CN101152310B - Traditional Chinese medicine liquid capsule and its preparing method - Google Patents
Traditional Chinese medicine liquid capsule and its preparing method Download PDFInfo
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Abstract
The invention discloses a liquid capsule of traditional Chinese medicine for remedying the inappetence, the nausea and vomitus, the abdominal flatulence and diarrhea and the dyspepsia and the preparation method of the liquid capsule. Catechu uncaria, corktree bark, liquorice, tangerine peel and cassia bark are decocted by water, and filtrate is condensed as thick ointment; run oil is added into the thick ointment to be mixed uniformly for obtaining a traditional Chinese medicine combination; the liquid capsule is prepared by adding the officinal auxiliary materials with the pharmic acceptable quantity into the traditional Chinese medicine combination. The liquid capsule of traditional Chinese medicine which is prepared by the invention has the advantages of simple technology, good curative effect and being convenient for taking and can be used for remedying the symptoms of inappetence, the nausea and vomitus, the abdominal flatulence and diarrhea, the dyspepsia etc.
Description
Technical field
The present invention relates to a kind of inappetence, nausea and vomiting, abdominal distention diarrhoea, dyspeptic liquid Chinese traditional medicine capsule of being used for the treatment of, be specifically related to a kind of adult that unhygienic diet or being not acclimatized cause and liquid Chinese traditional medicine capsule of infantile diarrhea of being used for the treatment of, the present invention also relates to the preparation method of this liquid Chinese traditional medicine capsule.
Background technology
The diarrhoea that unhygienic diet or being not acclimatized cause, stomachache are due to a kind of imbalance reaction to conditions such as new weather, physical features, water quality, foods of people's body.Infantile diarrhea is one group to be increased by many cause of diseases, the multifactor times of defecation that causes and the character of defecating is changed into the usual diseases of childhood of characteristics.Can be divided into infectious and non-infectious two kinds.Onset can be delayed can be anxious, and light disease only has gastrointestinal symptom, and inappetence occasionally has vomiting, times of defecation to increase and character changes; The severe one times of defecation will reach one day more than ten times, and even tens times, stool can be water sample, pasty state, mucus shape, and the bloody purulent stool separated that has can occur obvious dehydration and electrolyte disturbance and whole body poisoning symptom simultaneously as high heat, agitation, lethargy etc.The most onset of infantile diarrhea is very anxious, and frequent diarrhoea can make moisture and nutrient in body lose rapidly, causes acute dehydration.Be generally to take that symptom does not take a turn for the better after oral rehydration, lethargy, fever, frequent vomiting, water sample stool occur, even just in pus and blood, should remove hospital admission immediately, but continuous supplementary oral liquor body on the way.
The normal clinical commonly used drug of the adult that unhygienic diet or being not acclimatized cause and infantile diarrhea is HUOXIANG ZHENGQI WAN/water and infection and digestant such as berberine, but HUOXIANG ZHENGQI WAN/water and berberine have the strong impulse abnormal smells from the patient, are difficult for the particularly child patient acceptance for the patient.
Summary of the invention
The liquid Chinese traditional medicine capsule that the purpose of this invention is to provide a kind of effective treatment inappetence that can be easy to accept by the patient, nausea and vomiting, abdominal distention diarrhoea, indigestion symptom.
Another object of the present invention is to provide a kind of method for preparing above-mentioned liquid Chinese traditional medicine capsule.
For achieving the above object, the inventor designs through a large amount of experiment and performing creative labour on the basis of existing technology and is used for the treatment of inappetence, nausea and vomiting, abdominal distention diarrhoea, dyspeptic liquid Chinese traditional medicine capsule, comprise softgel shell and capsule liquid, described capsule liquid comprises the component of following weight parts:
Chinese medicine composition 6-15 dispersant 12-16 suspending agent 0.4～0.7;
Described Chinese medicine composition is prepared from by the component processing of following weight portion:
Heat up in a steamer oily 20-60 Uncaria gambier Roxb. 30-200 Cortex Phellodendri 10-60
Radix Glycyrrhizae 8-35 Pericarpium Citri Reticulatae 15-50 Cortex cinnamomi japonici (Ramulus Cinnamomi) 30-70.
Preferably, described Chinese medicine composition is prepared from through processing by the raw material of Chinese medicine of following weight portion:
Heat up in a steamer oily 30-50 Uncaria gambier Roxb. 50-150 Cortex Phellodendri 15-30
Radix Glycyrrhizae 10-30 Pericarpium Citri Reticulatae 20-40 Cortex cinnamomi japonici (Ramulus Cinnamomi) 40-60.
Most preferably, described Chinese medicine composition is prepared from through processing by the raw material of Chinese medicine of following weight portion:
Heat up in a steamer oily 35-45 Uncaria gambier Roxb. 75-120 Cortex Phellodendri 30-40
Radix Glycyrrhizae 15-20 Pericarpium Citri Reticulatae 30-40 Cortex cinnamomi japonici (Ramulus Cinnamomi) 40-60.
The described oil that heats up in a steamer is creosote, pine tar or bamboo tar.
Described dispersant is polyethylene glycols or vegetable oil; Described suspending agent is one or more the mixture in Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, propylene glycol.
Described vegetable oil is a kind of of Oleum Arachidis hypogaeae semen, soybean oil, Oleum sesami, Oleum Brassicae campestris or other consumption vegetable oil or several mixture wherein.
The antiseptic and/or the surfactant that contain convention amount in described capsule liquid.
Described antiseptic is parabens or glycerol monostearate; Described surface activity reaches and is tween or span.
A kind of method for preparing above-mentioned liquid Chinese traditional medicine capsule comprises the steps:
Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 2-3 time, and each 1-3 hour, collecting decoction filtered, and surveying relative density when filtrate is condensed into 60 ℃ is the thick paste of 1.10-1.30; Wherein amount of water be Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 6-10 doubly; To heat up in a steamer oil and join in thick paste, and stir, and get Chinese medicine composition, and add dispersant and suspending agent, colloid mill is ground to mix homogeneously, gets capsule liquid, and filling is prepared into liquid capsule in the capsule softgel shell.
The method of the above-mentioned liquid Chinese traditional medicine capsule of another kind of preparation comprises the steps:
1. getting Cortex Phellodendri is 60～90% alcohol heating reflux 2～3 times in percent by volume, each 1～3 hour, filter, and merging filtrate, filtrate recycling ethanol filters to without the alcohol flavor, gets filtrate A; Or,
Cortex Phellodendri is processed into coarse powder, doubly measures saturated limewater as solvent take 8-12, supersound extraction 2-3 time, 15-30min/ time, extracting solution is mixed with the solution of counting 30-35mg/ml with crude drug, filters, add the NaCl placement and spend the night, filter, oven dry is dissolved in water in precipitation, filters, and it is 1～2 that filtrate adds hydrochloric acid accent pH, wait precipitating rear filtration, get filtrate A;
2. Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 2～3 times, each 1～3 hour, collecting decoction filtered, and when filtrate is concentrated into 60 ℃, the survey relative density is 1.10～1.30 extractum B; Wherein amount of water is Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 6～10 times;
3. filtrate A is mixed with extractum B, when being concentrated into 60 ℃, relative density is 1.10～1.30 extractum, and drying is made fine powder, add and heat up in a steamer oil, stir, get Chinese medicine composition, add dispersant and suspending agent, colloid mill is ground to mix homogeneously, get capsule liquid, filling is prepared into liquid capsule in the capsule softgel shell.
The described oil that heats up in a steamer is with Fagaceae plant Fagus sinensis Oliv. Fagus sinensis Oliv., natural beech section natural plant Zelkova schneideriana Hand.-Mazz., maple, Xylosmae japonici, Quercus acutissima Carr., Pinaceae pinaceae Pinus pinus plant pinaster or Juniperus rigida Sieb.et Zucc., bamboo is placed in distillating still and distills, getting dry distillation liquid distills under 180-360 ℃ of condition, the fraction that collection is heavier than water, process as follows:
1. adding percentage by weight is the aqueous slkali of 5-20%, stir, and crystallisation by cooling;
2. filter, discard filtrate, the washing of filtering residue clear water discards washings, adding weight percent concentration is the 20-35% sulfuric acid solution, stirs, and discards sulfate wastewater, be rectification under vacuum under the 0.08-0.09MPa condition in vacuum after the clear water washing, the rectification of collecting 130-155 ℃ divides, and get final product;
Described fraction: aqueous slkali: the weight part ratio of sulfuric acid solution is 1-3: 2-4: 2-3.5.
Adding percentage by weight after 1. described step stirs is calcium acetate or the magnesium acetate solution of 10-30% again; Described fraction: the weight part ratio of calcium acetate or magnesium acetate is 1-3: 4-7.
Described step aqueous slkali 1. is sodium hydroxide or potassium hydroxide solution.
Described Fagaceae plant Fagus sinensis Oliv. Fagus sinensis Oliv., natural beech section natural plant Zelkova schneideriana Hand.-Mazz., maple, Xylosmae japonici, Quercus acutissima Carr., Pinaceae pinaceae Pinus pinus plant pinaster or Juniperus rigida Sieb.et Zucc., bamboo is placed in distillating still and distills, getting dry distillation liquid distills under 180-360 ℃ of condition, the collection fraction heavier than water is placed in rectifying still, it is 130-155 ℃ in temperature, withdrawing moisture and light fraction under vacuum 0.08-0.09MPa condition, with the freezing 12-48 hour crystallization under subzero 20 to 0 ℃ of conditions of the fraction in rectifying still, the crystal centrifugalize obtains heating up in a steamer oily crystal.
Also add antiseptic and/or surfactant in described capsule liquid.
The Chinese medicine composition of liquid Chinese traditional medicine capsule of the present invention is that the inventor passes through lot of experiments from crude drug preferably out, and having stagnation is rushed down, and is used for adult and infantile diarrhea that eating and drinking without temperance or being not acclimatized cause, belongs to damp and hot, dyspepsia card person.Card is seen: inappetence, nausea and vomiting, abdominal distention diarrhoea, dyspepsia.Heating up in a steamer the oils main component is guaiacol (Guaiacol), kreosol (Crosol) and other phenols, act on similar to phenol, but its toxicity and zest are all less, be colourless or pale yellow oily liquid, altering property cigarette is smelly, flavor burns strong, has the pharmacological actions such as anticorrosion, sterilization, local anaesthesia, clinical treatment for antidiarrheal, whole intestinal and toothache.The Chinese medicine composition of preparation of the present invention has strong penetrance smoke, for covering the bad smell of medicine, make the patient be easy to accept, the inventor has carried out a large amount of research to the dosage form of preparation and the selection of adjuvant used, simultaneously the moulding process of preparation carried out performing creative labour, finally determined to select liquid capsule preparation.
The dry concentrate of the leaf of Maguireothamnus speciosus gambier gambirplant leaf and branchlet (Uncariagambir) and sprout decocting liquid is used as medicine, and property is bitter, puckery, be slightly cold, nontoxic, enter lung meridian.Its main component is catechin (Cateehin) and Quercetin (Quereetin) etc.Have that removing dampness purges heat, promoting tissue regeneration and ulcer healing, the analgesic therapy hemostasis is promoted the production of body fluid and is reduced phlegm, the effects such as astringing to arrest diarrhea.The treatment of the diseases such as clinical, watery diarrhea swollen for aphtha, incised wound, skin ulceration, hemorrhoid, endo-enteritis.The Uncaria gambier Roxb. dry extract plays convergence in preparation of the present invention, adjust the effect of enteral moisture.
Cortex Phellodendri (Cortex phellodendri) is the dry bark of Rutaceae Cortex Phellodendri (Phelloden-dron amurense Rupr.), and bitter in the mouth is cold in nature, returns kidney, urinary bladder channel.The main component of Cortex Phellodendri is the bitter rope (Li-monin) of berberine (Berberine) and Fructus Citri Limoniae, and contain a small amount of fibrauretin (Palmatine) and obacunone (Obakunone), staphylococcus aureus, bloody dysentery bacterium, gonococcus etc. there are potent antibacterial action, suppress the cellular antibody generation.Have the effects such as antiinflammatory, blood pressure lowering.Clinical in warm dysentery, yellow cellulitis, leukorrhagia, pyretic stranguria, beriberi, flaccidity base, hectic fever due to YIN-deficiency consumptive fever; Night sweat, seminal emission, sore swollen toxin, the treatment of the diseases such as eczema pruritus.Cortex Phellodendri plays antibiotic, spasmolytic effect in preparation of the present invention.
Pericarpium Citri Reticulatae has the effect of fragrant stomach invigorating profit intestinal, the inventor is studied the plant amedica composition in preparation of the present invention and the interaction of guaiacol, it is unexpected that the discovery Pericarpium Citri Reticulatae have important impact to the pharmacokinetic parameter of guaiacol, and the mean dissolution time of guaiacol is measured, experimental details is as follows:
Materials and methods: the 1. preparation of pill: the powder of Uncaria gambier Roxb. dry extract 4g, Cortex Phellodendri 6g, Radix Glycyrrhizae 3g, Pericarpium Citri Reticulatae 6g is mixed, add glycerol, water and creosote, kneading 5min in the porcelain alms bowl, make the creosote ball (P4R) that is about 4.8mg and the pill (P4R-CUP2) that does not contain Pericarpium Citri Reticulatae, contain the pill (P4R-1/2CUP2) of half amount Pericarpium Citri Reticulatae.2. the mensuration of guaiacol stripping from pill: in (37 ± 0.5) ℃, 6 pills are put into dissolution medium, stir with 100r/min.Respectively at 5,10,20,40, after 60min, after sampling 1mL, then supply volume with fresh medium.Sample liquid is crossed microporous filter membrane, gets 500 μ L subsequent filtrates, adds mark liquid and 500 μ L ethyl acetate in 20 μ L.Mixed liquor is stirred 3min, with the centrifugal 3min of 5000r/min, get ethyl acetate layer and inject the GC-MS system and analyze after mixing, observe the stripping of guaiacol from pill.3. pharmacokinetic: the Wistar ST in 10 ages in week is rat feeding after 2 months, and the rat of choosing body weight 400～450g carries out pharmacokinetic.Fasting 18h is with pentobarbital sodium (30mg/kg) intraperitoneal injection of anesthesia, then in left side jugular vein intubate.P4R is bonded at the stomach probe tip, inserts administration in stomach, distilled water 0.3mL reinjects.After administration 0.5,10,20,30,60,90,120,180,240,300min, blood sampling 0.5mL, centrifugal from intubate, blood plasma-20 ℃ preservation.Oral castor oil causes the rat model of diarrhoea and also tests as stated above.4. the guaiacol concentration in blood plasma: add buffer in 150 μ L blood plasma, 37 ℃ of incubation 2h, then add 1N hydrochloric acid (60 μ L), fluorophenol (20 μ L) and ethyl acetate (1mL), stir 3min, with the centrifugal 3min of 5000r/min.The ethyl acetate soluble fraction is analyzed with GC-MS, and the standard curve that gets guaiacol concentration in blood plasma is Y=0.0005X+0.0086 (r=0.999).
Result: 1. 5,10, during 20min, the dissolution rate of guaiacol from P4R-CUP2 is significantly higher than the dissolution rate of guaiacol from P4R, P4R-1/2CUP2.The MRT of P4R group guaiacol obviously extends than P4R-CUP2.Due to AUC in the blood of two groups
0-5hThere is no significant difference, therefore think that the effect of Pericarpium Citri Reticulatae prolongation MRT is the impact that is subjected to MDT.The diarrhoea of 2. bringing out for Oleum Ricini, Pericarpium Citri Reticulatae also have the effect that extends MRT.After diarrhoea group rat was taken medicine, in blood plasma, guaiacol concentration was similar to normal rat, but the T of guaiacol
max, AUC
0～5h, mean residence time (MRT) is lower than normal group, but C
maxHigher than normal group.3. normal rat is taken after the P4R 5min that contains (286 ± 8) μ g guaiacol and guaiacol can be detected in blood plasma, after 45～115min, guaiacol concentration peaking in blood plasma, after 5h lower than detectable limit.Be the index that medicine has continuous action owing to extending MRT and MDT, therefore think that the lasting anti-diarrhea effect of pill is relevant with Pericarpium Citri Reticulatae.
Radix Glycyrrhizae in preparation of the present invention has analgesia, detoxifcation, protection gastric mucosa, the effect of coordinating the actions of various ingredients in a prescription.
The inventor selects through a large amount of testing sieves has increased the Cortex cinnamomi japonici (Ramulus Cinnamomi) composition on the basis of original formula, and determined to have the effect of warming the interior cold expelling due to the Cortex cinnamomi japonici powder Cortex cinnamomi japonici (Ramulus Cinnamomi) by its consumption, have synergism with other composition, make curative effect greatly improve, disease makes lasting medicine.
The technological difficulties of liquid capsule mainly are the preparation of capsule liquid, and for guaranteeing the uniform and stable of capsule liquid, general capsule liquid is comprised of medicine, dispersant and suspending agent.The dispersant that How to choose is suitable and suspending agent need be done creationary research.
One, the selection of dispersant: the selection of medicine dispersant is one of key of development liquid capsule, and it should be able to guarantee the stability of accuracy and the preparation of content, thereby guarantees the safety and effectiveness of medicine.Common dispersants has consumption vegetable oil and PEG-4000 (PEG-400) at present, and the inventor screens above consumption both by experiment.
Get three parts of Chinese medicine compositions, add respectively soybean oil, Oleum Arachidis hypogaeae semen and the PEG-4000 of capacity, fully mix by colloid mill and ground 30 minutes, put in the centrifuge of 2000 rev/mins centrifugal 20 minutes, the precipitation situation of observing two mixed liquors the results are shown in Table 1.
The different dispersant sedimentation of table 1 situation result of the test
| Dispersant | The sedimentation situation |
| Soybean oil Oleum Arachidis hypogaeae semen PEG-4000 | Do not find precipitation, vegetable oil and medicated powder not layering are not found precipitation, and precipitation, the not layering of PEG-4000 and medicated powder do not appear in vegetable oil and medicated powder not layering |
As seen from the experiment, two kinds of consumption vegetable oil and PEG-4000 all can be used as the dispersant of this prescription.But the research discovery, PEG-4000 has induration to softgel shell, need add propylene glycol to be regulated; In addition, during take PEG-4000 as dispersant, dry run than very fast, must appropriately be grasped drying time, and overlong time can make softgel shell break, and the time is too short, due to liquid aqueous in liquid capsule, causes liquid capsule seepage in storage period; There is not above-mentioned shortcoming with vegetable oil as dispersant.So vegetable oil is optimal choice, have good stability for guaranteeing liquid capsule preparation, this prescription preparation selects the consumption vegetable oil as dispersant.Through experiment confirm, vegetable oil used can also be Oleum sesami, Oleum Brassicae campestris and other edible vegetable oil, all can obtain essentially identical effect.
Two, the selection of dispersive agent ratio: the consumption of dispersant directly has influence on yield rate and the loading amount of liquid capsule.Dispersive agent ratio is too low, and good stability, but poor fluidity are difficult for pelleting, and yield rate is low; Dispersive agent ratio is excessive, and the thixotroping value is low, good fluidity, but loading amount is large and be easy to seepage.Therefore screen the dispersant of different proportion, thereby determine optimal proportion.Get the medicated powder of three parts of equivalent, add respectively not commensurability vegetable oil, fully mix by colloid mill and ground 30 minutes, observe its state, the results are shown in Table 2.
The selection result of the test of table 2 dispersive agent ratio
| Dispersant: medicated powder | The medicinal liquid situation |
| 1∶1 1.5∶1 2∶1 | The medicinal liquid thickness, the bad medicinal liquid of mobility is even, and the better medicinal liquid of mobility is rarer, good fluidity |
By result in table as can be known, when the ratio of dispersant and medicated powder was 1.5: 1, the mobility of medicinal liquid can satisfy the requirement of liquid capsule pressing.Further determining after test, be 1.2: 1～1.6: 1 o'clock in ratio, better effects is all arranged, best with 1.4: 1 o'clock.
Three, the selection of suspending agent: find in the process of preparation sample, when simple medication powder and vegetable oil suspendible, effect is not desirable especially, therefore it is very necessary needing to select suitable suspending agent, adding its Chinese medicine of liquid capsule of making after suspending agent is to be scattered in oil with molecularity, oil phase enters blood through lymph in vivo, is not subjected to the impact of first pass effect, thereby produces higher bioavailability.The kind of suspending agent is a lot of as Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, and suspending agent can be the mixture of above-mentioned one or more.Minimum and be easy to get due to the Cera Flava cost, therefore the inventor preferentially selects Cera Flava to test as suspending agent, as suspending agent, carry out the screening of suspending agent consumption with different Cera Flava ratios, the results are shown in Table 3.
The selection result of the test of table 3 suspending agent ratio
| Suspending agent accounts for medicated powder | The medicinal liquid situation |
| 2％ 5％ 10％ | Medicinal liquid is inhomogeneous, the lamination medicinal liquid occurs even, and without lamination, easily moulding capsule medicinal liquid is even, and without lamination, when the moulding capsule, medicinal liquid solidifies |
As can be seen from the above table, the consumption of suspending agent be medicated powder 5% the time, be fit to for this prescription, medicinal liquid is even, and is easy to the neutralizing liquid capsule.After further testing, find that the Cera Flava consumption is the effect that all can play stably in 4%～7% scope of medicated powder amount, optimised quantity is 6% again.Rear inventor still is studied other several suspending agents respectively, find the suspending agent consumption be medicated powder be 4%～7% the time, can play the effect of stablizing suspending.It is best suspending agent that final inventor still selects Cera Flava.
In order to guarantee the steady quality of final products, also can also to add a certain amount of antiseptic in capsule liquid, as parabens, glyceryl monostearate etc., according to circumstances different, addition is also different, and is general in 0.3% left and right of amount of liquid medicine, as long as reach fungistatic effect.Can also add appropriate surfactant, as the Tweens span, the suitable situation of addition and deciding generally is no more than 1%, with can make capsule liquid mix homogeneously, stabilize to good.
The liquid capsule of the present invention preparation can be covered the smelly and strong taste that burns of the altering property cigarette of drug substance contents, the problem that change is made us or made groups of people be difficult to take etc., and make that it is clean and tidy, attractive in appearance, easily swallow; Dosage is accurate relatively, and degree of accuracy is higher, can reach milligram/grain metering; The bioavailability of medicine is high, and comparatively speaking, capsule and tablet, pill are different, do not need to add binding agent and pressure during preparation, substantially belong to again dissolving or trickle powder and be scattered in content, in case disintegrate just together discharges, so be effect rapidly, it is good obviously also to absorb soon than pill, tablet; The reason that the bioavailability of medicine is high, reach the needed haemoconcentration of identical drug effect, the unit administration amount of liquid capsule reaches the curative effect of tablet with identical purpose etc. with regard to relatively reducing, test shows, liquid capsule of the present invention and tablet difference be oral 100mtg once, 6 examples take liquid capsule person is on average peaked at the 1.5h blood level, is 6g/ml; Another 6 examples take tablet person is on average just peaked at the 2.5h blood level, and is only had 3.5 μ g/ml.Improve medicine stability.As photosensitive medicine, meet damp and hot unsettled medicine, the medicine of easy oxidation etc., due to its relative closure encystation, so can be prepared into the liquid capsule that adds opacifier, protection medicine is subjected to the effect of oxygen, light in wet and air, thereby improves its stability; Contain a large amount of creosotes in Chinese medicine composition of the present invention, be difficult for making ball, tablet, and the liquid capsule preparation of making has that digestive tract good absorbing effect, curative effect are high, good stability, dosage advantage accurately, carries light and handy, easy to use.
Pharmacodynamics test research
The function that having of medicine stagnation of the present invention is rushed down is used for the treatment of adult that unhygienic diet or being not acclimatized cause and children's's inappetence, nausea and vomiting, abdominal distention, diarrhoea, dyspepsia etc.
This research is adopted the anti-diarrhea effect of Oleum Ricini induced mice diarrhoea and Folium Sennae induced mice diarrhoea, small intestine movement of mice is advanced and on the impact of the hyperfunction model mice intestinal propulsion motion of intestinal due to neostigmine, on the impact of the emptying motion of Mouse Stomach and on the test method that affects of rat gastric acid, pepsinia, to verify the drug effect of medicine of the present invention.
1 experiment material
Animal: white mice, the Kunming kind, one-level is qualified, male and female half and half, body weight 18-21g; The SD rat, male and female half and half, body weight 180～200g abovely provides by The Fourth Military Medical University's Experimental Animal Center.
Medicine and reagent: test group preparation used is the liquid capsule preparation (creosote 35kg, Uncaria gambier Roxb. 30kg, Cortex Phellodendri 60kg, Radix Glycyrrhizae 8kg, Pericarpium Citri Reticulatae 31kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 30kg) according to the embodiment of the present invention eight preparations, it is the lab scale medicine, lot number 060319 is provided by Jiangxi Yaodu Renhe Pharmaceutical Co., Ltd.Control drug: the whole intestinal ball of belly pain stomach invigorating, lot number 20051102, pharmaceutical factory, Thailand Lee Wanshan Mountain; Oleum Ricini, commercial, lot number 20060202, Nanchang white clouds medication chemistry factory; Folium Sennae, commercial, face the used time to be mixed with 15% suspension; Neostigmine methyl sulfate, lot number: 2006201, letter friendship Pharmaceutical is produced; Metoclopramide, lot number: 20060301, Beijing doube bridge drugmaker; Motilium, lot number: 200601140, Xian-Janssen Pharmaceutical Ltd. produces; Phenol reagent: (Folin-Ciocalteu) compound method is seen " herbal pharmacology experimental methodology ", Li Yikui, Science and Technology of Shanghai publishing house, P242; Bovine hemoglobin, Shanghai uncle bio tech ltd difficult to understand, lot number: G200601; L-Tyrosine, Shanghai uncle bio tech ltd difficult to understand, lot number: 20018402; 0.1% thimerosal, 5% trichloroacetic acid, 0.5mol/l sodium carbonate, 0.3mol/l hydrochloric acid, 0.04mol/l hydrochloric acid.
Instrument: the multi-functional analyzer of BECKMAN series type; PHS-3C type acidometer, Shanghai thunder magnetic instrument plant; Sartrius electronic balance (precision 1/1000).
2 experimental techniques and result
2.1 the anti-diarrhea effect to Oleum Ricini induced mice diarrhoea
Choose 50 of white mice, be divided at random 5 groups by body weight, positive drug matched group gavage is to the whole intestinal ball obtain solution 0.4mL/20g of institute of belly pain stomach invigorating, be 1mg/kg, the high, medium and low dosage group difference of liquid capsule gavage is to the lab scale medicine dosing 0.4mL/20g of institute of variable concentrations, i.e. 1.8g/kg, 0.9g/kg, 0.45g/kg; The normal saline 0.4mL/20g of blank group group gavage equal volume.Successive administration 3 days, after last administration 1h, gavage is to Semen Ricini fluid 0.4mL/20g; Then with the mice sub-cage rearing, 1, every cage, cage heelpiece adularescent filter paper is surveyed the incubation period of its appearance, and every h changes paper 1 time, Continuous Observation 6h, the loose stool number on recorder chart.Experimental result sees Table 4.
The anti-diarrhea effect of table 4 pair Oleum Ricini induced mice diarrhoea
Annotate: compare with the blank group
*P＜0.01,
*P＜0.05 (lower same).
Table 4 result shows, the low and high dose group of liquid capsule can make the loose stool of mice obviously reduce, parallel with positive control (P＜0.01).
2.2 the anti-diarrhea effect to Folium Sennae induced mice diarrhoea
Choose 50 of white mice, be divided at random 5 groups by body weight, positive drug matched group gavage is to the whole intestinal ball obtain solution 0.4mL/20g of institute of belly pain stomach invigorating, be 1mg/kg, the high, medium and low dosage group difference of liquid capsule gavage is to the lab scale medicine dosing 0.4mL/20g of institute of variable concentrations, i.e. 1.8g/kg, 0.9g/kg, 0.45g/kg; The normal saline 0.4mL/20g of blank group group gavage equal volume.Successive administration 3 days, after last administration 1h, gavage is to Folium Sennae suspension 0.4mL/20g; Then with the mice sub-cage rearing, 1, every cage, cage heelpiece adularescent filter paper are surveyed it, are surveyed the incubation period of its appearance, per hour change paper 1 time, Continuous Observation 6h, the loose stool number on recorder chart.Experimental result sees Table 5.
The anti-diarrhea effect of table 5 pair Folium Sennae induced mice diarrhoea
Table 5 result as seen, blank group is to after Folium Sennae, the loose stool of mice increases, and has showed symptom of diarrhea, the low dose group of liquid capsule can make the loose stool of mice reduce, and middle and high dosage group can make the loose stool of mice obviously reduce (P＜0.01).
2.3 the impact on the normal mouse intestine movement
Choose 50 of white mice, be divided at random 5 groups by body weight, positive drug matched group gavage is to the whole intestinal ball obtain solution 0.4mL/20g of institute of belly pain stomach invigorating, be 1mg/kg, the high, medium and low dosage group difference of liquid capsule gavage is to the lab scale medicine dosing 0.4mL/20g of institute of variable concentrations, i.e. 1.8g/kg, 0.9g/kg, 0.45g/kg; The normal saline 0.4mL/20g of blank group group gavage equal volume.Successive administration 3 days, after last administration 1h, gavage is to active carbon 0.4mL/ only; Put to death animal after 20 minutes, take pylorus as starting point, measure distance that active carbon is pushed into and the total length of small intestinal.Then calculate the propelling rate of active carbon:
Result such as table 6.
The impact of table 6 on the normal mouse intestine movement
Table 6 result shows, in liquid capsule, the dosage group can suppress the propelling moving (P≤0.05) of the small intestinal of normal mouse, and the visible trend that suppresses intestinal motility of other each group, but not statistically significant.
2.4 neostigmine is caused the impact of the hyperfunction model intestinal propulsion motion of mice intestinal
Choose 50 of white mice, be divided at random 5 groups by body weight, positive drug matched group gavage is to the whole intestinal ball obtain solution 0.4mL/20g of institute of belly pain stomach invigorating, be 1mg/kg, the high, medium and low dosage group difference of liquid capsule gavage is to the lab scale medicine dosing 0.4mL/20g of institute of variable concentrations, i.e. 1.8g/kg, 0.9g/kg, 0.45g/kg; The normal saline 0.4mL/20g of blank group group gavage equal volume.Successive administration 5d, last administration 40min lumbar injection neostigmine 0.1mg/kg causes the hyperfunction model of small intestinal, after 15min, gavage to active carbon 0.4mL/ only, put to death animal after 20min, take pylorus as starting point, measure distance that active carbon is pushed into and the total length of small intestinal.Then calculate the propelling rate of active carbon:
Result such as table 7.
Table 7 pair neostigmine causes the inhibitory action of the hyperfunction model intestinal propulsion motion of mice intestinal
Table 7 result shows, the ahead running (P＜0.01) of the small intestinal of the low and hyperfunction model that high dose group can obviously suppress.Middle dosage group has the trend that suppresses motion, but not statistically significant.
2.5 the impact on the emptying motion of normal Mouse Stomach
Choose 50 of white mice, be divided at random 5 groups by body weight, positive drug matched group gavage is to the whole intestinal ball obtain solution 0.4mL/20g of institute of belly pain stomach invigorating, be 1mg/kg, the high, medium and low dosage group difference of liquid capsule gavage is to the lab scale medicine dosing 0.4mL/20g of institute of variable concentrations, i.e. 1.8g/kg, 0.9g/kg, 0.45g/kg; The normal saline 0.4mL/20g of blank group group gavage equal volume.Successive administration 5d, last administration 1h gavage to gelatinized corn starch 0.8mL/ is only put to death animal after 20min, and then ligation cardia and pylorus get stomach.The full weight of stomach with clean after the net weight difference for being residual quantity, and then calculate residual rate.Experimental result sees Table 8.
The facilitation of the table 8 pair emptying motion of normal Mouse Stomach
As seen from Table 8, the middle dosage of liquid capsule can promote the gastric emptying motion of mice, compares (P＜0.05) with matched group.
2.6 on the pepsic impact of rat gastric acid
Choose 50 of white mice, be divided at random 5 groups by body weight, positive drug matched group gavage is to the whole intestinal ball obtain solution 0.4mL/20g of institute of belly pain stomach invigorating, be 1mg/kg, the high, medium and low dosage group difference of liquid capsule gavage is to the lab scale medicine dosing 0.4mL/20g of institute of variable concentrations, i.e. 1.8g/kg, 0.9g/kg, 0.45g/kg; The normal saline 0.4mL/20g of blank group group gavage equal volume.
Successive administration 10d, fasting 48 hours is freely drunk water.Use the etherization animal afterwards, cut off the hair of abdominal part, routine disinfection skin is opened the approximately otch of 2.5cm along hunter's line under xiphoid-process, and the careful stomach of mentioning at pylorus and duodenum joint portion suture ligature, is avoided blood vessel.The rear syringe duodenal administration of using is sent back to after stitching in cage, and water is prohibited in the postoperative fasting, and 5 hours femoral vein are got blood and put to death animal, take out stomach, collect gastric juice in graduated centrifuge tube, with the centrifugal 15min of 3000r/min, draws supernatant and surveys respectively gastric acid, pepsin.The gastric acid amount is calculated by the NaoH of the 0.01mmol/L that consumes; Pepsin is by " herbal pharmacology experimental methodology ", Li Yikui, Science and Technology of Shanghai publishing house, and P242 stipulates pepsic assay method.Experimental result sees Table 9.
The impact of table 9 on rat gastric acid pepsin activity
Table 9 result shows, the middle and high dosage group of liquid capsule can improve pepsic activity, has statistical significance, with matched group relatively (P＜0.01).
3 discuss
Experimentation by pharmacodynamics shows, medicine of the present invention can significantly reduce the loose stool number of mice, has anti-diarrhea effect; Can promote the gastric emptying motion of mice; The intestinal propulsion of the hyperfunction model mice of intestinal motion due to inhibition normal mouse and neostigmine, thereby the absorption of promotion nutrient substance; Promote the secretion of gastric juice and suppress pepsic activity, improving digestive function.Thereby for treatment inappetence, nausea and vomiting, abdominal distention, diarrhoea, dyspepsia etc. provide the pharmacodynamics foundation.
The specific embodiment:
Embodiment one
Capsule liquid: Chinese medicine composition 10kg, soybean oil 12kg, Cera Flava 0.4kg
Being prepared from by creosote 50kg, Uncaria gambier Roxb. 120kg, Cortex Phellodendri 10kg, Radix Glycyrrhizae 35kg, Pericarpium Citri Reticulatae 30kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 45kg processing of described Chinese medicine composition;
Preparation method:
The preparation of creosote:
Fagaceae plant Fagus sinensis Oliv. is placed in distillating still distills, get dry distillation liquid and distill under 180 ℃ of conditions, collect the fraction heavier than water, process as follows:
1. adding percentage by weight is solution in 15% hydroxide, stir, and crystallisation by cooling;
2. filter, discard filtrate, the washing of filtering residue clear water discards washings, adding weight percent concentration is 35% sulfuric acid solution, stirs, and discards sulfate wastewater, be rectification under vacuum under the 0.08-0.09MPa condition in vacuum after the clear water washing, the rectification of collecting 130-155 ℃ divides, and namely gets wooden pomegranate oil;
Described fraction: sodium hydroxide solution: the weight part ratio of sulfuric acid solution is 1: 2: 3;
The preparation of preparation:
Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 2 times, and 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and when filtrate is condensed into 60 ℃, the survey relative density is 1.15 thick paste; Wherein amount of water is respectively Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 10,8 times; The 50kg creosote is joined in thick paste, stir, get Chinese medicine composition.
Get Chinese medicine composition 10kg and add dispersant soybean oil and suspending agent Cera Flava, colloid mill is ground to mix homogeneously, and filling is prepared into liquid capsule in No. 1 capsule softgel shell
Embodiment two
Capsule liquid: Chinese medicine composition 12kg, Oleum Arachidis hypogaeae semen 16kg, lecithin 0.7kg, tween 80 0.1kg
Described Chinese medicine composition is to be prepared from by creosote 20kg, Uncaria gambier Roxb. 150kg, Cortex Phellodendri 35kg, Radix Glycyrrhizae 14kg, Pericarpium Citri Reticulatae 20kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 60kg;
Preparation method:
The preparation of creosote:
Natural Zelkova schneideriana Hand.-Mazz. is placed in distillating still distills, get dry distillation liquid and distill under 200 ℃ of conditions, collect the fraction heavier than water, process as follows:
1. adding percentage by weight is 5% sodium hydroxide solution, stirs, and adding percentage by weight is 15% calcium acetate solution, crystallisation by cooling;
2. filter, discard filtrate, the washing of filtering residue clear water discards washings, adding weight percent concentration is 25% sulfuric acid solution, stirs, and discards sulfate wastewater, be rectification under vacuum under the 0.08-0.09MPa condition in vacuum after the clear water washing, the rectification of collecting 130-155 ℃ divides, and namely gets wooden pomegranate oil;
Described fraction: sodium hydroxide solution: calcium acetate solution: the weight part ratio of sulfuric acid solution is 2: 3: 5: 2.5;
The preparation of preparation:
Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 3 times, and 2 hours for the first time, 3 hours for the second time, 1 hour for the third time, collecting decoction filtered, and when filtrate is condensed into 60 ℃, the survey relative density is 1.20 thick paste; Wherein amount of water is respectively Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 8,10,6 times; The 20kg creosote is joined in thick paste, stir, get Chinese medicine composition;
Get Chinese medicine composition 12kg and add dispersant Oleum Arachidis hypogaeae semen, suspending agent lecithin and surfactant tween 80, colloid mill is ground to mix homogeneously, and filling is prepared into liquid capsule in No. 1 capsule softgel shell.
Embodiment three
Capsule liquid: Chinese medicine composition 14kg, Polyethylene Glycol-200 13kg, aluminum monostearate 0.2kg, propylene glycol 0.4kg, ethyl hydroxybenzoate 0.1kg, tween 20 0.1kg;
Described Chinese medicine composition is to be prepared from by creosote 40kg, Uncaria gambier Roxb. 110kg, Cortex Phellodendri 30kg, Radix Glycyrrhizae 10kg, Pericarpium Citri Reticulatae 40kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 40kg;
Preparation method:
The preparation of creosote:
Maple is placed in distillating still distills, get dry distillation liquid and distill under 360 ℃ of conditions, collect the fraction heavier than water, process as follows:
1. adding percentage by weight is 20% sodium hydroxide solution, stirs, and adding percentage by weight is 30% magnesium acetate solution, crystallisation by cooling;
2. filter, discard filtrate, the washing of filtering residue clear water discards washings, adding weight percent concentration is 20% sulfuric acid solution, stirs, and discards sulfate wastewater, be rectification under vacuum under the 0.08-0.09MPa condition in vacuum after the clear water washing, the rectification of collecting 130-155 ℃ divides, and namely gets wooden pomegranate oil;
Described fraction: sodium hydroxide solution: magnesium acetate solution: the weight part ratio of sulfuric acid solution is 3: 4: 7: 3.5;
The preparation of preparation:
Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 2 times, and 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and when filtrate is condensed into 60 ℃, the survey relative density is 1.30 thick paste; Wherein amount of water be respectively Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 6,8, doubly; The 40kg creosote is joined in thick paste, stir, get Chinese medicine composition;
Get Chinese medicine composition 14kg and add dispersant Polyethylene Glycol-200, suspending agent aluminum monostearate and ethyl cellulose, antiseptic ethyl hydroxybenzoate, surfactant tween 20, colloid mill is ground to mix homogeneously, and filling is prepared into liquid capsule in No. 1 capsule softgel shell
Embodiment four
Capsule liquid: Chinese medicine composition 6kg, Oleum Brassicae campestris 15kg, aluminum monostearate 0.5kg, glycerol monostearate 0.1kg, Tween-60 0.1kg;
Described Chinese medicine composition is to be prepared from by creosote 41kg, Uncaria gambier Roxb. 75kg, Cortex Phellodendri 25kg, Radix Glycyrrhizae 25kg, Pericarpium Citri Reticulatae 15kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 55kg;
Preparation method:
The preparation of creosote:
Xylosmae japonici is placed in distillating still distills, get dry distillation liquid and distill under 300 ℃ of conditions, collect the fraction heavier than water, process as follows:
1. adding percentage by weight is 10% potassium hydroxide solution, stirs, and adding percentage by weight is 10% magnesium acetate solution, crystallisation by cooling;
2. filter, discard filtrate, the washing of filtering residue clear water discards washings, adding weight percent concentration is 30% sulfuric acid solution, stirs, and discards sulfate wastewater, be rectification under vacuum under the 0.08-0.09MPa condition in vacuum after the clear water washing, the rectification of collecting 130-155 ℃ divides, and namely gets wooden pomegranate oil;
Described fraction: potassium hydroxide solution: magnesium acetate solution: the weight part ratio of sulfuric acid solution is 2.5: 3: 4: 2;
The preparation of preparation:
Wherein the preparation method of Chinese medicine composition is with embodiment three, and when wherein filtrate being condensed into 60 ℃, the survey relative density is 1.10 thick paste;
Get Chinese medicine composition 6kg and add dispersant Oleum Brassicae campestris, suspending agent aluminum monostearate, antiseptic glycerol monostearate, surfactant Tween-60, colloid mill is ground to mix homogeneously, and filling is prepared into liquid capsule in No. 1 capsule softgel shell.
Embodiment five
Capsule liquid: Chinese medicine composition 8kg, PEG-4000 13kg, Cera Flava 0.3kg, lecithin 0.2kg, ethyl hydroxybenzoate 0.1kg, tween 20 0.1kg;
Described Chinese medicine composition is to be prepared from by pine tar 60kg, Uncaria gambier Roxb. 200kg, Cortex Phellodendri 50kg, Radix Glycyrrhizae 16kg, Pericarpium Citri Reticulatae 29kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 70kg;
Preparation method:
The preparation of pine tar:
Pinaster is placed in distillating still distills, get dry distillation liquid and distill under 280 ℃ of conditions, collect the fraction heavier than water, process as follows:
1. adding percentage by weight is 12% potassium hydroxide solution, stirs, and adding percentage by weight is 20% magnesium acetate solution, crystallisation by cooling;
2. filter, discard filtrate, the washing of filtering residue clear water discards washings, adding weight percent concentration is 28% sulfuric acid solution, stirs, and discards sulfate wastewater, be rectification under vacuum under the 0.08-0.09MPa condition in vacuum after the clear water washing, the rectification of collecting 130-155 ℃ divides, and namely gets unguentum picis pini;
Described fraction: potassium hydroxide solution: magnesium acetate solution: the weight part ratio of sulfuric acid solution is 1.5: 2.5: 6: 3;
The preparation of preparation:
1. getting Cortex Phellodendri is 90% alcohol heating reflux 2 times in percent by volume, 2 hours for the first time, and 1.5 hours for the second time, filter, merging filtrate, filtrate recycling ethanol filters to without the alcohol flavor, gets filtrate A;
2. Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 3 times, 2 hours for the first time, 3 hours for the second time, 1 hour for the third time, collecting decoction filtered, and when filtrate is concentrated into 60 ℃, the survey relative density is 1.10 extractum B; Wherein amount of water is respectively Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 10,8,6 times;
3. filtrate A is mixed with extractum B, when being concentrated into 60 ℃, relative density is 1.30 extractum, and drying is made fine powder, adds the 60kg pine tar, stirs, and gets Chinese medicine composition;
Get Chinese medicine composition 8kg and add dispersant PEG-4000, suspending agent Cera Flava and lecithin, antiseptic ethyl hydroxybenzoate, surfactant tween 20, colloid mill is ground to mix homogeneously, adopts filling in No. 1 capsule softgel shell, is prepared into liquid capsule.
Embodiment six
Capsule liquid: Chinese medicine composition 15kg, Oleum sesami 14kg, ethyl cellulose 0.6kg, glycerol monostearate 0.1kg, Arlacel-60 0.1kg;
Described Chinese medicine composition is to be prepared from by bamboo tar 30kg, Uncaria gambier Roxb. 140kg, Cortex Phellodendri 40kg, Radix Glycyrrhizae 30kg, Pericarpium Citri Reticulatae 25kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 35kg;
Preparation method:
The preparation of bamboo tar:
Bamboo is placed in distillating still to be distilled, getting dry distillation liquid distills under 180 ℃ of conditions, the collection fraction heavier than water is placed in rectifying still, it is 130-155 ℃ in temperature, withdrawing moisture and light fraction under vacuum 0.08-0.09MPa condition, with the crystallization in freezing 12 hours under subzero 20 conditions of the fraction in rectifying still, the crystal centrifugalize obtains the bamboo tar crystal, be placed in normal temperature condition, standby;
The preparation of preparation:
1. getting Cortex Phellodendri is 75% alcohol heating reflux 3 times in percent by volume, 3 hours for the first time, and 2 hours for the second time, 1 hour for the third time, filter, merging filtrate, filtrate recycling ethanol filters to without the alcohol flavor, gets filtrate A;
2. Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 2 times, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and when filtrate is concentrated into 60 ℃, the survey relative density is 1.20 extractum B; Wherein amount of water is Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 8,6 times;
3. filtrate A is mixed with extractum B, when being concentrated into 60 ℃, relative density is 1.10 extractum, and drying is made fine powder, adds the 30kg bamboo tar, stirs, and gets Chinese medicine composition;
Get Chinese medicine composition 15kg and add dispersant Oleum sesami, suspending agent ethyl cellulose, antiseptic glycerol monostearate, surfactant Arlacel-60, colloid mill is ground to mix homogeneously, and filling is prepared into liquid capsule in No. 1 capsule softgel shell
Embodiment seven
Capsule liquid: Chinese medicine composition 9kg, Oleum Brassicae campestris 14.5kg, aluminum monostearate 0.5kg, ethyl cellulose 0.1kg, glycerol monostearate 0.1kg, Tween-40 0.15kg;
Described Chinese medicine composition is prepared from by creosote 55kg, Uncaria gambier Roxb. 50kg, Cortex Phellodendri 65kg, Radix Glycyrrhizae 20kg, Pericarpium Citri Reticulatae 35kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 60kg;
Preparation method:
The preparation of creosote:
Quercus acutissima Carr. is placed in distillating still to be distilled, getting dry distillation liquid distills under 360 ℃ of conditions, the collection fraction heavier than water is placed in rectifying still, it is 130-155 ℃ in temperature, withdrawing moisture and light fraction under vacuum 0.08-0.09MPa condition, with the crystallization in freezing 48 hours under 0 ℃ of condition of the fraction in rectifying still, the crystal centrifugalize obtains the creosote crystal, be placed in normal temperature condition, standby;
The preparation of preparation:
1. getting Cortex Phellodendri is 60% alcohol heating reflux 2 times in percent by volume, 1.5 hours for the first time, and 3 hours for the second time, filter, merging filtrate, filtrate recycling ethanol filters to without the alcohol flavor, gets filtrate A;
2. Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 2 times, 3 hours for the first time, 1 hour for the second time, collecting decoction filtered, and when filtrate is concentrated into 60 ℃, the survey relative density is 1.30 extractum B; Wherein amount of water is Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 9,8,6 times;
3. filtrate A is mixed with extractum B, when being concentrated into 60 ℃, relative density is 1.20 extractum, and drying is made fine powder, adds the 55kg creosote, stirs, and gets Chinese medicine composition;
Get Chinese medicine composition 9kg and add dispersant Oleum Brassicae campestris, suspending agent aluminum monostearate and ethyl cellulose, antiseptic glycerol monostearate, surfactant Arlacel-40, colloid mill is ground to mix homogeneously, adopts filling in No. 1 capsule softgel shell, is prepared into liquid capsule.
Embodiment eight
Capsule liquid: Chinese medicine composition 12.5kg, Polyethylene Glycol-600 13kg, propylene glycol 0.55kg, ethyl hydroxybenzoate 0.1kg, Tween-40 0.12kg
Described Chinese medicine composition is to be prepared from by creosote 35kg, Uncaria gambier Roxb. 30kg, Cortex Phellodendri 60kg, Radix Glycyrrhizae 8kg, Pericarpium Citri Reticulatae 31kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 30kg;
Preparation method:
The preparation of creosote:
Natural Zelkova schneideriana Hand.-Mazz. is placed in distillating still to be distilled, getting dry distillation liquid distills under 220 ℃ of conditions, the collection fraction heavier than water is placed in rectifying still, it is 130-155 ℃ in temperature, withdrawing moisture and light fraction under vacuum 0.08-0.09MPa condition, with the crystallization in freezing 20 hours under subzero 10 ℃ of conditions of the fraction in rectifying still, the crystal centrifugalize obtains the creosote crystal, be placed in normal temperature condition, standby;
The preparation of preparation:
The preparation method of Chinese medicine composition is with embodiment five;
Wherein 1. step is processed into coarse powder with Cortex Phellodendri, take 10 times of amount saturated limewaters as solvent, and supersound extraction 2 times, 20min for the first time, 10min, be mixed with extracting solution the solution of counting 33.33mg/ml with crude drug for the second time, filter, add the NaCl placement and spend the night, filter oven dry, be dissolved in water in precipitation, filter, it is 1～2 that filtrate adds hydrochloric acid accent pH, wait precipitating rear filtration, gets filtrate A;
Get Chinese medicine composition 12.5kg and add dispersant Polyethylene Glycol-600, suspending agent propylene glycol, antiseptic list ethyl hydroxybenzoate, surfactant Tween-40, colloid mill is ground to mix homogeneously, and filling is prepared into liquid capsule in No. 1 capsule softgel shell.
Embodiment nine
Capsule liquid: Chinese medicine composition 7.5kg, soybean oil 15.5kg, Cera Flava 0.45kg, single ethyl hydroxybenzoate 0.1kg, Tween-40 0.12kg
Described Chinese medicine composition is to be prepared from by creosote 45kg, Uncaria gambier Roxb. 90kg, Cortex Phellodendri 29kg, Radix Glycyrrhizae 15kg, Pericarpium Citri Reticulatae 50kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 65kg;
Preparation method:
The preparation method of wood pomegranate oil is with embodiment three;
The preparation method of Chinese medicine composition is with embodiment six;
Step is measured saturated limewaters as solvent, supersound extraction 3 times 1. for Cortex Phellodendri is processed into coarse powder take 8 times, 30 minutes for the first time, 20 minutes for the second time, 15 minutes for the third time, extracting solution is mixed with the solution of counting 35mg/ml with crude drug, filters, add the NaCl placement and spend the night, filter, oven dry is dissolved in water in precipitation, filters, and it is 1～2 that filtrate adds hydrochloric acid accent pH, wait precipitating rear filtration, get filtrate A;
Get Chinese medicine composition 7.5kg and add dispersant soybean oil, suspending agent Cera Flava, antiseptic list ethyl hydroxybenzoate, surfactant Tween-40, colloid mill is ground to mix homogeneously, adopt dropping preparation method to be packed into softgel shell, filling is prepared into liquid capsule in No. 1 capsule softgel shell.
Embodiment ten
Capsule liquid: Chinese medicine composition 10.5kg, Oleum sesami 12.5kg, ethyl cellulose 0.65kg, single ethyl hydroxybenzoate 0.1kg, Tween-40 0.12kg
Described Chinese medicine composition is to be prepared from by creosote 39kg, Uncaria gambier Roxb. 180kg, Cortex Phellodendri 45kg, Radix Glycyrrhizae 12kg, Pericarpium Citri Reticulatae 45kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 70kg;
Preparation method:
The preparation method of wood pomegranate oil is with embodiment four;
The preparation method of Chinese medicine composition is with embodiment eight;
Wherein step 1. for Cortex Phellodendri is processed into coarse powder, is measured saturated limewaters as solvent, supersound extraction 3 times take 12 times, 30 minutes for the first time, 20 minutes for the second time, 15 minutes for the third time, extracting solution is mixed with the solution of counting 30mg/ml with crude drug, filters, add the NaCl placement and spend the night, filter, oven dry is dissolved in water in precipitation, filters, and it is 1～2 that filtrate adds hydrochloric acid accent pH, wait precipitating rear filtration, get filtrate A;
Get Chinese medicine composition 10.5kg and add dispersant Oleum sesami, suspending agent ethyl cellulose, antiseptic list ethyl hydroxybenzoate, surfactant Tween-40, colloid mill is ground to mix homogeneously, and filling is prepared into liquid capsule in No. 1 capsule softgel shell.
Embodiment 11
Capsule liquid: Chinese medicine composition 14.5kg, Oleum Arachidis hypogaeae semen 14.3kg, lecithin 0.48kg, single ethyl hydroxybenzoate 0.1kg, Tween-40 0.12kg
Described Chinese medicine composition is to be prepared from by creosote 25kg, Uncaria gambier Roxb. 130kg, Cortex Phellodendri 20kg, Radix Glycyrrhizae 32kg, Pericarpium Citri Reticulatae 43kg, Cortex cinnamomi japonici (Ramulus Cinnamomi) 50kg;
Preparation method:
Wherein the preparation method of pine tar is with embodiment five;
The preparation method of Chinese medicine composition is with embodiment seven;
Wherein step is 1. for to be processed into coarse powder with Cortex Phellodendri, measure saturated limewaters as solvent, supersound extraction 2 times, 25 minutes for the first time take 10,9 times respectively, 20 minutes for the second time, extracting solution is mixed with the solution of counting 34mg/ml with crude drug, adds the NaCl placement and spend the night, filter, oven dry, be dissolved in water in precipitation, filter, it is 1～2 that filtrate adds hydrochloric acid accent pH, filters to get filtrate A after precipitating;
Get Chinese medicine composition 14.5kg and add dispersant Oleum Arachidis hypogaeae semen, suspending agent lecithin, antiseptic list ethyl hydroxybenzoate, surfactant Tween-40, colloid mill is ground to mix homogeneously, and filling is prepared into liquid capsule in No. 1 capsule softgel shell.
Claims (13)
1. one kind is used for the treatment of inappetence, nausea and vomiting, abdominal distention diarrhoea, dyspeptic liquid Chinese traditional medicine capsule, comprises softgel shell and capsule liquid, it is characterized in that described capsule liquid comprises the component of following weight parts:
Chinese medicine composition 6-15 dispersant 12-16 suspending agent 0.4～0.7;
Described Chinese medicine composition is prepared from by the component processing of following weight portion:
Heat up in a steamer oily 20-60 Uncaria gambier Roxb. 30-200 Cortex Phellodendri 10-60
Radix Glycyrrhizae 8-35 Pericarpium Citri Reticulatae 15-50 Cortex cinnamomi japonici (Ramulus Cinnamomi) 30-70;
The described oil that heats up in a steamer is Fagaceae plant Fagus sinensis Oliv. Fagus sinensis Oliv., natural beech section natural plant Zelkova schneideriana Hand.-Mazz., maple, Xylosmae japonici, Quercus acutissima Carr., Pinaceae pinaceae Pinus pinus plant pinaster or Juniperus rigida Sieb.et Zucc., bamboo is placed in distillating still and distills, getting dry distillation liquid distills under 180-360 ℃ of condition, the fraction that collection is heavier than water, process as follows:
1. adding percentage by weight is the aqueous slkali of 5-20%, stir, and crystallisation by cooling;
2. filter, discard filtrate, the washing of filtering residue clear water discards washings, adding weight percent concentration is the 20-35% sulfuric acid solution, stirs, and discards sulfate wastewater, be rectification under vacuum under the 0.08-0.09MPa condition in vacuum after the clear water washing, the rectification of collecting 130-155 ℃ divides, and get final product;
Described fraction: aqueous slkali: the weight part ratio of sulfuric acid solution is 1-3: 2-4: 2-3.5;
Above-mentioned dispersant is polyethylene glycols or vegetable oil; Described suspending agent is one or more the mixture in Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, propylene glycol.
2. according to liquid Chinese traditional medicine capsule claimed in claim 1, it is characterized in that described Chinese medicine composition is prepared from through processing by the raw material of Chinese medicine of following weight portion:
Heat up in a steamer oily 30-50 Uncaria gambier Roxb. 50-150 Cortex Phellodendri 15-30
Radix Glycyrrhizae 10-30 Pericarpium Citri Reticulatae 20-40 Cortex cinnamomi japonici (Ramulus Cinnamomi) 40-60.
3. according to liquid Chinese traditional medicine capsule claimed in claim 1, it is characterized in that described Chinese medicine composition is prepared from through processing by the raw material of Chinese medicine of following weight portion:
Heat up in a steamer oily 35-45 Uncaria gambier Roxb. 75-120 Cortex Phellodendri 30-40
Radix Glycyrrhizae 15-20 Pericarpium Citri Reticulatae 30-40 Cortex cinnamomi japonici (Ramulus Cinnamomi) 40-60.
4. liquid Chinese traditional medicine capsule as claimed in claim 1 is characterized in that described vegetable oil is a kind of of Oleum Arachidis hypogaeae semen, soybean oil, Oleum sesami, Oleum Brassicae campestris or other consumption vegetable oil or several mixture wherein.
5. as claim 1,2 or 3 described liquid Chinese traditional medicine capsules, it is characterized in that containing in described capsule liquid antiseptic and/or the surfactant of convention amount.
6. liquid Chinese traditional medicine capsule as claimed in claim 5, is characterized in that described antiseptic is parabens or glycerol monostearate; Described surface activity reaches and is tween or span.
7. a method for preparing claim 1,2 or 3 described liquid Chinese traditional medicine capsules, comprise the steps:
Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 2-3 time, and each 1-3 hour, collecting decoction filtered, and surveying relative density when filtrate is condensed into 60 ℃ is the thick paste of 1.10-1.30; Wherein amount of water be Uncaria gambier Roxb., Cortex Phellodendri, Radix Glycyrrhizae, Pericarpium Citri Reticulatae, Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 6-10 doubly; To heat up in a steamer oil and join in thick paste, and stir, and get Chinese medicine composition, and add dispersant and suspending agent, colloid mill is ground to mix homogeneously, gets capsule liquid, and filling is prepared into liquid capsule in the capsule softgel shell.
8. a method for preparing claim 1,2 or 3 described liquid Chinese traditional medicine capsules, comprise the steps:
1. getting Cortex Phellodendri is 60～90% alcohol heating reflux 2～3 times in percent by volume, each 1～3 hour, filter, and merging filtrate, filtrate recycling ethanol filters to without the alcohol flavor, gets filtrate A; Or,
Cortex Phellodendri is processed into coarse powder, doubly measures saturated limewater as solvent take 8-12, supersound extraction 2-3 time, 15-30min/ time, extracting solution is mixed with the solution of counting 30-35mg/ml with crude drug, filters, add the NaCl placement and spend the night, filter, oven dry is dissolved in water in precipitation, filters, and it is 1～2 that filtrate adds hydrochloric acid accent pH, wait precipitating rear filtration, get filtrate A;
2. Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) are decocted with water 2～3 times, each 1～3 hour, collecting decoction filtered, and when filtrate is concentrated into 60 ℃, the survey relative density is 1.10～1.30 extractum B; Wherein amount of water is Uncaria gambier Roxb., Radix Glycyrrhizae, Pericarpium Citri Reticulatae and Cortex cinnamomi japonici (Ramulus Cinnamomi) gross weight 6～10 times;
3. filtrate A is mixed with extractum B, when being concentrated into 60 ℃, relative density is 1.10～1.30 extractum, and drying is made fine powder, add and heat up in a steamer oil, stir, get Chinese medicine composition, add dispersant and suspending agent, colloid mill is ground to mix homogeneously, get capsule liquid, filling is prepared into liquid capsule in the capsule softgel shell.
9. according to the described method of claim 7 or 8, it is characterized in that the described oil that heats up in a steamer is Fagaceae plant Fagus sinensis Oliv. Fagus sinensis Oliv., natural beech section natural plant Zelkova schneideriana Hand.-Mazz., maple, Xylosmae japonici, Quercus acutissima Carr., Pinaceae pinaceae Pinus pinus plant pinaster or Juniperus rigida Sieb.et Zucc., bamboo is placed in distillating still and distills, get dry distillation liquid and distill under 180-360 ℃ of condition, collect the fraction heavier than water, process as follows:
1. adding percentage by weight is the aqueous slkali of 5-20%, stir, and crystallisation by cooling;
2. filter, discard filtrate, the washing of filtering residue clear water discards washings, adding weight percent concentration is the 20-35% sulfuric acid solution, stirs, and discards sulfate wastewater, be rectification under vacuum under the 0.08-0.09MPa condition in vacuum after the clear water washing, the rectification of collecting 130-155 ℃ divides, and get final product;
Described fraction: aqueous slkali: the weight part ratio of sulfuric acid solution is 1-3: 2-4: 2-3.5.
10. in accordance with the method for claim 9, it is characterized in that adding after 1. described step stirs percentage by weight is calcium acetate or the magnesium acetate solution of 10-30% again; Described fraction: the weight part ratio of calcium acetate or magnesium acetate is 1-3: 4-7.
11. in accordance with the method for claim 9, it is characterized in that described step aqueous slkali 1. is sodium hydroxide or potassium hydroxide solution.
12. according to the described method of claim 7 or 8, it is characterized in that described Fagaceae plant Fagus sinensis Oliv. Fagus sinensis Oliv., natural beech section natural plant Zelkova schneideriana Hand.-Mazz., maple, Xylosmae japonici, Quercus acutissima Carr., Pinaceae pinaceae Pinus pinus plant pinaster or Juniperus rigida Sieb.et Zucc., bamboo is placed in distillating still and distills, getting dry distillation liquid distills under 180-360 ℃ of condition, the collection fraction heavier than water is placed in rectifying still, it is 130-155 ℃ in temperature, withdrawing moisture and light fraction under vacuum 0.08-0.09MPa condition, with the freezing 12-48 hour crystallization under subzero 20 to 0 ℃ of conditions of the fraction in rectifying still, the crystal centrifugalize obtains heating up in a steamer oily crystal.
13. according to the described method of claim 7 or 8, it is characterized in that also adding antiseptic and/or surfactant in described capsule liquid.
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