CN101269204A - Cow-bezoar bolus for resurrection and preparation method thereof - Google Patents
Cow-bezoar bolus for resurrection and preparation method thereof Download PDFInfo
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Abstract
The invention provides a dripping bezoar chest functioning pill and a preparation method thereof, which is prepared by mixing the medical components, which are extracted from eleven materials of bezoar, concentrated powder of cornu bubali, musk, pearls, cinnabar, realgar, coptis, scutellaria, gardenia, radix curcumae, and borneol with substrate by the ration of 1 to 1-4, and then conducting the steps of melting, dripping, drying and coating. The medicine of the invention takes effect quicker than the traditional bezoar chest functioning pill with less dosage, can be swallowed, kept in mouth, be taken from nasal delivery with better pharmacological effect.
Description
Technical field
What the present invention relates to is a kind of Chinese patent medicine and preparation method thereof; referring in particular to a kind of is a kind of cow-bezoar bolus for resurrection of feedstock production and preparation method thereof with Calculus Bovis, Pulvis Cornus Bubali Concentratus, Moschus, Margarita, Cinnabaris, Realgar, Rhizoma Coptidis, Radix Scutellariae, Fructus Gardeniae, Radix Curcumae, Borneolum Syntheticum, and its medicine is called cow-bezoar bolus for resurrection.
Background technology
Cow-bezoar bolus for resurrection derives from " Wenbing Tiaobian, Detailed Analysis of Epidemic Warm Diseases " volume one.Prescription is Calculus Bovis, Radix Curcumae, Cornu rhinocerotis, Radix Scutellariae, Rhizoma Coptidis, Realgar, Fructus Gardeniae, each 30 gram of Cinnabaris, Borneolum Syntheticum, each 7.5 gram of Moschus, and Margarita 15 grams, native gold is a clothing.Going up is superfine end, and the old honey of refining is ball, every ball 3 grams, and native gold is a clothing, wax protects.Every clothes 1 ball, the deficient pulse person is under the Ginseng Decoction; The forceful pulse person is under Flos Lonicerae, the Herba Menthae soup.The seriously ill body reality person that is grown up, every days two to three clothes, children's obeys half ball, does not know to obey half ball again.Principal agent in Calculus Bovis, Cornu rhinocerotis and the Moschus side of being; Calculus Bovis is cool in nature, can clear away heart-fire and the heat of foot stake, reaches the heresy of envelope, the merit of heat-clearing and toxic substances removing is arranged, eliminating phlegm for resuscitation thoroughly; Cornu rhinocerotis is cold in nature, and the main excess of the liver fire that clears away heart-fire can be separated the pericardium pathogenic heat, and can go into nutrient blood and separate toxic heat in blood; Moschus energy causing resuscitation with aromatic drugs, sensible passages through which vital energy circulates.This three flavors medicine compatibility have clear away heart-fire, promote blood circulation, have one's ideas straightened out, the effect of refreshment.Rhizoma Coptidis, Radix Scutellariae and Fructus Gardeniae are the accessory drugss in the prescription, and are the key medicines of resolving heat and reducing pathogenic fire in the prescription.Rhizoma Coptidis energy clearing away heart-fire, Radix Scutellariae is based on clear part of the body cavity above the diaphragm housing the heart and lungs fire, outside the Fructus Gardeniae decapacitation eliminating heart-fire, still three warmers are burning hot clearly, therefore, Rhizoma Coptidis, Radix Scutellariae and Fructus Gardeniae compatibility are used to remove that human body three warmers fire is contained and diseases such as the hyperpyrexia agitation that causes, unconsciousness and delirium, convulsions tic, infantile convulsion have better therapeutic effect, in addition, Radix Curcumae energy waking up the patient from unconsciousness by clearing away heat in the prescription, Borneolum Syntheticum can clear away heart-fire and allay excitement, and the detoxifcation of Realgar clearing away phlegm, Cinnabaris, Margarita are calmed the nerves.The merit that the cow-bezoar bolus for resurrection of being made up of these medicines has heat clearing away, detoxifies, eliminates phlegm for resuscitation.Be mainly used in treatment because of diseases such as hyperpyrexia and cardio-cerebrovascular disease such as epidemic cerebrospinal meningitis, encephalitis B, toxic dysentery, toxic hepatitis, toxic pneumonitis, hepatic coma, uremia, cerebrovascular accident the diseases such as cold, gnathospasma, hemiplegia aphasia, shock faintness of fainting of coma, delirium, tic, infantile convulsion, manic, extremity extremely.
Be subjected to the requirement of animal protection at present, Cornu rhinocerotis can not be used as medicine, replaces with Cornu Bubali, also has with Cornu Saigae Tataricae to replace; Natural Calculus Bovis output is less, has been that artificial culture's Calculus Bovis product replaces; But certain gap is arranged aspect effect.
The Pharmacopoeia of the People's Republic of China (version in 2005, one one) " cow-bezoar bolus for resurrection " that record " 'An Gong Niu Huang Wan ' looses " prescription is Calculus Bovis, Radix Curcumae, Radix Scutellariae, Rhizoma Coptidis, Realgar, Fructus Gardeniae, each 100 gram of Cinnabaris, Pulvis Cornus Bubali Concentratus 200 grams, Borneolum Syntheticum, each 25 gram of Moschus, Margarita 50 grams; It is 1.6 grams that the day dose of 2 kinds of dosage forms is all amounted to crude drug.
The prescription of " 'An Gong Niu Huang Wan ' capsule " that " national standard for traditional Chinese medicines compilation " (brain is a fascicle) recorded is Calculus Bovis, Radix Curcumae, Cornu rhinocerotis, Radix Scutellariae, Rhizoma Coptidis, Realgar, Fructus Gardeniae, each 40 gram of Cinnabaris; Pulvis Cornus Bubali Concentratus 80 grams, Borneolum Syntheticum, each 10 gram of Moschus; it is 2.4 grams that Margarita 20 grams, a day dose are all amounted to crude drug.
Because this medicine is a kind of first aid medicine, general effect the best at the initial stage of a disease.But because traditional cow-bezoar bolus for resurrection is to be used as medicine with crude drug, substitute the application of medical material in addition,, therefore be necessary to make improvements, to adapt to the needs of first aid sufferer so onset is slower.
Summary of the invention
The object of the present invention is to provide a kind of 'An Gong Niu Huang Wan ' Chinese medicine dripping pills.
Another object of the present invention provides a kind of preparation method of 'An Gong Niu Huang Wan ' Chinese medicine dripping pills.
The present invention is implemented by following scheme.
One. technical scheme of the present invention
A kind of 'An Gong Niu Huang Wan ' Chinese medicine dripping pills of the present invention; it is improved a kind of quick-effective preparation on traditional cow-bezoar bolus for resurrection prescription basis; extracted by the following method by the crude drug of following prescription ratio by weight and to obtain medicinal ingredient, in medicinal ingredient: substrate=1: the 1-4 ratio is prepared from:
1. crude drug (in weight portion) prescription ratio:
Calculus Bovis 4, Pulvis Cornus Bubali Concentratus 8, Moschus 1, Margarita 2, Cinnabaris 4, Realgar 4, Rhizoma Coptidis 4, Radix Scutellariae 4, Fructus Gardeniae 4, Radix Curcumae 4, Borneolum Syntheticum 1.
2. preparation technology
(1) get Cinnabaris, Realgar in the prescription ratio, water flies into impalpable powder;
(2) get Calculus Bovis, Moschus in the prescription ratio, respectively porphyrize;
(3) get Pulvis Cornus Bubali Concentratus, Margarita in the prescription ratio, use sulphuric acid hydrolysis 8 hours, 15% calcium hydroxide breast is transferred pH3～5, filters, filtrate is concentrated into relative density 1.20～1.30, adds ethanol to containing alcohol amount 60%, cold preservation, filter, filtrate recycling ethanol, concentrate drying become dried cream I;
(4) get Rhizoma Coptidis, Fructus Gardeniae in the prescription ratio, be ground into coarse powder, add 80% ethanol, reflux, extract, 2 times, medicinal liquid reclaims ethanol, add water to every 4ml and amount to the solution that contains the 1g crude drug, transfer pH 3.0～4.0 with sulphuric acid, centrifugal, clear liquid is crossed macroporous resin, the absorption of 80% ethanolysis, stripping liquid reclaims ethanol, and concentrate drying becomes dried cream II;
(5) get Radix Scutellariae in the prescription ratio, be ground into coarse powder, decoct 2 times with 10 times, 8 times water gagings of Radix Scutellariae weight respectively, each 1 hour, filter; Filtrate adds HCl and transfers pH 1-2, and 80 ℃ are incubated 30 minutes, leave standstill centrifugation; Precipitation adds suitable quantity of water and stirs evenly, and adds 40%NaOH solution and transfers PH to 7, adds an amount of ethanol again, filters; Filtrate adds HCl liquid and transfers pH 1-2, fully stirs, and is heated to 80 ℃, is incubated 30 minutes, filters; Through washing, reuse 50% washing with alcohol is used 95% ethyl alcohol recrystallization to precipitation at last earlier, gets baicalin;
(6) get Radix Curcumae in the prescription ratio, be ground into coarse powder, vapour method extracts volatile oil;
(7) get substrate in proportion, be heated to fusion, dried cream I and dried cream II are ground into fine powder, add Borneolum Syntheticum, the abundant mix homogeneously of baicalin, under agitation join in the molten matrix, be heated to dissolving, add above-mentioned Cinnabaris, Realgar, Calculus Bovis, Moschus fine powder, Radix Curcumae volatile oil again, abundant mixing obtains containing the pharmaceutical composition fused solution of ingredient and substrate, in 80 ℃ ± 2 ℃ insulations, standby;
(8) temperature control system of adjustment drop pill machine, the medicinal liquid of insulation is moved into drop pill machine storage tank, the storage tank temperature remains on 80 ℃ ± 5 ℃, adjust the dropping-pill machine head, splash into contraction shaping naturally in the condensing agent with suitable speed by water dropper, the drop pill of above-mentioned formation is drained, and wipe condensing agent, drying promptly gets drop pill;
(9) film coating:, make drop pill with the drop pill bag film-coat of drying; The proportioning of coating solution is hypromellose 3.9g, Tween-80 1.95g, steviosin 0.39g, water 39ml, dehydrated alcohol 156ml.
Macroporous adsorbent resin in the step (4) is any among D101, ADS-17, the AB-8.
Substrate described in the step (7) is the mixture of any one or two kinds in Macrogol 4000, PEG400, polyethylene glycol 6000, stearic acid, polyoxyethylene stearate 40 esters, the carboxymethyl starch sodium.Condensing agent in the step (8) can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil.The temperature cooling of the interior condensing agent of the middle condensation column of step (8) also remains on 4-15 ℃.
Two. beneficial effect of the present invention
1. utilize solid dispersion technology preparation and drop pill, both can swallow, but also sublingual administration, can also be through the nasal feeding administration; Sublingual administration can make effective ingredient fully contact with mucomembranous surface, absorbs by mucomembranous epithelial cell, directly enters blood circulation.Especially sublingual administration administration, contact promptly with saliva and to dissolve rapidly, absorb by oral mucosa, directly enter blood circulation without gastrointestinal tract and liver, not only avoided the liver sausage first pass effect, and brought into play the little advantage of side effect, particularly can't oral administration the time, adopt the nasal feeding administration significant to saving critical patient to critical patient.
2. cow-bezoar bolus for resurrection involved in the present invention; be with material medicine through be extracted into medicinal ingredient and substrate the heating, be melt into liquid state after; splash in the not miscible condensed fluid and make; the stability of drug height; not facile hydrolysis, oxidation; be not subject to the influence of crystal formation, thereby guaranteed drug quality, increased stability.
3. cow-bezoar bolus for resurrection involved in the present invention and since be with material medicine through being extracted into medicinal ingredient, easier being absorbed and used after the disintegrate, so onset is rapider, bioavailability is higher.
4. cow-bezoar bolus for resurrection involved in the present invention; sublingual administration directly enters blood circulation, so the significantly reducing of the pill that is used as medicine than traditional crude drug of dosage and capsule; the 1/5-1/2 that only needs conventional dosage forms medical material consumption, significant to saving valuable ingredient of Chinese medicine.
Three, pharmaceutical research
1. determination of dissolution rate
Experimental technique experimentizes by the Pharmacopoeia of the People's Republic of China (version was two ones in 2005) appendix XC first method, experiment medicine: cow-bezoar bolus for resurrection (Beijing Tongrentang Technology Development Co., Ltd.); 'An Gong Niu Huang Wan ' capsule (Hebei Anguo Pharmaceutical Group Co.,Ltd); Cow-bezoar bolus for resurrection of the present invention (Guangdong and this scientific and technological pharmaceutical Co. Ltd laboratory provide). cow-bezoar bolus for resurrection decided in accurate title; cow-bezoar bolus for resurrection and 'An Gong Niu Huang Wan ' capsule are an amount of; put to change in the basket and (change basket heelpiece microporous filter membrane); release medium is a simulated gastric fluid; volume is 500ml; water temperature is 37 ℃ ± 0.5 ℃; rotating speed is 100r/min; sample is dropped in the hanging basket; during contact medium; begin to rotate and writing time; at 1 minute; 3 minutes; 6 minutes; 12 minutes; draw samples liquid 10ml in the time of 15 minutes; and add the 10ml blank medium, precision is measured through the filterable sample liquid of 0.5um microporous filter membrane 0.3ml and is put in the 10ml measuring bottle, adds simulated gastric fluid and is diluted to scale; measure arsenic respectively; hydrargyrum; content of bilirubin, experimental result sees Table 1:
Table 1 dissolution in vitro is (μ g/ml) relatively
Conclusion: experimental result shows that cow-bezoar bolus for resurrection of the present invention has dissolution rate preferably.
2. external biological availability test
For better relatively soft capsule of the present invention and cow-bezoar bolus for resurrection; we select the content of Borneolum Syntheticum in bilirubin in the representative Calculus Bovis and the Borneolum Syntheticum to make index; measure the external biological availability of Angong niuhuang soft capsule of the present invention and cow-bezoar bolus for resurrection; get one section small intestinal; with the mucosa rollover laterally; one end of small intestinal is fixed; the other end is fixed on the sleeve pipe; during test fixed intestinal capsule on the sleeve pipe is immersed in the 1000ml of abundant oxygen supply; in 37 ℃ of solution; the solution that can draw serosa side by sleeve pipe at any time carries out assay determination, the results are shown in Table 2.Assay method is respectively with reference to the " content assaying method in the Chinese pharmacopoeia under Calculus Bovis and the Borneolum Syntheticum item.
Table 2 external biological availability test determination of bilirubin (μ g/ml)
3. see through the blood brain barrier experiment
See through the determination experiment medicine of blood brain barrier experiment cerebrospinal fluid Chinese medicine concentration: cow-bezoar bolus for resurrection (Beijing Tongrentang Technology Development Co., Ltd.); 'An Gong Niu Huang Wan ' capsule (Hebei Anguo Pharmaceutical Group Co.,Ltd); Cow-bezoar bolus for resurrection of the present invention (Guangdong and this scientific and technological pharmaceutical Co. Ltd laboratory provide) laboratory animal: new zealand rabbit, the about 2.5kg of body weight, male and female are not limit.Experimental technique: get new zealand rabbit, be divided into cow-bezoar bolus for resurrection group, 'An Gong Niu Huang Wan ' Capsules group, this patent cow-bezoar bolus for resurrection group, gastric infusion, cow-bezoar bolus for resurrection and 'An Gong Niu Huang Wan ' capsule dosage are 100mg crude drug/kg, this patent cow-bezoar bolus for resurrection group dosage is 50mg crude drug/kg, extract 0.5ml left and right sides cerebrospinal fluid after 30 minutes and blood carries out check and analysis in administration, measure free mercury in the cerebrospinal fluid, free arsenic, muscone, content of bilirubin, the results are shown in Table 3; Survey arsenic sulfide in the rabbit blood, cinnabar, free arsenic, free mercury, muscone, content of bilirubin, the results are shown in Table 4.
Content compares (μ g/ml) in the table 3 rabbit cerebrospinal fluid
| Group | Free arsenic | Free mercury | Muscone | Bilirubin |
| Commercially available cow-bezoar bolus for resurrection | 2.04 | 2.78 | 0.57 | 4.89 |
| Commercially available 'An Gong Niu Huang Wan ' capsule | 2.00 | 2.69 | 0.54 | 4.78 |
| Cow-bezoar bolus for resurrection | 2.39 | 2.78 | 0.78 | 5.70 |
Content compares (μ g/ml) in table 4 rabbit blood
| Group | Free arsenic | Free mercury | Arsenic sulfide | Cinnabar | Muscone | Bilirubin |
| Commercially available cow-bezoar bolus for resurrection | 0.81 | 0.78 | - | - | 0.07 | 1.02 |
| Commercially available 'An Gong Niu Huang Wan ' capsule | 0.83 | 0.80 | - | - | 0.06 | 0.98 |
| Cow-bezoar bolus for resurrection | 0.30 | 0.30 | - | - | 0.03 | 0.82 |
-expression does not detect
Conclusion: show by the blood brain barrier experiment, under the situation that cow-bezoar bolus for resurrection crude drug amount of the present invention is lacked than cow-bezoar bolus for resurrection and capsule, the amount that enters the cerebrospinal fluid effective ingredient is more than commercially available cow-bezoar bolus for resurrection, in blood, leave over and to lack, prove absolutely that the cow-bezoar bolus for resurrection under the technology of the present invention has the effect that better sees through blood brain barrier; This is to exceed our unexpected result.
By measuring the content of arsenic sulfide and cinnabar in the blood, the result does not detect, and what illustrate that Cinnabaris and Realgar play pharmacological action is less free mercury of content and free arsenic.
4. refrigeration function
Laboratory animal: healthy new zealand rabbit (the same measure of time normal rabbits anus temperature on the 1st day and experiment same day before test is got its meansigma methods as mean body temperature respectively, basal body temperature 37.9 ℃-38.4 ℃ rabbit as experimental rabbit; Experiment medicine: cow-bezoar bolus for resurrection (Beijing Pharmacy stock Co., Ltd of Tongrentang); 'An Gong Niu Huang Wan ' capsule (Hebei Anguo Pharmaceutical Group Co.,Ltd); Cow-bezoar bolus for resurrection of the present invention (Guangdong and this scientific and technological pharmaceutical Co. Ltd laboratory provide)
Experimental technique: the above-mentioned rabbit that meets experiment condition is divided into normal saline group, cow-bezoar bolus for resurrection group, 'An Gong Niu Huang Wan ' Capsules group, cow-bezoar bolus for resurrection agent group of the present invention; dosage is the same; press 0.5ml/kg auricular vein injection typhoid fever vi polysaccharide vaccine; behind the injection Typhoid Vaccine; inject different pharmaceutical immediately respectively; and respectively at 0.5,1,2,3,4,5 hour measurement rabbit body temperature after the administration, each treated animal is an index with body temperature value added after the pyrogenicity all, the results are shown in Table 5
Table 5 is respectively organized preparation causes fever in rabbits to the typhoid Vi polysaccharide vaccine influence
Annotate: compare * P＜0.05 with the normal saline group,
*P＜0.01
Conclusion: show that by above pharmacological evaluation cow-bezoar bolus for resurrection of the present invention has better pharmacological action.
5. to acute cerebral ischemia rabbit cerebral protection
Reagent and animal: cow-bezoar bolus for resurrection (Pharmaceutical Co., Ltd of Beijing Tongrentang); 'An Gong Niu Huang Wan ' capsule (Hebei Anguo Pharmaceutical Group Co.,Ltd); Cow-bezoar bolus for resurrection of the present invention (, providing) by Guangdong and this scientific and technological pharmaceutical Co. Ltd laboratory by the inventive method preparation; New zealand rabbit: body weight 2.0-2.5kg, male and female half and half.
Experimental technique: according to literature method (Liu Zhong, etc.Chinese and western medicine magazine 1990; 10 (3): 160) the two common carotid artery ligating methodses of surveying of rabbit are set up the acute experiment cerebral ischemic model; Control animals is separated two survey common carotid artery, ligation; Model control group gives normal saline, each administration group gastric infusion, the cow-bezoar bolus for resurrection dosage is for being equivalent to 2000mg crude drug/kg, drop pill dosage of the present invention is for being equivalent to 100mg crude drug/kg, the blank group waits the capacity distilled water, administration is all postoperative beginning in 2 hours, successive administration 7 days, every day 2 times, after the execution of rabbit usefulness air tap inserting method, broken end is got brain rapidly, with filter paper exhaustion brain surface liquid, cuts one of right side same area holostrome cerebral tissue, on analytical balance, weigh immediately, (ai.stroke 1985 for Gotoho, et according to literature method; 16:101) calculate cerebral tissue content; To dry cerebral tissue and accurately weigh, press literature method (Liu Zhongqi, etc.China's neuropsychiatric disease magazine 1990; 16 (4): 203) measure Ca
2+Content; Get one of left side same area cerebral tissue, adding distil water 2ml, low-temperature homogenate with the centrifugal 10min of 4000rpm, is got its supernatant, measures the neat wind chrysanthemum of MDA, SOD[according to literature method, etc.No.1 Military Medical Univ.'s journal 1986; 6 (2): 152; The Dinke is auspicious, etc.Old magazine 1987; 7 (2): 42], experimental result sees Table 6,7:
Table 6 is respectively organized brain water content and Ca
2+Content
Compare with model control group
*△ P＜0.05 is compared with positive controls in P＜0.01
Table 7 is respectively organized cerebral tissue MDA, SOD content
Compare with model control group
*△ P＜0.05 is compared with positive controls in P＜0.01
Above result of the test shows that a kind of cow-bezoar bolus for resurrection of the present invention has the effect of brain injury due to the better protection acute cerebral hemorrhage.
Above-mentioned pharmaceutical research result shows that a kind of cow-bezoar bolus for resurrection of the present invention has not just been saved valuable ingredient of Chinese medicine than traditional 'An Gong Niu Huang Wan ' preparation, the more important thing is to produce unexpected pharmacological effect.This effect mechanism is still waiting further research.
Four. to the development test of substrate
Be the ratio of the selection of preparation mesostroma of research cow-bezoar bolus for resurrection and substrate and the medicinal ingredient that extracted, we have carried out following test.
Below in conjunction with the experiment of two groups of specific embodiments, the preparation process and the experimental result of cow-bezoar bolus for resurrection involved in the present invention is described further.
Embodiment tests the group practices of 1 medicinal ingredient and different substrates
The processing of crude drug and extraction are undertaken by step of preparation process, obtain the medicinal ingredient of cow-bezoar bolus for resurrection.
Select the influence of different substrates for use in order to observe to cow-bezoar bolus for resurrection involved in the present invention, respectively that different substrates and part substrate combination numbering is as follows, obtain 12 kinds of single composition substrate and mixed-matrix:
A. Polyethylene Glycol
400B. Polyethylene Glycol
4000C. Polyethylene Glycol
6000
D. stearic acid; E. polyoxyethylene stearate 40 esters; F. carboxymethyl starch sodium;
G. PEG400 20%+ Macrogol 4000 80%; H. PEG400 20%+ polyethylene glycol 6000 80%; I. Macrogol 4000 80%+ stearic acid 20%; J. polyethylene glycol 6000 80%+ stearic acid 20%; K. stearic acid 50%+ polyoxyethylene stearate 40 esters 50%; L polyoxyethylene stearate 40 ester 50%+ carboxymethyl starch sodium 50%.
To carry out prescription respectively with 1: 4 ratio according to medicinal ingredient and above substrate that the step of stipulating in the preparation method is extracted, and according to the step of stipulating in the preparation method, each group prepared materials is placed the heating container internal heating respectively, obtain containing the pharmaceutical composition fused solution of medicinal ingredient and substrate, move into the drop pill machine, regulate its temperature control system and make the requirement of satisfying the system of dripping, with the methyl-silicone oil is condensing agent, can obtain medicinal ingredient and different substrates separately and/or 2 kinds of blended prescriptions experiments of substrate, and obtain 12 groups of different experimental results and see Table 8.
The prescription experiment of table 8 medicinal ingredient and different substrates
| The substrate numbering | Medicinal ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| A | 20.0 | 50 | ＜30 | ＞10 | + |
| B | 20.0 | 90 | ＜30 | ＜10 | +++ |
| C | 20.0 | 95 | ＜30 | ＜10 | +++ |
| D | 20.0 | 48 | ＜30 | ＞10 | + |
| E | 20.0 | 82 | ＜30 | ＞10 | ++ |
| F | 20.0 | 83 | ＜30 | ＜10 | ++ |
| G | 20.0 | 92 | ＜30 | ＜10 | +++ |
| H | 20.0 | 90 | ＜30 | ＜10 | +++ |
| I | 20.0 | 90 | ＜30 | ＜10 | +++ |
| J | 20.0 | 92 | ＜30 | ＜10 | +++ |
| K | 20.0 | 81 | ＜30 | ＜10 | ++ |
| L | 20.0 | 85 | ＜30 | ＜10 | +++ |
Result by table 8 can find out: in an embodiment, when selecting different substrate, indexs such as, dissolve scattered time limit different to rounding rate, the ball method of double differences and hardness all have comparatively significantly influence.
Embodiment tests the experiment of 2 medicinal ingredients and the different proportionings of substrate
Carry out the influence of prescription in varing proportions in order to observe medicinal ingredient and substrate to cow-bezoar bolus for resurrection involved in the present invention; according to above test; select B for use; C; G; H; I; J is as substrate; respectively with 1: 1/1: 2/1: 3/1: 4 ratio is with medicinal ingredient and substrate mix homogeneously, and the mixed material that each assembly is made places the fusion of heating container internal heating respectively, and according to defined terms in the preparation method and step; obtain containing the pharmaceutical composition fused solution of medicinal ingredient and substrate; moving into the drop pill machine, regulate its temperature control system system of dripping, is condensing agent with the methyl-silicone oil; obtain the test of 24 medicinal ingredients and the different proportionings of substrate, and obtain 24 groups of different result of the tests and see Table 9.
The real face of table 9 medicinal ingredient and the different proportionings of substrate
Can find out by table 9 result; In an embodiment, when medicinal ingredient has some variations with the mixed proportion of substrate with substrate is different, but every basically index all enters a comparatively ideal state, generally speaking, the rounding rate reaches 90%, dissolve scattered time limit＜30 minute, the ball method of double differences is different＜and 10%, hardness is +++it is qualified just to be considered as.From considering that economically substrates quantity can be saved cost less, thereby also is the factor that should consider.
Five. preparation embodiment
Below by preparation embodiment the technical scheme of a kind of cow-bezoar bolus for resurrection of the present invention and preparation method thereof is described further, but technical solution of the present invention is not limited to embodiment.
Embodiment 1
Crude drug prescription: Calculus Bovis 100g, Pulvis Cornus Bubali Concentratus 200g, Moschus 25g, Margarita 50g, Cinnabaris 100g, Realgar 100g, Rhizoma Coptidis 100g, Radix Scutellariae 100g, Fructus Gardeniae 100g, Radix Curcumae 100g, Borneolum Syntheticum 25g.
Preparation technology
(1) get Cinnabaris, Realgar by prescription, water flies into impalpable powder;
(2) get Calculus Bovis, Moschus by prescription, respectively porphyrize;
(3) get Pulvis Cornus Bubali Concentratus, Margarita by prescription, use sulphuric acid hydrolysis 8 hours, 15% calcium hydroxide breast is transferred pH3～5, filters, filtrate is concentrated into relative density 1.20～1.30, adds ethanol to solution and contains alcohol amount 60% (V/V), and cold preservation is filtered, filtrate recycling ethanol, concentrate drying, I 20g gets dry extract;
(4) get Rhizoma Coptidis, Fructus Gardeniae by prescription, be ground into coarse powder, add 80% ethanol, reflux, extract, 2 times, medicinal liquid reclaims ethanol, adds water to every 4ml and amounts to the solution that contains the 1g crude drug, transfers pH 3.0～4.0 with sulphuric acid, centrifugal, clear liquid is crossed the D101 macroporous adsorptive resins, the absorption of 80% ethanolysis, and stripping liquid reclaims ethanol, concentrate drying, II 15g gets dry extract;
(5) get Radix Scutellariae by prescription, be ground into coarse powder, decoct 2 times with 10 times, 8 times water gagings of Radix Scutellariae weight respectively, each 1 hour, filter; Filtrate adds the HCl accent pH 1-2 that concentration is 4mol, and 80 ℃ are incubated 30 minutes, leave standstill centrifugation; Precipitation adds suitable quantity of water and stirs evenly, and adding concentration is the NaOH solution accent PH to 7 of 40% (W/W), adds an amount of ethanol again, and making solution contain concentration of alcohol is 60% (V/V), filters; Filtrate adds HCl liquid and transfers pH 1-2, fully stirs, and is heated to 80 ℃, is incubated 30 minutes, filters; Through washing, reuse 50% washing with alcohol is used 95% ethyl alcohol recrystallization to precipitation at last earlier, gets baicalin 4g;
(6) get Radix Curcumae by prescription, be ground into coarse powder, vapour method extracts volatile oil 6ml;
(7) taking polyethylene glycol 400 20%+ Macrogol 4000s 80% are total to 400g, be heated to fusion, dried cream I and dried cream II are ground into fine powder, and adding Borneolum Syntheticum, baicalin fully grind well, and under agitation join in the molten matrix, be heated to dissolving, add above-mentioned Cinnabaris, Realgar, Calculus Bovis, Moschus fine powder, Radix Curcumae volatile oil again, abundant mixing obtains containing the pharmaceutical composition fused solution of ingredient and substrate, in 80 ℃ ± 5 ℃ insulations, standby;
(8) temperature control system of adjustment drop pill machine, the medicinal liquid of insulation is moved into drop pill machine storage tank, the storage tank temperature remains on 80 ℃, adjust the dropping-pill machine head, splashing into liquid paraffin with suitable speed by water dropper is in the condensation column of condensing agent, and the temperature cooling of the interior condensing agent of condensation column also remains on 4-10 ℃, naturally shrink and be shaped, the drop pill of above-mentioned formation is drained, and wipe condensing agent, drying promptly gets drop pill;
(9) with the drop pill bag film-coat of drying, the proportioning of coating solution is hypromellose 3.9g, Tween-80 1.95g, steviosin 0.39g, water 39ml, dehydrated alcohol 156ml; The heavy 100mg of the every ball of gained drop pill, every ball contains medicinal composition 44.1mg.
Embodiment 2
Crude drug prescription: Calculus Bovis 1000g, Pulvis Cornus Bubali Concentratus 2000g, Moschus 250g, Margarita 500g, Cinnabaris 1000g, Realgar 1000g, Rhizoma Coptidis 1000g, Radix Scutellariae 1000g, Fructus Gardeniae 1000g, Radix Curcumae 1000g, Borneolum Syntheticum 250g.
Preparation technology
(1) get Cinnabaris, Realgar by prescription, water flies into impalpable powder;
(2) get Calculus Bovis, Moschus by prescription, respectively porphyrize;
(3) get Pulvis Cornus Bubali Concentratus, Margarita by prescription, use sulphuric acid hydrolysis 8 hours, 15% calcium hydroxide breast is transferred pH3～5, filters, filtrate is concentrated into relative density 1.20～1.30, adds ethanol to containing alcohol amount 60%, and cold preservation is filtered, filtrate recycling ethanol, concentrate drying, I 210g gets dry extract;
(4) get Rhizoma Coptidis, Fructus Gardeniae by prescription, be ground into coarse powder, add 80% ethanol, reflux, extract, 2 times, medicinal liquid reclaims ethanol, adds water to every 4ml and amounts to the solution that contains the 1g crude drug, transfers pH 3.0～4.0 with sulphuric acid, centrifugal, clear liquid is crossed the ADS-17 macroporous adsorptive resins, the absorption of 80% ethanolysis, and stripping liquid reclaims ethanol, concentrate drying, II 160g gets dry extract;
(5) get Radix Scutellariae by prescription, be ground into coarse powder, decoct 2 times with 10 times, 8 times water gagings of Radix Scutellariae weight respectively, each 1 hour, filter; Filtrate adds HCl and transfers pH 1-2, and 80 ℃ are incubated 30 minutes, leave standstill centrifugation; Precipitation adds suitable quantity of water and stirs evenly, and adds 40%NaOH solution and transfers PH to 7, adds an amount of ethanol again, filters; Filtrate adds HCl liquid and transfers pH 1-2, fully stirs, and is heated to 80 ℃, is incubated 30 minutes, filters; Through washing, reuse 50% washing with alcohol is used 95% ethyl alcohol recrystallization to precipitation at last earlier, gets baicalin 38g;
(6) get Radix Curcumae by prescription, be ground into coarse powder, vapour method extracts volatile oil 48ml;
(7) taking polyethylene glycol 400 20%+ polyethylene glycol 6000s 80% are total to 5000g, be heated to fusion, dried cream I and dried cream II are ground into fine powder, and adding Borneolum Syntheticum, baicalin fully grind well, and under agitation join in the molten matrix, be heated to dissolving, add above-mentioned Cinnabaris, Realgar, Calculus Bovis, Moschus fine powder, Radix Curcumae volatile oil again, abundant mixing obtains containing the pharmaceutical composition fused solution of ingredient and substrate, in 80 ℃ ± 5 ℃ insulations, standby;
(8) temperature control system of adjustment drop pill machine, the medicinal liquid of insulation is moved into drop pill machine storage tank, the storage tank temperature remains on 80 ℃, adjust the dropping-pill machine head, splashing into methyl-silicone oil with suitable speed by water dropper is in the condensation column of condensing agent, and the temperature cooling of the interior condensing agent of condensation column also remains on 6-15 ℃, naturally shrink and be shaped, the drop pill of above-mentioned formation is drained, and wipe condensing agent, drying promptly gets drop pill;
(9) with the drop pill bag film-coat of drying, the every ball of (the coating solution prescription is with example 1) gained drop pill weighs 100mg, and every ball contains medicinal composition 44.2mg.
Embodiment 3
Crude drug prescription: Calculus Bovis 10000g, Pulvis Cornus Bubali Concentratus 20000g, Moschus 2500g, Margarita 5000g, Cinnabaris 10000g, Realgar 10000g, Rhizoma Coptidis 10000g, Radix Scutellariae 10000g, Fructus Gardeniae 10000g, Radix Curcumae 10000g, Borneolum Syntheticum 2500g.
Preparation technology
(1) get Cinnabaris, Realgar by prescription, water flies into impalpable powder;
(2) get Calculus Bovis, Moschus by prescription, respectively porphyrize;
(3) get Pulvis Cornus Bubali Concentratus, Margarita by prescription, use sulphuric acid hydrolysis 8 hours, 15% calcium hydroxide breast is transferred pH3～5, filters, filtrate is concentrated into relative density 1.20～1.30, adds ethanol to containing alcohol amount 60%, and cold preservation is filtered, filtrate recycling ethanol, concentrate drying, I 2100g gets dry extract;
(4) get Rhizoma Coptidis, Fructus Gardeniae by prescription, be ground into coarse powder, add 80% ethanol, reflux, extract, 2 times, medicinal liquid reclaims ethanol, adds water to every 4ml and amounts to the solution that contains the 1g crude drug, transfers pH 3.0～4.0 with sulphuric acid, centrifugal, clear liquid is crossed the ADS-17 macroporous adsorptive resins, the absorption of 80% ethanolysis, and stripping liquid reclaims ethanol, concentrate drying, II 1460g gets dry extract;
(5) get Radix Scutellariae by prescription, be ground into coarse powder, decoct 2 times with 10 times, 8 times water gagings of Radix Scutellariae weight respectively, each 1 hour, filter; Filtrate adds HCl and transfers pH 1-2, and 80 ℃ are incubated 30 minutes, leave standstill centrifugation; Precipitation adds suitable quantity of water and stirs evenly, and adds 40%NaOH solution and transfers PH to 7, adds an amount of ethanol again, filters; Filtrate adds HCl liquid and transfers pH 1-2, fully stirs, and is heated to 80 ℃, is incubated 30 minutes, filters; Through washing, reuse 50% washing with alcohol is used 95% ethyl alcohol recrystallization to precipitation at last earlier, gets baicalin 360g;
(6) get Radix Curcumae by prescription, be ground into coarse powder, vapour method extracts volatile oil 520ml;
(7) taking polyethylene glycol 6000 is total to 40000g, be heated to fusion, dried cream I and dried cream II are ground into fine powder, and adding Borneolum Syntheticum, baicalin fully grind well, and under agitation join in the molten matrix, be heated to dissolving, add above-mentioned Cinnabaris, Realgar, Calculus Bovis, Moschus fine powder, Radix Curcumae volatile oil again, abundant mixing obtains containing the pharmaceutical composition fused solution of ingredient and substrate, in 80 ℃ ± 5 ℃ insulations, standby;
(8) temperature control system of adjustment drop pill machine, the medicinal liquid of insulation is moved into drop pill machine storage tank, the storage tank temperature remains on 80 ℃, adjust the dropping-pill machine head, splashing into soybean oil with suitable speed by water dropper is in the condensation column of condensing agent, and the temperature cooling of the interior condensing agent of condensation column also remains on 4-10 ℃, naturally shrink and be shaped, the drop pill of above-mentioned formation is drained, and wipe condensing agent, drying promptly gets drop pill;
(9) with the drop pill bag film-coat of drying, the every ball of (the coating solution prescription is with example 1) gained drop pill weighs 100mg, and every ball contains medicinal composition 49.6mg.
Embodiment 4
Crude drug prescription: Calculus Bovis 500g, Pulvis Cornus Bubali Concentratus 1000g, Moschus 125g, Margarita 250g, Cinnabaris 500g, Realgar 500g, Rhizoma Coptidis 500g, Radix Scutellariae 500g, Fructus Gardeniae 500g, Radix Curcumae 500g, Borneolum Syntheticum 125g.
Preparation technology
(1) get Cinnabaris, Realgar by prescription, water flies into impalpable powder;
(2) get Calculus Bovis, Moschus by prescription, respectively porphyrize;
(3) get Pulvis Cornus Bubali Concentratus, Margarita by prescription, use sulphuric acid hydrolysis 8 hours, 15% calcium hydroxide breast is transferred pH3～5, filters, filtrate is concentrated into relative density 1.20～1.30, adds ethanol to solution and contains alcohol amount 60% (V/V), and cold preservation is filtered, filtrate recycling ethanol, concentrate drying, I 110g gets dry extract;
(4) get Rhizoma Coptidis, Fructus Gardeniae by prescription, be ground into coarse powder, add 80% ethanol, reflux, extract, 2 times, medicinal liquid reclaims ethanol, adds water to every 4ml and amounts to the solution that contains the 1g crude drug, transfers pH 3.0～4.0 with sulphuric acid, centrifugal, clear liquid is crossed the AB-8 macroporous adsorptive resins, the absorption of 80% ethanolysis, and stripping liquid reclaims ethanol, concentrate drying, II 80g gets dry extract;
(5) get Radix Scutellariae by prescription, be ground into coarse powder, decoct 2 times with 10 times, 8 times water gagings of Radix Scutellariae weight respectively, each 1 hour, filter; Filtrate adds the HCl accent pH 1-2 that concentration is 4mol, and 80 ℃ are incubated 30 minutes, leave standstill centrifugation; Precipitation adds suitable quantity of water and stirs evenly, and adding concentration is the NaOH solution accent PH to 7 of 40% (W/W), adds an amount of ethanol again, and making solution contain concentration of alcohol is 60% (V/V), filters; Filtrate adds HCl liquid and transfers pH 1-2, fully stirs, and is heated to 80 ℃, is incubated 30 minutes, filters; Through washing, reuse 50% washing with alcohol is used 95% ethyl alcohol recrystallization to precipitation at last earlier, gets baicalin 21g;
(6) get Radix Curcumae by prescription, be ground into coarse powder, vapour method extracts volatile oil 28ml;
(7) taking polyethylene glycol 6000 80%+ stearic acid 20% are total to 4000g, be heated to fusion, dried cream I and dried cream II are ground into fine powder, and adding Borneolum Syntheticum, baicalin fully grind well, and under agitation join in the molten matrix, be heated to dissolving, add above-mentioned Cinnabaris, Realgar, Calculus Bovis, Moschus fine powder, Radix Curcumae volatile oil again, abundant mixing obtains containing the pharmaceutical composition fused solution of ingredient and substrate, in 80 ℃ ± 5 ℃ insulations, standby;
(8) temperature control system of adjustment drop pill machine, the medicinal liquid of insulation is moved into drop pill machine storage tank, the storage tank temperature remains on 80 ℃, adjust the dropping-pill machine head, splashing into liquid paraffin with suitable speed by water dropper is in the condensation column of condensing agent, and the temperature cooling of the interior condensing agent of condensation column also remains on 4-10 ℃, naturally shrink and be shaped, the drop pill of above-mentioned formation is drained, and wipe condensing agent, drying promptly gets drop pill;
(9) with the drop pill bag film-coat of drying, the every ball of (the coating solution prescription is with example 1) gained drop pill weighs 100mg, and every ball contains medicinal composition 38.3mg.
Claims (5)
1. 'An Gong Niu Huang Wan ' Chinese medicine dripping pills and preparation method thereof, it is improved a kind of quick-effective preparation on traditional cow-bezoar bolus for resurrection prescription basis, it is characterized in that adopting following preparation method to extract to former prescription medical material obtains medicinal ingredient, in medicinal ingredient: substrate=1: the 1-4 ratio is prepared into drop pill; Described preparation method is: crude drug (in weight portion) prescription ratio:
Calculus Bovis 4, Pulvis Cornus Bubali Concentratus 8, Moschus 1, Margarita 2, Cinnabaris 4, Realgar 4, Rhizoma Coptidis 4, Radix Scutellariae 4, Fructus Gardeniae 4, Radix Curcumae 4, Borneolum Syntheticum 1;
(1) get Cinnabaris, Realgar in the prescription ratio, water flies into impalpable powder;
(2) get Calculus Bovis, Moschus in the prescription ratio, grind respectively and be fine powder;
(3) get Pulvis Cornus Bubali Concentratus, Margarita in the prescription ratio, use sulphuric acid hydrolysis 8 hours, 15% calcium hydroxide breast is transferred pH3～5, filters, filtrate is concentrated into relative density 1.20～1.30, adds ethanol to containing alcohol amount 60%, cold preservation, filter, filtrate recycling ethanol, concentrate drying become dried cream I;
(4) get Rhizoma Coptidis, Fructus Gardeniae in the prescription ratio, be ground into coarse powder, add 80% ethanol, reflux, extract, 2 times, medicinal liquid reclaims ethanol, add water to every 4ml and amount to the solution that contains the 1g crude drug, transfer pH 3.0～4.0 with sulphuric acid, centrifugal, clear liquid is crossed macroporous resin, the absorption of 80% ethanolysis, stripping liquid reclaims ethanol, and concentrate drying becomes dried cream II;
(5) get Radix Scutellariae in the prescription ratio, be ground into coarse powder, decoct 2 times with 10 times, 8 times water gagings of Radix Scutellariae weight respectively, each 1 hour, filter; Filtrate adds HCl and transfers pH 1-2, and 80 ℃ are incubated 30 minutes, leave standstill centrifugation; Precipitation adds suitable quantity of water and stirs evenly, and adds 40%NaOH solution and transfers PH to 7, adds an amount of ethanol again, filters; Filtrate adds HCl liquid and transfers pH 1-2, fully stirs, and is heated to 80 ℃, is incubated 30 minutes, filters; Through washing, reuse 50% washing with alcohol is used 95% ethyl alcohol recrystallization to precipitation at last earlier, gets baicalin;
(6) get Radix Curcumae in the prescription ratio, be ground into coarse powder, vapour method extracts volatile oil;
(7) get substrate in proportion, be heated to fusion, dried cream I and dried cream II are ground into fine powder, add Borneolum Syntheticum, the abundant mix homogeneously of baicalin, under agitation join in the molten matrix, be heated to dissolving, add above-mentioned Cinnabaris, Realgar, Calculus Bovis, Moschus fine powder, Radix Curcumae volatile oil again, abundant mixing obtains containing the pharmaceutical composition fused solution of ingredient and substrate, in 80 ℃ ± 2 ℃ insulations, standby;
(8) temperature control system of adjustment drop pill machine, the medicinal liquid of insulation is moved into drop pill machine storage tank, the storage tank temperature remains on 80 ℃ ± 5 ℃, adjust the dropping-pill machine head, splash into contraction shaping naturally in the condensing agent with suitable speed by water dropper, the drop pill of above-mentioned formation is drained, and wipe condensing agent, drying promptly gets drop pill;
(9) film coating:, make drop pill with the drop pill bag film-coat of drying; The proportioning of coating solution is hypromellose 3.9g, Tween-80 1.95g, steviosin 0.39g, water 39ml, dehydrated alcohol 156ml.
2. a kind of 'An Gong Niu Huang Wan ' Chinese medicine dripping pills as claimed in claim 1 and preparation method thereof, the macroporous adsorbent resin in the described step (4) are any among D101, ADS-17, the AB-8.
3. a kind of 'An Gong Niu Huang Wan ' Chinese medicine dripping pills as claimed in claim 1 and preparation method thereof, the substrate described in the described step (7) are the mixture of any one or two kinds in PEG400, Macrogol 4000, polyethylene glycol 6000, stearic acid, polyoxyethylene stearate 40 esters, the carboxymethyl starch sodium.
4. a kind of 'An Gong Niu Huang Wan ' Chinese medicine dripping pills as claimed in claim 1 and preparation method thereof, the condensing agent in the described step (8) are any one in liquid paraffin, methyl-silicone oil, the vegetable oil.
5. a kind of 'An Gong Niu Huang Wan ' Chinese medicine dripping pills as claimed in claim 1 and preparation method thereof, the temperature cooling of the interior condensing agent of the middle condensation column of described step (8) also remains on 4-15 ℃;
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526279A (en) * | 2012-02-12 | 2012-07-04 | 贾奎 | Chinese medicinal composition for treating central high fever caused by acute cerebrovascular disease and preparation method for Chinese medicinal composition |
| CN102058832B (en) * | 2009-11-12 | 2012-07-18 | 刘丽颖 | Medicine composition preparation and preparation method thereof |
| CN102058836B (en) * | 2009-11-12 | 2013-03-20 | 刘丽颖 | Medicament composition with effects of resisting thrombus, reducing blood pressure and treating leukemia |
| CN106266969A (en) * | 2016-08-31 | 2017-01-04 | 单晓春 | Saigae Tataricae peace palace capsule and its preparation method and application |
| CN109260424A (en) * | 2018-12-10 | 2019-01-25 | 付宏伟 | A kind of cow-bezoar bolus for resurrection and preparation method thereof |
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2008
- 2008-04-24 CN CNA2008100939705A patent/CN101269204A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058832B (en) * | 2009-11-12 | 2012-07-18 | 刘丽颖 | Medicine composition preparation and preparation method thereof |
| CN102058836B (en) * | 2009-11-12 | 2013-03-20 | 刘丽颖 | Medicament composition with effects of resisting thrombus, reducing blood pressure and treating leukemia |
| CN102526279A (en) * | 2012-02-12 | 2012-07-04 | 贾奎 | Chinese medicinal composition for treating central high fever caused by acute cerebrovascular disease and preparation method for Chinese medicinal composition |
| CN102526279B (en) * | 2012-02-12 | 2013-08-28 | 贾奎 | Chinese medicinal composition for treating central high fever caused by acute cerebrovascular disease and preparation method for Chinese medicinal composition |
| CN106266969A (en) * | 2016-08-31 | 2017-01-04 | 单晓春 | Saigae Tataricae peace palace capsule and its preparation method and application |
| CN109260424A (en) * | 2018-12-10 | 2019-01-25 | 付宏伟 | A kind of cow-bezoar bolus for resurrection and preparation method thereof |
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