Summary of the invention
The object of the present invention is to provide the gynostemma pellet preparation and the method for preparing that are used to prevent and treat bovine subclinical mastitis; Produce through leukocyte increasing number, enhancing T cell, promotion macrophage, reach the purpose that improves immunity, prevention and treatment latent mammitis, curative effect height, drug residue free; Adopt pellet preparations technology, can make medicine have the sustained-release and controlled release ability, release is stable, and bioavailability is high.
Technical scheme of the present invention is:
Be used to prevent and treat the gynostemma pellet preparation of bovine subclinical mastitis, be prepared from following materials of weight proportions: Herb Gynostemmae Pentaphylli 10-50 part,, starch 1-50 part, dextrin 1-50 part, cellulose acetate 1-10 part, polyethylene glycol 1500 1-5 part.
The present invention also provides the method for preparing of the gynostemma pellet preparation that is used to prevent and treat bovine subclinical mastitis, comprises the steps:
Take by weighing the raw material that contains above-mentioned weight ratio; Herb Gynostemmae Pentaphylli powder is broken into fine powder adds 20 times of 80% ethanol, put 90 ℃ of supersound extraction 1h in the ultrasonic extraction extractor, extract altogether 3 times, merging filtrate reclaims ethanol, and vacuum drying promptly gets Herb Gynostemmae Pentaphylli and extracts powder; Cellulose acetate and polyethylene glycol 1500 are added an amount of dissolve with ethanol make into coating solution; Herb Gynostemmae Pentaphylli is extracted powder and starch, dextrin mix homogeneously, cross 20 mesh sieve system wet granulars, put wet granular in the coating pan behind the rolling 10-30min with 70% alcoholic solution; Uncap, heat 60 ℃, rolling 1h; Take out micropill and put drying in oven, more exsiccant micropill is put into coating pan, spray into coating solution; Coating until coating weightening finish 10%-20%, promptly gets gynostemma pellet.
Advantage of the present invention and beneficial effect are: through the leukocyte increasing number, strengthen the T cell, promote macrophage to produce, reach raising immunity, prevention and treatment mastitis have the drug effect height, have no side effect, the advantage of noresidue; Adopt cellulose acetate and polyethylene glycol 1500 as micropill microporous membrane coating material; Water can penetrate microporous membrane; Dissolving medicine wherein forms the saturated solution of medicine, in micropill, reach the sustained-release and controlled release effect through micropore to external diffusion release, and release is stable; Bioavailability is high, can reach 5-6h at gastric transit time.
The specific embodiment
Describe the present invention for example below.
Embodiment 1:
By weight taking by weighing 50 parts of Herb Gynostemmae Pentaphylli, 30 parts of starch, 20 parts in dextrin, 7 parts of cellulose acetate, 2.5 parts of polyethylene glycol 1500s.Herb Gynostemmae Pentaphylli powder is broken into fine powder adds 20 times of 80% ethanol, put 90 ℃ of supersound extraction 1h in the ultrasonic extraction extractor, extract altogether 3 times, merging filtrate reclaims ethanol, and vacuum drying promptly gets Herb Gynostemmae Pentaphylli and extracts powder; Cellulose acetate and polyethylene glycol 1500 are added an amount of dissolve with ethanol make into coating solution; Herb Gynostemmae Pentaphylli is extracted powder and starch, dextrin mix homogeneously, cross 20 mesh sieve system wet granulars, put wet granular in the coating pan behind the rolling 10-30min with 70% alcoholic solution; Uncap, heat 60 ℃, rolling 1h; Take out micropill and put drying in oven, more exsiccant micropill is put into coating pan, spray into coating solution; Coating until coating weightening finish 10%-20%, promptly gets gynostemma pellet.
Embodiment 2:
By weight taking by weighing 20 parts of Herb Gynostemmae Pentaphylli, 50 parts of starch, 25 parts in dextrin, 8 parts of cellulose acetate, 3 parts of polyethylene glycol 1500s.Herb Gynostemmae Pentaphylli powder is broken into fine powder adds 20 times of 80% ethanol, put 90 ℃ of supersound extraction 1h in the ultrasonic extraction extractor, extract altogether 3 times, merging filtrate reclaims ethanol, and vacuum drying promptly gets Herb Gynostemmae Pentaphylli and extracts powder; Cellulose acetate and polyethylene glycol 1500 are added an amount of dissolve with ethanol make into coating solution; Herb Gynostemmae Pentaphylli is extracted powder and starch, dextrin mix homogeneously, cross 20 mesh sieve system wet granulars, put wet granular in the coating pan behind the rolling 10-30min with 70% alcoholic solution; Uncap, heat 60 ℃, rolling 1h; Take out micropill and put drying in oven, more exsiccant micropill is put into coating pan, spray into coating solution; Coating until coating weightening finish 10%-20%, promptly gets gynostemma pellet.
Embodiment 3:
By weight taking by weighing 40 parts of Herb Gynostemmae Pentaphylli, 30 parts of starch, 30 parts in dextrin, 4 parts of cellulose acetate, 1.5 parts of polyethylene glycol 1500s.Herb Gynostemmae Pentaphylli powder is broken into fine powder adds 20 times of 80% ethanol, put 90 ℃ of supersound extraction 1h in the ultrasonic extraction extractor, extract altogether 3 times, merging filtrate reclaims ethanol, and vacuum drying promptly gets Herb Gynostemmae Pentaphylli and extracts powder; Cellulose acetate and polyethylene glycol 1500 are added an amount of dissolve with ethanol make into coating solution; Herb Gynostemmae Pentaphylli is extracted powder and starch, dextrin mix homogeneously, cross 20 mesh sieve system wet granulars, put wet granular in the coating pan behind the rolling 10-30min with 70% alcoholic solution; Uncap, heat 60 ℃, rolling 1h; Take out micropill and put drying in oven, more exsiccant micropill is put into coating pan, spray into coating solution; Coating until coating weightening finish 10%-20%, promptly gets gynostemma pellet.
The gynostemma pellet preparation of control mammitis of cow is carried out following test:
1, content of effective determination test:
Herb Gynostemmae Pentaphylli mainly contains Saponin, polysaccharide, flavone, aminoacid, vegetable protein, materials such as alcohol, pigment, organic acid, cellulose, chlorophyll, trace element now.Gypenoside has the ability of enhancing human body immunity power widely; And can suppress rejection obviously the leukocyte increasing number, improve the T lymphocyte, strengthen splenocyte breeder reaction, the T cell in the mixed lymphocytes is had potentiation, and can promote to secrete macrophage.Have the tumor of inhibition, defying age, blood fat reducing, enhancing immunity and protection action of the heart.
Gypenoside has the dammarane type four-ring triterpenoid structure identical with the ginsenoside for the summation of the multiple Saponin that extracts, so be that the standard substance analysis is analyzed three batches of finished products with ginsenoside Rb1.
Lot number |
Total saponin content g/g |
RSD% |
080201 |
0.276 |
1.21 |
080202 |
0.275 |
1.32 |
080203 |
0.271 |
1.18 |
Above-mentioned three batches of preparations are same preparation technology embodiment product, and every g finished product contains Herb Gynostemmae Pentaphylli crude drug 6g, and the Herb Gynostemmae Pentaphylli crude drug contains total Saponin amount and is approximately 4%-6%.Can reach a conclusion by last data: owing to adopted ultrasonic extraction that extraction ratio can be reached more than 4.5% on the technology of the present invention, not loss basically, effective component extraction rate is high, and process stabilizing is reliable.
2, controlled release dissolution test
Get three batches of preparation lot numbers 080201,080202,080203 of the present invention and be test group; By same preparation process, not carrying out controlled-release material coating process is produced three batches of products is matched group lot number 001,002,003 in addition.Carry out assay by quality standard respectively, draw the effective ingredient total saponin content of gynostemma pentaphyllum.By " People's Republic of China's veterinary drug allusion quotation 2005 editions " slow release, controlled release and slowbreak preparation guideline, the test of vitro drug release degree, put in the dissolution appearance every at a distance from 30min sampling carrying out assay with survey total content and compare and confirm medicine stripping percentage ratio.
Test group and matched group dissolution determination be % as a result
Conclusion: can know that from above-mentioned test data matched group does not carry out controlled release coat, medicine reaches about 2 hours and discharges the peak; Test group peaks at 5-6h through the controlled-release material coating, and drug release is even gently, can be near the constant release medicine.This is owing to adopting the microporous membrane coating material on the technology when medicine contacts with gastro-intestinal Fluid; The water solublity porogen that exists on the film is met the water section dissolving or is come off; On coating membrane, form sightless micropore of countless naked eyes or crooked trail, make the clothing film have permeability, the liquid in the gastrointestinal tract infiltrates in the film through these micropores; The medicine of solution tablet in-core arrives to a certain degree; The drug solution of sheet in-core just produces certain osmotic pressure, because the difference of the inside and outside osmotic pressure of film, drug molecule just discharges to the film external diffusion through these micropores.Medicine descends the osmotic pressure in the sheet to the result of film external diffusion, and moisture is again to get into dissolved substance in the film, so repeatedly, as long as there is sink condition in medicine inside and outside keeping saturated concentration and film in the film, then can obtain zero level or near the drug release of zero level speed.Coating membrane is not destroyed in gastrointestinal tract, is excreted by intestinal at last.
3, stability test: the condition held 12 months that three batches of products is packaged in 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10% by finished product; Sampling in per 3 months once detected by stable high spot reviews project respectively at 0 month, 3 months, 6 months, 9 months, 12 months.After 12 months, carry out outward appearance, content detection respectively at sampling in 18 months, 24 months.
Conclusion: character of the present invention, content are all very stable, meet " People's Republic of China's veterinary drug allusion quotation 2005 editions " related request.
4, safety testing
Mouse gavaging preparation 10g/kg of the present invention is equivalent to 100 times of the positive usual amounts of milch cow, does not have dead in 72 hours; Feed 10g/kg every day, be equivalent to 100 times of the positive usual amounts of milch cow, continuous 1 month, ordinary circumstance, body weight gain, food-intake, blood, routine urinalysis and pathology blood examination were looked into all no abnormal.
5, the control mammitis of cow test of pesticide effectiveness
1. test method: Fructus Pruni forestry and animal husbandry cattle farm is used California, USA mammitis of cow detectable (CMT) to detect to choose " ++ " below negative and suffer from 200 of latent mammitis cows in milk in Harbin, is divided into test group and matched group, every group respectively 100.Feed with a kind of feedstuff two groups of every days, and test group adds feeds preparation 50g/ day/head of the present invention, logotype 5 days.Use CMT to detect after January.
Conclusion: 57 of negative cattle, 43 of ill cattle before the matched group test, 54 of the negative cattle in test back, 46 of ill cattle do not see and take a favorable turn.58 of negative cattle, 42 of ill cattle before the test group test, 92 of the negative cattle in test back, 8 of ill cattle, negative conversion rate 81.0%.Samely feed, under the condition of environment; Explain that the present invention has fairly obvious preventive effect to mammitis of cow; Test group detects ill cattle and has turned out cloudy or alleviated disease in various degree after test, explain that the present invention is remarkable in effect aspect the latent mammitis treatment.And what the present invention used is the natural medicinal plant extract; With Herb Gynostemmae Pentaphylli total glycosides enhancing human body immunity power is the mechanism of action; Pharmacology is clear and definite; Bioavailability is high, Drug resistance, the drug residue of having avoided simultaneously using antibiotic to bring, abandons damnous shortcoming of milk phase, and milk cattle cultivating is already had huge economic and social benefit.