CN108261440B - Soft capsule for treating postpartum endometritis of sow and preparation method thereof - Google Patents
Soft capsule for treating postpartum endometritis of sow and preparation method thereof Download PDFInfo
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- CN108261440B CN108261440B CN201611262972.3A CN201611262972A CN108261440B CN 108261440 B CN108261440 B CN 108261440B CN 201611262972 A CN201611262972 A CN 201611262972A CN 108261440 B CN108261440 B CN 108261440B
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- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
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Abstract
The invention provides a soft capsule for treating sow postpartum endometritis and a preparation method thereof. The soft capsule consists of a capsule wall material and liquid medicine, wherein the capsule wall material comprises sizing material, a plasticizer, a stabilizer and water in a weight ratio of 100:40-50:3-8:90-100, the liquid medicine consists of chlorhexidine acetate and volatile oil in a ratio of 4:1(w/w), the chlorhexidine acetate part contains 2.5-25wt% of the chlorhexidine acetate and 75-97.5 wt% of pharmaceutical excipients, and the volatile oil part contains 70wt% of the elsholtzia volatile oil and 30wt% of the pharmaceutical excipients. The invention utilizes the synergistic effect of chlorhexidine acetate and the elsholtzia volatile oil to prepare the soft capsule which is applied to the field of veterinary drugs and intrauterine drug delivery and is used for treating the postpartum endometritis of the sow, and the soft capsule has the advantages of short drug melting time limit, quick response, high curative effect, reliable quality and convenient use.
Description
Technical Field
The invention relates to a veterinary drug for treating diseases of female animals, in particular to a new veterinary dosage form for treating sow endometritis, namely a soft capsule and a preparation method thereof.
Background
The sow endometritis is one of main diseases in the pig breeding disorder diseases, and is mainly mucoid and purulent inflammation of uterine mucosa caused by invasion of pathogenic microorganisms into the surface layer or deep layer of the uterine mucosa of a sow, the disease is frequently caused after delivery, if the sick sow cannot be timely and effectively treated, the sick sow is often converted into recessive or chronic infection, the lactation yield is reduced, no milk or poor milk quality is caused, and the suckling piglets are unwilling to suckle, so that the suckling piglets are thin and have poor development; the oestrus cycle is disordered, the breeding is frequently infested, the farrowing is less, the fetus is stilled, the yellow and white dysentery of the suckling pigs and other diseases occur, if the intractable metritis is developed, the elimination rate of the sows is increased, and the sows are easy to secondarily infect other diseases. Statistics shows that in large-scale pig raising production, more than 50% of reproductive diseases of sows are caused by endometritis, and annual factor endometritis eliminated sows account for 48% -50% of the total elimination rate.
The chlorhexidine acetate uterus injection has broad-spectrum antibacterial and bactericidal effects, and is a good medicine for treating endometritis of pig and cattle. The product is an oily suspension packaged by a plastic syringe, and is easy to have the following problems due to prescription and process reasons: 1) the main drug is simply suspended in the oily matrix, the matrix research is not thorough, the dissolution rate of the main drug from the oily matrix is low, and the pharmacological action of the main drug cannot be fully exerted. 2) Delamination, poor redispersibility and easy precipitation and agglomeration at low temperature. After being placed for a long time and layered, the mixture can not be uniformly mixed again to reach a use state; the emulsion breaking is easy to happen at low temperature, the medicine is separated out, and the caking phenomenon occurs. 3) The biocompatibility is poor, and the medicine is easy to precipitate and separate out after being injected into uterus, so that the slow release effect cannot be achieved. 4) When the plastic syringe is packaged and stored for a long time, the part of the piston contacting with the syringe body is easy to deform, so that medicine leakage is caused. In addition, the product has some inconveniences in use, which are mainly shown in that: 1) when in use, the sealed head of the plastic perfusion apparatus needs to be cut off; 2) the oily suspension is fully and uniformly shaken before use; 3) after the medicine is injected, air or warm boiled water needs to be injected again to ensure that the catheter has no medicine residue.
Disclosure of Invention
The invention provides a compound chlorhexidine acetate soft capsule, which is prepared by compounding chlorhexidine acetate and elsholtzia volatile oil, and is a suitable soft capsule prepared in the form of microemulsion solution, the soft capsule has proper elasticity and stable content, overcomes the defects of chlorhexidine acetate uterine injectant, and is used in uterus, and has the advantages of short melting time limit, quick effect, high curative effect, reliable quality and convenient use.
The invention also aims to disclose a preparation method of the chlorhexidine acetate soft capsule preparation.
In order to realize the purpose, the following technical scheme is adopted:
a soft capsule for treating puerperal endometritis of sow comprises capsule wall material and medicinal liquid, wherein the medicinal liquid comprises water soluble part containing chlorhexidine acetate and volatile oil at a ratio of 4:1(w/w), the water soluble part comprises 2.5-25wt% of chlorhexidine acetate, 66-92.5wt% of PEG400 (polyethylene glycol 400), 2-9wt% of propylene glycol and 0-5wt% of glycerol; the volatile oil part consists of 70wt% of elsholtzia volatile oil, 20wt% of water and 10wt% of polyoxyethylene lauryl ether 58.
The water soluble fraction preferably consists of 25wt% chlorhexidine acetate, 66 wt% PEG400 (polyethylene glycol 400), 9wt% propylene glycol.
The soft capsule for treating sow postpartum endometritis comprises capsule wall materials including rubber compound, plasticizer, stabilizer and water according to the weight ratio of 100:40-50:3-8: 90-100.
The sizing material can be gelatin and/or acacia; the plasticizer is one or 2-3 compositions of glycerol, propylene glycol and sorbitol; the stabilizer is PEG 400.
Preferably, the glue is gelatin and the plasticizer is glycerol; the capsule wall material comprises the following components in percentage by mass of 100: 40: 3: 100 of gelatin, glycerol, PEG400 and water.
The invention provides a soft capsule for treating sow postpartum endometritis, wherein the preparation method of the liquid medicine comprises the following steps: (1) water-soluble moiety: uniformly mixing PEG400, propylene glycol and glycerol, heating to 70 ℃, adding chlorhexidine acetate, stirring to dissolve completely, uniformly mixing, and filtering to obtain a water-soluble part;
(2) and (3) volatile oil part: weighing herba Moslae chinensis volatile oil, water and polyoxyethylene lauryl ether 58, and mixing to obtain volatile oil part;
(3) preparing a liquid medicine: adding the volatile oil part into the solution of the water-soluble part at the temperature of 30 ℃ and the stirring speed of 3000r/min to obtain clear and transparent microemulsion. The soft capsule can be prepared by conventional preparation method. The capsule is pressed by a full-automatic rotary steel die pressing machine, the unit dosage of the capsule wall material of each soft capsule contains 0.1-1g of chlorhexidine acetate, preferably 1g, and 0.7g of elsholtzia volatile oil.
The chlorhexidine acetate of the invention has killing effect on gram-positive bacteria, gram-negative bacteria and fungi, but only has bacteriostasis effect on tubercle bacillus, bacterial spores and certain fungi. The elsholtzia volatile oil not only has broad-spectrum antibacterial effect on pathogenic bacteria (such as streptococcus pyogenes, staphylococcus, escherichia coli, proteus, corynebacterium pyogenes, diplococcus septica, clostridium necrotica and the like) of endometritis of mammals, but also has obvious anti-inflammatory effect and direct detoxifying and inactivating effect on endotoxin. The combination of the two can greatly enhance the effect of resisting endometritis.
Compared with the prior art, the invention has the following advantages:
compared with the existing chlorhexidine acetate uterus injectant (oily suspension), the liquid medicine selects the polyethylene glycol as a filling agent, the chlorhexidine acetate has low solubility in the polyethylene glycol but is dissolved in the propylene glycol and the glycerin, the disintegration of the soft capsule can be improved by adding the propylene glycol or the glycerin, so that the glycerin and the propylene glycol are used as a stabilizing agent and also used as a cosolvent, the solubility of the chlorhexidine acetate is increased to form a solution, meanwhile, the volatile oil of herba elsholtziae, which is an effective traditional Chinese medicine extract for endometritis, is selected to be compounded with the volatile oil, the volatile oil and the glycerin are successfully prepared into a clear and transparent microemulsion, the stability is high, the medicine melting time limit is short, the effect is quick, the curative effect is high (the cure rate reaches 91.66%), and the quality is reliable. The curative effect is better than that of the chlorhexidine acetate uterus injectant, the effect is good, the use is more convenient, and a large amount of manpower and material resources are saved.
The chlorhexidine acetate soft capsule is applied to the field of veterinary medicines for the first time, and is used for treating the postpartum endometritis of the sow. The preparation process is simple, the cost is low, and the method is suitable for large-scale industrial production.
Detailed Description
The invention is further illustrated by the following examples.
Example 1:
a preparation method of a soft capsule for treating sow postpartum endometritis comprises the following steps:
(1) 3700g of polyethylene glycol 400(92.5 wt%), 80g of propylene glycol (2 wt%) and 120g of glycerol (3 wt%) are taken, stirred and mixed uniformly, heated to 70 ℃, then 100g of chlorhexidine acetate (2.5 wt%) is added, stirred until complete dissolution is achieved, and the water-soluble part containing the chlorhexidine acetate is obtained after filtration. Weighing 700g of elsholtzia volatile oil (70 wt%), 200g of water (20 wt%) and 100g of polyoxyethylene lauryl ether 58(10 wt%), and uniformly mixing to obtain a volatile oil part. Adding the volatile oil part into the water-soluble part solution at the temperature of 30 ℃ and the stirring speed of 3000r/min to obtain clear and transparent microemulsion.
(2) 100 parts of gelatin, 90 parts of purified water, 8 parts of PEG400 and 50 parts of glycerol are taken. Adding glycerol, purified water and PEG400 into a gelatin melting tank, stirring and heating to 50-60 ℃; then adding gelatin powder at uniform speed under stirring, heating to 70 deg.C, stirring well after gelatin is dissolved, pumping to vacuum for degassing to obtain gelatin solution, maintaining at 55-60 deg.C, and standing for use.
(3) Pressing with a full-automatic rotary steel die press, and adjusting the content of medicinal liquid in each capsule to 5g to obtain chlorhexidine acetate soft capsule. Each granule contains chlorhexidine acetate 0.1g and herba Moslae volatile oil 0.7g, and the melting time is 36 min.
Example 2:
a preparation method of a soft capsule for treating sow postpartum endometritis comprises the following steps:
(1) 3100g of polyethylene glycol 400(77.5 wt%), 200g of propylene glycol (5 wt%) and 200g of glycerol (5 wt%) were mixed by stirring, heated to 70 ℃, added with 500g of chlorhexidine acetate (12.5 wt%), stirred until completely dissolved, and filtered to obtain a water-soluble fraction containing chlorhexidine acetate. 700g of elsholtzia volatile oil (70 wt%) is weighed and mixed with 200g of water (20 wt%) and 100g of polyoxyethylene lauryl ether 58(10 wt%) uniformly to obtain a volatile oil part. Adding the volatile oil part into the water-soluble part solution at the temperature of 30 ℃ and the stirring speed of 3000r/min to obtain clear and transparent microemulsion.
(2) Taking 50 parts of gelatin, 50 parts of Arabic gum, 90 parts of purified water, 5 parts of PEG400, 30 parts of glycerol, 10 parts of propylene glycol and 10 parts of sorbitol; adding glycerol, propylene glycol, sorbitol, purified water and PEG400 into a gelatin melting tank, stirring and heating to 50-60 ℃; then adding gelatin and acacia powder at uniform speed under stirring, heating to 70 deg.C, stirring until gelatin and acacia melt, vacuum degassing to obtain gelatin solution, keeping the temperature at 55-60 deg.C, and standing.
(3) Pressing with a full-automatic rotary steel die press, and adjusting the content of medicinal liquid in each capsule to 5g to obtain chlorhexidine acetate soft capsule. When the content of chlorhexidine acetate and herba Moslae volatile oil in each capsule is measured to be 0.5g and the content of herba Moslae volatile oil is measured to be 0.7g, the melting time limit is 28 min.
Example 3:
a preparation method of a soft capsule for treating sow postpartum endometritis comprises the following steps:
(1) 2640g of polyethylene glycol 400(66 wt%) and 360g of propylene glycol (9 wt%) are taken, stirred and mixed uniformly, heated to 70 ℃, then 1000g of chlorhexidine acetate (25 wt%) is added, stirred until the chlorhexidine acetate is completely dissolved, and filtered to obtain the water-soluble part containing the chlorhexidine acetate. 700g of elsholtzia volatile oil (70 wt%) is weighed and mixed with 200g of water (20 wt%) and 100g of polyoxyethylene lauryl ether 58(10 wt%) uniformly to obtain a volatile oil part. Adding the volatile oil part into the water-soluble part solution at the temperature of 30 ℃ and the stirring speed of 3000r/min to obtain clear and transparent microemulsion.
(2) 100 parts of gelatin, 100 parts of water, 3 parts of PEG400 and 40 parts of glycerol are taken. The other operations were the same as in preparation example 1.
(3) Pressing with a full-automatic rotary steel die press, and adjusting the content of the medicinal liquid to 5g per capsule to obtain chlorhexidine acetate soft capsule. Each granule contains chlorhexidine acetate 1g and herba Moslae volatile oil 0.7g, and the melting time limit is 23 min.
Clinical efficacy contrast test
Test material
Test animal
300 sows with different degrees of endometritis are judged to have the weight of about 60 kg. The injection is divided into two groups, 150 heads each, one group is a chlorhexidine acetate uterus injection group, and the other group is a compound chlorhexidine acetate soft capsule group.
The test method comprises the following steps:
the compound chlorhexidine acetate soft capsule group comprises: the soft capsule of the embodiment 3 of the invention is used for treatment, and the medicine is used in the uterus: the preparation is administered 1 granule at a time, and is administered repeatedly for 1 time every 3 days, and for 4 times.
Chlorhexidine acetate injectant group: treatment with commercially available chlorhexidine acetate injectant, intrauterine administration: one tablet at a time, and the medicine is repeatedly administered for 1 time every 3 days, and is continuously administered for 4 times.
Determination of clinical efficacy
After the first administration, the sow is observed for the whole body condition for 30 days continuously, and the treatment effect of the test group is judged according to the cure rate, the effective rate and the ineffective rate. The cure rate means that after treatment, the mental state, the body temperature and the appetite of the sows are recovered to be normal, the vagina is not red and swollen, and inflammatory secretion and pus are not discharged inside the vagina, so that the sows are cured; the effective rate refers to the sum of the number of sows which are completely recovered and obviously improved after healing. The obvious improvement means that the mental state, the body temperature and the appetite of the sow are basically recovered to be normal, certain secretion flows out but is relatively transparent and clear, and no pus is discharged; the inefficiency means that the mental state, the body temperature and the appetite of the sow are not recovered to be normal, and inflammatory pus is still discharged in the uterus.
Therapeutic results
The following table shows the comparison of the therapeutic effects of the two groups
As can be seen from the table, the cure rate and effective rate of the sows in the compound chlorhexidine acetate soft capsule group are obviously higher than those of the sows in the chlorhexidine acetate uterine injectant control group. Therefore, the compound chlorhexidine acetate soft capsule of the invention has good curative effect and good curative effect.
Examples are: 60 sows are in a Nanchong pig farm of Tianhao livestock technology Limited, Chuanzhou province, 12 months and 6 days in 2015, the body temperature is increased to different degrees, the mind is not vibrated, the appetite is reduced or abolished, the reason is often taken with great care, particularly when the sows are just laid down, white mucus or odorous dirty reddish brown mucus or purulent secretion flows out of the vagina, and the secretion is adhered to the tail root part and smells smelly. The soft capsules of example 3 were fed to 60 sows, 1 capsule at a time, and the administration was repeated 1 time every 3 days for 4 times in succession, according to the bed symptoms and the test methods to confirm the diagnosis of endometritis in sows. The cure rate is 91.66%, the effective rate reaches 95%, and the disease does not relapse after half a year of follow-up visit.
Claims (3)
1. A soft capsule for treating sow postpartum endometritis is composed of a capsule wall material and a liquid medicine, and is characterized in that: the liquid medicine consists of a water-soluble part containing chlorhexidine acetate and a volatile oil, the ratio of the water-soluble part to the volatile oil is 4:1w/w, and the water-soluble part: mixing 66-92.5wt% of PEG400, 2-9wt% of propylene glycol and 0-5wt% of glycerol uniformly, heating to 70 ℃, adding 2.5-25wt% of chlorhexidine acetate, stirring until completely dissolved, mixing uniformly, filtering to obtain water-soluble part,
the volatile oil part consists of 70wt% of elsholtzia volatile oil, 20wt% of water and 10wt% of polyoxyethylene lauryl ether 58,
the capsule wall material comprises rubber material, plasticizer, stabilizer and water in a weight ratio of 100:40-50:3-8:90-100, wherein the plasticizer is one of glycerin, propylene glycol and sorbitol or a composition of 2-3, and the stabilizer is PEG 400.
2. The soft capsule for treating sow postpartum endometritis according to claim 1, characterized in that: the sizing material is gelatin and/or Arabic gum.
3. The soft capsule for treating sow postpartum endometritis according to any one of claims 1-2, characterized in that: the unit dosage of the capsule wall material contains chlorhexidine acetate 0.1-1g, and herba Moslae volatile oil 0.7 g.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201611262972.3A CN108261440B (en) | 2016-12-30 | 2016-12-30 | Soft capsule for treating postpartum endometritis of sow and preparation method thereof |
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| CN201611262972.3A CN108261440B (en) | 2016-12-30 | 2016-12-30 | Soft capsule for treating postpartum endometritis of sow and preparation method thereof |
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| CN108261440A CN108261440A (en) | 2018-07-10 |
| CN108261440B true CN108261440B (en) | 2020-10-27 |
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| CN110075156B (en) * | 2019-05-20 | 2021-10-15 | 武汉国粹医药科技有限公司 | Elsholtzia ciliata microcapsule, preparation method thereof and application of elsholtzia ciliata microcapsule |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1463699A (en) * | 2002-06-07 | 2003-12-31 | 北京立时达药业有限公司 | A composition for treating animal endometritis |
| CN103040931A (en) * | 2012-11-19 | 2013-04-17 | 王丽君 | Chinese medicinal preparation for treating endometritis of mammal |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1463699A (en) * | 2002-06-07 | 2003-12-31 | 北京立时达药业有限公司 | A composition for treating animal endometritis |
| CN103040931A (en) * | 2012-11-19 | 2013-04-17 | 王丽君 | Chinese medicinal preparation for treating endometritis of mammal |
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