40%, lysozyme according to mass percent
3-7%, vitamin A 0.1%, matrix 20%-50%, water 12.9%-46.9%；
Step 2 sterilizes to raw material；Bromelain uses radiation sterilization, and 100 ± 2 DEG C of matrix sterilize 60 ± 5 minutes；
Water after sterilizing is heated to 80 DEG C, vitamin A is added after mixing evenly, adds matrix, is sufficiently stirred by step 3
It is even, after temperature is lower than 37 degrees Celsius, lysozyme and bromelain is added, stirs evenly.
7. a kind of manufacturing method of compound bromelain ointment according to claim 6, which is characterized in that the matrix
For vaseline.
8. a kind of manufacturing method of compound bromelain ointment according to claim 6, which is characterized in that radiation sterilization
It uses with radioactive isotope60The gamma-rays of Co radiation, dosage are (1.5-5.0) * 104Gy。
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114558123A (en) * | 2020-12-20 | 2022-05-31 | 天津中医药大学第二附属医院 | Pharmaceutical composition for treating foot ulcer |
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Application publication date: 20190222 |