CN101480439A - Compound Chinese lobelia oral preparation and preparation method thereof - Google Patents
Compound Chinese lobelia oral preparation and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine compound Chinese Lobelia preparation and a preparation technology thereof, which belong to the field of traditional Chinese medicine. The traditional Chinese medicine compound Chinese Lobelia preparation is prepared from Chinese Lobelia, herba scutellariae barbatae and herba oldenlandiae, and is used through oral administration. Compared with the prior art, the invention has reliable curative effect, low toxic side effect, low cost and easy quality control. The invention has the efficacies of heat and toxic material clearing and swelling and pain relieving, and is used for multiple furuncle, tonsillitis, mastitis, and the like.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate to Chinese medicine compound Herba Lobeliae Chinensis preparation and preparation method thereof.
Background technology
FUFANG BANBIANLIAN ZHUSHEYE is that State Food and Drug Administration's approval is applied to clinical modern Chinese medicine preparation.The sterile water solution of FUFANG BANBIANLIAN ZHUSHEYE for extracting from Chinese medicine Herba Lobeliae Chinensis, Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae has heat-clearing and toxic substances removing, and the effect of reducing swelling and alleviating pain is used for the treatment of multiple furuncle and phyma, tonsillitis, mastitis etc. clinically.
Though the FUFANG BANBIANLIAN ZHUSHEYE listing for many years, the clinical practice curative effect certainly.But, the popularization and the use of this kind have been limited because injection uses inconvenience, causes adverse reactions of patients easily.Therefore we promptly change oral administration into by drug administration by injection in the route of administration of guaranteeing to have changed under the prerequisite of curative effect this compound recipe.Prove that through pharmacodynamic experiment the oral administration curative effect is sure, easy to use.
Summary of the invention
The invention reside in and disclose a kind of compound Chinese lobelia oral preparation and preparation method thereof.
Described compound Chinese lobelia oral preparation comprises oral administration form of administration clinically such as oral liquid, granule, tablet, capsule, soft capsule, masticatory, aerosol, drop pill.
Content of the present invention and main points are: adopt extraction, spissated method, main pharmacodynamics composition in Herba Lobeliae Chinensis, Herba Scutellariae Barbatae, the Herba Hedyotidis Diffusae is extracted, and the process of adding corresponding auxiliary material process preparation is prepared into corresponding compound Chinese lobelia oral preparation.Adopt zoopery further to guarantee the curative effect of oral administration.
The technical solution adopted in the present invention is: get three flavor medical materials, decoct with water 2 times, 1～10 hour for the first time, 1～5 hour for the second time, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.05～1.20 (55 ~ 60 ℃), clarifying treatment, and adding ethanol is 50 ~ 70% to containing the alcohol amount, left standstill 1 ~ 24 hour, and filtered, filtrate recycling ethanol is to there not being the alcohol flavor, filtrate is regulated pH value to 5.0 ~ 8.0, filter, obtain herbal extract, the reuse diverse ways is made different preparations.Be the checking curative effect, observe Compuond Chinese lobelia herb preparation respectively bacterial endotoxin is caused the influence that rabbit body temperature raises, Compuond Chinese lobelia herb preparation causes the influence that rabbit body temperature raises to beer yeast, Compuond Chinese lobelia herb preparation is to the vitro antibacterial activity (Plating) of staphylococcus aureus, Compuond Chinese lobelia herb preparation is to colibacillary vitro antibacterial activity (Plating), Compuond Chinese lobelia herb preparation is to the therapeutical effect of infection of staphylococcus aureus mice, Compuond Chinese lobelia herb preparation is to the therapeutical effect of coli-infection mice, the half of preparation liquid of compound recipe xylol causes the influence test of mice auricle swelling, Compuond Chinese lobelia herb preparation causes the influence test of rat paw edema to Ovum Gallus domesticus album, Compuond Chinese lobelia herb preparation causes the influence test of mouse skin capillary permeability to histamine, Compuond Chinese lobelia herb preparation is to the bullate influence test of rat granuloma, Compuond Chinese lobelia herb preparation is to the analgesic activity (hot plate method) of mice, Compuond Chinese lobelia herb preparation is to the analgesic activity (writhing method) of mice, Compuond Chinese lobelia herb preparation is to the analgesic activity (pressing the tail method) of rat.
Experimental example
One, observes Compuond Chinese lobelia herb preparation bacterial endotoxin is caused the influence that rabbit body temperature raises
Get the rabbit of body weight 1.7～3.0kg, body temperature is 38.0～39.6 ℃ after predicting, and body temperature fluctuates at 0.4 ℃ with 36 of interior healthy rabbits, measure twice normal body temperature before the administration, 30min at interval, the difference of twice body temperature must not surpass 0.2 ℃, with the meansigma methods of this twice body temperature as normal body temperature, evenly be divided into six groups by normal body temperature then, every group of 6 animals: 1. blank group; 2. model control group; 3. positive controls (aspirin); 4. compound Chinese lobelia oral liquid high dose group; 5. dosage group in the compound Chinese lobelia oral liquid; 6. compound Chinese lobelia oral liquid low dose group.The rabbit per os inserts human catheter gastric infusion, and one day 3 times, interval 2h, the administration volume is 5.0ml/kg.Promptly begin take temperature after the first administration, from auricular vein bacterial injection endotoxin solution 20EU/kg (the blank group does not give bacterial endotoxin for 20EU/ml, 1.0ml/kg), every 30min record body temperature 1 time is observed 6h continuously behind the 1h.As radix, calculate the variation (△ ℃) of each minute point rabbit body temperature with normal body temperature before the administration.
The result shows, rabbit body temperature promptly begins to rise behind the intravenous injection bacterial endotoxin, reaches the peak to 1.5h, fervescence〉0.8 ℃, after this body temperature descends gradually, continues about 3h.Model control group and blank group compare, 1～3h behind the injection endotoxin, and fervescence (△ ℃) difference has highly significant meaning or significance (P＜0.01 or P＜0.05), and the modeling success is described; Aspirin group and model control group compare, 2.5～5h behind the injection endotoxin, and difference has highly significant meaning or significance (P＜0.01 or P＜0.05); Compound Chinese lobelia oral liquid high dose group and model control group compare, 2～2.5h behind the injection endotoxin, difference significance (P＜0.05); Middle dosage group and model control group compare, 2～5h behind the injection endotoxin, and difference has highly significant meaning or significance (P＜0.01 or P＜0.05); Low dosage and model control group compare, the difference nonsignificance (P〉0.05).Illustrate that compound Chinese lobelia oral liquid causes the rabbit body temperature rising to bacterial endotoxin tangible refrigeration function is arranged.
Two, observe Compuond Chinese lobelia herb preparation beer yeast is caused the influence that rabbit body temperature raises
Get body weight 1.7～3.0kg rabbit, body temperature is 38.0～39.6 ℃ after predicting, and body temperature fluctuates at 0.4 ℃ with 36 of interior healthy rabbits, measure twice normal body temperature before the administration, 30min at interval, the difference of twice body temperature must not surpass 0.2 ℃, with the meansigma methods of this twice body temperature as normal body temperature, evenly be divided into six groups by normal body temperature then, every group of 6 animals: 1. blank group; 2. model control group; 3. positive controls (aspirin); 4. compound Chinese lobelia oral liquid high dose group; 5. dosage group in the compound Chinese lobelia oral liquid; 6. compound Chinese lobelia oral liquid low dose group.The rabbit per os inserts human catheter gastric infusion, and one day 3 times, interval 3h, the administration volume is 5.0ml/kg.The 5% beer yeast suspension 1.0ml/kg (the blank group does not give beer yeast) of intramuscular injection immediately begins take temperature simultaneously after the first administration, and every 30min record body temperature 1 time is observed 10h continuously.Calculate the variation (△ ℃) of each minute point rabbit body temperature as radix with normal body temperature before the administration.
The result shows that rabbit body temperature promptly begins slow rising behind the intramuscular injection beer yeast, reaches the peak to 6h, fervescence〉1.3 ℃, after this body temperature descends gradually, continues about 4h.Model control group and blank group compare, 4～9h behind the injection yeast, and fervescence (△ ℃) difference has highly significant meaning or significance (P＜0.01 or P＜0.05), and the modeling success is described; Aspirin group and model control group compare, 4.5～6h behind the injection yeast, and difference has highly significant meaning or significance (P＜0.01 or P＜0.05); Compound Chinese lobelia oral liquid high dose group and model control group compare, 5～6h behind the injection yeast, and difference has highly significant meaning or significance (P＜0.01 or P＜0.05); In dosage group and model control group relatively, inject 5～6h behind the yeast, difference significance (P＜0.05), but body temperature is changed to and is higher than model control group; Low dosage and model control group compare, 7.5～8.5h behind the injection yeast, difference significance (P＜0.05).Illustrate that compound Chinese lobelia oral liquid causes the rabbit body temperature rising to beer yeast certain refrigeration function is arranged.
Three, Compuond Chinese lobelia herb preparation is to the vitro antibacterial activity (Plating) of staphylococcus aureus
3.1 the preparation of medicine plating medium
Take by weighing nutrient agar 1.7g, totally 5 parts, join respectively among the medicinal liquid 50ml that contains Compuond Chinese lobelia herb 100,50,25,12.5,6.25mg (crude drug)/ml, rock and make dissolving, 121 ℃ of autoclaving 15min.Get 10 aseptic plates (90mm diameter, down with), number covering, add respectively and above-mentionedly melted and be cooled to pastille culture medium 20ml about 40 ℃, 2 plates of the parallel preparation of each concentration, treat that agar solidifies after, promptly be made for the plating medium that contains medicine.Other gets 4 aseptic plates, does not contain the blank plating medium of medicine with the method preparation.
3.2 the preparation of bacterium liquid and inoculation
The fresh cultured thing of inoculation staphylococcus aureus is to nutrient broth medium, behind 33 ℃ of cultivation 24h, with the 0.9% sodium chloride injection bacterial suspension that is variable concentrations such as 10-1,10-2,10-3,10-4,10-5 with 10 times of serial dilutions, the bacterium liquid 0.2ml that gets 10-5 concentration respectively is inoculated on each plating medium, take out behind 33 ℃ of cultivation 24h, observe the growing state of antibacterial on the medicine flat board of variable concentrations.The least concentration that antibacterial is not grown is the MIC of medicine to this bacterium.
The result shows, compound Chinese lobelia oral liquid has to a certain degree inhibitory action to staphylococcus aureus, and its MIC is 50mg (crude drug)/ml.The results are shown in Table 1
Table 1 compound Chinese lobelia oral liquid is to the vitro antibacterial activity of staphylococcus aureus
Four, Compuond Chinese lobelia herb preparation is to colibacillary vitro antibacterial activity (Plating)
4.1 the preparation of medicine plating medium
Take by weighing nutrient agar 1.7g, totally 5 parts, join respectively among the medicinal liquid 50ml that contains Compuond Chinese lobelia herb 500,400,300,200,100mg (crude drug)/ml, rock and make dissolving, 121 ℃ of autoclaving 15min.Get 10 aseptic plates, number covering, add respectively and above-mentionedly melted and be cooled to pastille culture medium 20ml about 40 ℃, 2 plates of the parallel preparation of each concentration, treat that agar solidifies after, promptly be made for the plating medium that contains medicine.Other gets 4 aseptic plates, does not contain the blank plating medium of medicine with the method preparation.
4.2 the preparation of bacterium liquid and inoculation
Inoculate colibacillary fresh cultured thing to nutrient broth medium, behind 33 ℃ of cultivation 24h, with the 0.9% sodium chloride injection bacterial suspension that is variable concentrations such as 10-1,10-2,10-3,10-4,10-5 with 10 times of serial dilutions, the bacterium liquid 0.4ml that gets 10-5 concentration respectively is inoculated on each plating medium, take out behind 33 ℃ of cultivation 24h, observe the growing state of antibacterial on the medicine flat board of variable concentrations.The least concentration that antibacterial is not grown is the MIC of medicine to this bacterium.
The result shows, compound Chinese lobelia oral liquid people has to a certain degree inhibitory action to escherichia coli, and its MIC is 500mg (crude drug)/ml.The results are shown in Table 2.
Table 2 compound Chinese lobelia oral liquid is to colibacillary vitro antibacterial activity
Five, compound Chinese lobelia oral liquid is to the therapeutical effect of infection of staphylococcus aureus mice
5.1 the preparation of bacterium liquid: the fresh cultured thing of inoculation staphylococcus aureus is to nutrient broth medium, 33 ℃ cultivate 24h after, being variable concentrations such as 10-1,10-2,10-3,10-4,10-5,10-6 with 0.9% sodium chloride injection with 10 times of serial dilutions, bacterial suspension is standby.Choose the bacterium liquid of 10-6 concentration, with the viable count of plate surface viable bacteria counting method determination experiment infection.
5.2 the foundation of mouse peritoneal infection model: get 24 of mices, difference tail vein injection hydrocortisone 40mg/kg (2mg/ml, 0.2ml/10g body weight), every day 1 time, continuous 2 days.The 3rd day respectively lumbar injection variable concentrations (stock solution, 10-1,10-2,10-3,10-4,10-5) bacterium liquid 0.5ml/ only, 4 mices of each concentration are observed the death condition of animal in 4 days.Select minimum lethal dose (MLD), can cause after promptly infecting that the bacterial concentration of mice 80～100% death carries out the medical treatment experiment.
5.3 medical treatment experiment: get 60 of the mices of body weight 18～22g, male and female half and half are divided into six groups at random, every group of 10 animals: 1. blank group; 2. model control group; 3. positive controls (SHUANGHUANGLIAN KOUFUYE); 4. compound Chinese lobelia oral liquid high dose group; 5. dosage group in the compound Chinese lobelia oral liquid; 6. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 10 days, the administration volume was the 0.2ml/10g body weight.Administration the 4th, 5 days, except that the blank group, each organizes tail vein injection hydrocortisone 40mg/kg (2mg/ml, 0.2ml/10g body weight).Administration the 6th day, except that the blank group, each organizes bacterium liquid 0.5ml/ (3.725 * 108 bacterium/Mus) that lumbar injection concentration is 7.45 * 108/ml, causes infection.Day by day observe the death condition of animal, observed continuously 7 days.Make index with life span, survival rate, adopt the simplification exact propability that the result is carried out statistical analysis.
The result shows that the model control group mouse death rate is 90%, and the modeling success is described.Compare with model control group, SHUANGHUANGLIAN KOUFUYE group and compound Chinese lobelia oral liquid high dose group have significant protective effect to the infection of staphylococcus aureus mice, can significantly reduce the mortality rate of infecting mouse, and also there is certain delay the death time; Though in, the low dose group not statistically significant, mortality rate also decreases.The results are shown in Table 3.
Table 3 compound Chinese lobelia oral liquid is to the therapeutical effect (n=10) of infection of staphylococcus aureus mice
Annotate:
*P＜0.05,
*Compare with model control group P＜0.01
Six, Compuond Chinese lobelia herb preparation is to the therapeutical effect of coli-infection mice
6.1 the preparation of bacterium liquid: inoculate colibacillary fresh cultured thing to nutrient broth medium, 33 ℃ cultivate 24h after, being variable concentrations such as 10-1,10-2,10-3,10-4,10-5,10-6,10-7 with 0.9% sodium chloride injection with 10 times of serial dilutions, bacterial suspension is standby.Choose the bacterium liquid of 10-7 concentration, with the viable count of plate surface viable bacteria counting method determination experiment infection.
6.2 the foundation of mouse peritoneal infection model: get 24 of mices, difference tail vein injection hydrocortisone 40mg/kg (2mg/ml, 0.2ml/10g body weight), every day 1 time, for three days on end.The 4th day respectively lumbar injection variable concentrations (stock solution, 10-1,10-2,10-3,10-4,10-5) bacterium liquid 0.5ml/ only, 4 mices of each concentration are observed the death condition of animal in 4 days.Select minimum lethal dose (MLD), can cause after promptly infecting that the bacterial concentration of mice 80～100% death carries out the medical treatment experiment.
6.3 medical treatment experiment: get 60 of the mices of body weight 18～22g, male and female half and half are divided into six groups at random, every group of 10 animals: 1. blank group; 2. model control group; 3. positive controls (SHUANGHUANGLIAN KOUFUYE); 4. compound Chinese lobelia oral liquid high dose group; 5. dosage group in the compound Chinese lobelia oral liquid; 6. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 10 days, the administration volume was the 0.2ml/10g body weight.Administration the 4th, 5,6 days, except that the blank group, each organizes tail vein injection hydrocortisone 40mg/kg (2mg/ml, 0.2ml/10g body weight).Administration the 7th day, except that the blank group, each organizes bacterium liquid 0.5ml/ (4.625 * 109 bacterium/Mus) that lumbar injection concentration is 9.25 * 109/ml, causes infection.Day by day observe the death condition of animal, observed continuously 7 days.Make index with life span, survival rate, adopt the simplification exact propability that the result is carried out statistical analysis.
The result shows that the model control group mouse death rate is 100%, and the modeling success is described.Compare with model control group, SHUANGHUANGLIAN KOUFUYE group and compound Chinese lobelia oral liquid high dose group have significant protective effect to the coli-infection mice, can significantly reduce the mortality rate of infecting mouse, and also there is certain delay the death time; Though middle dosage group not statistically significant, mortality rate has certain reduction, and the death time slightly postpones.The results are shown in Table 4.
Table 4 compound Chinese lobelia oral preparation is to the therapeutical effect (n=10) of coli-infection mice
Annotate:
*P＜0.05,
*Compare with model control group P＜0.01
Seven, the Compuond Chinese lobelia herb preparation xylol causes the influence of mice auricle swelling
Get 50 of the male mices of body weight 18～22g, be divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (aspirin); 3. compound Chinese lobelia oral liquid high dose group; 4. dosage group in the compound Chinese lobelia oral liquid; 5. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 4 days, the administration volume was the 0.2ml/10g body weight.Water 12h is can't help in the animal fasting before the last administration, 30min after the last administration, and the two sides only is coated with 100% dimethylbenzene 0.02ml/ before and after mouse right ear respectively, and left ear is not done any processing.Behind the 4h dislocation of animal cervical vertebra is put to death, cut two ears, lay round auricle at same position respectively, weigh, calculate swelling degree, swelling rate and suppression ratio by following formula respectively with the card punch of 9mm diameter along the auricle baseline.(x ± s) expression adopts the SPSS14.0 statistical analysis software to carry out the t check with mean ± standard deviation for swelling degree and swelling rate result.
Swelling degree (g)=auris dextra sheet weight-left auricle is heavy
The result shows that tangible redness promptly appearred in 30min after Mice Auricle was smeared dimethylbenzene, and the swelling degree can be kept substantially in the 4h.The swelling degree of aspirin group and Compuond Chinese lobelia herb preparation high dose group and swelling rate compare with the blank group respectively, and difference has highly significant meaning (P＜0.01), and suppression ratio is respectively 64.60% and 66.44%; Middle dosage group and blank group compare, swelling degree difference significance (P＜0.05), swelling rate difference nonsignificance (P〉0.05), suppression ratio is 40.57%; Low dose group and blank group compare, the difference nonsignificance (P〉0.05).The mice auricle swelling that prompting Compuond Chinese lobelia herb preparation xylol causes has the obvious suppression effect.The results are shown in Table 5.
Table 5 Compuond Chinese lobelia herb preparation xylol cause mice auricle swelling influence (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with the blank group P＜0.01
Eight, compound Chinese lobelia oral liquid causes the influence of rat paw edema to Ovum Gallus domesticus album
Get 50 of the male rats of body weight 130～150g, be divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (aspirin); 3. compound Chinese lobelia oral liquid high dose group; 4. dosage group in the compound Chinese lobelia oral liquid; 5. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 7 days, the administration volume was the 1.0ml/100g body weight.Water 12h is can't help in the animal fasting before the last administration, and is at once that the animal hind leg is stretching after the last administration, only causes inflammation from the left back sufficient sole of the foot subcutaneous injection 10% Ovum Gallus domesticus album 0.1ml/ in middle part.Respectively at cause scorching before and cause scorching back 0.5,1,2,4,6h measures rat paw thickness, calculates swelling degree, swelling rate and the suppression ratio of each time point by following formula, observes swelling peak time and regression time simultaneously.(x ± s) expression adopts the SPSS14.0 statistical analysis software to carry out the t check with mean ± standard deviation for swelling degree and swelling rate result.
The scorching front foot sole of the foot thickness of the scorching metapedes sole of the foot thickness of swelling degree (mm)=cause-cause
The result shows that i.e. swelling gradually behind the rat paw injection Ovum Gallus domesticus album reaches the swelling peak in 0.5～1h, begins then slowly to disappear.Three dosage groups of aspirin group and compound Chinese lobelia oral liquid all can significantly reduce swelling degree and the swelling rate that causes scorching back 0.5～1h, compare difference significance (P＜0.05 or P＜0.01) with the blank group, the swelling degree of 2～6h and swelling rate are not had obvious influence (P〉0.05), and suppression ratio is respectively 37.51%, 17.78%, 35.71%, 42.35%, 26.25%.The rat paw edema that prompting compound Chinese lobelia oral liquid causes Ovum Gallus domesticus album has the obvious suppression effect.The results are shown in Table 6.
Nine, compound Chinese lobelia oral liquid causes the influence of mouse skin capillary permeability to histamine
Get 50 of the mices of body weight 18～22g, male and female half and half are divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (aspirin); 3. compound Chinese lobelia oral liquid high dose group; 4. dosage group in the compound Chinese lobelia oral liquid; 5. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 4 days, the administration volume was the 0.2ml/10g body weight.Water 12h is can't help in the animal fasting before the last administration, 30min after the last administration, in mouse web portion center unhairing position intradermal injection 0.1% 0.02ml/ of histamine only, tail vein injection 1% azovan blue solution 0.1ml/10g body weight immediately, behind the 30min with sacrifice of animal, take off abdominal part indigo plant and dye skin, shred, put and 6ml acetone-normal saline extraction liquid is housed (7: 3, v: soak 24h in the tool plug test tube v), shake test tube therebetween gently 2～3 times, the centrifugal 10min of 2000rpm gets supernatant and measures absorbance in the 610nm place.(x ± s) expression adopts SPSS 14.0 statistical analysis softwares to carry out the t check to the result with mean ± standard deviation.
The result shows that aspirin group and blank group compare, difference significance (P＜0.05), and three dosage groups of Compuond Chinese lobelia herb preparation compare with the blank group respectively, and difference has highly significant meaning (P＜0.01).Prompting compound Chinese lobelia oral liquid has the obvious suppression effect to the mice capillary permeability increase that histamine causes.The results are shown in Table 7.
Table 7 compound Chinese lobelia oral liquid to histamine cause the mouse skin capillary permeability influence (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with the blank group P＜0.01
Ten, compound Chinese lobelia oral liquid is to the bullate influence of rat granuloma
Get 50 of the rats of body weight 120～150g, male and female half and half, lumbar injection pentobarbital sodium 30mg/kg (0.3%, the 1ml/100g body weight) anesthesia, strange portion iodine disinfection about every Mus is after 75% cotton ball soaked in alcohol takes off iodine, respectively cut the long osculum of 0.5～1cm, with the ophthalmology tweezers autoclaving cotton balls of 20mg is implanted from incision subcutaneous, skin suture immediately, and only at wound local subcutaneous injection gentamycin sulfate 0.2ml/.Be divided into five groups then at random, every group of 10 animals: 1. blank group; 2. positive controls (aspirin); 3. compound Chinese lobelia oral liquid high dose group; 4. dosage group in the compound Chinese lobelia oral liquid; 5. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 7 days, the administration volume was the 1.0ml/100g body weight.Open former otch after the dislocation of the 8th day cervical vertebra is put to death, cotton balls is taken out together with connective tissue on every side, reject fatty tissue, put in 60 ℃ of baking ovens and weigh behind the baking 12h.By will claim weight deduct the former weight of cotton balls and promptly get granuloma weight, get the meansigma methods of both sides granuloma weight.(x ± s) expression adopts the SPSS14.0 statistical analysis software to carry out the t check to the result with mean ± standard deviation.
The result shows, aspirin group and blank group are relatively, difference significance (P＜0.05), compound Chinese lobelia oral liquid high dose group and blank group are relatively, difference has highly significant meaning (P＜0.01), in, low dosage and blank group relatively, difference nonsignificance (P〉0.05), but granuloma weight all is lower than the blank group.The prompting Compuond Chinese lobelia herb preparation has certain inhibitory action to the granuloma induced by implantation of cotton pellets of rat.The results are shown in Table 8.
Table 8 compound Chinese lobelia oral liquid to the bullate influence of rat granuloma (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with the blank group P＜0.01
11, compound Chinese lobelia oral liquid is to the analgesic activity (hot plate method) of mice
Get the female mice of body weight 18～22g, on each 1 metallic plate that is placed in advance the hot-plate instrument that is heated to (55 ± 0.5) ℃, from the contact hot plate to the pain threshold of metapedes required time (second) occurring licking as this Mus, pain threshold 5～30 seconds and not the leaper be qualified Mus.Get 50 of qualified mices, measure its normal pain threshold,, be divided into five groups then at random, every group of 10 animals: 1. blank group as pain threshold before the administration; 2. positive controls (aspirin); 3. compound Chinese lobelia oral liquid high dose group; 4. dosage group in the compound Chinese lobelia oral liquid; 5. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 4 days, the administration volume was the 0.2ml/10g body weight.Water 12h is can't help in the animal fasting before the last administration, and 30min after the last administration measures the mice pain threshold.As 60 seconds still reactionless, mice is taken out, in order to avoid scald, its pain threshold calculated with 60 seconds.(expression of x ± s) adopts SPSS 14.0 statistical analysis softwares to match the check of t value method to the pain threshold result with mean ± standard deviation.
The result shows, aspirin group and Compuond Chinese lobelia herb preparation high dose group compare respectively with before the administration, difference has highly significant meaning (P＜0.01), compare before middle dosage group and the administration, difference significance (P＜0.05), compare before low dose group and the administration, the difference nonsignificance (P〉0.05).Prompting compound Chinese lobelia oral liquid has significant analgesia role to mice.The results are shown in Table 9.
Table 9 compound Chinese lobelia oral liquid to the analgesic activity (hot plate method) of mice (x ± s, n=10)
Annotate:
*P＜0.05,
*P＜0.01 is with comparison before the administration
12, compound Chinese lobelia oral liquid is to the analgesic activity (writhing method) of mice
Get 50 of the mices of body weight 18～22g, male and female half and half are divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (aspirin); 3. compound Chinese lobelia oral liquid high dose group; 4. dosage group in the compound Chinese lobelia oral liquid; 5. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 4 days, the administration volume was the 0.2ml/10g body weight.Water 12h is can't help in the animal fasting before the last administration, 30min after the last administration, respectively lumbar injection 0.6% glacial acetic acid solution 0.2ml/ only observes and writes down turning round the body number of times and the number of animals of writhing response occurring of animal in the 20min immediately, calculates the analgesia percentage rate of administration group by following formula.(x ± s) expression adopts the SPSS14.0 statistical analysis software to carry out nonparametric statistics (Mann-Whitney method), adopts x2 (2 * 2) method that the number of animals result who writhing response occurs is carried out statistical analysis with mean ± standard deviation to turn round body number of times result.
The result shows, aspirin group and blank group are relatively, difference has highly significant meaning (P＜0.01), the analgesia percentage rate reaches 80%, and compound Chinese lobelia oral liquid high dose group and blank group compare, difference significance (P＜0.05), the analgesia percentage rate reaches 70%, in, low dose group and blank group relatively, difference nonsignificance (P〉0.05), but the animal number average of turning round the body number of times and writhing response occurring is lower than the blank group.Illustrate that Compuond Chinese lobelia herb preparation has certain analgesic activity to mice.The results are shown in Table 10.
Table 10 compound Chinese lobelia oral liquid to the analgesic activity (writhing method) of mice (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with the blank group P＜0.01
13, compound Chinese lobelia oral liquid is to the analgesic activity (pressing the tail method) of rat
Get 60 of the male rats of body weight 130～150g, be divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (aspirin); 3. compound Chinese lobelia oral liquid high dose group; 4. dosage group in the compound Chinese lobelia oral liquid; 5. compound Chinese lobelia oral liquid low dose group.Gastric infusion, every day 1 time, continuous 6 days, the administration volume was the 1.0ml/100g body weight.Adopt the tenderness instrument in the most advanced and sophisticated 1/3 place's tenderness of rat tail, the weight when shouting with generation (g) is as pain threshold.Measure the normal pain threshold of rat before the first administration, as pain threshold before the administration.Water 12h is can't help in the animal fasting before the last administration, and 30min after the last administration measures the rat pain threshold.Animal does not shout yet when reaching 1000g as weight, and its pain threshold calculates with 1000g.(expression of x ± s) adopts SPSS 14.0 statistical analysis softwares to match the check of t value method to the pain threshold result with mean ± standard deviation.
The result shows, aspirin group and compound Chinese lobelia oral liquid high dose group compare respectively with before the administration, difference has highly significant meaning (P＜0.01), high, middle dosage group compares respectively with before the administration, difference significance (P＜0.05), compare before low dose group and the administration, the difference nonsignificance (P〉0.05).Prompting compound Chinese lobelia oral liquid has significant analgesia role to rat.The results are shown in Table 11.
Table 11 compound Chinese lobelia oral liquid to the analgesic activity of rat (pressing the tail method) (x ± s, n=10)
Annotate:
*P＜0.05,
*P＜0.01 is with comparison before the administration
Draw to draw a conclusion in conjunction with above result:
1, Compuond Chinese lobelia herb preparation causes the rabbit body temperature rising to bacterial endotoxin, beer yeast all tangible refrigeration function.
2, Compuond Chinese lobelia herb preparation all has tangible antiinflammatory action to mice and rat.
3, Compuond Chinese lobelia herb preparation has vitro antibacterial activity to a certain degree to staphylococcus aureus (G+), escherichia coli (G-), and its minimum inhibitory concentration (MIC) is respectively 50,500mg (crude drug)/ml; Staphylococcus aureus, coli-infection mice are had significant protective effect, can significantly reduce the mortality rate of infecting mouse, also there is certain delay the death time.
4, Compuond Chinese lobelia herb preparation all has significant analgesia role to mice and rat.
Illustrate that based on the above results oral administered compound Herba Lobeliae Chinensis preparation can reach heat-clearing and toxic substances removing, the effect of reducing swelling and alleviating pain.
Embodiment
Further specify the present invention by the following examples, should be noted that, these embodiment only are used for illustrative purposes, do not constitute the restriction to scope of the present invention.It will be apparent to those skilled in that under situation without departing from the spirit and scope of the present invention, can make some variations and improvement, these all are included in the category of the present invention.
Embodiment 1
Get Herba Lobeliae Chinensis, Herba Scutellariae Barbatae, each 500 gram of Herba Hedyotidis Diffusae three flavor medical materials, decoct with water 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.15 (55 ~ 60 ℃), and adding ethanol is 60% to containing the alcohol amount, leaves standstill the back and filters, filtrate recycling ethanol is to there not being the alcohol flavor, filtrate is regulated pH value to 6.0～7.0, and filtration adds dextrin and correctives is an amount of, make granule, drying, promptly get the Compuond Chinese lobelia herb granule.One time 1～2 bag, 3 times on the one (a day clothes crude drug amount 45～90 grams), oral.Heat-clearing and toxic substances removing, reducing swelling and alleviating pain.Be used for multiple furuncle and phyma, tonsillitis, mastitis etc.
Embodiment 2
Herba Lobeliae Chinensis, Herba Scutellariae Barbatae, each 500g of Herba Hedyotidis Diffusae with above three flavors, decocts with water twice, 5 hours for the first time, 3 hours for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.05 (55 ~ 60 ℃), clarifying treatment, adding ethanol is 70% to containing the alcohol amount, leaves standstill 12 hours, filters, filtrate recycling ethanol is not to there being the alcohol flavor, and filtrate is regulated pH value to 6.0-7.0, cold preservation 24 hours, filter, drying gets dry extract, after the pulverizing, add microcrystalline Cellulose 40 grams, 90% alcohol granulation, drying, granulate, add magnesium stearate 1 gram, starch transfers in right amount, and tabletting promptly gets the Compuond Chinese lobelia herb tablet.One time 3～6,3 times on the one, oral.Heat-clearing and toxic substances removing, reducing swelling and alleviating pain.Be used for multiple furuncle and phyma, tonsillitis, mastitis etc.
Embodiment 3
Herba Lobeliae Chinensis, Herba Scutellariae Barbatae, each 500g of Herba Hedyotidis Diffusae with above three flavors, decoct with water twice, 2 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.15 (55 ~ 60 ℃), clarifying treatment, and adding ethanol is 60% to containing the alcohol amount, left standstill 12 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and filtrate is regulated pH value to 6.0-7.0, cold preservation 24 hours, filter,, add the injection water to 1000ml with sucrose 180g, re-adjustment pH value to 6.0 ~ 7.0, embedding, sterilization promptly gets compound Chinese lobelia oral liquid.A 10～20ml, 3 times on the one, oral.Heat-clearing and toxic substances removing, reducing swelling and alleviating pain.Be used for multiple furuncle and phyma, tonsillitis, mastitis etc.
Embodiment 4
Herba Lobeliae Chinensis, Herba Scutellariae Barbatae, each 500g of Herba Hedyotidis Diffusae with above three flavors, decocts with water twice, 3 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.20 (55 ~ 60 ℃), clarifying treatment, adding ethanol is 550% to containing the alcohol amount, leaves standstill 12 hours, filters, filtrate recycling ethanol is not to there being the alcohol flavor, and filtrate is regulated pH value to 6.0-7.0, cold preservation 24 hours, filter, after the pulverizing, add microcrystalline Cellulose 40 grams, 90% alcohol granulation, dry, granulate adds magnesium stearate 1 gram, and starch transfers in right amount, fill, promptly get the Compuond Chinese lobelia herb capsule.One time 3～6,3 times on the one, oral.Heat-clearing and toxic substances removing, reducing swelling and alleviating pain.Be used for multiple furuncle and phyma, tonsillitis, mastitis etc.
Embodiment 5
Herba Lobeliae Chinensis, Herba Scutellariae Barbatae, each 500g of Herba Hedyotidis Diffusae, with above three flavors, decoct with water twice, 1 hour for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.05 (55 ~ 60 ℃), clarifying treatment, adding ethanol is 70% to containing the alcohol amount, leaves standstill 12 hours, filters, filtrate recycling ethanol is to there not being the alcohol flavor, filtrate is regulated pH value to 6.0-7.0, and cold preservation 24 hours filters, after being ground into 80 order fine powders, be mixed with vegetable oil 950 grams, pill promptly gets the Compuond Chinese lobelia herb soft capsule.One time 3～6,3 times on the one, oral.Heat-clearing and toxic substances removing, reducing swelling and alleviating pain.Be used for multiple furuncle and phyma, tonsillitis, mastitis etc.
Claims (5)
1, compound Chinese lobelia oral preparation, calculate according to weight ratio: by Herba Lobeliae Chinensis 500 weight portions, Herba Scutellariae Barbatae 500 weight portions, Herba Hedyotidis Diffusae 500 weight portions are prepared into oral liquid, granule, tablet, capsule, soft capsule, masticatory, mouth collapses agent, drop pill, oral spray, it is characterized in that: get three flavor medical materials, decoct with water 2 times, 1～5 hour for the first time, 1～3 hour for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.05～1.20 (55 ~ 60 ℃), clarifying treatment, adding ethanol is 50 ~ 70% to containing the alcohol amount, left standstill 1 ~ 24 hour, and filtered, filtrate recycling ethanol is to there not being the alcohol flavor, filtrate is regulated pH value to 5.0 ~ 8.0, filter, obtain herbal extract, the reuse diverse ways is made different preparations.
2, compound Chinese lobelia oral preparation as claimed in claim 1, it is characterized in that: the preparation technology of oral liquid is: get each 500 gram of three flavor medical materials, decoct with water, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.15 (55 ~ 60 ℃), adding ethanol is 60% to containing the alcohol amount, leave standstill the back and filter, filtrate recycling ethanol is not to there being the alcohol flavor, and filtrate is regulated pH value to 6.0～7.0, filter, it is an amount of to add correctives, adds water to 1000ml, promptly gets compound Chinese lobelia oral liquid.
3, the preparation technology of compound Chinese lobelia oral liquid as claimed in claim 2 is characterized in that: the correctives of adding is including but not limited to following one or more: sucrose, Mel, stevioside, aspartame, glycerol, sweet plough alcohol, xylitol, high fructose, cyclamate, rob etc.
4, compound Chinese lobelia oral preparation as claimed in claim 1, it is characterized in that: the preparation technology of granule is: get each 500 gram of three flavor medical materials, decoct with water, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.15 (55 ~ 60 ℃), adding ethanol is 60% to containing the alcohol amount, leave standstill the back and filter, filtrate recycling ethanol is not to there being the alcohol flavor, and filtrate is regulated pH value to 6.0～7.0, filter, add dextrin and correctives is an amount of, make granule, drying, promptly get the Compuond Chinese lobelia herb granule.
5, the particulate preparation technology of Compuond Chinese lobelia herb as claimed in claim 4 is characterized in that: the correctives of adding is including but not limited to following one or more: sucrose, Mel, stevioside, aspartame, glycerol, sweet plough alcohol, xylitol, high fructose, cyclamate, rob etc.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547151A (en) * | 2015-01-27 | 2015-04-29 | 黑龙江中医药大学 | Traditional Chinese medicine extract and preparation method thereof |
| CN108837015A (en) * | 2018-06-28 | 2018-11-20 | 信阳农林学院 | The preparation method of Compuond Chinese lobelia herb lipoid plastid and its dripping pill |
| CN109010496A (en) * | 2018-10-29 | 2018-12-18 | 河南中医药大学 | A kind of herbal mixture oral solution for treating acpuei pharyngitis |
| CN113144027A (en) * | 2021-04-23 | 2021-07-23 | 陈为公 | Traditional Chinese medicine composition for removing acne, whitening skin and lightening spots as well as preparation method and application thereof |
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2008
- 2008-01-11 CN CNA2008100006426A patent/CN101480439A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547151A (en) * | 2015-01-27 | 2015-04-29 | 黑龙江中医药大学 | Traditional Chinese medicine extract and preparation method thereof |
| CN108837015A (en) * | 2018-06-28 | 2018-11-20 | 信阳农林学院 | The preparation method of Compuond Chinese lobelia herb lipoid plastid and its dripping pill |
| CN108837015B (en) * | 2018-06-28 | 2021-07-30 | 信阳农林学院 | Compound Chinese lobelia liposome and preparation method of dripping pill thereof |
| CN109010496A (en) * | 2018-10-29 | 2018-12-18 | 河南中医药大学 | A kind of herbal mixture oral solution for treating acpuei pharyngitis |
| CN113144027A (en) * | 2021-04-23 | 2021-07-23 | 陈为公 | Traditional Chinese medicine composition for removing acne, whitening skin and lightening spots as well as preparation method and application thereof |
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