CN1410115A - Capsule for treating coryza and its preparation method - Google Patents

Capsule for treating coryza and its preparation method Download PDF

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CN1410115A
CN1410115A CN 02148340 CN02148340A CN1410115A CN 1410115 A CN1410115 A CN 1410115A CN 02148340 CN02148340 CN 02148340 CN 02148340 A CN02148340 A CN 02148340A CN 1410115 A CN1410115 A CN 1410115A
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parts
capsule
hour
volatile oil
cold
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CN1254266C (en
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哈木拉提·吾甫尔
斯拉甫·艾白
阿不都热依木·玉苏甫
苏来满
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New Qikang Pharmaceutical Co ltd
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Abstract

A medical capsule for treating cold is prepared from 10 Chinese medicinal materials including mint, cyanide, lavandulaleaf dendrantheme, jujube, liquorice root, etc. through immersing first three ingredients of them in water, extracting, volatile, coating with beta-cyclodextrin, cold-storing over night, filtering, drying, grinding, and sieving to obain powder ready for use; decocting the decoction dregs with water, filtering, and merging the filtrate with the distilled water solution ready for use; decocting the rest ingredients, merging the decoctions, filtering, merging the filtrate with the ready-for-use liquid, pressure-reduction concentration, adding alcohol, then filtering, pressure-reduction concentrating, spray-drying the concentrated liquid to prepare powered extract, adding the ready-for-use coated powder, adding micro-crystal cellulose starch.

Description

Cold relief capsule and preparation method thereof
Technical field
The present invention relates to a kind of medicine flu (the Uygur medicine name is called Zu Kamu) capsule and its production and application, this medicine is used for treatment flu and influenza
Background technology
Flu and influenza disease are to endanger healthy commonly encountered diseases and the frequently-occurring diseases of people, can cause heating, diseases such as the watery nasal discharge of having a headache, have a stuffy nose, cough, shed tears, throat hyperemia, sneeze, extremities aching pain.Uygur's medical science has original Therapeutic Method at aspects such as treatment flu and influenzas.It is granule that former ancestral blocks wooden dosage form, and dose is big, one time 12 gram, three times on the one, and contain more sucrose, to many old peoples with prohibit sugared patient's medication and be restricted, though simultaneously among the former dosage form preparation technology volatile oil extraction process is arranged, but there is not inclusion, volatile oil component is still volatilized have been fallen, so does not have volatile oil component in the finished product, has influenced the effectiveness of this medicine, the quality standard of this medicine only rests on two thin layer identification beacons, can't represent the inherent quality of this kind.In order to reduce dosage, remove sugar, the present invention blocks wooden granule with the ancestral and changes capsule into, adopts clathrate process that volatile oil is carried out inclusion, thereby having strengthened the curative effect of this medicine, is adjuvant with microcrystalline Cellulose and starch, once oral 1.4 grams, three times on the one, taking convenience, steady quality.Simultaneously, increase by two assay indexs and five thin layer identification beacons, improved the quality standard of this medicine.Flu (Zu Kamu) capsule in clinical practice for many years, and is good to treatment flu and the sick curative effect of influenza.
Uygur's theory of medicine thinks that flu has the branch of cold type, pattern of fever, dry type and wet type, and it is unbalance to have good manners, the characteristics of body fluid imbalance.Oral Zukam capsule is taken into account cold and heat and asthenia and sthenia, and scalable makings body fluid melts maturation, removes and set upright to be one, carries out polytropic equilibrium, removes unusual body fluid, and convergence healthy energy is regulated cold-damp makings, thus effectively preventing flu and influenza and complication thereof.
Summary of the invention
The object of the invention is, according to the two strong point of tcm theory and Uygur's theory of medicine, develop a kind of treatment flu and grippal oral medicine flu (Zu Kamu) capsule, this medicine is made up of Rhizoma Kaempferiae, Fructus Jujubae, Radix Glycyrrhizae, Flos nymphaeae (Nymphaea teragona Georgi), Herba Menthae, Flos Matricariae chamomillae, fruit of Cordia dichotoma Forst. f., Semen althaeae roseae, Radix Et Rhizoma Rhei, Pericarpium Papaveris medical material; Adopt at first Herba Menthae, Rhizoma Kaempferiae, Flos Matricariae chamomillae three flavor medicines are placed in the extraction pot, adding 6-12 times of water gaging soaks, extract volatile oil, the aqueous solution after the distillation filters standby, collects volatile oil, per 1 milliliter of volatile oil restrains the beta-schardinger dextrin-inclusions with 5, cold preservation is spent the night, sucking filtration, drying, porphyrize, it is standby to cross 120 mesh sieves; Medicinal residues add 6-12 times of water gaging again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby; Again with Fructus Jujubae, Radix Glycyrrhizae, Flos nymphaeae (Nymphaea teragona Georgi), fruit of Cordia dichotoma Forst. f., another name for Sichuan Province Cai Zi, Radix Et Rhizoma Rhei, Pericarpium Papaveris seven flavor medicine material adds 4-8 times of water gaging and decocts, collecting decoction, filter, filtrate merges in reserve liquid, concentrating under reduced pressure, add ethanol, leave standstill, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, concentrated solution spray drying method for preparation extract powder, after the clathrate of adding beta-schardinger dextrin-inclusion volatile oil is mixed, add the adjuvant of microcrystalline Cellulose starch, granulate, cold drying, granulate adds micropowder silica gel and is mixed, for pale brown color to brown granule, the fill capsule can obtain gas perfume (or spice), the flu of mildly bitter flavor (Zu Kamu) capsule; This medicine in clinical practice for many years, and is good to treatment flu and influenza curative effect.Have no side effect through zoopery and observation on Clinical Application, 172 example flu and grippal patient are adopted the capsular treatment of oral cold (Zu Kamu), once oral 1.4 grams, three times on the one, its total cure rate is 85.2%.
Flu of the present invention (Zu Kamu) capsule oral medicine, this oral medicine is made up of Rhizoma Kaempferiae, Fructus Jujubae, Radix Glycyrrhizae, Flos nymphaeae (Nymphaea teragona Georgi), Herba Menthae, Flos Matricariae chamomillae, fruit of Cordia dichotoma Forst. f., Semen althaeae roseae, Radix Et Rhizoma Rhei, Pericarpium Papaveris medical material; Adopt at first Herba Menthae, Rhizoma Kaempferiae, Flos Matricariae chamomillae three flavor medicines are placed in the extraction pot, add 6-12 times of water gaging and soaked 4 hours, extracted volatile oil 3-8 hour, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, 40 ℃ were descended dry 2-7 hour, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 6-12 times of water gaging again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby; Again with Fructus Jujubae, Radix Glycyrrhizae, Flos nymphaeae (Nymphaea teragona Georgi), fruit of Cordia dichotoma Forst. f., another name for Sichuan Province Cai Zi, Radix Et Rhizoma Rhei, Pericarpium Papaveris seven flavor medicine material adds 4-8 times of water gaging and decocts 3 times, each 1 hour, collecting decoction, filter, filtrate merges in reserve liquid, concentrating under reduced pressure adds ethanol and makes and contain the alcohol amount and reach 50%, leaves standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, and concentrated solution spray drying method for preparation extract powder is after the clathrate of adding beta-schardinger dextrin-inclusion volatile oil is mixed, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate 45 ℃ of cold drying, granulate, adding micropowder silica gel is mixed, for pale brown color to brown granule, the fill capsule can obtain gas perfume (or spice), the flu of mildly bitter flavor (Zu Kamu) capsule; Wherein the ratio of each component is: 1 part-3 parts of Rhizoma Kaempferiae, 3 parts-6 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 8 parts-12 parts of Herba Menthaes, 4 parts-7 parts in Fructus Jujubae, 2 parts-4 parts of Flos Matricariae chamomillae, 2 parts-4 parts of fruit of Cordia dichotoma Forst. f., 0.5 part-2 parts in Radix Glycyrrhizae, 1 part-3 parts of another name for Sichuan Province Cai Zi, 1 part-2 parts of Radix Et Rhizoma Rhei, 1 part-3 parts of Pericarpium Papaveriss.
The preparation method of flu (Zu Kamu) capsule oral medicine, this oral medicine is pressed routine step and is made:
A, get 2 parts-4 parts three flavors of 8 parts-12 parts of Herba Menthaes, 1 part-3 parts of Rhizoma Kaempferiae, Flos Matricariae chamomillae medicines are placed in the extraction pot, add 6-12 times of water gaging and soaked 4 hours, extracted volatile oil 3-8 hour, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, 40 ℃ were descended dry 2-7 hour, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 6-12 times of water gaging again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby;
B, 4 parts-7 parts in Fructus Jujubae, 0.5 part-2 parts in Radix Glycyrrhizae, 3 parts-6 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 2 parts-4 parts of fruit of Cordia dichotoma Forst. f., 1 part-3 parts of Semen althaeae roseae, 1 part-2 parts of Radix Et Rhizoma Rhei, 1 part of-3 parts of seven flavor medicine material of Pericarpium Papaveris are added the decocting that 4-8 doubly measures again and boil 3 times, each 1 hour, collecting decoction filters, and filtrate merges in reserve liquid, concentrating under reduced pressure, add ethanol and make and contain the alcohol amount and reach 50%, left standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, concentrated solution spray drying method for preparation extract powder;
C, extract powder is added after clathrate with beta-schardinger dextrin-inclusion volatile oil is mixed again, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate, 45 ℃ of cold drying, granulate adds micropowder silica gel and is mixed, for pale brown color to brown granule, the fill capsule can obtain flu (Zu Kamu) capsule of gas perfume (or spice), mildly bitter flavor.
Flu (Zu Kamu) capsule is as the application of preparation treatment flu and the sick medicine of influenza, and this medicine is made up of 1 part-3 parts of Rhizoma Kaempferiae, 3 parts-6 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 8 parts-12 parts of Herba Menthaes, 4 parts-7 parts in Fructus Jujubae, 2 parts-4 parts of Flos Matricariae chamomillae, 2 parts-4 parts of fruit of Cordia dichotoma Forst. f., 0.5 part-2 parts in Radix Glycyrrhizae, 1 part-3 parts of Semen althaeae roseae, 1 part-2 parts of Radix Et Rhizoma Rhei, 1 part of-3 parts of medical material of Pericarpium Papaveris; At first Herba Menthae, Rhizoma Kaempferiae, Flos Matricariae chamomillae three flavor medicines are placed in the extraction pot, add 6-12 times of water gaging and soaked 4 hours, extracted volatile oil 3-8 hour, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, 40 ℃ were descended dry 2-7 hour, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 6-12 times of water gaging again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby; Again with Fructus Jujubae, Radix Glycyrrhizae, Flos nymphaeae (Nymphaea teragona Georgi), fruit of Cordia dichotoma Forst. f., another name for Sichuan Province Cai Zi, Radix Et Rhizoma Rhei, Pericarpium Papaveris seven flavor medicine material adds 4-8 times of water gaging and decocts 3 times, each 1 hour, collecting decoction, filter, filtrate merges in reserve liquid, concentrating under reduced pressure adds ethanol and makes and contain the alcohol amount and reach 50%, leaves standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, and concentrated solution spray drying method for preparation extract powder adds after clathrate with beta-schardinger dextrin-inclusion volatile oil is mixed, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate 45 ℃ of cold drying, granulate, adding micropowder silica gel is mixed, for pale brown color to brown granule, the fill capsule can obtain gas perfume (or spice), the flu of mildly bitter flavor (Zu Kamu) capsule; This medicine is used for treatment flu and influenza.
Flu of the present invention (Zu Kamu) capsule and preparation method thereof, wherein each component pharmacological properties of this medicine is:
Rhizoma Kaempferiae: be the dry root footpath of zingiberaceous plant Kaempferia gaianga L..Mainly contain volatile oil, different places of production volatile oil content is 0.8-2.6%; Contain in the volatile oil more than 40 kind of compositions such as methoxyl group Cortex cinnamomi japonici (Ramulus Cinnamomi) ethyl esters; Other contains flavones ingredients such as kaempferol, kaempferide.The root decoct all has in various degree inhibitory action to trichophyton and several frequently seen pathomycete in vitro.Kaempferol has antiinflammation and Citrin activity to animal.
Flos nymphaeae (Nymphaea teragona Georgi): be the dried floral of nymphaeaceae plant Nymphaea candida C.Presl.This kind of domestic literature is not reported, and through chemical constituent prerun, contains flavones ingredient.Congener Flos Nelumbinis Nelumoo nucifera Gaertn, flower contains Quercetin, luteolin, Isoquercitrin, luteolin glycoside, kaempferol-3-galactose glycoside, multiple flavones ingredients such as kaempferol glycoside.
Herba Menthae: be the dry aerial parts of labiate Mentha haplcalyx Briq..Contain volatile oil 1.3-2%, claim Oleum menthae, colourless have Herba Menthae fragrance to faint yellow or yellow green, and acrid in the mouth is peppery refrigerant, d 0.899-0.909, n 1.460-1,465, [a]-30-37 ℃.Containing 1-menthone 77-87% in having, is 1-Herba Menthae cerebrol about 10% and Herba Menthae esters 3-6% etc. secondly.1: 20 concentration of aqua methnae decoct has inhibitory action to viral ECHO strain; Mentholum has very strong bactericidal action, and the expelling phlegm for arresting cough effect is arranged; Mentholum is 2.0g/kg to the lethal dose of rat.
Fructus Jujubae: be the dry mature fruit of Rhamnaceae plant Ziziphus jujuba Mill..Mainly contain belulinic acid Betulinic acid, oleanolic acid, Crataegolic acid, Fructus Jujubae Saponin I, II, multiple Saponin constituents such as III and jujuboside B; Si Tefaling, different quinoline Alkaloids such as N-nornuciferine and asimilobrine, cyclopeptide alkaloids such as zizyphine and zizyphinine alkali; Multiple flavone component such as swertisin; Monosaccharide is arranged, oligosaccharide, acidic polysaccharose etc.; Amount contains ring phosphorus gland glycoside (cAMP) 100-600nmol/g (dry weight), and cGMP is multiple compositions such as 30-60nmol/g, ascorbic acid, Citrin, vitamin A, vitamin B.The human peripheral basophil discharged leukotriene (LTD) due to Fructus Jujubae water extract antagonism IgE stimulated inhibitory action, and generation has specific inhibitory effect to IgE antibody.With 5-hydroxy tryptamine and histamine antagonism is arranged.Fructus Jujubae has the liver protecting, increases the effect in body constitution and the enhancing body.Traditional Chinese medical science Fructus Jujubae treatment qi-deficiency type is caught a cold clinically, and leukopenia all has curative effect preferably.
Flos Matricariae chamomillae: be cadre's herb of feverfew Matricaria chamommolla L..Herb contains volatile oil 0.46-0.67%, is mainly multiple chemical compounds such as blue Oleum sesami Australia; Other contains globulariacitrin, multiple flavones ingredient such as hyperin; Blue Oleum sesami Australia and synthesis of derivatives thereof more all have antiinflammation, and Flos Matricariae chamomillae can strengthen regenerative process, weakens anaphylaxis, can be used for bronchial asthma, rheumatic fever, allergic gastroenteritis, eczema etc.; Its volatile oil is better than Bulbus Allii to the bacteriostasis of bacillus larvae.
Radix Glycyrrhizae: be dry root and the stem of leguminous plant Glycyrrhiza uralensis Fisch. Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. G.inflata a Bat. or Glycyrrhiza glabra L. G.glabr L..The main glycyrrhizin, a kind of triterpenoid saponin of containing in the Radix Glycyrrhizae.Generate a part enoxolone and two molecule glucose aldehydic acid after the glycyrrhizin hydrolysis.Glycyrrhiza glabra L. still contains dehydrogenation enoxolone I, and II, 18-α hydroxyl are removed from office careless subacid etc.Other contains liquiritin, multiple flavone such as isoliquiritin, liquiritigenin, osajin composition.Radix Glycyrrhizae has the antiinflammatory of 17-hydroxy-11-dehydrocorticosterone sample, anti-allergic effects; Radix Glycyrrhizae is to plain in the multiple medicine, and element and bacteriotoxin etc. in the food all have certain detoxification ability; Glycyrrhizin can prevent hepatic injury and the hepatocarcinoma effect that chemical carcinogens causes, protection upper respiratory tract infection mucosa, and reducing stimulates, so can be used for heat syndrome cough, cough caused by dryness etc.In addition, Radix Glycyrrhizae also has certain antibacterial action.
Semen althaeae roseae: be Malvaceae plant Althaea rosea (L.) Cavan. Althaea rosea (L.) Car. dry seed.The chemical efficacy of a drug of Semen althaeae roseae is not seen reported in literature, in trial test flavones ingredient is arranged through chemical constituent.
Radix Et Rhizoma Rhei: be the dry root and rhizome of polygonum rheum palmatum Rhoum palmatum L., pool historical relics Radix Et Rhizoma Rhei R.tanguticum Maxim et Balf. or Rheum officinale R.officinale Baill..The Radix Et Rhizoma Rhei main component is an anthraquinone derivative, and total amount is that 3-5% is partly free, most of and grapevine knot elbs reaction glycoside.There are big sulfonic acid, chrysophanol, aloe-emodin, emodin in the glycoside unit of free type, at the flavin methyl ether etc.In conjunction with the anthracene glycoside is the cathartic effective ingredient, comprises Sennoside A, B, C, D, E, F.Other contains compositions such as tannin.The anti-infectious function of Radix Et Rhizoma Rhei, showing all has in various degree bacteriostasis to various bacteria, wherein with staphylococcus, streptococcus sensitivity; Diphtheria corynebacterium, typhoid fever, Salmonella paratyphi and dysentery bacterium are also responsive, and effective ingredient is for playing acid altogether, and the effect of emodin and aloe-emodin is the strongest.The Radix Et Rhizoma Rhei decoct all has stronger inhibitory action to multiple fungus and influenza virus.Radix Et Rhizoma Rhei also plays regulating action to immunologic function.
Pericarpium Papaveris: be the drying and ripening shell of bloodroot Papaver somniferum L..Contain morphine 0.015%, narcotine 0.004%, codeine 0.002%, papaverine 0.0002%, protopine trace, multiple alkaloids such as narcotoline about 0.05%; Morphine has significant analgesic activity, and high selectivity is arranged; The analgesic activity of codeine is 1/4 of a morphine; Morphine has the hypnosis work but sleeps shallow and easy waking up, and codeine does not then cause sleep.Morphine has the high selectivity inhibitory action to respiratory center, when being lower than the analgesic dose, to breathing existing the inhibition.The antitussive action of morphine is also very strong, main inhibition to coughing centre.
Fruit of Cordia dichotoma Forst. f.: be comfrey Cordia dichotoma Forst.f. dry mature fruit.Domestic literature is not reported.
The capsular drug efficacy study of flu of the present invention (Zu Kamu), acute toxicity test and clinical trial are as follows:
Test objective: observe the non-specific antiinflammatory of Zukam capsule, analgesic, cough-relieving, antiasthmatic effect by this research.
Experimental animal: Kunming mouse, NIH mice, Wistar rat, Cavia porcellus available from autonomous region's medical experiment animal center, are secondary.
Method and result
(1) Zukam capsule is to the bullate influence of mice auricular concha caused by dimethylbenzene xylene
Dosage design: the agent amount of being tried of this test is that the pharmacodynamic study data of being carried out according to this medicine forefathers and the maximum tolerated dose of said preparation determine.
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.45g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.90g/kg, bid * 7 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.80g/kg, bid * 7 day.
(5) positive controls: the ig ancestral blocks wooden granule, each 5.40g/kg, bid * 7 day.
Method: get 60 of mices, body weight 19.7 ± 1.2g divides 5 groups and gastric infusion, twice of every day at random, successive administration 7 days, after the last administration 30 minutes, every group of mouse right ear two sides is coated with touched dimethylbenzene 0.1ml and causes inflammation, caused scorching 2 hours and take off neck to put to death animal, get same position, left and right sides auricle with the 8mm card punch, weighing, is the swelling degree with two auricle weight differences, organizes a mean t check.
As a result, Zukam capsule various dose ig administration, the swelling of xylol induced mice auricular concha has inhibitory action (table 1) significantly.
Table 1 Zukam capsule is to the bullate influence of mice auricular concha caused by dimethylbenzene xylene (X ± SD)
Animal dosage swelling degree
Group
(only) be (mg) (g/kg.bid)
Blank group 10--27.23 ± 3.79
Zukam capsule 11 0.45 14.49 ± 6.52 * *
12????0.90????????15.37±3.85 ***
12????1.80????????16.39±3.85 ***
The ancestral blocks wooden granule 12 5.40 18.58 ± 6.21 * *Annotate: compare with matched group * *P＜0.01.
(2) Zukam capsule is to the influence of mouse peritoneal capillary permeability increase
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.45g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.90g/kg, bid * 7 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.80g/kg, bid * 7 day.
(5) positive controls: the ig ancestral blocks wooden granule, each 5.40g/kg, bid * 7 day.
Method and result: get 70 of NIH mices, body weight 19.5 ± 1.3g, male and female half and half, divide 5 groups and gastric infusion at random, twice of every day, gastric infusion is 7 days continuously, the equal tail vein injection 1% azovan blue normal saline solution 0.1ml/10g body weight of each Mus of 1h after the last administration, lumbar injection 0.6% glacial acetic acid 0.2ml/ only takes off neck and puts to death mice behind the 20min at random, with 5ml normal saline flushing abdominal cavity, collect cleaning mixture, the centrifugal 10min of 1000rpm gets supernatant and measures trap (OD value) in 721 spectrophotometer 590nm places, with mean t check between OD value work group.
As a result, mice and ancestral are respectively organized in the Zukam capsule administration, and to block wooden groups of grains mouse peritoneal cleaning mixture OD value low than matched group, shows that the mouse peritoneal capillary permeability that said preparation obviously suppresses due to the acetic acid increases (table 2).
The influence that table 2 Zukam capsule increases the mouse peritoneal capillary permeability (X ± SD)
Animal dosage abdominal cavity cleaning mixture suppresses
Group
(only) (g/kg.bid) (0D value) (%)
Blank group 13--0.531 ± 0.053--
Ancestral's wood glue capsule 11 0.45 0.201 ± 0.040 * *62.15
13????0.90????????0.202±0.054 ***???61.96
11????1.80????????0.252±0.052 ***???52.54
The ancestral blocks wooden granule 13 5.40 0.280 ± 0.099 * *47.27 Wang: compare with matched group * *P＜0.01.
(3) Zukam capsule causes bullate influence to mice foot sole of the foot carrageenin
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.45g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.90g/kg, bid * 7 day.
(4) positive controls: the ig ancestral blocks wooden granule, each 5.40g/kg, bid * 7 day.
Method and result: get 40 of white mice, body weight 20 ± 2g, male and female half and half, divide 4 groups at random, every day twice, continuously gastric infusion is 7 days, injects the subcutaneous inflammation that causes of the right back sufficient sole of the foot of mice with 2% carrageenin 0.05ml in 1 hour after the last administration, cause scorching back 1,3,4,5 hour with miking foot sole of the foot thickness, so that the difference of the sufficient sole of the foot is organized a mean t check for the swelling degree before and after scorching.
As a result, Zukam capsule various dose ig administration all can obviously suppress the caused mice pedal swelling of carrageenin (table 3).
Table 3 Zukam capsule causes bullate influence (X ± SD) to mice foot sole of the foot carrageenin
Animal dosage swelling degree group
(only) be 1h 3h 4h 5h blank group 10 (g/kg.bid)--0.36 ± 0.14 0.57 ± 0.10 0.59 ± 0.13 0.57 ± 0.15 Zukam capsule 10 0.45 0.19 ± 0.10 * *0.34 ± 0.14 * *0.40 ± 0.15 *0.50 ± 0.16 *
10 0.90 0.17 ± 0.06 * *0.29 ± 0.14 * *0.38 ± 0.06 * *0.41 ± 0.07 * *The ancestral blocks wooden granule 10 5.40 0.19 ± 0.10 * *0.35 ± 0.14 * *0.46 ± 0.22 *0.50 ± 0.18 *
Annotate: compare with the matched group of same time * *P＜0.01, *P＜0.05, *P＞0.05.
(4) the Zukam capsule granule is to the analgesic activity of mice
1. writhing method
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.45g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.90g/kg, bid * 7 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.80g/kg, bid * 7 day.
(5) positive controls: the ig ancestral blocks wooden granule, each 5.40g/kg, bid * 7 day.
Method and result: get 70 of white mice, body weight 19.1 ± 1.3g, male and female half and half are divided 5 groups and ig administration at random, every day twice, continuous 7 days.The every Mus lumbar injection 1% glacial acetic acid 0.1ml/10g of 2h after the last administration, observe the writhing response that each Mus occurs in the 20min (abdominal part indent, stretching, extension hind leg, buttocks are raised) number of times, as analgesic activity index relatively, organize a mean t check with the writhing response number of times.
The result shows that Zukam capsule various dose ig administration all can obviously reduce the writhing response number of times of mice, with the blank group utmost point significant difference is arranged relatively, points out this medicine that analgesic activity (table 4) is arranged.
Table 4 Zukam capsule is to the analgesic activity (writhing method) of mice (X ± SD)
Animal dosage suppresses
Group is turned round the body number of times
(only) be (%) (g/kg.bid)
Blank group 13--46.23 ± 9.13--
Zukam capsule 14 0.45 31.54 ± 8.51 * *31.78
14????0.90????????????21.86±4.57 ***???52.71
14????1.80????????????16.50±4.05 ***???64.31
Ancestral's wood granule 14 5.40 28.86 ± 4.13 * *37.57 annotate: compare with matched group * *P＜0.01.
2. hot plate method
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.45g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.90g/kg, bid * 7 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.80g/kg, bid * 7 day.
(5) positive controls: the ig ancestral blocks wooden granule, each 5.40g/kg, bid * 7 day.
Get 80 of female white mice, be put in before the administration in the beaker in the constant water bath box that is heated to 55 ± 0.5 ℃ in advance, being subjected to thermostimulation metapedes to occur adding with mice is the pain indicator reaction, and time of pain reaction appears in the record mice, with the pain threshold (second) of twice meansigma methods before as administration.Choose pain threshold before the administration less than 60 of 30 seconds mices, divide 5 groups at random, 12 every group.Measured the pain threshold time of respectively organizing mice respectively in 1,2,3 hour after the last administration, organize a mean t with the pain threshold time and check.
The result shows, Zukam capsule various dose ig administration all can obviously improve the threshold of pain of mice, points out this medicine that analgesic activity (table 5) is arranged.
Table 5 Zukam capsule is to the analgesic activity (hot plate method) of mice (X ± SD)
Different time pain threshold (sec) group after the preceding threshold of pain administration of animal dosed administration
(only) (g/kg.bid) is worth (sec) 1h 2h 3h blank group 11--and 20.78 ± 2.66 21.67 ± 4.78 *22.68 ± 5.08 *22.32 ± 2.04 *Group card wood glue capsule 12 0.45 21.66 ± 3.74 28.14 ± 3.50 * *30.81 ± 6.62 * *36.29 ± 6.95 * *
12????0.90????21.17±3.50????32.20±7.80 ***?30.71±7.39 ***?30.50±7.19 ***
11 1.80 23.31 ± 3.29 32.95 ± 8.46 * *31.01 ± 6.34 * *30.38 ± 6.96 * *The ancestral blocks wooden granule 11 5.40 23.08 ± 2.24 32.02 ± 3.97 * *29.19 ± 4.74 * *27.90 ± 5.44 * *Annotate: compare with pain threshold before the administration *P＞0.05, * *P＜0.01.
(5) Zukam capsule is grabbed the influence of the reaction of nose and sneeze to Cavia porcellus due to the histamine
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.28g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.56g/kg, bid * 7 day.
(4) positive controls: the ig ancestral blocks wooden granule, each 3.35g/kg, bid * 7 day.
Method and result: get 28 of Cavia porcelluss, 1h splashes into the Cavia porcellus nasal cavity with 0.6% histamine solution with sample injector after the last administration, every side 50 μ l, both sides 100 μ l, observe the sneeze number of times that occurs grabbing the nose number of times and occur in 1 minute in 10 minutes after waiting nose and sneeze to occur grabbing, organize a mean t check to grab nose number of times and sneeze number of times.
As a result, Zukam capsule various dose ig administration all can obviously suppress the caused Cavia porcellus of histamine and grab nose and sneeze reaction (table 6).
Table 6 Zukam capsule is grabbed the influence of nose and sneeze reaction to Cavia porcellus due to the histamine
( X±SD)
Animal dosage occurred group occurring in 1 minute in 10 minutes
(only) the sneeze number of times blank group 7 of grabbing the nose number of times--64.6 ± 25.2 28.4 ± 11.2 Zukam capsules 7 0.28 20.2 ± 6.1 (g/kg.bid) * *10.1 ± 4.6 * *
7 0.56 18.4 ± 4.3 * *8.3 ± 3.1 * *The ancestral blocks wooden granule 7 3.35 18.1 ± 5.1 * *7.5 ± 3.0 * *Annotate: compare with matched group * *P＜0.01.
(6) Zukam capsule influences grouping and administration to rat fever reaction due to the dry yeast:
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.32g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.64g/kg, bid * 7 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.28g/kg, bid * 7 day.
(5) positive controls: the ig ancestral blocks wooden granule, each 3.84g/kg, bid * 7 day.
Method and result: get 50 of rats, male and female half and half, body weight 180-220g is divided into 5 groups at random, ig administration, 2ml/100g/ time, every day twice, successive administration 7 days.Immediately in the subcutaneous injection 20% sterilised yeast suspension 10ml/kg of rat back, respectively surveyed the anus temperature once in 0.5,1,2,4,6,8,10,12 hour then after the last administration.Make the body temperature change curve, compare between body temperature difference (Δ T) group.
As a result, Zukam capsule various dose ig administration has good cooling effect (table 7) to rat fever body temperature due to the dry yeast.
Table 7 Zukam capsule is to the influence of rat fever reaction due to the dry yeast (X ± SD)
Group Animal (only) Dosage (g/kg .bid) The body temperature changing value of different time (Δ T)
????0.5h ????1h ????2h ????4h
The blank group ????10 ??0.471±0.279 ????(n＝7) ??0.778±0.327 ????(n＝9) ??1.41±0.387 ????(n＝10) ??1.144±0.439 ????(n＝9)
Zukam capsule ????10 ????0.32 ??0.363±0.185 *????(n＝8) ??0.590±0.233 *????(n＝10) ??1.60±0.392 *????(n＝10) ??0.96±0.458 *????(n＝10)
????10 ????0.64 ??0.390±0.142 *????(n＝10) ??0.840±0.212 *????(n＝10) ??1.41±0.296 *????(n＝10) ??1.18±0.316 *????(n＝10)
????10 ????1.28 ??0.286±0.121 *????(n＝7) ??0.640±0.227 *????(n＝10) ??1.46±0.276 *????(n＝10) ??1.07±0.427 *????(n＝10)
The ancestral blocks wooden granule ????10 ????3.84 ??0.675±0.276 *????(n＝9) ??0.867±0.391 *????(n＝9) ??1.03±0.386 *????(n＝10) ??0.87±0.440 *????(n＝10)
Group Animal (only) Dosage (g/kg. bid) The body temperature changing value of different time (+Δ T)
????6h ????8h ????10h ????12h
The blank group ????10 ????0.675±0.354 ????(n＝8) ??1.056±0.403 ????(n＝9) ??1.38±0.391 ????(n＝10) ??1.61±0.382 ????(n＝10)
Zukam capsule ????10 ????0.32 ????0.68±0.377 *????(n＝10) ??0.94±0.417 *????(n＝10) ??1.29±0.449 *????(n＝10) ??1.42±0.447 *????(n＝10)
????10 ????0.64 ????0.55±0.127 *????(n＝10) ??0.80±0.394 *????(n＝10) ??0.55±0.135 ***????(n＝10) ??0.36±0.076 ***????(n＝10)
????10 ????1.28 ????0.588±0.203 *????(n＝8) ??0.443±0.181 *????(n＝7) ??0.26±0.091 ***????(n＝10) 0.167±0.058 ***????(n＝10)
The ancestral blocks wooden granule ????10 ????3.84 ????0.789±0.392 *????(n＝9) ??1.12±0.410 *????(n＝10) ??0.98±0.365 **????(n＝10) 0.513±0.340 ***????(n＝8)
Annotate: compare with the matched group body temperature changing value of identical time *P＞0.05, *P＜0.05, * *P＜0.01.
(7) Zukam capsule is to the phlegm-dispelling functions of mice
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 12 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.45g/kg, bid * 12 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.90g/kg, bid * 12 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.80g/kg, bid * 12 day.
(5) positive controls: the ig ancestral blocks wooden granule, each 5.40g/kg, bid * 12 day.Method and result: get 60 of mices, 18-20g, male and female half and half are divided into 5 groups at random, and 12 every group, ig administration, every day twice, successive administration 12 days.With animal fasting 6 hours, 1 hour phenol red normal saline solution 0.7ml of every Mus ip0.25% after the administration in afternoon drew neck to put to death animal after 30 minutes after the administration in morning last day.Separate trachea, insert No. 7 syringe needle, wash trachea 3 times with 5% sodium bicarbonate normal saline solution, each 0.4ml merges flushing liquor, and with 721 type spectrophotometers, wavelength 546nm place measures the OD value.Now use the phenol red standard curve of doing, calculate phenol red content (μ g/ml), organize a mean t check with phenol red content according to standard curve.
As a result, the Zukam capsule of various dose and ancestral block wooden granule ig administration does not all have phlegm-dispelling functions (table 8).
Table 8 Zukam capsule is to the influence of the phenol red excretion amount in mouse breathing road (X ± SD)
The phenol red excretion amount of number of animals dosage respiratory tract
Group
(only) be (μ g/ml) (g/kg.bid)
Blank group 10--2.65 ± 0.34
Zukam capsule 10 0.45 2.67 ± 0.95 * *
10????0.90????????????2.86±0.82 ***
11????1.80????????????2.62±0.70 ***
The ancestral blocks wooden granule 8 5.40 2.71 ± 0.82 * *Annotate: compare with the blank group, * *
(8) Zukam capsule is to the influence of prostaglandin content in the rat paw inflammation tissue
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.32g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.64g/kg, bid * 7 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.28g/kg, bid * 7 day.
(5) positive controls: the ig ancestral blocks wooden granule, each 3.84g/kg, bid * 7 day.
Method and result: get 50 of rats, male and female half and half are divided into 5 groups at random, and 10 every group, ig administration, every day twice, successive administration 7 days.30min after the last administration in the 8th day, the right sole of the foot sc2% intersection of rat dish glue 0.06ml causes inflammation, broken end sacrificed by exsanguination rat behind the 4h, to cause scorching sufficient sole of the foot 0.5cm on ankle joint and cut at the place, weigh, shred skin and other tissue except that skeleton after the peeling, place 7ml NS to soak 1h, the centrifugal 5min of 3000r/min gets supernatant 1ml with the full-automatic radioimmunity γ-enumerator of FMJ-, according to 6-ketone-prostaglandin F 1 αPut the method for exempting from the medicine box description, the PGF of working sample 1 αAnd TXB 2Content; Get above-mentioned supernatant 0.3ml simultaneously, add 0.5mol/L KOH methanol solution 2ml,, add methanol then and be diluted to 9mL at 50 ℃ of water-bath isomerization 20min, measure ultraviolet OD value in the 278nm place with M750-A type spectrophotometer, organize suitable OD value representation PGE with every gram 2Content.As a result, PGE in the remarkable inflammation-inhibiting tissue of the Zukam capsule ig administration of various dose energy 1 α, and TXB 2Content.
Table 9 ancestral blocks wood to PGE in the rat sex organization 1 α, and TXB 2The influence of content (X ± SD)
Number of animals dosage PGF 1 αTXB 2Group
(only) be (pg/mg) (pg/mg) blank group 8--1.740 ± 0.500 0.424 ± 0.107 Zukam capsules 8 0.32 1.100 ± 0.370 (g/kg.bid) *0.283 ± 0.076 * *
8????0.64???????1.023±0.467 **??0.308±0.084 **
8 1.28 1.094 ± 0.418 *0.241 ± 0.104 * *The ancestral blocks wooden granule 9 3.84 1.962 ± 0.908 *0.427 ± 0.082 *Annotate: compare with the blank group *P＜0.05, * *P＜0.01, *P＞0.05.
Table 10 ancestral blocks wooden sugar-free granule to PGE in the rat inflammatory tissue 2The influence of content (X ± SD)
Number of animals dosage OD value group suppression ratio (%)
(only) (g/kg.bid) (* 10 -3) blank group 8--178 ± 44--Zukam capsule 9 0.32 74 ± 36 * *58.4
8?????0.64????????42±24 ***??????????????76.4
10 1.28 68 ± 29 * *61.8 the ancestral blocks wooden granule 10 3.84 115 ± 40 * *35.4 annotate: compare with the blank group * *P＜0.01.
The result shows that the Zukam capsule ig administration of various dose is to PGE in the rat sex organization 1 α, and TXB 2Content has obvious inhibitory action.
(9) antitussive action (ammonia draws the method for coughing)
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 7 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.45g/kg, bid * 7 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.90g/kg, bid * 7 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.80g/kg, bid * 7 day.
(5) be subjected to reagent thing group: ig Zukam capsule, each 3.60g/kg, bid * 7 day.
(6) positive controls: the ig ancestral blocks wooden granule, each 5.40g/kg, bid * 7 day.
Method and result: choose 60 of Kunming mouses, body weight 18-22g, male and female half and half are divided into 6 groups at random, and 10 every group, ig administration, every day twice, successive administration 7 days.Behind the last administration 1h mice is pursued the wide mouthed bottle of only putting into 500ml, the built-in cotton balls of bottle, only inject strong aqua ammonia 0.5ml/ to cotton balls, seal bottleneck immediately, after 5 seconds mice is taken out rapidly, observe the cough number of times that mouse cough incubation period (injecting strong aqua ammonia and begin, is incubation period to cough institute takes place through the time) and injection strong aqua ammonia begin appearance in 3 minutes.Organize a mean t check with the cough number of times that occurs in incubation period and 3 minutes as index.
As a result, the Zukam capsule ig administration of various dose can obviously prolong mice ammonia and draw and cough incubation period, and can obviously reduce the cough number of times (table 11) that occurs in 3 minutes.
Table 11 Zukam capsule draws the influence (X ± SD) that coughs incubation period and cough number of times to mice ammonia
The volt phase before the cough of volt phase before the cough of number of animals dosage
Group
(n)??????(g/kg.bid)??(sec)????????????????(sec)
Blank group 10--36.92 ± 6.29 21.1 ± 5.13
Zukam capsule 10 0.45 65.79 ± 5.38 * *17.8 ± 3.26 * *
10????????0.90????123.20±22.57 ***???11.2±2.78 ***
10????????1.80????141.44±20.28 ***???7.0±2.05 ***
10????????3.60????153.80±22.09 ***???3.1±1.60 ***
The ancestral blocks wooden granule 10 5.40 74.63 ± 12.51 * *15.5 ± 3.44 * *Annotate: compare with the blank group * *P＜0.01.
(10) antiasthmatic effect
Grouping and administration:
(1) blank group: ig normal saline, each 20ml/kg, bid * 5 day.
(2) be subjected to reagent thing group: ig Zukam capsule, each 0.28g/kg, bid * 5 day.
(3) be subjected to reagent thing group: ig Zukam capsule, each 0.56g/kg, bid * 5 day.
(4) be subjected to reagent thing group: ig Zukam capsule, each 1.12g/kg, bid * 5 day.
(5) positive controls: the ig ancestral blocks wooden granule, each 3.35g/kg, bid * 5 day.
Method and result: get 60 Cavia porcelluss, body weight 150-200g, male and female dual-purpose.Earlier Cavia porcellus is placed in the airtight glass bell jar one by one, after treating peace and quiet, start nebulizer, draw with constant-pressure atomization 2% acecoline and 0.1% histamine equivalent mixed liquor 15sec and to breathe heavily, after spraying stops, observe the interior Cavia porcellus of 6min immediately and the incubation period of panting property tic occurs (after promptly spraying stops, the time that the tic of panting property occurs), if incubation period is then unelected greater than 120-150 person, select qualified animal, be divided into 5 groups at random by body weight, sex,, 10 every group, the ig administration, every day twice, successive administration 5 days.Behind the last administration 1h, draw with similarity condition and to breathe heavily, observe preclinical variation and fall the time.
The result shows, Zukam capsule various dose ig successive administration is after 5 days, and obviously prolonged guinea pig is drawn and breathed heavily incubation period, occurs the later time of falling of panting property tic simultaneously also obviously to prolong.Show that Zukam capsule has tangible antiasthmatic effect (table 12)
The antiasthmatic effect of table 12 Zukam capsule (X ± SD)
The number of animals dosage draw breathe heavily before the volt phase time group of falling
(n) (g/kg.bid) (sec) (sec) blank group 10--60.7 ± 9.67 84.5 ± 11.55 Zukam capsules 10 0.28 94.2 ± 15.92 * *118.9 ± 17.01 * *
10??????0.56??????116.0±21.61 ***???161.3±26.96 ***
10 1.12 136.7 ± 36.06 * *184.4 ± 18.40 * *The ancestral blocks wooden granule 10 3.35 101.0 ± 20.61 * *132.1 ± 17.97 * *Annotate: compare with the blank group * *P＜0.01.
Conclusion:
Above experimental result shows that Zukam capsule suppresses the swelling of dimethylbenzene induced mice auricular concha; Mouse peritoneal capillary permeability due to the antagonism acetic acid increases; Suppress intersection dish glue induced mice pedal swelling; Writhing method and hot plate method cause and suppress the mouse writhing reaction on the pain model and improve pain wealthy simultaneously; The rat fever reaction has antagonism due to the dry yeast simultaneously; That suppresses that histamine causes grabs nose and sneeze reaction; And can reduce PGE in the rat inflammation tissue 2, PGE 1 α, and TXB 2Deng content.This medicine can suppress the mouse cough reaction that strong aqua ammonia brings out simultaneously; And can be to asthma reaction due to anti-acetylcholine and the histamine equivalent mixed liquor.
Effects such as the prompting Zukam capsule has significant antiinflammatory, analgesic, analgesia and cough-relieving, relieving asthma.Simultaneously, its antiinflammatory action may with its inflammation-inhibiting position PGE 2, PGE 1 α, and TXB 2Deng content relevant.
The Zukam capsule animal acute toxicity test
Maximum tolerance determination
Be subjected to the reagent thing: the Zukam capsule content is a brown yellow granule, the dense fragrance of tool, and Qikanghabo Uygur Medicine Co., Ltd., Xinjiang provides.
Experimental animal: Kunming mouse, one-level, body weight 19.2 ± 1.4, male and female half and half detect conformance with standard, available from autonomous region's medical experiment animal center.
Method and result: should find out capsule with sequential method and cause animal 0% (Dn) and the dead dosage of 100% (Dm).Said preparation is tried object long-pending (0.3ml/10g.bid under condition ig), is not seen tangible toxic reaction and animal dead, so only carry out mtd test at Cmax (150%) and maximum giving as a result.
Choose 30 of mices, male and female half and half, the ig administration, a 0.3ml/10g, continuous 2 times, dosing interval 2 hours was observed 14 days after the administration continuously.As a result, administration animal on the same day occurs outside the calmness, tangible toxic reaction do not occur, and food ration is also no abnormal.Therefore, the maximum tolerated dose of Zukam capsule oral administration is 60ml/kg (18g/kg) body weight.
Conclusion: because the mice maximum tolerated dose allows the administration quantitative limitation, only making maximum tolerated dose is 18g/kg.General adult (60kg calculating) each 1.4g of oral dose, every day 3 times, it is 4.2g/60kg/ day, calculate by pharmacology of Chinese materia medica research methodology " the maximum tolerance of mice is the multiple computational methods ", this test determination mice maximum tolerated dose 18g/kg, press 257 times of the body weight oral dose for being grown up, Zukam capsule oral administration safety is described.
Flu of the present invention (Zu Kamu) capsule has been through having carried out oral medication to 172 example flu and influenza patient, and method of administration is every day 3 times, 3-5 grain at every turn, and be 3-7 days the course of treatment, its total cure rate is 85.2%.
The wood invention has been carried out the preliminarily stabilised test to flu (Zu Kamu) capsule, its result shows: the clinical research of flu (Zu Kamu) capsule was stored three months at ambient temperature with three batch samples, significant change does not take place in sample appearance, character, discriminating, disintegration, content uniformity, microbial limit and content, meet said preparation quality standard regulation, place the inspection of anteroposterior diameter thin layer chromatography, its characteristic component speckle does not have significant change, shows that high capsule quality is stable.
The specific embodiment
Embodiment 1
A, get 2 part of three flavor of 8 parts of Herba Menthaes, 1 part of Rhizoma Kaempferiae, Flos Matricariae chamomillae medicine is placed in the extraction pot, add 6 times of water gagings and soaked 4 hours, extracted volatile oil 3 hours, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, drying is 2 hours under 40 ℃, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 6 times of water gagings again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby;
B, the decocting that again 4 parts in Fructus Jujubae, 0.5 part in Radix Glycyrrhizae, 3 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 2 parts of fruit of Cordia dichotoma Forst. f., 1 part of Semen althaeae roseae, 1 part of Radix Et Rhizoma Rhei, 1 part of seven flavor medicine material of Pericarpium Papaveris is added 4 times of amounts boil 3 times, each 1 hour, collecting decoction filters, and filtrate merges in reserve liquid, concentrating under reduced pressure, add ethanol and make and contain the alcohol amount and reach 50%, left standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, concentrated solution spray drying method for preparation extract powder;
C, extract powder is added after clathrate with beta-schardinger dextrin-inclusion volatile oil is mixed again, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate, 45 ℃ of cold drying, granulate adds micropowder silica gel and is mixed, for pale brown color to brown granule, the fill capsule can obtain flu (Zu Kamu) capsule of gas perfume (or spice), mildly bitter flavor.
Catch a cold and influenza person to suffering from, each 3-5 grain, every day 3 times, cure rate is 85.2%, be 5 days the course of treatment.
Embodiment 2
A, get 3 part of three flavor of 10 parts of Herba Menthaes, 2 parts of Rhizoma Kaempferiae, Flos Matricariae chamomillae medicine is placed in the extraction pot, add 9 times of water gagings and soaked 4 hours, extracted volatile oil 6 hours, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, drying is 5 hours under 40 ℃, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 9 times of water gagings again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby;
B, the decocting that again 5 parts in Fructus Jujubae, 1 part in Radix Glycyrrhizae, 4 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 3 parts of fruit of Cordia dichotoma Forst. f., 2 parts of Semen althaeae roseae, 1.5 parts of Radix Et Rhizoma Rhei, 2 parts of seven flavor medicine materials of Pericarpium Papaveris is added 6 times of amounts boil 3 times, each 1 hour, collecting decoction filters, and filtrate merges in reserve liquid, concentrating under reduced pressure, add ethanol and make and contain the alcohol amount and reach 50%, left standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, concentrated solution spray drying method for preparation extract powder;
C, extract powder is added after clathrate with beta-schardinger dextrin-inclusion volatile oil is mixed again, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate, 45 ℃ of cold drying, granulate adds micropowder silica gel and is mixed, for pale brown color to brown granule, the fill capsule can obtain flu (Zu Kamu) capsule of gas perfume (or spice), mildly bitter flavor.
Catch a cold and influenza person to suffering from, each 3-5 grain, every day 3 times, cure rate is 88.1%, be 7 days the course of treatment.
Embodiment 3
A, get 4 part of three flavor of 3 parts of Herba Menthaes, 3 parts of Rhizoma Kaempferiae, Flos Matricariae chamomillae medicine is placed in the extraction pot, add 12 times of water gagings and soaked 4 hours, extracted volatile oil 8 hours, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, drying is 2 hours under 40 ℃, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 12 times of water gagings again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby;
B, the decocting that again 7 parts in Fructus Jujubae, 2 parts in Radix Glycyrrhizae, 6 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 4 parts of fruit of Cordia dichotoma Forst. f., 3 parts of Semen althaeae roseae, 2 parts of Radix Et Rhizoma Rhei, 3 parts of seven flavor medicine materials of Pericarpium Papaveris is added 8 times of amounts boil 3 times, each 1 hour, collecting decoction filters, and filtrate merges in reserve liquid, concentrating under reduced pressure, add ethanol and make and contain the alcohol amount and reach 50%, left standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, concentrated solution spray drying method for preparation extract powder;
C, extract powder is added after clathrate with beta-schardinger dextrin-inclusion volatile oil is mixed again, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate, 45 ℃ of cold drying, granulate adds micropowder silica gel and is mixed, for pale brown color to brown granule, the fill capsule can obtain flu (Zu Kamu) capsule of gas perfume (or spice), mildly bitter flavor.
Catch a cold and influenza person to suffering from, each 3-5 grain, every day 3 times, effective percentage is 80.5%, be 3 days the course of treatment.

Claims (3)

1, a kind of cold relief capsule oral medicine is characterized in that this oral medicine is made up of Rhizoma Kaempferiae, Fructus Jujubae, Radix Glycyrrhizae, Flos nymphaeae (Nymphaea teragona Georgi), Herba Menthae, Flos Matricariae chamomillae, fruit of Cordia dichotoma Forst. f., Semen althaeae roseae, Radix Et Rhizoma Rhei, Pericarpium Papaveris medical material; At first Herba Menthae, Rhizoma Kaempferiae, Flos Matricariae chamomillae three flavor medicines are placed in the extraction pot, add 6-12 times of water gaging and soaked 4 hours, extracted volatile oil 3-8 hour, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, 40 ℃ were descended dry 2-7 hour, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 6-12 times of water gaging again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby; Again with Fructus Jujubae, Radix Glycyrrhizae, Flos nymphaeae (Nymphaea teragona Georgi), fruit of Cordia dichotoma Forst. f., another name for Sichuan Province Cai Zi, Radix Et Rhizoma Rhei, Pericarpium Papaveris seven flavor medicine material adds 4-8 times of water gaging and decocts 3 times, each 1 hour, collecting decoction, filter, filtrate merges in reserve liquid, concentrating under reduced pressure adds ethanol and makes and contain the alcohol amount and reach 50%, leaves standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, and concentrated solution spray drying method for preparation extract powder adds after clathrate with beta-schardinger dextrin-inclusion volatile oil is mixed, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate 45 ℃ of cold drying, granulate, adding micropowder silica gel is mixed, for pale brown color to brown granule, the fill capsule can obtain gas perfume (or spice), the cold relief capsule of mildly bitter flavor; Wherein the ratio of each component is: 1 part-3 parts of Rhizoma Kaempferiae, 3 parts-6 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 8 parts-12 parts of Herba Menthaes, 4 parts-7 parts in Fructus Jujubae, 2 parts-4 parts of Flos Matricariae chamomillae, 2 parts-4 parts of fruit of Cordia dichotoma Forst. f., 0.5 part-2 parts in Radix Glycyrrhizae, 1 part-3 parts of Semen althaeae roseae, 1 part-2 parts of Radix Et Rhizoma Rhei, 1 part-3 parts of Pericarpium Papaveriss.
2, a kind of preparation method of cold relief capsule oral medicine is characterized in that this oral medicine presses routine step and make:
A, get 2 parts-4 parts three flavors of 8 parts-12 parts of Herba Menthaes, 1 part-3 parts of Rhizoma Kaempferiae, Flos Matricariae chamomillae medicines are placed in the extraction pot, add 6-12 times of water gaging and soaked 4 hours, extracted volatile oil 3-8 hour, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, 40 ℃ were descended dry 2-7 hour, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 6-12 times of water gaging again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby;
B, 4 parts-7 parts in Fructus Jujubae, 0.5 part-2 parts in Radix Glycyrrhizae, 3 parts-6 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 2 parts-4 parts of fruit of Cordia dichotoma Forst. f., 1 part-3 parts of Semen althaeae roseae, 1 part-2 parts of Radix Et Rhizoma Rhei, 1 part of-3 parts of seven flavor medicine material of Pericarpium Papaveris are added the decocting that 4-8 doubly measures again and boil 3 times, each 1 hour, collecting decoction filters, and filtrate merges in reserve liquid, concentrating under reduced pressure, add ethanol and make and contain the alcohol amount and reach 50%, left standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, concentrated solution spray drying method for preparation extract powder;
C, extract powder is added after clathrate with beta-schardinger dextrin-inclusion volatile oil is mixed again, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate, 45 ℃ of cold drying, granulate adds micropowder silica gel and is mixed, for pale brown color to brown granule, the fill capsule can obtain the cold relief capsule of gas perfume (or spice), mildly bitter flavor.
3, a kind of cold relief capsule is as the application of preparation treatment flu and the sick medicine of influenza, it is characterized in that this medicine is made up of 1 part-3 parts of Rhizoma Kaempferiae, 3 parts-6 parts of Flos nymphaeae (Nymphaea teragona Georgi)s, 8 parts-12 parts of Herba Menthaes, 4 parts-7 parts in Fructus Jujubae, 2 parts-4 parts of Flos Matricariae chamomillae, 2 parts-4 parts of fruit of Cordia dichotoma Forst. f., 0.5 part-2 parts in Radix Glycyrrhizae, 1 part-3 parts of Semen althaeae roseae, 1 part-2 parts of Radix Et Rhizoma Rhei, 1 part of-3 parts of medical material of Pericarpium Papaveris; At first Herba Menthae, Rhizoma Kaempferiae, Flos Matricariae chamomillae three flavor medicines are placed in the extraction pot, add 6-12 times of water gaging and soaked 4 hours, extracted volatile oil 3-8 hour, the aqueous solution after the distillation filters standby, collect volatile oil, per 1 milliliter of volatile oil restrains beta-schardinger dextrin-s with 5, and 30 ℃ of constant temperature stir 1 hour inclusion, and cold preservation is spent the night, sucking filtration, 40 ℃ were descended dry 2-7 hour, porphyrize, and it is standby to cross 120 mesh sieves; Medicinal residues add 6-12 times of water gaging again and decocted 1 hour, filter, and the aqueous solution after filtrate and the distillation merges standby; Again with Fructus Jujubae, Radix Glycyrrhizae, Flos nymphaeae (Nymphaea teragona Georgi), fruit of Cordia dichotoma Forst. f., another name for Sichuan Province Cai Zi, Radix Et Rhizoma Rhei, Pericarpium Papaveris seven flavor medicine material adds 4-8 times of water gaging and decocts 3 times, each 1 hour, collecting decoction, filter, filtrate merges in reserve liquid, concentrating under reduced pressure adds ethanol and makes and contain the alcohol amount and reach 50%, leaves standstill 24 hours, filter, it is 1.20-1.25 that filtrate decompression is concentrated into relative density, and concentrated solution spray drying method for preparation extract powder adds after clathrate with beta-schardinger dextrin-inclusion volatile oil is mixed, add 1: 1 adjuvant of 15% microcrystalline Cellulose starch, granulate 45 ℃ of cold drying, granulate, adding micropowder silica gel is mixed, for pale brown color to brown granule, the fill capsule can obtain gas perfume (or spice), the cold relief capsule of mildly bitter flavor; This medicine is used for treatment flu and influenza.
CN 02148340 2002-11-08 2002-11-08 Capsule for treating coryza and its preparation method Expired - Lifetime CN1254266C (en)

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CN1308004C (en) * 2003-12-31 2007-04-04 中山市恒生药业有限公司 Pepper mint eucalyptus lozenge and its preparation method
CN100337659C (en) * 2005-02-23 2007-09-19 广州固志医药科技开发有限公司 Chinese medicine composition for treating acne and its preparing method
CN101007122B (en) * 2007-01-20 2010-11-17 韩礼 Extraction solution of traditional Chinese medicine for treating common cold and upper respiratory tract diseases and preparation method
CN102526573A (en) * 2011-12-07 2012-07-04 中国科学院新疆理化技术研究所 Medicament for treating child cold
CN105770661A (en) * 2016-03-03 2016-07-20 新疆银朵兰维药股份有限公司 Preparation method for Zukamu granules
CN105816583A (en) * 2016-05-06 2016-08-03 中国科学院新疆理化技术研究所 Compound medicine for treating cold and preparation method thereof

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1308004C (en) * 2003-12-31 2007-04-04 中山市恒生药业有限公司 Pepper mint eucalyptus lozenge and its preparation method
CN100337659C (en) * 2005-02-23 2007-09-19 广州固志医药科技开发有限公司 Chinese medicine composition for treating acne and its preparing method
CN101007122B (en) * 2007-01-20 2010-11-17 韩礼 Extraction solution of traditional Chinese medicine for treating common cold and upper respiratory tract diseases and preparation method
CN102526573A (en) * 2011-12-07 2012-07-04 中国科学院新疆理化技术研究所 Medicament for treating child cold
CN105770661A (en) * 2016-03-03 2016-07-20 新疆银朵兰维药股份有限公司 Preparation method for Zukamu granules
CN105770661B (en) * 2016-03-03 2019-12-27 新疆银朵兰维药股份有限公司 Preparation method of Zukamu granules
CN105816583A (en) * 2016-05-06 2016-08-03 中国科学院新疆理化技术研究所 Compound medicine for treating cold and preparation method thereof
CN105816583B (en) * 2016-05-06 2021-06-15 新疆银朵兰药业股份有限公司 Compound medicine for treating cold and preparation method thereof

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