CN102258615B - Yanning capsule and preparation method thereof - Google Patents
Yanning capsule and preparation method thereof Download PDFInfo
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- CN102258615B CN102258615B CN2011101879135A CN201110187913A CN102258615B CN 102258615 B CN102258615 B CN 102258615B CN 2011101879135 A CN2011101879135 A CN 2011101879135A CN 201110187913 A CN201110187913 A CN 201110187913A CN 102258615 B CN102258615 B CN 102258615B
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract
The invention discloses a preparation method of a traditional Chinese medicine for treating the respiratory tract infection, the amygdalitis, the urinary tract infection, the acute bacillary dysentery and the enteritis. The preparation method comprises the following steps of: preparing 1953.12g of herb of savatier monochasma, 976.56g of oldenlandia diffusa and 976.56g of common dayflower herb, adopting a carbon dioxide supercritical extraction method to obtain supernatant liquor, concentrating the filtrate, drying, crushing extractum into fine powder by using an airflow crushing machine, adding an excipient, mixing uniformly and then bagging. The preparation method has the advantages that the extraction of active ingredients is complete, the bioavailability is high, the absorption is good, the quality is stable and the repeatability is good and the like.
Description
Technical field
The present invention relates to the field of Chinese medicines, specifically, relate to a kind of upper respiratory tract infection for the treatment of, tonsillitis, urinary tract infection, acute bacillary dysentery, inflammation diminishing capsule of enteritis and preparation method thereof.
Background technology
Inflammation diminishing capsule, heat-clearing and toxic substances removing, anti-inflammtory anti-dysentery.Be used for the treatment of upper respiratory tract infection, tonsillitis, urinary tract infection, acute bacillary dysentery, the diseases such as enteritis, but exist active ingredient to extract the deficiencies such as incomplete, that bioavailability is low.
Summary of the invention
For overcoming above-mentioned deficiency, the objective of the invention is to adopt that modern high tech method provides a kind of active ingredient to extract fully, bioavailability is high, stay-in-grade inflammation diminishing capsule and preparation method thereof.
Inflammation diminishing capsule is by following method preparation:
Get Herba monochasmatis 1953.12g, Herba Hedyotidis Diffusae 976.56g, Herba Commelinae 976.56g, adopt carbon dioxide supercritical extraction method to extract extracting pressure 20-50Mpa, extraction temperature 30-60 ℃, separator pressure 5-10Mpa, separator temperature 40-60 ℃, disengaging time 2-6 hour, carbon dioxide flow is 20-30L/H, get supernatant, filtrate is concentrated, dry, adopts jet mill that extract powder is broken into superfine powder, add pharmaceutically acceptable excipient mixing dress capsule, make 1000.
Wherein, jet mill is broken into extract powder the superfine powder of particle diameter＜50 micron.
The Chinese crude drug source that above-mentioned embodiment is mentioned is as follows:
Herba monochasmatis: the herb for profound careless section Herba monochasmatis platymiscium MIAOMAO Herba monochasmatis, have heat-clearing and toxic substances removing, the effect of cooling blood for hemostasis is used for flu, the cough due to lung-heat, the air port toothache, infantile thrush, acute mastitis, menoxenia, metrorrhagia, leukorrhagia is spitted blood, and has blood in stool traumatic hemorrhage, rheumatic ostalgia.
Herba Hedyotidis Diffusae: be the herb of Rubiaceae cerastium Herba Hedyotidis Diffusae.Have heat-clearing and toxic substances removing, promoting blood circulation and detumescence, the effect of dampness removing jaundice eliminating is used for the lung-heat cough with asthma, lung abscess, laryngopharynx swelling and pain, acute appendicitis, furuncle and phyma skin infection, venom, the puckery pain of pyretic stranguria, edema, dysentery enteritis, jaundice due to damp-heat, cancerous protuberance.
Herba Commelinae: be the dry aerial parts of Commelianaceae plant Herba Commelinae Commelina communis L..Has clearing away heat-fire, detoxifcation, the effect of inducing diuresis to remove edema.Be used for cold, fever, calentura excessive thirst, laryngopharynx swelling and pain, edema oliguria, the puckery pain of pyretic stranguria, carbuncle furunculosis.
The used crude drug of inflammation diminishing capsule all can be bought from common pharmacy and obtain, and its specification meets national medical standard.
The specific embodiment
The following example only is used for explanation the present invention, rather than limits by any way the present invention.
Specific embodiments of the invention 1
Get Herba monochasmatis 976.56g, Herba Hedyotidis Diffusae 488.28g, Herba Commelinae 488.28g, the employing carbon dioxide supercritical extraction method is extracted, extracting pressure 20Mpa, 30 ℃ of extraction temperature, separator pressure 5Mpa, 40 ℃ of separator temperatures, disengaging time 2 hours, carbon dioxide flow is 20L/H, get supernatant, filtrate is concentrated, dry, adopts jet mill that extract powder is broken into particle diameter＜50 micron (fully by 300 mesh sieves) superfine powder, adds pharmaceutically acceptable excipient mixing dress capsule and makes 1000.
Specific embodiments of the invention 2
Get Herba monochasmatis 2929.68g, Herba Hedyotidis Diffusae 1464.84g, Herba Commelinae 1464.84g, the employing carbon dioxide supercritical extraction method is extracted, extracting pressure 50Mpa, 60 ℃ of extraction temperature, separator pressure 10Mpa, 60 ℃ of separator temperatures, disengaging time 6 hours, carbon dioxide flow is 30L/H, get supernatant, filtrate is concentrated, dry, adopt jet mill that extract powder is broken into particle diameter＜50 micron (fully by 300 mesh sieves) superfine powder, add pharmaceutically acceptable excipient mixing dress capsule and make 1000.
The most preferred specific embodiment 3 of the present invention
Get Herba monochasmatis 1953.12g, Herba Hedyotidis Diffusae 976.56g, Herba Commelinae 976.56g, adopt carbon dioxide supercritical extraction method to extract extracting pressure 35Mpa, 45 ℃ of extraction temperature, separator pressure 8Mpa, 50 ℃ of separator temperatures, disengaging time 4 hours, carbon dioxide flow are 25L/H.Get supernatant, filtrate is concentrated, dry,, adopt jet mill that extract powder is broken into particle diameter＜50 micron (fully by 300 mesh sieves) superfine powder, add pharmaceutically acceptable excipient mixing dress capsule and make 1000.
(1) method of inspection of inflammation diminishing capsule embodiment:
This product 1g is got in [discriminating] (1), adds ethanol 20ml dipping after several minutes, filters, and gets filtrate 2ml, adds 1～2 of ferric chloride test solution, and is namely aobvious blackish green.
(2) get this product 1g, add ethanol 20ml dipping after several minutes, filter, get filtrate 2ml, add remaining filtrate 5ml behind 1～2 of the ferric chloride test solution, evaporate to dryness adds chloroform 5ml and makes dissolving, gets chloroform liquid, add 2 in sulphuric acid, placement is micro-yellow afterwards, puts to heat in the water-bath to become pink.
[assay]
The preparation precision of reference substance solution takes by weighing at the control substance of Rutin 20mg of 120 ℃ of drying under reduced pressure to constant weight, put in the 100ml measuring bottle, add 60% appropriate amount of ethanol, put in 80 ℃ of water-baths heating and make dissolving, let cool,, shake up to scale with 60% ethanol dilution, precision is measured 25ml, put in the 50ml measuring bottle, thin up shakes up to scale, namely gets (every 1ml contains anhydrous rutin 0.1mg)
The content of 10 of this product is got in the preparation of need testing solution, and mixing is accurately weighed, takes by weighing 0.5g, and is accurately weighed, put in the 50ml measuring bottle, add 30% ethanol dilution to scale, shake up, filter, discard just filtrate, precision is measured 3ml, puts in the 25ml measuring bottle, adds 30% ethanol dilution to scale, shakes up, and get final product.
Above-mentioned two kinds of each 2ml of solution of the accurate absorption of algoscopy, put respectively in the 10ml measuring bottle, each adds 30% ethanol 3ml and shakes up, accurate sodium nitrite solution (1 → 20) 0.3ml that adds, shake up, placed 6 minutes, accurate aluminum trichloride solution (1 → 10) 0.3ml that adds shakes up, and places 10 minutes, add sodium hydroxide solution (1mol/L) 4ml,, shake up to scale with 30% ethanol dilution, placed 10 minutes, get in addition simultaneously above-mentioned two kinds of each 2ml of solution, put respectively in the 10ml measuring bottle, add 30% ethanol to graduation mark and shake up and do blank, measure respectively trap according to spectrophotography (" appendix VA of Chinese pharmacopoeia version in 2010) at 5l0nm wavelength place, calculate content, and get final product.
Every of this product contains total flavones with anhydrous rutin (C
37H
30O
16) meter, must not be less than 50mg.
Every dress of specification 0.25g
(2) inflammation diminishing capsule pharmacodynamic study
1. upper respiratory tract infection antiinflammatory, analgesic, analgesia, antibacterial, antiviral experiment
1.1 material
1.1.1 medicine
Inflammation diminishing capsule 30g of the present invention; Ibuprofen tablet (Anhui Province Quanjiang pharmaceutical factory); Aspirin tablet (Shandong Xinhua Pharmaceutical Factory); Compound Folium Isatidis mixture, 10ml/ props up, and produces (lot number: 20090816) by Lunan Pharmacy Co. Ltd; Carrageenin is produced by Sigma company; Caseinhydrolysate agar (MH) culture medium is produced (lot number: 20090404) by Shanghai Yi Hua medical science and technology company limited; Nutrient broth is produced (lot number: 20090203) by Shanghai Biological Products Inst., Ministry of Public Health; The PRMI1640 culture medium is produced (lot number: 31800-089), add 15% aseptic calf serum during use by U.S. CIBCOBRL company.
1.1.2 animal: SD rat, male and female dual-purpose, body weight 180-240g; The NIH mice, male, body weight 20-25g; Rabbit, male and female dual-purpose, body weight 1.8-2.4Kg.Provide by school district, Zhejiang University lakeside Experimental Animal Center.
1.1.3 compounding medicine
Scorching peaceful suspension grinds the inflammation diminishing capsule adding distil water, is mixed with the suspension of desired concn;
Ibuprofen or aspirin suspension grind to form fine powder with ibuprofen tablet or aspirin tablet, are made into the suspension of desired concn with 0.5% sodium carboxymethyl cellulose (CMC-Na) liquid.
1.1.4 yeast suspension
Fresh yeast (Hegang brewery provides) is made into 30% yeast suspension with distilled water.
1.2 method and result
1.2.1 rat paw injection carrageenin is caused the impact of inflammatory swelling
40 of rats are divided into 5 groups at random, 8 every group.1 group is the blank group, gives normal saline 10ml/kgig, and 3 groups is the basic, normal, high dosage group of inflammation diminishing capsule, gives respectively inflammation diminishing capsule 2.5,5.0,10.0g/kg ig, and 1 group of positive matched group is given ibuprofen 0.1g/kg ig.1H after the administration goes through 1% chondrus ocellatus Holmes glue 0.1ml of the new preparation of metapedes plantar subcutaneous injection in rat under the sterile working.Adopt the rat's foot volume analyzer to measure and cause the different time rat's foot volume variation of scorching front and back, per hour 1 time, continuous 5 times.So that the difference of sufficient sole of the foot volume is as swelling before and after scorching.The result shows, behind inflammation diminishing capsule 2.5,5.0, the 10.0g/kg ig 1 hour, the inflammatory swelling that rat paw injection carrageenin is caused all had obvious inhibitory action (P＜0.05, P＜0.01, with P＜0.001), through gradient check P＜0.001, show that effect is relevant with dosage.The positive control drug ibuprofen also has obvious antiinflammatory action (P＜0.01).See Table 1
Annotate the t check, compare * 1 P＜0.05, * 2P＜0.01, * 3P＜0.001 with the normal saline group.
1.2.2 xylol causes the impact that the mouse ear capillary permeability increases.50 of mices are divided into 5 groups at random, 10 every group.1 group is the blank group, gives normal saline 0.2ml/10g ig; 3 groups is the basic, normal, high dosage group of inflammation diminishing capsule, gives respectively inflammation diminishing capsule 5.0,10.0,20.0g/kg ig; 1 group of positive matched group, group ibuprofen 0.1g/kg ig.1H after the administration, each is organized mice and injects 0.5% azovan blue normal saline 10g through the tail vein.Rapidly dimethylbenzene 0.041 is applied to two sides, mouse right ear front and back.Behind the 20min, auris dextra section locus coeruleus is obvious, mice is taken off cervical vertebra put to death, and cuts auris dextra along the auricle baseline, lays circular auricle with the card punch of diameter 9mm in each Mus auris dextra same area.Extract with acetone-normal saline (7: 3) extracting solution, centrifugal, the amount of dye that contains with colorimetric method for determining ear disk.The result shows, inflammation diminishing capsule 10.0,20.0g/kg ig all can obviously suppress the thin vascular permeability of mice caused by dimethylbenzene xylene tragus and increase, more all there were significant differences (P＜0.05 and P＜0.01) with the normal saline matched group, through gradient check P＜0.001, shows that effect is relevant with dosage.The positive control drug ibuprofen also has obvious antiinflammatory action.See Table 2
Table 2 inflammation diminishing capsule ig xylol causes impact/n=10 that the mouse ear capillary permeability increases,
Annotate the t check, compare * 1P＜0.05, * 2P＜0.01 with normal saline
1.2.3 on the impact of leukocytoplania in the subcutaneous rat carboxymethyl cellulose capsule, 40 of rats are divided into 5 groups at random, and 8 every group, male and female half and half.1 group is the blank group, gives normal saline 10m1/Kg ig; 3 groups is the basic, normal, high dosage group of inflammation diminishing capsule, gives respectively inflammation diminishing capsule 2.5,5.0,10.0g/kg ig; 1 group of positive matched group is given ibuprofen 0.1g/kg.Each organizes equal administration 2 times, interval 4H.Each group rat back is shaved hair, under the sterile working to the back subcutaneous injection air 5, form round balloon, next day, 1H injects each 5ml of 1.5%CMC liquid, CMC liquid 0.1ml in 3H and the 7H suction bags after first administration with sterilization syringe needle and syringe in capsule after first administration, accurately draw 0.01, be diluted to 0.5ml, drip on blood cell counting plate, under mirror, count leukocyte count.The result shows, inflammation diminishing capsule 2.5g/kg ig is all obviously minimizings of leukocyte count in the 7H CMC capsule after first administration, relatively there were significant differences (P＜0.05, P＜0.01) with the normal saline group, with P＜0.001) through gradient check P＜0.001, show that effect is relevant with dosage.The leukocyte count of ibuprofen group also obviously reduces (P＜0.01).See Table 3.
Table 3 inflammation diminishing capsule ig is on the impact/n=8 of leukocytoplania in the subcutaneous rat carboxymethyl cellulose capsule,
Annotating * 1 is single administration, and * 2 is the secondary administration; The t check is compared * 3P＜0.01, * 4P＜0.05, * 5P＜0.001 with the normal saline group
1.2.4 to the refrigeration function that generates heat behind the rabbit vein injection yeast mixture
Get 20 of thermometric qualified (38.6-39.4 ℃) rabbit, equal intravenous injection 30% yeast mixture 2ml/kg, 2H heats up more than 1 ℃, forms fever model, is divided at random 4 groups, 5 every group.1 group is physiology saline control group, gives normal saline 5ml/kg, and 2 groups to inflammation diminishing capsule, and dosage is respectively 5,10; 1 group of positive matched group is given aspirin 0.2g/kg in addition.Every group of equal gastric infusion every 1H thermometric 1 time, continuous 6 times, observed the refrigeration function of medicine after the administration.The result shows that normal saline matched group body temperature after giving yeast mixture 5H drops to normally gradually.The pyrogenicity rabbit to inflammation diminishing capsule 5g/kg gavage after the 1H mean body temperature reduce by 0.3 ℃, the 2H mean body temperature reduces by 0.8 ℃, 3H temperature decline level to the pyrogenicity.1H after the inflammation diminishing capsule 10g/kg gavage, mean body temperature reduces by 0.9 ℃, and the 2H mean body temperature descends 1.1 ℃, has been down to the front level of pyrogenicity.The positive controls rabbit to aspirin 0.2g/kg gavage after 12H, mean body temperature reduces by 1.2 ℃, has been down to level before the pyrogenicity.See Table 4.
Table 4 inflammation diminishing capsule ig is to refrigeration function/n=5 of 30% yeast mixture (2ml/kg iv) pyrogenicity rabbit
Annotate: the t check, compare * 1P＜0.001, * 2P＜0.05, * 3P＜0.01 with the normal saline matched group
1.2.5 the observation of bacteriostatic activity
1.2.5.1 the preparation of bacterium liquid quantitatively is inoculated in staphylococcus aureus in the suitable MH meat soup, put incubator and increase bacterium 6H, get this bacterium liquid 0.1ml transferred species in 10mlMH meat soup, put 37 ℃ of incubators and hatch 18H, this bacterium is original bacteria liquid, suitably after the dilution, be mixed with infection animal desired concn bacterium liquid with 5% sterilization gastric Mucin, standby experiment is used.
1.2.5.2 minimum lethal dose (MLD) experiment is carried out the successive dilution with original bacteria liquid with 5% gastric Mucin.Select 60 male and female half and half of healthy mice, the bacterium liquid of difference lumbar injection variable concentrations, the minimum of carrying out staphylococcus aureus causes the test of 100% animal dead, and recording staphylococcus aureus MLD is 1.2 * 10
5CFU/m1.
1.2.5.3 protection test in vivo is divided into 6 groups at random with mice, namely inflammation diminishing capsule of the present invention heavy dose of (8g/kg) is organized, middle dosage (4g/kg) group, low dose of (2g/kg) group; Positive drug compound Folium Isatidis mixture (8ml/kg) group, penicillin (100,000 U/kg) group; The blank group.20 of every group of mices, get the staphylococcus aureus of cultivating 18H, diluting with 5% gastric Mucin is the bacteria suspension of MLD, every Mus lumbar injection 0.5ml, after infecting 1,6,12,24,48,72,84,96, the 108H gastric infusion, administration volume 0.5ml/20g mice, penicillin intraperitoneal injection 0.5ml/20g mice, record dead mouse number.
1.2.5.4 idle moving appears in 30min behind each treated animal bacterial infection as a result, clinostatism then occurs, lethargy, rapid breathing, and death mostly occurs in 48H.Positive control drug compound Folium Isatidis mixture and penicillin treated animal group above-mentioned symptom also occurs after infecting.Along with the increase of dosage, infection, death time postpone.Blank group mouse death rate is 95%; The heavy dose of group of inflammation diminishing capsule of the present invention, Folium Isatidis mixture group mouse death rate is respectively 50%, 55%, has statistical significance (P＜0.05) with blank group difference; Penicillin group mice medicine mortality rate is 10%, has statistical significance (P＜0.01) with blank group difference; In the inflammation diminishing capsule of the present invention, the small dose group mortality rate is respectively 65%, 85%, with blank group comparing difference not statistically significant (P＞0.05).
1.2.6 the observation of antivirus action
1.2.6.1 inflammation diminishing capsule toxicity test of the present invention is diluted to inflammation diminishing capsule of the present invention 5 kinds of dilution factors of 1: 25,1: 50,1: 100,1: 200,1: 400 with PRMI1640 liquid, be inoculated in Hela cell culture (each dilution factor is made 4 porocytes and cultivated), 37 ℃ of cultivations, observe medicine to the maximum concentration of the cell free of toxic effects limes null as experiment usefulness.
1.2.6.2 inflammation diminishing capsule of the present invention is done 1: 100,1: 200,1: 400 dilution with inflammation diminishing capsule of the present invention with PRMI1640 liquid on the impact of pathological changes caused by virus effect, the Hela monolayer cell culture, culture fluid inclines, with the medicinal liquid of above-mentioned three dilution medicinal liquids, difference virus dilution RSV and Ad
3Become 100TCID
50Every hole adds the viral 0.2ml of above-mentioned concentration, 35 ℃ of cultivations, observation of cell pathological changes.
1.2.6.3 inflammation diminishing capsule concentration of the present invention is when 1: 100 (1%), to viral RSV, Ad as a result
3All produce obvious inhibitory action, see Table 5
The antivirus action of table 5 inflammation diminishing capsule of the present invention on cell culture
2 urinary tract infection clinical experiments
2.1 clinical data
With at random, double blinding, contrast method establish treatment group, each 40 example of matched group, treatment group male's 2 examples, women's 38 examples; Age 18-64 year, average 48 years old; The course of disease≤7 day 32 examples, 8-14 days 5 examples, 15-28 days 3 examples, average 5.65 days; The sick kind is acute cystitis 10 examples, acute pyelonephritis 4 examples, acute episode of chronic pyelonephritis 26 examples.Matched group male 10 examples, women's 30 examples; Age 20-65 year, average 45 years old; The course of disease≤7 day 29 examples, 8-14 days 7 examples, 15-28 days 4 examples, average 6.25 days; The sick kind is acute cystitis 12 examples, acute pyelonephritis 5 examples, acute episode of chronic pyelonephritis 23 examples.Two groups of case ordinary circumstances are similar, have comparability.
2.2 medicine
Select in contrast medicine of NIAOGANNING CHONGJI.Treatment group adopts No. 1, inflammation diminishing capsule (curative), and 8 are oral, No. 1, NIAOGANNING CHONGJI (blank medicine), and 1 bag is taken after mixing it with water every day 3 times.Matched group inflammation diminishing capsule No. 2 (blank medicine) and No. 2, NIAOGANNING CHONGJI (curative), instructions about how to take medicine are the same.14 days courses for the treatment of.The damp and hot disease of the record traditional Chinese medical science before and after the treatment checks greasy urine cell, urine clump count.Safety indexes is looked into liver, renal function, routine blood test, electrocardiogram.
2.3 criterion of therapeutical effect is decided criterion of therapeutical effect according to " new Chinese medicine guideline of clinical investigations " and is judged curative effect.Cure: clinical disease all disappears, and routine urinalysis is normal, and the urine clump count is negative, and the 2nd, 6 weeks check urine bacterium is negative after treatment finishes.Produce effects: clinical disease disappears (control rear damp-heat syndrome integrated value reduce more than 80%) substantially, and routine urinalysis is normal or approach normal (leukocyte≤±), and the urine bacterium is negative.Effectively: clinical disease is improved (integrated value reduces more than 50%), and routine urinalysis improves (leukocyte thirty Nian or Nian ±), urine bacterium＜10,000/ml.Invalid clinical disease is improved not obvious (integrated value reduces more than 50%), and routine urinalysis is urinated bacterium＞10,000/ml without improvement.
2.4 therapeutic outcome damp-heat syndrome integral contrast: treatment group treatment is front 8.33 ± 2.88, after the treatment 3.75 ± 2.07, and comparison P＜0.01, front and back; Treatment of control group is front 8.78 ± 2.95, and after the treatment 5.97 ± 2.42, front and back are P＞0.05 relatively.
The urine clump count changes: be thirty before two groups of patient treatments (〉=10 ten thousand/ml), after the treatment group treatment thirty be 2 Li ， Nian (＜10 ten thousand/ml) is 3 examples ,+(＜1 ten thousand/ml) is 10 examples, negative 25 examples of urine bacterium; Thirty is that 4 Li ， Nian are 10 examples after the treatment of control group ,+be 12 examples, feminine gender is 14 examples.Treatment group urine bacterium negative conversion rate is 62.5%, between 35%, two group of matched group significant differences (P＜0.01) is arranged relatively.
Clinical curative effect analysis: through 2 all medications, in treatment group 40 examples, cure 13 examples, produce effects 11 examples, effective 11 examples, invalid 5 examples, total effective rate is 87.5%; In matched group 40 examples, cure 5 examples, produce effects 8 examples, effective 13 examples, invalid 14 examples, total effective rate is 65%.Two groups relatively have significant difference (P＜0.05).
Change before and after the renal dysfunction person treats: 12 examples are arranged in the treatment group, have 3 examples to control front serum creatinine 120ummol/L in the matched group, these patients' creatinine, blood urea nitrogen are without obviously changing (P＞0.05) after the treatment.Look into treatment end rear 2 all checks 2.5 check and follow up a case by regular visits to knot, in treatment group 35 examples (Ineffective Cases is no longer checked), 3 examples are urinated bacterium＜10,000/ml, greasy urine cells (+).In matched group 26 examples, 4 example urine bacterium＜10,000/ml, greasy urine cell (+).Treatment is randomly drawed treatment group 14 examples (curing 4 examples, produce effects 4 examples, effective 6 examples) after finishing, and follows up a case by regular visits to 6 months, and the cultivation of urine bacterium and routine urinalysis are all negative, follows up a case by regular visits to and measures liver, renal function when finishing, and routine blood test and electrocardiogram are all found without unusual.
3 enteritis pharmacodynamic experiments
3.1 materials and methods
3.1.1 instrument tonotransducer and PowerLab data record and analytical system (Australian AD Instruments company); Magnus' bath (Zhangjagang City, Jiangsu Province Lignum Pini Nodi Biomedical Instruments company limited); Lambda25 type visible ultraviolet spectrophotometer (U.S. PerkinElmer company).
3.1.2 reagent and medicine
Folium Sennae (Shanghai Leiyunshang Chinese Traditional Medicine Crude Slices Factory); Oleum Ricini (Sanjing Qianhe Pharmaceutical Co., Ltd., Hayao Group's self-control, lot number 20100801); Berberine hydrochloride (Shanghai Li Sheng pharmaceutical factory, lot number: Y-001-0001); Sodium carboxymethyl cellulose (lot number F20100913 is made into desired concn with distilled water for CMCNa, Chinese Medicine group Solution on Chemical Reagents in Shanghai company limited); Atropine injection (Shanghai Hefeng Pharmaceutical Co., Ltd., lot number 100901 are made into the solution of 0.01mg/ml with 0.5%CMCNa); Neostigmine methyl sulfate injection (specification: 0.5mg/ml, friendship Jin Zhu pharmaceutcal corporation, Ltd of upper Hisense, lot number: 100401); Acecoline (Chinese Medicine group Solution on Chemical Reagents in Shanghai company limited, lot number 20100122 usefulness tri-distilled waters are made into the solution of 0.4mg/ml); Phenol red (Shanghai San'aisi Reagent Co., Ltd., lot number 100112 are made into the solution of 0.7mg/L with 2%CMCNa).Inflammation diminishing capsule of the present invention is even with the 0.5%CMCNa suspendible of milling, and is made into respectively 1.14,0.57, the medicinal liquid of 0.29g crude drug/ml.
3.1.3 the large raticide of animal SD [cleaning level, The 2nd Army Medical College Experimental Animal Center, the animal quality certification number: SCXK (Shanghai) 2010-0006], male and female half and half, body weight 250-300g; ICR mice [cleaning level, Chinese Academy of Sciences's Shanghai Experimental Animal Center, the animal quality certification number: SCXK (Shanghai) 2010-0010], male and female are not limit, body weight 18-22g; White rabbit [The 2nd Army Medical College Experimental Animal Center, the animal quality certification number: SCXK (Shanghai) 2010-0003], male and female half and half, body weight 1.8-2.2kg.
3.1.4 the normal intestinal propulsion exercise testing of rat is got 50 SD rats, is divided into 5 groups by body weight with the digitized randomized, each is organized the administration volume and is the 10ml/Kg body weight.Inflammation diminishing capsule is high, middle low dose group respectively gavage give 1.14,0.57, the inflammation diminishing capsule solution of 0.29g crude drug/ml, namely the dosage of high, medium and low dosage group be respectively 11.4,5.7,2.9g crude drug/Kg body weight.Blank group gavage gives 0.5%CMCNa solution, and the positive controls gavage gives the atropine solution of 0.01mg/ml.Administration every day 1 time, continuous 3d, carry out the carbon powder Promoting Experiment before, the rat overnight fasting.Behind the last administration 1H, gavage gives Insta-Char (being made into the 0.1g/ml suspension with 0.5%CMCNa) 10ml/kg body weight, disconnected neck is put to death rat after 30 minutes, open the abdominal cavity, separate mesentery, clip pylorus to the intestinal tube of ileocecus places on the pallet, gently small intestinal is pulled into straight line, measures Length of intestine as the small intestinal total length.With pylorus to the distance in forward position, charcoal end as the charcoal end at the enteral advance distance, calculate the suppression ratio of charcoal end ink propulsive rate and medicine.Charcoal end propelling rate=[the charcoal end is at enteral advance distance/small intestinal total length] * 100%, medicine suppression ratio [(blank group charcoal end ink propulsive rate-administration group charcoal end ink propulsive rate)/blank group charcoal end ink propulsive rate] * 100%.The result: the average charcoal of blank group end ink propulsive rate is (72.01 ± 5.77) %, the average charcoal end ink propulsive rate of the high, medium and low dosage group of inflammation diminishing capsule and positive controls (atropine) is (53.93 ± 5.71) %, (65.98 ± 7.94) %, (68.10 ± 6.98) % and (66.24 ± 5.61) %, and suppression ratio is respectively 25.11%, 8.37%, 5.43% and 8.01%.The charcoal end ink propulsive rate of inflammation diminishing capsule height, middle dosage group and positive controls is compared difference with the blank group have statistical significance (P＜0.05, P＜0.001), shows the inflammation diminishing capsule of height, middle dosage and the ahead running that atropine all can significantly suppress the normal small intestinal of rat.The charcoal end ink propulsive rate of inflammation diminishing capsule low dose group is compared the difference not statistically significant with the blank group, but still shows inhibition trend.
3.1.5 mice advances the experiment of superfunction intestinal motility to get 60 of ICR mices, each is organized the administration volume and is the 15ml/Kg body weight.The administration group respectively gavage give 1.14,0.57, the inflammation diminishing capsule solution of 0.29g crude drug/ml, then dosage be respectively 17.1,8.6,4.3g crude drug/kg body weight.Model control group and the equal gavage of blank group give 0.5%CMCNa, and the positive controls gavage gives the atropine solution of 0.01mg/ml.Administration every day 1 time, continuously 3d.Behind the last administration 1H, except the blank group, it respectively organizes the modeling of equal subcutaneous injection neostigmine 0.1g/Kg body weight, carries out charcoal end Promoting Experiment after 15 minutes, calculates the suppression ratio of charcoal end ink propulsive rate and medicine.Charcoal end ink propulsive rate calculate with the 3.1.4 item under identical.The suppression ratio of medicine=[(model control group charcoal end ink propulsive rate-administration group charcoal end ink propulsive rate)/model control group charcoal end ink propulsive rate] * 100%.
The result: inflammation diminishing capsule advances in the impact experiment of superfunction intestinal motility on the ICR mice, the average charcoal end ink propulsive rate of blank group and model control group is respectively (66.29 ± 16.04) % and (77.46 ± 13.94) %, inflammation diminishing capsule is high, in, the average charcoal end ink propulsive rate of low dose group and positive controls (atropine) is respectively (54.98 ± 7.07) %, (69.20 ± 7.25) %, (70.79 ± 10.98) % and (74.79 ± 15.38) %, the suppression ratio of medicine is respectively 29.02%, 10.66%, 8.61% and 3.45%.Subcutaneous injection neostigmine 0.1g/kg body weight can cause that the ICR mouse small intestine advances superfunction.The charcoal end ink propulsive rate of inflammation diminishing capsule high dose group is compared difference with model control group statistical significance, the inflammation diminishing capsule that shows high dose can significantly suppress the propelling superfunction intestinal motility function that neostigmine causes, in the inflammation diminishing capsule, low dose group and positive controls compare the difference not statistically significant with the blank group, but still have the trend that suppresses to advance the superfunction intestinal motility.
3.1.6 40 of rabbit are got in the experiment of family's rabbits' isolated duodenum smooth muscle activity, male and female half and half are divided into 5 groups by body weight with the digitized randomized, i.e. blank group, positive controls (atropine) and the high, medium and low dosage group of inflammation diminishing capsule, 8 every group.All rabbit are fasting 24H before experiment, and it is deadly to tap the head, and cuts open the belly immediately, takes out one section duodenum, preserves in cold tyrode's solution rapidly.Clip 1.5cm intestinal segment during experiment is suspended in 37 ℃, the Magnus' bath of 39ml tyrode's solution (pH value 7.2-7.4) logical 100% oxygen, rest tension 0.5g, begin experiment behind the balance 0.5H, measure the intramuscular contractility through tonotransducer, carry out data record and analysis with PowerLab.(1) on the impact of family's rabbits' isolated duodenum smooth muscle spontaneous activity, after pressing aforesaid operations, trace the normal contraction curve, each group adds respectively 1.14,0.57, the inflammation diminishing capsule solution of 0.29g crude drug/ml, each 1ml of atropine solution and 0.5%CMCNa traces the shrinkage curve after the dosing.(2) the conventional preparation of the aforesaid operations rabbit intestinal specimen that exsomatizes is pressed in the impact of enterospasm due to the acecoline, trace the normal contraction curve, then in bath, add 0.4mg/ml acecoline 0.2ml (final concentration is 2ug/ml), cause the intestinal tube spasm, after it is steady, add respectively 1.14,0.57 in the bath, 0.29g crude drug/ml inflammation diminishing capsule medicinal liquid, atropine solution and each 1ml of 0.5%CMCNa, trace the shrinkage curve after the dosing.Positive controls and inflammation diminishing capsule are high, middle dosage group is to the contraction of rabbit smooth muscle spontaneous activity, tension force is compared difference with the blank group statistical significance, illustrates that atropine and inflammation diminishing capsule high, middle dosage can significantly suppress a rabbits' isolated duodenum section spontaneous activity.Positive controls and inflammation diminishing capsule are high, middle dosage group is compared with the blank group the shrink tension of enterospasm due to the acecoline, difference has statistical significance, illustrate that inflammation diminishing capsule and atropine all can significantly suppress enterospasm due to the acecoline, the results are shown in Table 6 table 6 inflammation diminishing capsules to the impact (n=8 of family's rabbits' isolated duodenum smooth muscle contraction tension force
G)
P＜0.05, compare with the blank group P＜0.001
3.1.7 40 of SD rats are got in the emptying experiment of rat stomach, are divided into 5 groups by body weight with the digitized randomized, each is organized the administration volume and is the 10ml/kg body weight.Blank group gavage gives 0.5%CMCNa solution, and the positive controls gavage gives the atropine solution of 1mg/ml, the high, medium and low dosage group of inflammation diminishing capsule respectively every day gavage give 1.14,0.57,0.29g crude drug/ml inflammation diminishing capsule medicinal liquid, continuously 3d.Rat overnight fasting before the gastric emptying experiment.2H after the last administration, every rat oral gavage gives 0.07% phenol red solution 1.5ml, puts to death rat after 15 minutes, gets immediately stomach, gastric content is washed in the 10ml distilled water 3.0 * 10
3Centrifugal 10 minutes of g gets supernatant 546 wavelength and measures absorbance.Other gets 10 distilled water and adds 0.07% phenol red solution 1.5ml, and its 546nm absorbance of centrifugal rear mensuration calculates the phenol red residual rate of gastric as basic value.The phenol red residual rate of gastric=(respectively organize A
546Value/basic A
546Value) * 100%.
The result: the gastric residual rate of blank group and positive controls rat is respectively (46.79 ± 32.13) % and (97.06 ± 24.96) %, comparing difference for two groups has statistically significant meaning (P＜0.01), illustrates that 10mg/kg body weight atropine can significantly suppress the gastric emptying of rat.The gastric residual rate of the high, medium and low dosage group of inflammation diminishing capsule is respectively (40.33 ± 25.94) %, (27.75 ± 10.96) % and (36.06 ± 18.24) %, compare the difference not statistically significant with the blank group, illustrate that the inflammation diminishing capsule of each dosage is on the not impact of gastric emptying of SD rat.
3.1.8 1d adds water 300ml with Folium Sennae 25g before antidiarrheal experiment (1) Folium Sennae diarrhea inducing experiment modeling, straight fire decocts used filtered through gauze in 15 minutes, was condensed into the 1g/ml solution for standby at water-bath.Get 60 of ICR mices, male and female half and half are divided into 6 groups by body weight with the digitized randomized, and each is organized the administration volume and is the 15ml/kg body weight.Blank group and model control group gavage give 0.5%CMCNa solution, the positive controls gavage gives 1.0% berberine hydrochloride solution, the high, medium and low dosed administration of inflammation diminishing capsule respectively gavage gives that concentration is 1.14,0.57,0.29g crude drug/ml inflammation diminishing capsule medicinal liquid, be that dosage is respectively 17.1,8.6,4.3g crude drug/kg body weight, continuous 5d.Except the blank group, each organizes the oral Folium Sennae decocting liquid of 1H 0.02ml/g body weight after the last administration.The single cage of every Mus is placed, and the clean filter paper of cage heelpiece changed paper 1 time in per 1 hour, and argol number and muck number in the counting 5H calculate loose stool rate.Loose stool rate=(loose stool number/always just count) * 100%.(2) 60 of ICR mices are got in the experiment of Oleum Ricini diarrhea inducing in addition, and male and female half and half are divided into 6 groups by body weight with the digitized randomized.It is identical with the experiment of Folium Sennae diarrhea inducing that each organizes dosage, administration every day 1 time, continuously 5d.Except Normal group, it makes all 1H oral castor oil 0.02ml/g body weight after the last administration of each group, and record feces quantity is also calculated loose stool rate.
The result: (1) has no loose stool to the antidiarrheal effect blank group of Folium Sennae diarrhea inducing, and the loose stool rate of model control group is (80.11 ± 14.99) %, shows that the Folium Sennae decocting liquid can inducing mouse diarrhoea.The loose stool rate of positive controls (berberine hydrochloride) and inflammation diminishing capsule high dose group is respectively (51.43 ± 23.61) % and (60.15 ± 15.95) %, and comparing difference with model control group has statistical significance.In the inflammation diminishing capsule, the loose stool rate of low dose group is respectively (73.34 ± 13.75) % and (71.36 ± 16.08) %, compare the difference not statistically significant with model control group, but still have antidiarrheal trend, and be certain dosage correlation.(2) the antidiarrheal effect blank group of Oleum Ricini diarrhea inducing had no loose stool, the loose stool rate of model control group is (81.44 ± 14.23) %, shows Oleum Ricini diarrhea inducing modeling success.The loose stool rate of the high, medium and low dosage group of inflammation diminishing capsule and positive controls is respectively (72.51 ± 17.13) %, (71.01 ± 13.20) %, (76.86 ± 17.08) %, (71.03 ± 10.43) %, compare the difference not statistically significant with model control group, the dependency of loose stool rate and dosage is also not obvious.
The above results shows, the inflammation diminishing capsule of the present invention's preparation is in treatment upper respiratory tract infection, tonsillitis, urinary tract infection, acute bacillary dysentery, during the enteritis symptom, other medicine with respect to commercially available identical drug effect has the active component extraction fully, taking dose is little, disintegration rate is fast, the remarkable advantages such as batch production energy savings steady quality, the medicated powder granularity of simultaneously micron technology processing is fine and even more, the total surface area of medicine is increased, the contact area of taking rear and gastrointestinal mucosa also increases thereupon, can disperse in gastrointestinal tract better, dissolve and absorb, greatly improved the bioavailability of medicine.
Claims (3)
1. treat upper respiratory tract infection, tonsillitis, urinary tract infection for one kind, acute bacillary dysentery, the Chinese medicine of enteritis is characterized in that getting Herba monochasmatis 1953.12g, Herba Hedyotidis Diffusae 976.56g, Herba Commelinae 976.56g, adopt carbon dioxide supercritical extraction method to get supernatant, filtrate is concentrated, dry, extracting pressure 20-50Mpa wherein, extraction temperature 30-60 ℃, separator pressure 5-10Mpa, separator temperature 40-60 ℃, disengaging time 2-6 hour, carbon dioxide flow was 20-30L/H; Adopt jet mill that extract powder is broken into particle diameter＜50 micron superfine powder, add the excipient mixing and make 1000.
2. the preparation method of described Chinese medicine according to claim 1 is characterized in that the extracting pressure 20-50Mpa of carbon dioxide supercritical extraction method, extraction temperature 30-60 ℃, separator pressure 5-10Mpa, separator temperature 40-60 ℃, disengaging time 2-6 hour, carbon dioxide flow was 20-30L/H.
3. the preparation method of described Chinese medicine according to claim 1 is characterized in that jet mill is broken into extract powder the superfine powder of particle diameter＜50 micron.
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