CN101342231A - Ultramicro powder formulation of strengthen the body resistance detoxication powder and preparation method thereof - Google Patents
Ultramicro powder formulation of strengthen the body resistance detoxication powder and preparation method thereof Download PDFInfo
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- CN101342231A CN101342231A CNA2008101369357A CN200810136935A CN101342231A CN 101342231 A CN101342231 A CN 101342231A CN A2008101369357 A CNA2008101369357 A CN A2008101369357A CN 200810136935 A CN200810136935 A CN 200810136935A CN 101342231 A CN101342231 A CN 101342231A
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Abstract
The invention relates to a submicron powder preparation of healthy-strengthening toxicidum and a preparation method thereof. Raw materials of radix isatidis and raidx astragail, epimedium herb are parched until the water content of the raw materials is below 6 percent; the raw materials are grinded by a plant grinder to obtain the coarse powder of the raw materials; the coarse powders of the radix isatidis, the raidx astragail and the epimedium herb are evenly mixed together by a weight percentage of 2:2:1; the mixed powder and air that is frozen and dried are poured into an atomizer; high pressure draft is adopted to break cell wall and the mixed powder is grinded below 15Mum; and after being frozen and dried, the temperature of the air is below 10 DEG C. That the invention can release the effective components of Chinese medicine totally is beneficial to absorption and improving the control efficiency and the bioavailability of the medicine. Therefore, the invention solves problems that the conventional powder of the healthy-strengthening toxicidum is difficult to be released and has the low bioavailability. In addition, the healthy-strengthening toxicidum has high cell wall-breaking rate and is easy to be absorbed with the improvement of the bioavailability and a curative effect.
Description
(1) technical field
What the present invention relates to is a kind of medicine for animals, specifically a kind of ultrafine preparation of Fuzheng Jiedu powder.
(2) background technology
Chinese herbal medicine is abundant in china natural resources, and is cheap.For chemical synthetic drug, Chinese herbal medicine has plurality of active ingredients, not only have toxicity low, be difficult for having side effects, many target spots, pathogenic microorganism be difficult for producing chemical sproof advantage to it, and in anti-bacteria and anti-virus, can also promote growth of animal, strengthen the immune function of animal, improve body disease-resistant power.At present, the resisiting influenza virus Chinese herbal medicine great majority of domestic research are diaphoretic medicine and antipyretic and are the Chinese patent medicine that principal agent is formed with them, receive the concern of Chinese scholars.
Superfine communication technique is a kind of material New Machining Technology that produces for the development that adapts to modern high technology after the seventies in 20th century.This technology can be crushed into material the superfines below the 15 μ m, even can reach nanoscale, has that processing is pollution-free, original chemical property of keeping material, pulverizes precision height, characteristics that the powder body moulding is good.After adopting the Chinese medicine ultra-fine powder administration to reach cell wall breaking, the effective ingredient in the medical material can fully discharge, and surface area increases, and effective ingredient increases at the gastrointestinal dissolubility, and drug dose is few, instant effect, short treating period.
The extensive manufacturing process of Chinese medicine can not adapt to current people's requirement in the past, expansion and extension along with ultra tiny technology, the exploitation curative effect is more outstanding, and the more excellent ultra tiny Chinese traditional powder of quality will form good development momentum, and this will produce impetus to the control that improves disease.
Infectious bursal disease (IBD) is the multiple infectious disease of harm poultry husbandry.Fuzheng Jiedu powder is Cheng Fang in the veterinary drug allusion quotation, cures mainly infectious bursal disease.Chinese medicine powder normal usual manner that adopts in poultry disease prevention and control is pulverized (low speed pulverizing) administration, because the intestinal of chicken is shorter, medicine is compared very short gastral by the time with domestic animal, low to cellulosic digestion power, the digestive enzyme in the Digestive system can only leach the seldom a part of effective ingredient in the medicine under the influence of drug cell wall, the absorption rate of medicine is low, the per weight consumption is big, and it is slow to take effect, and causes very big waste.Therefore the present invention develops the superfine powder novel form of Fuzheng Jiedu powder and the new veterinary drug of effectively treating IBD.Both can shorten the R﹠D cycle of new veterinary drug, reduce the research and development expense; Also effectively reduce the use amount of Chinese medicine, save a large amount of medical materials; Simultaneously also opened up a new road for the effectively preventing infectious bursal disease.
The Chinese traditional patent formulation powder that Fuzheng Jiedu powder records for " Chinese veterinary drug allusion quotation " cures mainly infectious bursal disease, and there is certain effect this one-tenth side to avian viral disease.But traditional powder have discharge slow, absorption difference, shortcoming such as bioavailability is low, consumption is big.
(3) summary of the invention
The object of the present invention is to provide a kind of have effective ingredient dissolving and discharge fast, good absorbing, a kind of ultrafine preparation of the Fuzheng Jiedu powder of bioavailability advantages of higher.The present invention also aims to provide a kind of effective percentage that can improve Fuzheng Jiedu powder, in the clinical service life of prolong drug, make the preparation method of a kind of ultrafine preparation of the Fuzheng Jiedu powder that the Chinese material medicine resource of China is fully used.
The object of the present invention is achieved like this:
It is with the crude drug oven dry of Radix Isatidis, the Radix Astragali, Herba Epimedii, makes water content below 6%, carries out the coarse powder that coarse pulverization acquires each crude drug with the plant pulverizer; Then with the coarse powder of Radix Isatidis, the Radix Astragali, Herba Epimedii by behind 2: 2: 1 the part by weight mix homogeneously, inject super micron mill jointly with air after lyophilization, be crushed to the following resulting product of 15 μ m after adopting high pressure draught to make cell wall breaking.
Fuzheng Jiedu powder ultramicro powder of the present invention is to adopt such method to prepare:
With the crude drug oven dry of Radix Isatidis, the Radix Astragali, Herba Epimedii, make water content earlier, carry out the coarse powder that coarse pulverization obtains each crude drug with the plant pulverizer below 6%; After then the coarse powder of Radix Isatidis, the Radix Astragali, Herba Epimedii being pressed 2: 2: 1 part by weight mix homogeneously, inject super micron mill jointly with the air after lyophilization, be crushed to below the 15 μ m after adopting high pressure draught to make cell wall breaking, the air themperature after the lyophilization will be below 10 ℃.
Recommend the clinical treatment of Fuzheng Jiedu powder micropowder preparation to be: therapeutic dose is 1% concentration mixed feeding, free choice feeding drinking-water, logotype 5 days; Preventive dose is 0.5% concentration mixed feeding, logotype 3-5 days.
The superfine powder that the experiment proved that Fuzheng Jiedu powder of the present invention has following characteristics:
1. product of the present invention is to adopt cell wall breaking technology to produce, process pollution-free, as to keep material original chemical property, pulverize the precision height, the powder body moulding is good, after the micronizing, generally need not decoct leaching just directly preparation so both can reduce the loss of effective ingredient, improve the utilization rate of medical material, can reduce the waste of resource again.
2. micronizing of the present invention is pulverized under low temperature state, no superheating phenomenon, and pulverizing speed is fast, and retains biological activity material and nutritional labeling so to greatest extent, micronization can improve the nutrition and the medical value of Fuzheng Jiedu powder.
3. product of the present invention proves the result of the test of preventing and treating of infectious bursal disease, the Fuzheng Jiedu powder ultramicro powder is certain to the prevention and the therapeutic effect of infectious bursal disease, significantly be better than infecting matched group, product of the present invention just can reach prevention or the therapeutic effect identical with the powder of Fuzheng Jiedu powder with half dosage of powder, has saved medical material and drug cost.
4. behind bursal disease virus infected chicken product of the present invention for oral administration and the powder, show the slower characteristics of elimination, absorption rate is variant, compares with powder, and the intravital absorption of product chicken of the present invention is very fast, and it is also very fast to distribute.Behind the superfine powder and powder of chicken Fuzheng Jiedu powder for oral administration, the relative bioavailability (F)=160.5% of the relative bioavailability of main component polysaccharide (F)=123.6%, indirubin.Superfine powder compares with powder that to have a peak time very fast, and bioavailability is higher relatively, the characteristics that maximum peak concentration is higher.
The These characteristics of Fuzheng Jiedu powder ultramicro powder preparation draws by following test:
1. the experimental study of product control infectious bursal disease of the present invention
Feed to blue chicken 300 plumages in 24 ages in days non-immune health sea, male and female half and half are divided into 10 groups at random, every group 30 plumage.Normal healthy controls group 30 plumages wherein, isolated rearing, free choice feeding guarantees competent drinking-water.Each is organized to observe after 48 hours before test and weighs, detect female original antibody negative after, adopt the definite method of prerun test to carry out counteracting toxic substances to I～IX group experimental animal.The dosage of powder matched group is to design by the dosage of advising in the pharmacopeia.Each group of micropowder is all added dose (seeing Table 1) by chicken feeding feed stuff every day amount.
By antibody titer, immune organ index, antibody positive rate in mortality rate, the serum and cut open the action effect that several respects indexs such as inspection variations, histology's variation carry out comprehensively comparing Chinese medicine ultra-fine powder (at certain dosage range) dosage form and powder.
Table 1 grouping and control dosage
The prevention experimental result shows: the sickness rate of Fuzheng Jiedu powder ultramicro powder height (1% Chinese medicine spice), middle dosage group (0.5% Chinese medicine spice) is respectively 26.67%, 33.33%, mortality rate is respectively 10%, 13.30%, can obviously reduce the M ﹠ M of infectious bursal disease, and infect matched group (mortality rate is 46.67%) difference extremely significantly (P＜0.01).At aspects such as weightening finish, antibody response positive rate, immune organ damage ratios, its effect all is significantly higher than superfine powder low dose group (0.25% Chinese medicine spice) (P＜0.05), and is good or suitable slightly with powder matched group (the 1% Chinese medicine spice) effect of comparing.Show that Fuzheng Jiedu powder ultramicro powder 0.5% Chinese medicine spice amount is equivalent to the action effect of powder 1% Chinese medicine spice amount, saved medical material and increased the preventive effect of medicine.
Therapeutic test is the result show: behind the Hai Lanfei immunized chicks artificial challenge infectious bursal disease of 180 24 ages in days, application Fuzheng Jiedu powder ultramicro powder high dose group (2% Chinese medicine spice), middle dosage group (1% Chinese medicine spice), low dose group (0.5% Chinese medicine spice) spice are fed continuous use 5 days.Wherein superfine powder height, middle dosage group are better to infectious bursa of Fabricius virus treatment of infection effect, and significantly be better than micropowder low (0.5% Chinese medicine spice) dosage group and infect matched group (P＜0.05), with powder matched group (2% Chinese medicine spice) effect quite or good slightly, show that the therapeutic effect of Fuzheng Jiedu powder ultramicro powder 1% Chinese medicine is equivalent to the therapeutic effect of powder 2% Chinese medicine, saved medical material and increased the therapeutic effect of medicine.
Superfine powder height, higher relatively 3.6log2, the 3.4log2 of being respectively of middle dosage group antibody horizontal, the height of antibody horizontal has direct relation with Radix Astragali content and the two-way immunomodulating of the Radix Astragali.The antibody positive rate of micropowder high dose group is up to 80%, mortality rate be minimum be 6.67%.The result shows that the positive rate of antibody is high more, and mortality rate is low more.After infecting infectious bursa of Fabricius virus, fabricius bursa is destroyed, and compensatory weightening finish has appearred in spleen, and the micropowder height, middle dosage group spleen index is higher is respectively 3.39,2.93, illustrate that micropowder height, middle dosage group are better relatively to the effect that this compensatory increases weight.Simultaneously micropowder height, middle dosage can alleviate the pathological changes of immune organs such as disease chicken bursa and spleen significantly, and lower limb flesh is hemorrhage, kidney is hemorrhage and enlargement etc., all is lighter than other each groups.
According to results of pharmacodynamic test, clinical recommendation using dosage is: therapeutic dose is 1% concentration spice, free choice feeding drinking-water, logotype 5 days; Preventive dose is 0.5% concentration spice, 3d administration in advance.
2. breaking method is to the influence research of characteristics of pharmacokinetics and relative bioavailability
120 chickens on the 28th that infect IBD virus are divided into two groups at random, 60 every group, Fuzheng Jiedu powder powder for oral administration respectively and ultrafine preparation, dosage is 5gKg
-1, wherein five chickens make blank.By predetermined sampling plan, 5min after administration, 15min, 30min, 45min, 60min, 90min, 120min, 240min, 360min, 450min, 720min cut open 5 chickens extremely respectively, gather blood, place the centrifuge tube that is added with heparin sodium aqua, centrifugal, separated plasma is put in-20 ℃ of refrigerators and is saved to mensuration.
With the quantitative and qualitative analysis method of high performance liquid chromatography (HPLC) as indirubin, anthrone-sulphuric acid colorimetry is as the quantitative analysis method of polysaccharide; Adopt MCPKP automatization pharmacokinetic analysis program analysis blood drug level-time data, research Fuzheng Jiedu powder powder and superfine powder thereof are determined the influence of breaking method to pharmacokinetics and bioavailability infecting intravital characteristics of pharmacokinetics of bursal disease virus chicken and the relative bioavailability of the two.Result of study shows: the oral Fuzheng Jiedu powder powder of chicken (5gKg
-1) after, the data fit one-level absorbs the open model in two Room during the blood plasma of polysaccharide-medicine, and its major impetus mathematic(al) parameter is: C
Max=8.57 μ gmL
-1, AUC=2864.4mgKg
-1Min
-1, Tp=66.83min, Tcp=1031.8min; The data fit one-level absorbs the open model in a Room during blood plasma of indirubin-medicine, and its major impetus mathematic(al) parameter is: C
Max=0.19 μ gmL
-1, AUC=61.80mgKg
-1Min
-1, Tp=94.92min, Tcp=774.46min.
The oral superfine powder Fuzheng Jiedu powder of chicken (5gKg
-1) after, the data fit one-level absorbs the open model in a Room during blood plasma of polysaccharide-medicine, and its major impetus mathematic(al) parameter is: AUC=3560.60mgKg
-1Min
-1, C
Max=10.74 μ gmL
-1, Tp=73.05min, Tcp=1509.80min.The data fit one-level absorbs the open model in a Room during blood plasma of indirubin-medicine, and its major impetus mathematic(al) parameter is: C
Max=0.23 μ gmL
-1, Tp=80.94min, AUC=99.24mgKg
-1Min
-1, Tcp=608.77min.
Pharmacokinetic studies result shows: behind two kinds of preparations for oral administration, they all show the slower characteristics of elimination, but oral product of the present invention is very fast in the intravital absorption of chicken, and it is also very fast to distribute.The relative bioavailability (F)=123.6% of polysaccharide, the relative bioavailability (F)=160.5% of indirubin behind chicken superfine powder Fuzheng Jiedu powder for oral administration and the powder.Superfine powder compares with powder that to have a peak time very fast, and bioavailability is higher relatively, the characteristics that maximum peak concentration is higher.This shows that the degree of grinding of Fuzheng Jiedu powder can influence the pharmacokinetics feature of medicine, the bioavailability of product of the present invention is better than powder.
(4) specific embodiment
With the crude drug oven dry of Radix Isatidis, the Radix Astragali, Herba Epimedii, make water content earlier, carry out the coarse powder that coarse pulverization obtains each crude drug with the plant pulverizer below 6%; After then the coarse powder of Radix Isatidis, the Radix Astragali, Herba Epimedii being pressed 2: 2: 1 part by weight mix homogeneously, inject super micron mill jointly with the air after lyophilization, be crushed to below the 15 μ m after adopting high pressure draught to make cell wall breaking, the air themperature after the lyophilization will be below 10 ℃.
Claims (2)
1, a kind of ultrafine preparation of Fuzheng Jiedu powder is characterized in that: it is with the crude drug oven dry of Radix Isatidis, the Radix Astragali, Herba Epimedii, makes water content below 6%, carries out the coarse powder that coarse pulverization acquires each crude drug with the plant pulverizer; Then with the coarse powder of Radix Isatidis, the Radix Astragali, Herba Epimedii by behind 2: 2: 1 the part by weight mix homogeneously, inject super micron mill jointly with air after lyophilization, be crushed to the following resulting product of 15 μ m after adopting high pressure draught to make cell wall breaking.
2, a kind of preparation method of a kind of ultrafine preparation of Fuzheng Jiedu powder is characterized in that: with the crude drug oven dry of Radix Isatidis, the Radix Astragali, Herba Epimedii, make water content below 6% earlier, carry out the coarse powder that coarse pulverization obtains each crude drug with the plant pulverizer; After then the coarse powder of Radix Isatidis, the Radix Astragali, Herba Epimedii being pressed 2: 2: 1 part by weight mix homogeneously, inject super micron mill jointly with the air after lyophilization, be crushed to below the 15 μ m after adopting high pressure draught to make cell wall breaking, the air themperature after the lyophilization is below 10 ℃.
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102406687A (en) * | 2011-11-28 | 2012-04-11 | 河南省康星药业有限公司 | Normal-temperature preparation method of isatis root submicron powder and special bidirectional airflow sieving machine used by same |
| CN102423333A (en) * | 2011-11-28 | 2012-04-25 | 河南省康星药业有限公司 | Ultramicro powder epimedium constant-temperature preparation method and dedicated bidirectional air flow screening machine thereof |
| CN103720779A (en) * | 2014-01-06 | 2014-04-16 | 四川德润通生物科技有限公司 | High-stability ultramicropowder agent capable of supporting healthy energy and eliminating toxin |
| CN103720778A (en) * | 2014-01-06 | 2014-04-16 | 重庆金邦动物药业有限公司 | Medicine capable of supporting healthy energy and eliminating toxin |
| CN105708910A (en) * | 2014-01-06 | 2016-06-29 | 四川德润通生物科技有限公司 | Preparation method of powder for clearing away heat and toxic materials of livestock and poultry |
| CN105726660A (en) * | 2014-01-06 | 2016-07-06 | 四川德润通生物科技有限公司 | Body resistance strengthening and toxin removing ultrafine powder for livestock and poultry |
| CN105748616A (en) * | 2014-01-06 | 2016-07-13 | 四川德润通生物科技有限公司 | Preparation method of heat-clearing and toxin-removing oral liquid for livestock and poultry |
| CN110075983A (en) * | 2019-04-30 | 2019-08-02 | 河北维尔利动物药业集团有限公司 | A kind of biological ferment ball milling broken wall preparation process of circulation crushing for Chinese medicine |
| CN111920844A (en) * | 2020-08-04 | 2020-11-13 | 安徽天安生物科技股份有限公司 | Production process of body resistance strengthening and detoxifying powder |
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2008
- 2008-08-15 CN CNA2008101369357A patent/CN101342231A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102406687A (en) * | 2011-11-28 | 2012-04-11 | 河南省康星药业有限公司 | Normal-temperature preparation method of isatis root submicron powder and special bidirectional airflow sieving machine used by same |
| CN102423333A (en) * | 2011-11-28 | 2012-04-25 | 河南省康星药业有限公司 | Ultramicro powder epimedium constant-temperature preparation method and dedicated bidirectional air flow screening machine thereof |
| CN102406687B (en) * | 2011-11-28 | 2013-11-20 | 河南省康星药业股份有限公司 | Normal-temperature preparation method of isatis root submicron powder and special bidirectional airflow sieving machine used by same |
| CN102423333B (en) * | 2011-11-28 | 2013-12-04 | 河南省康星药业股份有限公司 | Ultramicro powder epimedium constant-temperature preparation method |
| CN103720779A (en) * | 2014-01-06 | 2014-04-16 | 四川德润通生物科技有限公司 | High-stability ultramicropowder agent capable of supporting healthy energy and eliminating toxin |
| CN103720778A (en) * | 2014-01-06 | 2014-04-16 | 重庆金邦动物药业有限公司 | Medicine capable of supporting healthy energy and eliminating toxin |
| CN103720779B (en) * | 2014-01-06 | 2016-04-20 | 四川德润通生物科技有限公司 | The Fuzheng Jiedu superfine powder of high stable |
| CN105708910A (en) * | 2014-01-06 | 2016-06-29 | 四川德润通生物科技有限公司 | Preparation method of powder for clearing away heat and toxic materials of livestock and poultry |
| CN105726660A (en) * | 2014-01-06 | 2016-07-06 | 四川德润通生物科技有限公司 | Body resistance strengthening and toxin removing ultrafine powder for livestock and poultry |
| CN105748616A (en) * | 2014-01-06 | 2016-07-13 | 四川德润通生物科技有限公司 | Preparation method of heat-clearing and toxin-removing oral liquid for livestock and poultry |
| CN110075983A (en) * | 2019-04-30 | 2019-08-02 | 河北维尔利动物药业集团有限公司 | A kind of biological ferment ball milling broken wall preparation process of circulation crushing for Chinese medicine |
| CN111920844A (en) * | 2020-08-04 | 2020-11-13 | 安徽天安生物科技股份有限公司 | Production process of body resistance strengthening and detoxifying powder |
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