CN103156924A - Chinese medicinal suppository for treating mammal endometritis and preparation method thereof - Google Patents
Chinese medicinal suppository for treating mammal endometritis and preparation method thereof Download PDFInfo
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- CN103156924A CN103156924A CN201310109362XA CN201310109362A CN103156924A CN 103156924 A CN103156924 A CN 103156924A CN 201310109362X A CN201310109362X A CN 201310109362XA CN 201310109362 A CN201310109362 A CN 201310109362A CN 103156924 A CN103156924 A CN 103156924A
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Abstract
The invention relates to a Chinese medicinal suppository for treating mammal endometritis and a preparation method thereof. The Chinese medicinal suppository effectively solves the problems of residue, resistance and poor effect of an antibacterial medicament. The Chinese medicinal suppository is characterized by being prepared from the following raw materials in parts by weight: 1 to 5 parts of eucalyptus oil, 1 to 5 parts of glycerol, and 90 to 98 parts of polyoxyethylene monostearate matrix. The preparation method of the Chinese medicinal suppository is characterized by comprising the following steps of: a) heating and melting the polyoxyethylene monostearate matrix, and carrying out heat preservation on the matrix at the temperature of 80 DEG C for later use; b) adding little polyoxyethylene monostearate matrix preserved at the temperature of 80 DEG C in the step a) into 31.25 grams of eucalyptus oil, stirring the eucalyptus oil and the matrix uniformly to obtain liquid I, adding 37.80 grams of eucalyptus oil into the liquid I, stirring uniformly to obtain liquid II, then adding 1,000 grams of polyoxyethylene monostearate matrix into the liquid II, carrying out heat preservation on the liquid at the temperature of 80 DEG C and stirring fully to obtain liquid III; and c) injecting the liquid III into a mold, cooling, and preparing 125 granules of Chinese medicinal suppository.
Description
Technical field
The invention belongs to the veterinary drug technical field, be specifically related to a kind of Chinese medicine suppository that is used for the treatment of mammalian endometritis.
Background technology
Endometritis is common reproductive system disease such as mammal such as milch cow, sow etc., and sickness rate is high.The sickness rate of cow endometritis 20～50%, is the principal disease that causes the milch cow Repeat breeding, accounts for 70% left and right of infertility.During endometritis makes calving cycle stretch-out, milk yield minimizing, medical expense increase and antibiotic therapy, milk is discarded, causes very large economic loss.Gilt Uterus intimitis sickness rate causes oestrus of sow disorderly in 15～30% left and right, Repeat breeding, and lactation amount reduces or agalactia, causes suckling pig to be had loose bowels or dysplasia.
Treatment mammalian endometritis conventional method has at present:
1. injection antimicrobial drug, whole body therapeutic, the blood drug level that arrives the uterus after this method drug absorption is lower, therapeutic effect is undesirable, and antimicrobial drug easily develops immunity to drugs and drug resistance, at Residues in Milk, health is worked the mischief, in sow milk, residual health and growth promoter to piglet causes harmful effect.
2. antimicrobial drug or Cidex-7 solution uterine perfusion, local application, after this method administration, liquid medicine is easily exerted duty by the uterus and is squeezed out, and drug treating time is short, can not give full play to drug action, and administration number of times is many.
Suppository thawing speed after administration is slow, and drug treating time is long, and administration number of times is few, has long-acting effect.Application number is to have announced a kind of Chinese medicinal compound suppository and preparation method thereof in 201010230717.7 " treatment endometritis of livestock Chinese medicinal compound suppository and preparation method thereof ", is comprised of Chinese medicines such as Rhizoma Coptidis, Cortex Phellodendri, Radix Sophorae Flavescentis, Herba Leonuri, Flos Carthami, Radix Angelicae Sinensis, the Radixs Astragali.But this compound preparation component is too many, and effective ingredient is indefinite, and extraction process is complicated, product quality be difficult to control and curative effect unstable, just can reach certain curative effect by three administrations.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of Chinese medicine suppository that is used for the treatment of mammalian endometritis,, drug resistance residual with the antimicrobial drug that overcomes prior art, the shortcoming that effect is undesirable, administration number of times is many.By hypersensitive, muscle irritation, rabbit vagina mucomembranous pungency test and clinical trial, a kind of Chinese medicine suppository that is used for the treatment of mammalian endometritis of the present invention, can reach safety, efficient, purpose drug residue free, that easy to use, administration number of times is few, and main component is clear and definite, and is quality controllable.
For achieving the above object, technical scheme of the present invention is as follows:
A kind of Chinese medicine suppository that is used for the treatment of mammalian endometritis is characterized in that, is made by the raw material of following weight portion: 1～5 part of Oleum Eucalypti, 1～5 part of glycerol, polyoxyethylene monostearate substrate 90-98 part.
As preferably, be used for the treatment of the Chinese medicine suppository of mammalian endometritis, it is characterized in that: the raw material by following weight portion is made: 3.125 parts of Oleum Eucalyptis, 3.780 parts of glycerol, 93.095 parts of polyoxyethylene monostearate substrate.
As preferably, be used for the treatment of the Chinese medicine suppository of mammalian endometritis, it is characterized in that, made by the raw material of following weight portion: 4.688 parts of Oleum Eucalyptis, 2.217 parts of glycerol, 93.095 parts of polyoxyethylene monostearate substrate.
Glycerol of the present invention and polyoxyethylene monostearate (S40) are as plasticizer and the excipient of suppository, Oleum Eucalypti is myrtle Eucalyptus globulus Labill myrtle Eucalyptus globulus Labill Eucalyptus globules Labill., canella Camphor tree Cinnamomum camphor(L.) Presl. or above-mentioned two sections belong to other plant together through the volatile oil of water vapour distillation, are that Chinese veterinary pharmacopoeia (version in 2010) records medical material.Mainly contain eucalyptol (C in Oleum Eucalypti
10H
18O), its content also has the compositions such as limonene, australene greater than 70.0%.The volatile oil main component that the canella Camphor tree is distilled is also eucalyptol, but also contains the toxic components such as safrole.The volatile oil that the myrtle Eucalyptus globulus Labill distills does not contain the toxic components such as safrole.In the present invention's formula, the main component Oleum Eucalypti is the effective ingredient that extracts from the Eucalyptus globulus Labill base of leaf, and this product has obvious heat-clearing and toxic substances removing, antibacterial and anti-inflammation functions.Be used for prevention and the acute and chronic endometritis for the treatment of mammal, vaginitis, retained afterbirth etc.
Be used for the treatment of the preparation method of the Chinese medicine suppository of mammalian endometritis, it is characterized in that:
A) with polyoxyethylene monostearate substrate heating and melting, be incubated 80 ℃ standby,
B) get Oleum Eucalypti 31.25g, add a little above-mentioned polyoxyethylene monostearate substrate of advancing 80 ℃ of insulations in a) in described Oleum Eucalypti 31.25g, after being stirred evenly, both obtain the liquid I, add glycerol 37.80g again in described liquid I, obtain liquid after stirring evenly, then add described polyoxyethylene monostearate substrate 1000g in liquid, be incubated 80 ℃ and fully stir evenly, obtain the liquid III
C) with described liquid III injection molding, cooling, make 125, make Chinese medicine suppository of the present invention.
As preferably, the described Chinese medicine suppository that is used for the treatment of mammalian endometritis is characterized in that, the weight of every suppository is at 8.0g ± 0.4g, and containing eucalyptol is 120mg ± 6mg.
As preferably, described a kind of Chinese medicine suppository that is used for the treatment of mammalian endometritis is characterized in that the Chinese medicine suppository of making is long 8cm, diameter 1cm bullet shaped suppository.
As preferably, the described Chinese medicine suppository that is used for the treatment of mammalian endometritis, Oleum Eucalypti refers to the volatile oil of myrtle Eucalyptus globulus Labill Eucalyptus globules Labill. plants distillation, and Oleum Eucalypti is Eucalyptus Globulus oil, contains eucalyptol (C
10H
18O) 〉=70%(g/g).
As preferably, the described Chinese medicine suppository that is used for the treatment of mammalian endometritis is the medicine that is used for the treatment of mammalian endometritis.
Described a kind of using method that is used for the treatment of the Chinese medicine suppository of mammalian endometritis be to adopt the administering mode of inputting in birth canal, suppository is placed on to push away helps the device top, imports intrauterine by birth canal, and 1 of each administration 1 time on the one, is used in conjunction 2.
Beneficial effect of the present invention:
it is the Eucalyptus Globulus oil of Eucalyptus globulus Labill distillation extraction that the present invention selects Oleum Eucalypti, be natural Chinese medicine, has very long clinical practice historical, and recorded by many editions veterinary drug allusion quotations, make suppository of the present invention, through anaphylaxis, muscle irritation, Vaginal mucosa irritation test, the result safety evaluation all shows well, and natural Chinese medicine raw material and product thereof all can be degraded in natural environment, can not cause environmental pollution, therefore the safety of Chinese medicine suppository that is used for the treatment of mammalian endometritis is good, environmental protection, main active ingredient is Oleum Eucalypti, every heavy 8.0g ± 0.4g, contain eucalyptol 120mg ± 6mg, make the quality controllable of the Chinese medicine suppository that is used for the treatment of mammalian endometritis, Chinese medicine suppository shows the evident in efficacy of Chinese medicine suppository through clinical test results, it is negative that Chinese medicine suppository shows that through clinical test results antibiotics detects, and the nonreactive bacterium is residual, Chinese medicine suppository shows that through clinical test results twice administration cure rate reaches 80%, makes administration number of times few, and medication is convenient.
The specific embodiment
Below in conjunction with implementation column, the specific embodiment of the present invention is elaborated.
Embodiment one
A kind of recipe ingredient of the Chinese medicine suppository that is used for the treatment of mammalian endometritis is as follows: Oleum Eucalypti 31.25g, and glycerol 37.8g, polyoxyethylene monostearate (S40) substrate adds to 1000g, makes 125.Every heavy 8.0g ± 0.4g contains eucalyptol 120mg ± 6mg.
Preparation method is as follows: first with polyoxyethylene monostearate (S40) heating and melting, be incubated 80 ℃ standby.Get Oleum Eucalypti 31.25g, add a little above-mentioned substrate to stir evenly, add glycerol 37.8g to stir evenly, then add substrate to 1000g, be incubated 80 ℃ and fully stir evenly, injection molding, cooling, make 125, and get final product.
Embodiment two
A kind of recipe ingredient of the Chinese medicine suppository that is used for the treatment of mammalian endometritis is as follows: Oleum Eucalypti 46.88g, and glycerol 22.17g, polyoxyethylene monostearate (S40) substrate adds to 1000g, makes 125.Every heavy 8.0g ± 0.4g contains eucalyptol 180mg ± 9mg.
Preparation method is as follows: first with polyoxyethylene monostearate (S40) heating and melting, be incubated 80 ℃ standby.Get Oleum Eucalypti 46.88g, add a little above-mentioned substrate to stir evenly, add glycerol 22.17g to stir evenly, then add substrate to 1000g, be incubated 80 ℃ and fully stir evenly, injection molding, cooling, make 125, and get final product.
The safety evaluatio test of embodiment three Chinese medicine suppository
1. Oleum Eucalypti suppository hypersensitive test
Requirement according to " technological guidance's principle of Chinese medicine, natural drug immunotoxicity (anaphylaxis, photo sensitive reaction) research ", the skin anaphylactic test of taking the initiative method, again through after the sensitivity response of three times, carry out at last provocative reaction, result shows that the allergic symptom of erythema and edema appears in positive controls, shows that reagent and method that experiment is adopted meet the requirements; And the symptoms of allergic such as erythema and edema do not appear in excipient blank group and suppository matched group.This skin experiment result shows that said preparation does not cause the reaction of contact skin paraphilia.
2. Oleum Eucalypti suppository muscle irritation test
get 4 of healthy rabbits, male and female half and half, (tested material is dissolving before injection to sentence aseptic method injection 1ml tested material respectively at a rear flank limb quadriceps femoris, and dry in the air to preference temperature), the opposite side corresponding position with method injecting normal saline 1ml in contrast, inject air in ear vein after 48h lethal, dissect and take out quadriceps femoris, vertically cut, observing injection site muscular tissue changes and estimates by standards of grading, be converted into the respective reaction score value, get fritter muscle as specimen simultaneously around getting muscle entry point, specimen is liquid-solid fixed with BouinShi, make the routine paraffin wax tissue slice, have or not inflammatory to change around observing muscle, have or not degeneration and other pathological changes, carry out histopathologic slide's microscopy.
After result of the test injection Oleum Eucalypti suppository lysate, in 48h, the rabbit health condition is good, and extremity are movable normal, show without pain.Dissect to put to death rear four rabbit quadriceps femoris injection sites and have no obvious congested situation and downright bad situation, result shows, four quadriceps femoris that give four quadriceps femoris of tested material and give normal saline all find no the pathological changes such as inflammatory cell and tissue degeneratiaon.This experiment shows Oleum Eucalypti suppository to muscle thing zest, and the muscular irritation safety evaluatio is good.
3. Oleum Eucalypti suppository is tested the rabbit vagina mucous membrane irritation
Oleum Eucalypti suppository and tester are accomplished high 1cm left and right heavy 1g(rabbit vagina maximum dosage-feeding with blade) conical suppository, as the animal experiment medication.Get test medication 1 during 9:00 every day, puts into rabbit vagina, observes animal clinical manifestation (as pain symptom etc.) and vaginal secretions (as blood, mucus) and animal dead situation after administration.Decontrol rabbit after fixing 4 hours after administration, 1 times/day, continuous 7 days.After last administration 24 hours, put to death animal, dissect and take out the vagina specimen, vertically cut, the perusal mucosa has or not the phenomenons such as hyperemia, swelling.Simultaneously with every rabbit vagina tissue, fixedly more than 24h, choose the middle part through dehydration, embedding, section and HE dyeing with 10% formalin, carry out histopathological examination at microscopically after film-making.
Administration is by observation, and administration group, matched group rabbit all find no pain symptom and the clinical manifestations such as vaginal hemorrhage, secreting mucus during administration; And feed intake is normal.Dissect the vagina specimen, perusal, each rabbit vagina mucosa of administration group and matched group is ruddy, smooth, except administration group and matched group respectively have a specimen to see a small amount of secretions, has no the pathological changes such as edema, hemorrhage, rotten to the corn, ulcer.This vaginal mucomembranous irritant test result shows, cervicitis disappears Oleum Eucalypti suppository to rabbit vagina mucosal tissue nonirritant.
The stability test of embodiment four suppositorys
1. room temperature reserved sample observing test:
Test site is Jinhua, Zhejiang, and minimum monthly mean temperature is 4 ℃, and approximately 29 ℃ of the highest monthly mean temperatures, average temperature of the whole year are about 17 ℃.Sample listing packing is placed in the stability test case, takes a sample respectively in the stipulated time, data measured sees Table 1.
Table 1:
2. hot accelerated test:
Sample listing packing under 40 ℃, relative humidity 75% condition, was placed 6 months respectively, distinguished per month sampling and measuring, the results are shown in Table 2.
Table 2:
3. acceleration by light test:
Sample is placed in the water white transparency container, and (under 4500 ± 500LX), range is 15cm approximately, places 10 days, detects sampling in 5,10 days respectively to be placed on clear and bright detection lamp.Result of the test sees Table 3.
Table 3:
Conclusion (of pressure testing): show from room temperature reserved sample observing, heat acceleration and acceleration by light result of the test, content is all without significantly changing.
The clinical trial of embodiment five suppositorys to cow endometritis
50 Fresians of suffering from endometritis are divided into 5 groups, every group of 10 cases at random.Group 1～3: every cattle is dropped into respectively 1 of Oleum Eucalypti suppository, 2,3 at every turn in cavity of uterus, every day 1 time, treated continuously 2 days; Group 4: with chlorhexidine acetate bolt (cattle type), every cattle is dropped into 2 at every turn in cavity of uterus, treated continuously 2 days positive medicine matched group every day 1 time; Group 5: for the blank group, do not treat.Observe uterus secretions character and carry out bacteriological analysis with rear 1,2 weeks for the treatment of before treatment, the tenderly white cellular change of detection blood is with antibacterial medicine residue in milk after ECLIPSE 50 test kits inspection drug withdrawals.
1. uterus secretions character observation result:
Group 1～4 had 50%～70% milch cow in 1 week after drug withdrawal, had 70%～80% milch cow to be transferred to normally by muddy, stench after drug withdrawal in 2 weeks; Only have 1 cattle to transfer to normally and organize 5; Oleum Eucalypti suppository group and chlorhexidine acetate bolt group be zero difference relatively.
2. uterus secretions bacterioscopy result:
In group 1～4 1 week after drug withdrawal, every group of the milch cow of the bacteriology checking positive is down to respectively 5 (1 group), 4 (2 groups), 4 (3 groups) and 5 (positive drug group) by 10, all detects antibacterial and organize 5 10 cow heads; 2 weekly checks after drug withdrawal, group 1～4 detects every group of the positive milch cow of antibacterial and is down to respectively 5 (1 group), 3 (2 groups), 2 (3 groups) and 3 (positive drug group) by 10, is down to 9 and organize 5 by 10 cow heads.
3. blood leucocyte testing result:
Group 1～4 blood leucocyte sum, neutrophilic granulocyte, lymphocyte, amount of mononuclear cells all have decline, and organizing 5 has rising trend.
4. comprehensive therapeutic effect:
Character and the bacteriology checking result of comprehensive uterus secretions are judged curative effect, and the cure rate of group 1～5 is respectively: 50%, 70%, 80%, 70% and 10%; Effective percentage is respectively 70%, 80%, 80%, 80% and 10%.
5. drug residue testing result:
3 Oleum Eucalypti suppository in treatment groups do not detect antibacterial medicine residue in treatment within rear 5 days, and the milk that in the positive drug matched group, 2 cow heads produce detected at 1,3,5 day, antibacterial medicine residue all detected.Each group has no the milk outward appearance during treating and after treatment and abnormal smells from the patient has ANOMALOUS VARIATIONS.Conclusion: with the in utero administration of each 1～3 particle of Oleum Eucalypti suppository, every day 1 time, continuous 2 days, cow endometritis there is therapeutical effect, each recommended dose is 2.
Originally studies have shown that at 1～3 Oleum Eucalypti suppository of milch cow intrauterine 1 input every day, treated continuously 2 days, endometritis has been had therapeutical effect.After treatment, uterus secretions is transferred to normally by muddy, smelly, and the bacterium picking out rate of uterus secretions is down to 20%～50% by 100%, and blood leucocyte sum and neutrophilic granulocyte number descend.
The main component of Oleum Eucalypti suppository is eucalyptol (C
10H
18O), Oleum Eucalypti suppository in treatment cow endometritis, convenient drug administration are adopted in this research.Suppository melts in the uterus, is converted into liquid by solid, discharges eucalyptol, brings into play therapeutical effect antibiotic, antiinflammatory.After treatment, blood leucocyte sum and neutrophilic granulocyte descend, and illustrate that inflammation alleviates.And the blood leucocyte of blank group milch cow sum and neutrophilic granulocyte do not descend, and illustrate that inflammation does not alleviate.When chronic infection occured, blood lymphocytes and mononuclear cell increased (Han Bo, 2011).The untreated blank group cow blood lymphocyte number of this research and mononuclear cell are in rising trend, and the endometritis of the blank group of prompting milch cow is to chronic conversion.
This research has detected 30 cow heads of Oleum Eucalypti suppository in treatment with the E50 test kit, after drug withdrawal within 5 days the milk that produces be E50 and detect negatively, illustrate with Oleum Eucalypti suppository in treatment endometritis and can not cause the Residues in Milk antibiotic substance.And with the milk that 10 cow heads of chlorhexidine acetate suppository in treatment produce, have milk that 2 cow heads produce to be the E50 test within 5 days after drug withdrawal positive, illustrating has antibacterial medicine residue in milk.30 cow heads of this research Oleum Eucalypti suppository in treatment and blank group 10 cow heads that do not heal with medicine are E50 and detect negatively, illustrate that these milch cows did not use other antibacterials at duration of test.In addition, each group has no milk abnormal appearance and unusual odor during treating and after treatment, illustrates with Oleum Eucalypti suppository in treatment endometritis and do not cause hazard residue in milk.
Conclusion: with the in utero administration of each 1～3 particle of Oleum Eucalypti suppository, every day 1 time, continuous 2 days, cow endometritis there is therapeutical effect, each recommended dose is 2.
Purpose of the present invention, feature and advantage be in connection with embodiment.To help to understand the present invention by embodiment, but not limit content of the present invention.All distortion that those of ordinary skill in the art can directly derive or associate from content disclosed by the invention all should be thought protection scope of the present invention.
Claims (8)
1. Chinese medicine suppository that is used for the treatment of mammalian endometritis, it is characterized in that: the raw material by following weight portion is made:
1～5 part of Oleum Eucalypti, 1～5 part of glycerol, polyoxyethylene monostearate substrate 90-98 part.
2. be used for the treatment of as claimed in claim 1 the Chinese medicine suppository of mammalian endometritis, it is characterized in that: the raw material by following weight portion is made: 3.125 parts of Oleum Eucalyptis, 3.780 parts of glycerol, 93.095 parts of polyoxyethylene monostearate substrate.
3. be used for the treatment of as claimed in claim 1 the Chinese medicine suppository of mammalian endometritis, it is characterized in that, made by the raw material of following weight portion: 4.688 parts of Oleum Eucalyptis, 2.217 parts of glycerol, 93.095 parts of polyoxyethylene monostearate substrate.
4. be used for the treatment of as claimed in claim 1 the preparation method of the Chinese medicine suppository of mammalian endometritis, it is characterized in that:
A) with polyoxyethylene monostearate substrate heating and melting, be incubated 80 ℃ standby,
B) get Oleum Eucalypti 31.25g, add a little above-mentioned polyoxyethylene monostearate substrate of advancing 80 ℃ of insulations in a) in described Oleum Eucalypti 31.25g, after being stirred evenly, both obtain the liquid I, add glycerol 37.80g again in described liquid I, obtain liquid after stirring evenly, then add described polyoxyethylene monostearate substrate 1000g in liquid, be incubated 80 ℃ and fully stir evenly, obtain the liquid III
C) with described liquid III injection molding, cooling, make 125, make Chinese medicine suppository of the present invention.
5. be used for the treatment of the Chinese medicine suppository of mammalian endometritis described in claim 4, it is characterized in that, the weight of every suppository is at 8.0g ± 0.4g, and containing eucalyptol is 120mg ± 6mg.
6. as a kind of Chinese medicine suppository that is used for the treatment of mammalian endometritis as described in any one claim in claim 5, it is characterized in that, the Chinese medicine suppository of making is long 8cm, diameter 1cm bullet shaped suppository.
7. be used for the treatment of the Chinese medicine suppository of mammalian endometritis described in claim 1, Oleum Eucalypti refers to the volatile oil of myrtle Eucalyptus globulus Labill Eucalyptus globules Labill. plants distillation, contains eucalyptol (C
10H
18O) 〉=70%(g/g).
8. the Chinese medicine suppository that is used for the treatment of mammalian endometritis described in claim 5 is the medicine that is used for the treatment of mammalian endometritis.
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2013
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| JPS57123114A (en) * | 1980-12-19 | 1982-07-31 | Chinoin Gyogyszer Es Vegyeszet | Stable suppository and manufacture |
| CN1448131A (en) * | 2003-04-28 | 2003-10-15 | 浙江大学 | Medicine composition containing alpha-pinene and 1,8-eucalyptol fever-tree oil and use thereof |
| WO2006041527A1 (en) * | 2004-10-04 | 2006-04-20 | Marc Selner | Penetrating carrier, anti-fungal composition using the same and method for treatment of dermatophytes |
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Application publication date: 20130619 |