A kind of Chinese medicine composition of kidney tonifying moistening lung and its preparation method of different dosage forms
Technical field
Embodiments of the present invention are related to Chinese medicine composition field, more specifically, embodiments of the present invention are related to one
The Chinese medicine composition of kind kidney tonifying moistening lung and its preparation method of different dosage forms.
Background technology
Lung is located at thoracic cavity, on barrier film, left and right each one, upper even air flue, is directly communicated with extraneous by mouth and nose, in the five internal organs
Position highest, occupy it is all it is dirty on, have the title of " canopy ", lung being a delicate viscus is suitable to be reduced to, corresponding to cool autumn weather, the major physiological of lung
Function is the breathing of main gas department, and main a surname send out respectful drop, regulating fluid apssage, and kidney be located at human abdominal cavity lumbar spinal column both sides, left and right each one, Tibetan elder generation
It essence, it is the basis of human life, therefore is referred to as " the congenital foundation ", it is store essential substances to answer the main Physiological Function of kidney with winter gas phase, main
Water, main bone give birth to marrow, main to receive gas, main to grow and reproduction.The lung belonging to metal, kidney category water, metal generating water, water can moisten gold, so by lung kidney
Relation is referred to as " mutual generation between metal and water ", also known as " mutually promotion of lung and kidney ".Deficiency of both the lung and kidney refers to that lung kidney two is dirty and see asthenic symptoms, and lung kidney is that mothers and sons are closed
System, two dirty physiology mutually cooperate with, and pathology influences each other, and a dirty weakness can cause another dirty deficiency, cause deficiency of both the lung and kidney, often there is lung kidney
The deficiency of Yin and qi deficiency of lung and kidney are not.Lung-kidney deficiency night sweat hectic fever, dysphoria in chestpalms-soles, soreness and weakness of waist and knees, is passed out semen as primary symptom with coughing;Lung kidney
The deficiency of vital energy is with shortness of breath of coughing, aversion to cold and cold limbs, spontaneous perspiration, impotence, or sees that edema is primary symptom.
Modern medicine think chronic bronchitis be due to infection or non-infective agent cause trachea-bronchial epithelial cell mucous membrane and its
The chronic nonspecific inflammation of surrounding tissue, clinically using the chronic process of the symptoms such as cough, abundant expectoration, shortness of breath and recurrent exerbation as
Feature, it is the common frdquently encountered disease of the elderly, belongs to cough, asthma, the scope of phlegm and retained fluid in motherland's medical science, its primary symptom is:Cough, gas
Asthma, expectoration, the course of disease it is long and repeatedly acute attack and aggravate, fallen ill more in winter-spring season, cough aggravation during breaking-out, amount of expectoration increases, breathed heavily
Rush is not peaceful, and some patients can not even lie down.Cough and expectoration, obvious after being got up especially with daystart, amount of expectoration is also more with early morning.Such as
Belong to chronic asthmatic bronchitis, have wheezing sound often in breaking-out, breathe often aobvious difficulty.Its etiology and pathogenesis is chronic bronchitis
Patient, it is addicted to drink more by daily life, smoking, many factors such as environmental pollution interact for a long time, gradually cause lung insufficiency of the spleen weak, multiple
Feel exopathogen invasion and attack, be induced into disease.Lung governing qi, department's breathing, outer conjunction fur;Insufficiency of lung-QI, defends empty outside, is taken advantage of a weak point in opponent's defence beneficial to six external factors which cause diseases exopathogen
And enter, evil visitor makes lung qi normally to declare drop, therefore cough, the disease of asthma are made then in lung.The spleen has the function to transport and transform nutrients, insufficiency of the spleen then transformation failure of spleen,
Not only diet cereal it is precise and tiny on give day and lack, water is wet also therefore to stop to gather as phlegm and retained fluid, phlegm and retained fluid superinverse, obstructing airway, therefore syndrome characterized by dyspnea abundant expectoration.Kidney
Main to receive gas, the main main gate of vitality's fire of water, then gas does not return root to kidney deficiency, therefore dynamic then shortness of breath;Life fire deficiency, then water lose its system, it is upper it is general be phlegm.
According to card type difference diagnosis and treatment based on an overall analysis of the illness and the patient's condition, showed according to patient's state of an illness, distinguish sample and distinguish prolonged illness and new disease.Follow
The theory of traditional Chinese medical science of " symptomatic treatment in acute condition, radical treatment in chronic case ", general acute attack stage based on taking stopgap measures, or be equipped with Western medicine anti-inflammatory,
Spasmolysis, cough-relieving, eliminating the phlegm etc. are treated;Paracmasis then consolidates treatment with traditional Chinese medicine more based on consolidating, to adjust tonifying lung spleen kidney three dirty
Based on.Chinese patent CN200410053545.5 disclose it is a kind of treat deficiency of both the lung and kidney, deficiency of both vital energy and Yin pharmaceutical composition and its
Preparation method, said composition contains cordyceps sinensis and American Ginseng, and the weight of cordyceps sinensis and American Ginseng ratio is 1: 2~2: 1.The invention medicine
Composition has qi-restoratives damage, strengthening the essence gas, tonifies Qi of the kidney, relieving cough and reducing sputum and other effects, for treat deficiency of both the lung and kidney, deficiency of both vital energy and Yin it
Disease, it is now invalid;Chinese patent CN200510200351.8 discloses a kind of Chinese medicine composition, and said composition is by necessarily comparing
What the ferment cordyceps sinensis powder and ginseng powder of example were mixed.The Chinese medicine composition is for caused by improvement deficiency of both the lung and kidney, deficiency of both vital energy and Yin
Cough, shortness of breath, soreness of waist and knee joint, spiritlessness and weakness, hectic fever, the symptom such as polydipsia has the effect of good.But both Chinese traditional medicine compositions
Thing is not sufficiently effective in terms of relieving cough and asthma, tonifying both YIN and YANG only using cordyceps sinensis powder and American Ginseng as chinese medicine material.
The content of the invention
Instant invention overcomes the deficiencies in the prior art, there is provided the Chinese medicine composition of kidney tonifying moistening lung a kind of and its different dosage forms
The embodiment of preparation method, it is expected can solve the problems, such as that kidney tonifying moistening lung Chinese medicine composition conditioning effect is unilateral.
To solve above-mentioned technical problem, one embodiment of the present invention uses following technical scheme:
A kind of Chinese medicine composition of kidney tonifying moistening lung, it is with 10~30 parts of cordyceps sinensis powder, 10~30 parts of meat deserts by weight
That Rong, 5~15 parts of mushrooms, 5~15 portions of ganoderma lucidums, 5~15 portions of Fructus Cornis, 5~15 parts of tubers of dwarf lilyturf and 10~30 portions of radix polygonati officinalis are prepared into
Granula, oral liquid or suspension oral liquid.
A kind of preparation method of the Chinese medicinal composition granules of kidney tonifying moistening lung, it comprises the following steps:
A, 10~30 parts of cordyceps sinensis powder by weight, 10~30 portions of saline cistanches, 5~15 parts of mushrooms, 5~15 parts of spirits are weighed
Sesame, 5~15 portions of Fructus Cornis, 5~15 parts of tubers of dwarf lilyturf and 10~30 portions of radix polygonati officinalis are as medicinal raw material, with 8 times of medicinal raw material gross weights
Water soaks medicinal raw material 0.5h, and then decocting herbs raw material 1.5h, is filtered while hot, filtrate be concentrated into relative density for 1.25~
1.30 obtain medicinal extract, and medicinal extract then is naturally cooled into room temperature;
B, by medicinal extract obtained by step A with dextrin, Icing Sugar according to weight than 1:0.5:5 are mixed and made into softwood, then by softwood
Particle is made to dry at 80 DEG C, obtains the granule of the Chinese medicine composition of kidney tonifying moistening lung.
Further technical scheme is:The decocting herbs raw material includes decocting twice, decocts 1h for the first time, and second pan-fried
Boil 0.5h;The filtering while hot includes the filtering after the filtering after decocting for the first time decocts with second, mistake after decocting for the first time
The filter gained dregs of a decoction carry out second with the water of 8 times of medicinal raw material gross weights again and decocted;The filtrate is filtered after decocting for the first time
The merging liquid of the filtrate of filtering gained after the filtrate of gained and second of decoction.
Further technical scheme is:The temperature of the concentration is 60 DEG C.
A kind of preparation method of the Chinese medicine composition oral liquid of kidney tonifying moistening lung, it comprises the following steps:
A. 10~30 parts of cordyceps sinensis powder by weight, 10~30 portions of saline cistanches, 5~15 parts of mushrooms, 5~15 parts of spirits are weighed
Sesame, 5~15 portions of Fructus Cornis, 5~15 parts of tubers of dwarf lilyturf and 10~30 portions of radix polygonati officinalis are as medicinal raw material, with 8 times of medicinal raw material gross weights
Water soaks medicinal raw material 0.5h, and then decocting herbs raw material 1.5h, is filtered while hot, filtrate be concentrated into relative density for 1.25~
1.30 obtain medicinal extract, and medicinal extract then is naturally cooled into room temperature;
B. add ethanol into medicinal extract to be precipitated, stirring while adding to alcohol content is 45%~65%, and it is heavy then to stand
8~24h, filtering drop, and gained filtrate recycling ethanol is subsequently added into distilled water and matches somebody with somebody liquid, adjusted with 0.1% potassium sorbate to without alcohol taste
PH is saved to 7.5~8.0, then adds distilled water to enough, it is filling after moist heat sterilization 30 minutes, natural cooling under 110 DEG C, 0.1MPa
The oral liquid of the Chinese medicine composition of kidney tonifying moistening lung is produced afterwards.
Further technical scheme is:The decocting herbs raw material includes decocting twice, decocts 1h for the first time, and second pan-fried
Boil 0.5h;The filtering while hot includes the filtering after the filtering after decocting for the first time decocts with second, mistake after decocting for the first time
The filter gained dregs of a decoction carry out second with the water of 8 times of medicinal raw material gross weights again and decocted;The filtrate is filtered after decocting for the first time
The merging liquid of the filtrate of filtering gained after the filtrate of gained and second of decoction.
Further technical scheme is:The temperature of the concentration is 60 DEG C.
A kind of preparation method of the Chinese medicine composition suspension oral liquid of kidney tonifying moistening lung, it comprises the following steps:
(1) 10~30 parts of cordyceps sinensis powder by weight, 10~30 portions of saline cistanches, 5~15 parts of mushrooms, 5~15 parts of spirits are weighed
Sesame, 5~15 portions of Fructus Cornis, 5~15 parts of tubers of dwarf lilyturf and 10~30 portions of radix polygonati officinalis take the worm of 90%~99% gross weight as medicinal raw material
Grass meal obtains mixture after being mixed with remaining medicinal raw material, with the water of 8 times of total weight of the mixture soak the mixture 0.5~
1h, 1~2h is then decocted, filtrate is standby after filtering and continues the decoction dregs of a decoction with the water of 3~6 times of total weight of the mixture again
0.5~1.5h, continue to filter, merging filtrate, it is 1.15~1.20 to be concentrated under reduced pressure into proportion, and ethanol is added into filtrate and is entered
Row precipitation, it is stirring while adding to alcohol content be 45%~65%, then 8~24h of standing sedimentation, filtering, gained filtrate recovery second
Alcohol obtains medicinal extract to without alcohol taste;
(2) add purified water to carry out glue mill in colloid mill in remaining cordyceps sinensis powder and obtain glue grinding fluid, agar and water heating is molten
Solution obtains agar solution, and the agar accounts for the 0.01%~0.05% of agar solution gross weight;
(3) add appropriate purified water to dissolve the medicinal extract, add the glue grinding fluid and agar solution of step (2), then add honeybee
Honey, potassium sorbate and protein sugar obtain match somebody with somebody liquid, and the honey, potassium sorbate and protein sugar account for the liquid gross weight of matching somebody with somebody respectively
2.0%~4.0%, 0.05%~0.2% and 0.03%, then add fresh purified water to enough, with colloid mill glue mill one after stirring evenly
It is secondary, it is filling immediately, finally sterilized under 0.1MPa pressure, the suspension that natural cooling produces the Chinese medicine composition of kidney tonifying moistening lung is oral
Liquid.
Further technical scheme is:Step (2) the purified water weight is the 20~50 of the remaining cordyceps sinensis powder weight
Times.
Further technical scheme is:The temperature being concentrated under reduced pressure is 60~70 DEG C.
Compared with prior art, one of beneficial effects of the present invention are:The Chinese medicine composition of the present invention is that a kind of auxiliary is controlled
Treatment chronic bronchitis, Chinese medical discrimination belong to the medicine of deficiency of both the lung and kidney, cordyceps sinensis powder both kidney-replenishings, and beneficial lung yin, are tonifying both YIN and YANG
Product;Saline cistanche can strengthen the effect of warming and invigorating kidney Yang;Mushroom, ganoderma lucidum QI invigorating, and ganoderma lucidum has relieving cough and asthma effect;Fructus Corni improves this
Effect of tonifying the kidney and support yang of Chinese medicine composition, and kidney qi can be taken the photograph admittedly;The tuber of dwarf lilyturf, radix polygonati officinalis nourish lung yin;All medicines share, altogether into kidney tonifying
Sun, the effect for supporting lung yin.This composition kidney, lung two are passed through and mended, and are worked in coordination, warm but not dry, and negative and positive are simultaneously adjusted, actually yin-yang deficiency
Preferable adjuvant therapy medicaments.In addition, this Chinese medicine composition is additionally operable to the auxiliary treatment of hyperlipidemia, chronic hepatitis and cancer.And
The Chinese medicine composition of the present invention is to combine modern traditional Chinese medicine theory of development, is gone out from the angle of raising curative effect of medication, reduction side effect
Hair, by carrying out screening preparation made from extraction and/or compatibility to traditional Chinese medicine ingredients, its Small side effects is safe, has chemistry
The advantage that synthetic drug can not compare.
Embodiment
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.
Embodiment 1
The Chinese medicine material of the Chinese medicine composition of kidney tonifying moistening lung is included by weight:10 parts of cordyceps sinensis powder, 30 parts of saline cistanche, perfume
5 parts of mushroom, 5 parts of ganoderma lucidum, 15 parts of Fructus Corni, 15 parts of the tuber of dwarf lilyturf, 20 parts of radix polygonati officinalis.
Said composition can be prepared to as granule, oral liquid and suspension oral liquid.
The preparation of granule:
After weighing above-mentioned Chinese medicine material, water (weight of Chinese medicine material and water ratio is 1: 8) immersion medicine of 800 parts by weight is added
Material 0.5h, then decoct twice, decoct 1h for the first time, gained filtrate is standby after filtering while hot, and the gained dregs of a decoction add 800 weight again
The water of part decocts 0.5h again, filters while hot, merges the filtrate decocted twice, filtrate is concentrated into relative density under the conditions of 60 DEG C
Medicinal extract is obtained for 1.25, medicinal extract is then naturally cooled into room temperature.Medicinal extract and dextrin, Icing Sugar is more mixed than 1: 0.5: 5 according to weight
Softwood is made in conjunction, and softwood then is made into particle, is dried at 80 DEG C, is obtained granule.
The preparation of oral liquid:
After weighing above-mentioned Chinese medicine material, water (weight of Chinese medicine material and water ratio is 1: 8) immersion medicine of 800 parts by weight is added
Material 0.5h, then decoct twice, decoct 1h for the first time, gained filtrate is standby after filtering while hot, and the gained dregs of a decoction add 800 weight again
The water of part decocts 0.5h again, filters while hot, merges the filtrate decocted twice, filtrate is concentrated into relative density under the conditions of 60 DEG C
Medicinal extract is obtained for 1.25, medicinal extract is then naturally cooled into room temperature.Into medicinal extract add ethanol precipitated, it is stirring while adding extremely
Alcohol content is 45%, then standing sedimentation 24h, and filtering, gained filtrate recycling ethanol is subsequently added into distilled water and matched somebody with somebody to without alcohol taste
Liquid, pH is adjusted to 8.0 with 0.1% potassium sorbate, then add distilled water to enough, it is filling to be gone out after damp and hot under 110 DEG C, 0.1MPa
Bacterium 30 minutes, it is oral liquid after natural cooling.
The preparation of suspension oral liquid:
After weighing above-mentioned Chinese medicine material, the cordyceps sinensis powder (i.e. 9 parts) of 90% gross weight is taken to be obtained after being mixed with remaining medicinal raw material
To mixture, mixture 0.5h is soaked with the water of 792 parts by weight (mixture and water weight ratio be 1: 8), then decocts 2h, mistake
Filtrate is standby after filter and with the water of 297 parts by weight, (mixture and water weight ratio are 1 again:3) continue to decoct dregs of a decoction 0.5h, continue
Filtering, merging filtrate, it is 1.15 that it is concentrated under reduced pressure into proportion at 60 DEG C, and ethanol is added into filtrate and is precipitated, Bian Jia
While it is 45% to stir to alcohol content, then standing sedimentation 24h, filtering, gained filtrate recycling ethanol obtain medicinal extract to without alcohol taste.
Add 20 parts of purified waters to carry out glue mill in colloid mill in remaining 1 portion of cordyceps sinensis powder to obtain glue grinding fluid, agar and water are dissolved by heating
Agar solution is obtained, the agar accounts for the 0.01% of agar solution gross weight;Add appropriate purified water to dissolve the medicinal extract, add above
The glue grinding fluid and agar solution of preparation, then add honey, potassium sorbate and protein sugar and obtain and match somebody with somebody liquid, the honey, potassium sorbate
Accounted for respectively with protein sugar it is described match somebody with somebody 2.0%, 0.2% and the 0.03% of liquid gross weight, then add fresh purified water to enough, after stirring evenly
With colloid mill glue mill once, it is filling immediately, finally sterilized under 0.1MPa pressure, natural cooling produces suspension oral liquid.
Embodiment 2
The Chinese medicine material of the Chinese medicine composition of kidney tonifying moistening lung is included by weight:20 parts of cordyceps sinensis powder, 10 parts of saline cistanche, perfume
15 parts of mushroom, 15 parts of ganoderma lucidum, 5 parts of Fructus Corni, 5 parts of the tuber of dwarf lilyturf, 30 parts of radix polygonati officinalis.
Said composition can be prepared to as granule, oral liquid and suspension oral liquid.
The preparation of granule:
After weighing above-mentioned Chinese medicine material, water (weight of Chinese medicine material and water ratio is 1: 8) immersion medicine of 800 parts by weight is added
Material 0.5h, then decoct twice, decoct 1h for the first time, gained filtrate is standby after filtering while hot, and the gained dregs of a decoction add 800 weight again
The water of part decocts 0.5h again, filters while hot, merges the filtrate decocted twice, filtrate is concentrated into relative density under the conditions of 60 DEG C
Medicinal extract is obtained for 1.30, medicinal extract is then naturally cooled into room temperature.Medicinal extract and dextrin, Icing Sugar is more mixed than 1: 0.5: 5 according to weight
Softwood is made in conjunction, and softwood then is made into particle, is dried at 80 DEG C, is obtained granule.
The preparation of oral liquid:
After weighing above-mentioned Chinese medicine material, water (weight of Chinese medicine material and water ratio is 1: 8) immersion medicine of 800 parts by weight is added
Material 0.5h, then decoct twice, decoct 1h for the first time, gained filtrate is standby after filtering while hot, and the gained dregs of a decoction add 800 weight again
The water of part decocts 0.5h again, filters while hot, merges the filtrate decocted twice, filtrate is concentrated into relative density under the conditions of 60 DEG C
Medicinal extract is obtained for 1.30, medicinal extract is then naturally cooled into room temperature.Into medicinal extract add ethanol precipitated, it is stirring while adding extremely
Alcohol content is 65%, then standing sedimentation 8h, and filtering, gained filtrate recycling ethanol extremely without alcohol taste, is subsequently added into distilled water and matches somebody with somebody liquid,
PH is adjusted to 7.5 with 0.1% potassium sorbate, then adds distilled water to enough, it is filling after moist heat sterilization under 110 DEG C, 0.1MPa
30 minutes, be oral liquid after natural cooling.
The preparation of suspension oral liquid:
After weighing above-mentioned Chinese medicine material, the cordyceps sinensis powder (i.e. 18 parts) of 90% gross weight is taken to be obtained after being mixed with remaining medicinal raw material
To mixture, mixture 1h is soaked with the water of 784 parts by weight (mixture and water weight ratio be 1: 8), 1h is then decocted, filters
Filtrate is standby afterwards and with the water of 588 parts by weight, (mixture and water weight ratio are 1 again:6) continue to decoct dregs of a decoction 1.5h, continued
Filter, merging filtrate, it is 1.20 that it is concentrated under reduced pressure into proportion at 70 DEG C, and ethanol is added into filtrate and is precipitated, side edged
Stirring to alcohol content is 65%, then standing sedimentation 8h, filtering, and gained filtrate recycling ethanol obtains medicinal extract to without alcohol taste.Will be surplus
2 parts of remaining cordyceps sinensis powder add 70 parts of purified waters to carry out glue mill acquisition glue grinding fluid in colloid mill, and agar and water are dissolved by heating and obtained
Agar solution, the agar account for the 0.05% of agar solution gross weight;Add appropriate purified water to dissolve the medicinal extract, add prepared above
Glue grinding fluid and agar solution, then add honey, potassium sorbate and protein sugar obtain and match somebody with somebody liquid, the honey, potassium sorbate and egg
White sugar account for respectively it is described match somebody with somebody 4.0%, 0.05% and the 0.03% of liquid gross weight, then add fresh purified water to be used after stirring evenly to enough
Colloid mill glue is ground once, filling immediately, is finally sterilized under 0.1MPa pressure, natural cooling produces suspension oral liquid.
Embodiment 3
The Chinese medicine material of the Chinese medicine composition of kidney tonifying moistening lung is included by weight:20 parts of cordyceps sinensis powder, 20 parts of saline cistanche, perfume
10 parts of mushroom, 10 parts of ganoderma lucidum, 10 parts of Fructus Corni, 10 parts of the tuber of dwarf lilyturf, 20 parts of radix polygonati officinalis.
Said composition can be prepared to as granule, oral liquid and suspension oral liquid.
The preparation of granule:
After weighing above-mentioned Chinese medicine material, water (weight of Chinese medicine material and water ratio is 1: 8) immersion medicine of 800 parts by weight is added
Material 0.5h, then decoct twice, decoct 1h for the first time, gained filtrate is standby after filtering while hot, and the gained dregs of a decoction add 800 weight again
The water of part decocts 0.5h again, filters while hot, merges the filtrate decocted twice, filtrate is concentrated into relative density under the conditions of 60 DEG C
Medicinal extract is obtained for 1.27, medicinal extract is then naturally cooled into room temperature.Medicinal extract and dextrin, Icing Sugar is more mixed than 1: 0.5: 5 according to weight
Softwood is made in conjunction, and softwood then is made into particle, is dried at 80 DEG C, is obtained granule.
The preparation of oral liquid:
After weighing above-mentioned Chinese medicine material, water (weight of Chinese medicine material and water ratio is 1: 8) immersion medicine of 800 parts by weight is added
Material 0.5h, then decoct twice, decoct 1h for the first time, gained filtrate is standby after filtering while hot, and the gained dregs of a decoction add 800 weight again
The water of part decocts 0.5h again, filters while hot, merges the filtrate decocted twice, filtrate is concentrated into relative density under the conditions of 60 DEG C
Medicinal extract is obtained for 1.27, medicinal extract is then naturally cooled into room temperature.Into medicinal extract add ethanol precipitated, it is stirring while adding extremely
Alcohol content is 50%, then standing sedimentation 12h, and filtering, gained filtrate recycling ethanol is subsequently added into distilled water and matched somebody with somebody to without alcohol taste
Liquid, pH is adjusted to 7.5 with 0.1% potassium sorbate, then add distilled water to enough, it is filling to be gone out after damp and hot under 110 DEG C, 0.1MPa
Bacterium 30 minutes, it is oral liquid after natural cooling.
The preparation of suspension oral liquid:
After weighing above-mentioned Chinese medicine material, after taking the cordyceps sinensis powder (i.e. 19.8 parts) of 99% gross weight to be mixed with remaining medicinal raw material
Mixture is obtained, mixture 45min is soaked with the water of 798.4 parts by weight (mixture and water weight ratio be 1: 8), then decocts
1.5h, filtrate is standby after filtering and with the water of 499 parts by weight, (mixture and water weight ratio are 1 again:5) continue to decoct the dregs of a decoction
1h, continue to filter, merging filtrate, it is 1.20 that it is concentrated under reduced pressure into proportion at 65 DEG C, and ethanol is added into filtrate and is sunk
Form sediment, stirring while adding to alcohol content is 50%, and then standing sedimentation 12h, filtering, gained filtrate recycling ethanol obtains to without alcohol taste
To medicinal extract.Add 25 parts of purified waters to carry out glue mill in colloid mill in remaining 0.2 portion of cordyceps sinensis powder and obtain glue grinding fluid, by agar and water
Dissolve by heating and obtain agar solution, the agar accounts for the 0.03% of agar solution gross weight;Appropriate purified water is added to dissolve the medicinal extract,
Glue grinding fluid prepared above and agar solution are added, honey, potassium sorbate and protein sugar is then added and obtains and match somebody with somebody liquid, the honey,
Potassium sorbate and protein sugar match somebody with somebody 3.0%, 0.1% and the 0.03% of liquid gross weight described in accounting for respectively, then add fresh purified water to foot
Amount, it is after stirring evenly with colloid mill glue mill once, filling immediately, finally sterilized under 0.1MPa pressure, natural cooling produces suspension mouth
Take liquid.
Embodiment 4
The Chinese medicine material of the Chinese medicine composition of kidney tonifying moistening lung is included by weight:30 parts of cordyceps sinensis powder, 20 parts of saline cistanche, perfume
10 parts of mushroom, 10 parts of ganoderma lucidum, 10 parts of Fructus Corni, 10 parts of the tuber of dwarf lilyturf, 10 parts of radix polygonati officinalis.
The preparation method of oral liquid and granule is same as Example 3.
The preparation of suspension oral liquid:
After weighing above-mentioned Chinese medicine material, after taking the cordyceps sinensis powder (i.e. 28.5 parts) of 95% gross weight to be mixed with remaining medicinal raw material
Mixture is obtained, mixture 45min is soaked with the water of 788 parts by weight (mixture and water weight ratio be 1: 8), then decocts
1.5h, filtrate is standby after filtering and with the water of 492.5 parts by weight, (mixture and water weight ratio are 1 again:5) continue to decoct the dregs of a decoction
1h, continue to filter, merging filtrate, it is 1.20 that it is concentrated under reduced pressure into proportion at 65 DEG C, and ethanol is added into filtrate and is sunk
Form sediment, stirring while adding to alcohol content is 50%, and then standing sedimentation 12h, filtering, gained filtrate recycling ethanol obtains to without alcohol taste
To medicinal extract.By remaining 1.5 portions of cordyceps sinensis powder add 52.5 parts of purified waters carried out in colloid mill glue mill obtain glue grinding fluid, by agar with
Water, which dissolves by heating, obtains agar solution, and the agar accounts for the 0.03% of agar solution gross weight;The medicinal extract is added purify in right amount it is water-soluble
Solution, adds glue grinding fluid prepared above and agar solution, then adds honey, potassium sorbate and protein sugar and obtains and matches somebody with somebody liquid, the honeybee
Honey, potassium sorbate and protein sugar match somebody with somebody 3.0%, 0.1% and the 0.03% of liquid gross weight described in accounting for respectively, then add fresh purified water extremely
It is enough, it is after stirring evenly with colloid mill glue mill once, filling immediately, finally sterilized under 0.1MPa pressure, natural cooling produces suspension
Oral liquid.
The experiment of influence of the Chinese medicine composition of different dosage forms of the present invention to mouse stress ability is studied to evaluate this combination
The effect of thing " kidney-replenishing ".
Experiment material:Using granule (code name A), oral liquid (code name B), suspension oral liquid obtained by preparation method of the present invention
(code name C), it is 3.62g/ml containing crude drug amount, is configured to 300g/L, 600g/L suspensions with distilled water during experiment;Animal NIH
Healthy mice (is provided) by animal housing of Academy of Medical Sciences institute of oncology, 20~22g of body weight, male and female dual-purpose.
Experiment one, antifatigue experiment
Mouse is taken, is randomly divided into blank control group, the high low dose group of A, B, C, every group 12, gastric infusion, control group is given
Isometric distilled water, once a day, continuous 6 times, swum after mouse is born a heavy burden within 40 minutes after last dose.Depth of water 20cm, water
25 ± 0.5 DEG C of temperature, bears a heavy burden for body weight 10%.Record mouse sinks to the bottom the time, examines or check animal endurance.Each DBMS t is examined, and is as a result seen
Table 1-1.
Table this composition of 1-1 different process prepares the influence to mouse swimming time
Note:The * P compared with distilled water group<0.05 **P<0.01.
Table 1-1 shows, takes the animal swimming time of the Chinese medicine composition of different dosage forms prepared by preparation method of the present invention
Extend compared with distilled water group, illustrate that present composition preparation has antifatigue effect, wherein present composition suspension extends
Mouse weight carrying swimming is most long, compared with distilled water group, P<0.01.
Experiment two, cold-resistant experiment
The packet of animal and the same experiment one of medication, every group 18.40 minutes after last dose, mouse is put into special
Wire mesh cage in, per one, cage, be put into -0.5 DEG C of refrigerator.Mouse is taken out after 2 hours, counts the survival of each group mouse
Number, percentage survival is calculated, using chi-square criterion, the results are shown in Table 1-2.
The influence that table 1-2 this composition different dosage forms techniques are acted on hardy
Group |
Number of animals (n) |
Dosage (g/kg) |
Existence number (only) |
Survival rate (%) |
Distilled water group |
18 |
-- |
4 |
23.8 |
A |
18 |
6.12 |
14 |
61.1* |
A |
18 |
12.32 |
15 |
55.5* |
B |
18 |
6.12 |
11 |
44.4* |
B |
18 |
12.32 |
10 |
44.4* |
C |
18 |
6.12 |
8 |
77.8*** |
C |
18 |
12.32 |
8 |
83.3*** |
Note:The * P compared with distilled water group<0.05 **P<0.01 ***P<0.001.
Table 1-2 shows, take the animal of the Chinese medicine composition of different dosage forms prepared by preparation method of the present invention can improve it is small
Survival rate of the mouse under cold state, illustrate that present composition preparation has the function that cold resistance, wherein suspension strengthens small
Mouse cold tolerance is most strong, mouse survival rate highest, compared with distilled water group, P<0.001, and remaining is organized compared with distilled water group, P
<0.01。
Experiment three, anoxia tolerance experiment
Animal packet and medication every group 8, after last dose after 40 minutes, are put into experiment one and fill 15g sodium stones
In the port grinding bottle of ash, port grinding bottle painting vaseline, when record envelope bottleneck to mouse breathing stops the time of (dead index) to survive
Between, examined using t, the results are shown in Table 1-3.
Influence of table 1-3 this composition different dosage forms techniques to mouse resist oxygen lack endurance
Note:The * P compared with distilled water group<0.05**P<0.01.
Table 1-3 illustrates that the resistance to of mouse can be improved by taking the Chinese medicine composition of different dosage forms prepared by preparation method of the present invention
Hypoxia ability, and suspension type oral liquid high dose group enhancing mouse hypoxia-bearing capability is optimal, the mouse survival time is most long, with distillation
Water group compares P<0.01.
One is tested to the conclusion for testing three:The Chinese medicine composition of the different dosage forms prepared using preparation method of the present invention is had
Preferable anti-stress effect, wherein, suspension type oral liquid extends mouse swimming time, strengthens cold tolerance, improves resist oxygen lack energy
Power is more excellent.
Embodiment 5
The suspension oral liquid prepared using preparation method of the present invention is mainly used in chronic bronchitis, hyperlipidemia, acute
The auxiliary treatment of the diseases such as hepatitis.We have carried out reducing blood lipid, the improvement to Acute Liver Injury Induced by carbon tetrachloride to the medicine, have resisted and answer
Swash (see before), Immune-enhancing effect, cough-relieving, relieving asthma, many research such as resolving sputum, be as a result reported as follows:
First, the cough-relieving of suspension oral liquid, relieving asthma, the pharmacodynamic study of resolving sputum
Experiment material is as follows:
Medicine:Suspension oral liquid (1 gram every milliliter):It is preclinical to be configured to three kinds of 10.8%, 21.6%, 43.2% administrations
Concentration.
Instrument and reagent:721 spectrophotometers (Shanghai the second analytical instrument factory);UN-8 types ultrasonic atomizer (Guangdong Shan
Head photoelectricity research institute);DC-001 type isolated organs analyzer (Nanjing analytical instrument factory);Phenol red (Solution on Chemical Reagents in Shanghai dispenses factory,
Lot number 861026);Sodium thiosulfate (Nanjing chemical reagent factory, lot number 880302);Hydrochloric acid (Xu Du chemical plant, lot number
881103);Histamine phosphate (Shanghai biochemical research institute, lot number 771158);Acetylcholine bromide (factory of Shanghai reagent three, batch
Number 930226).
Animal:NIH small white mouse 18-22g, cavy 150-200g, Institute for Atomic Research of Jiangsu Province Experimental Animal Center provide,
The quality certification:Su Wei rings 91038.
Test (one) cough-relieving experiment
Healthy mice 40 is taken, male and female half and half, respectively 4 groups, every group 10, suspension oral liquid of the present invention is basic, normal, high by three
2.71g/kg, 5.42g/kg and 10.48g/kg (equivalent to the 25ml/kg of corresponding concentration) is administered in dosage respectively, and control group is given
Small white mouse once, continuous three days, is placed in 2L driers by the daily gavages of physiological saline 25ml/kg for 1 hour after last dose, leads to
Enter the SO that generation is fully reacted by 1M5ml hydrochloric acid and 0.5g sodium thiosulfate2Gas, record the cough latent period and 2 of small white mouse
The cough number of minute, the results are shown in Table 2-1.
The antitussive effect (X ± SD) of table 2-1 suspension oral liquids
Note:The * P compared with physiological saline group<0.05 **P<0.01.
From table 2-1, the oral liquid energy of present invention suspension is obviously prolonged the cough latent period of small white mouse, substantially reduces certain
Cough number in time, effect are proportionate with dosage.
Test (two) resolving sputum experiment
Healthy mice 40 is taken, male and female dual-purpose, respectively 4 groups, every group 10, basic, normal, high three dosage of suspension oral liquid divides
2.71g/kg is not given, and 5.42g/kg, 10.84g/kg (equivalent to the 25ml/kg of corresponding concentration), control group gives physiological saline
25ml/kg, daily gavage once, continuous three days, last dose after 30 minutes every mice by intraperitoneal injection 0.25% it is phenol red molten
Liquid 0.7ml, small white mouse was put to death after 30 minutes, separate tracheae, No. 7 syringe needles of insertion are with 5%NaHCO3Solution rinses tracheae 3 times,
Merge washing lotion, supernatant colorimetric at 540nm is taken after centrifugation, is compareed with the phenol red colour tube of standard, obtain phenol red dense in washing lotion
Spend, as a result table 2-2.
The Eradicates phlegm effect of table 2-2 suspensions
Note:The * P compared with physiological saline group<0.05 **P<0.01.
From table 2-2, the middle and high dosage group of suspension oral liquid of the present invention has used in obvious eliminating the phlegm, but small dose
Amount group unknown significance difference.
The overall experiment of relievining asthma of experiment (three)
Take 150-200g healthy guinea pigs 40, male and female dual-purpose, respectively 4 groups, every group 10, composition suspension oral liquid is low,
Middle and high dosage group gives 1.62g/kg, 3.24g/kg respectively;With 6.48g/kg (equivalent to corresponding concentration 15m1/kg), daily one
It is secondary, continuously three times, cavy was placed in 2ml drier in 1 hour after last dose, 0.1% phosphorus is sprayed into ultrasonic atomizer
Sour histamine and 2% bromination ethamine choline isometric(al) mixed liquor 15 seconds, the time that record cavy is had a convulsion, it the results are shown in Table 2-
3。
The antiasthmatic effect (X ± SD) of table 2-3 suspensions
Group |
Number of animals (n) |
Dosage (g/kg) |
Asthmatic latent period (s) |
Physiological saline group |
10 |
15ml/kg |
56.3±3.8 |
Suspension oral liquid 1 |
10 |
2.71 |
61±14* |
Suspension oral liquid 2 |
10 |
5.42 |
71.4±4.9** |
Suspension oral liquid 3 |
10 |
10.84 |
77.5±5.1** |
Note:The * P compared with physiological saline group<0.05 **P<0.01
From table 2-3, suspension oral liquid of the present invention has to guinea pig experimental asthma caused by histamine and acetylcholine
Obvious inhibitory action.
Test (four) isolated tissue experiment
Take 250~350g of body weight cavys 10, tapped the head with waddy lethal, immediately by outside of belly midsection neck skin and
Hypodermis separates tracheae, is all cut, is put into the culture dish for filling nutrient solution from thyroid cartilage, wiped out and around tie
Tissue is formed, tracheae is cut into strip-spiral from one end to the other end, a spiral bar is cut into per 2--3 cartilaginous ring, is fixed on and contains
Have in the maxwell bath ware of 10ml nutrient solutions, lead to oxygen, maintain 37 DEG C ± 0.5 DEG C of bath temperature, make tracheal strip heavy burden 5g, treat that baseline is put down
It is administered after steady.
In normal state, 100% composition suspension 0.lml, 0.2m1 are added into maxwell bath ware respectively,
There is slow and lasting diastole in 0.3m1, tracheae, and the diastole duration is respectively (X scholar SD) (min):52.6 soil 13.4,
65.7 ± 17.3, and the diastole degree of 93.1 scholar 24.5 is directly proportional to drug concentration in maxwell bath ware.Add physiological saline and have no it
Diastole acts on, and illustrates that this product has relexation to bronchial smooth muscle.
In normal state, the μ g/ml of acetylcholine 3 are added or the μ g/ml of histamine phosphate 1, tracheal strip shrinks rapidly, shunk
To at utmost when to being separately added into 100% composition suspension oral liquid suspension 0.1ml, 0.2ml, 0.3ml, tracheal strip is stood
That is diastole, the diastole amplitude of 30 minutes respectively reach (%) 56.0 ± 8.9,63.49 ± 2 and 66.2 of acetylcholine shrinkage amplitude
±11.5.Add physiological saline and have no effect, illustrate this product to because m receptor is excited and the tracheal smooth muscle of spasm have it is significantly easypro
Zhang Zuoyong.
(1) is tested to the conclusion for testing (four):Present composition suspension oral liquid suspension have certain cough-relieving,
Resolving sputum, relieving asthma and the relaxation effect to isolated tracheal, action intensity and concentration are into positive correlation.
2nd, the pharmacodynamic study of the lipid-loweringing of suspension oral liquid, anti-liver injury, resisting stress and immunological enhancement
Test the influence of (1) to rat hyperlipemia
Experiment material is as follows:
Medicine:Suspension oral liquid medicinal extract of the present invention, per 1ml 3.27g containing crude drug.
Instrument and reagent:Cholesterol, imported from Holland, the packing of Guangzhou Medical Depot chemical reagents corporation, lot number:920818;Go
Oxycholic acid sodium, U.S.'s SERVA Products, lot number:910710;Propylthiouracil, Guangzhou bridge pharmaceutical factory product, lot number:
920314;High lipoprotein emulsion composition, cholesterol 16g, deoxysodium cholate 2g, propylthiouracil 0.8g, lard 90g.
The type automatic clinical chemistry analyzer of U.S. CORNING 550, measure reagent are Australia TRACE Products.
Animal:SD systems rat, provided by Department of Health of Guangdong Province medical experimental animal field, quality certification number:93021;Body weight
180g~200g, male.
Experimental method:Rat hyperlipemia model moulding, takes rat, is randomly divided into normal group, model group, and the present invention is suspended
Oral liquid high and low dose group.Gastric infusion, once 6 hours model groups gave high lipoprotein emulsion (courage were solid after administration the daily morning
Emulsion is made in alcohol 16g, deoxysodium cholate 2g, third class thiouracil 0.8g, lard 90g, co-ground) 10ml/Kg, normal group gives
Isometric(al) distilled water is given, continuous 21 days, the 22nd day (after fasting 12 hours), orbital venous plexus took blood, serum was separated, with U.S.'s health
The content of peaceful 550 type automatic clinical chemistry analyzer measure serum total cholesterol and triglyceride, the results are shown in Table 2-4.
Influence of the table 2-4 present composition suspension oral liquids to serum lipids in rats
Note:The * P compared with normal group<0.05 **<0.01, the △ P compared with model group<0.05 △△<0.01.
As a result it is as shown in the table, and with after a large amount of high lipoprotein emulsion moulding, serum total cholesterol and triglycerides substantially rise model group
Height, the P compared with normal group<0.01, illustrate that model is successfully established.This composition suspension oral liquid low dosage is to T-CHOL and sweet
Oily three esters influence unobvious, and high dose has some improvement to serum total cholesterol and triglycerides, the P compared with model group
<0.05。
Test the conclusion of (1):30 times of successive administrations of suspension oral liquid plan clinical dosage 21 days, to caused by high lipoprotein emulsion
The rise of rat blood serum T-CHOL and triglycerides has some improvement, and low dosage (5 times of plan clinical dosage
Amount) to unobvious.
Test the influence of (2) to carbon tetrachloride induced mice acute liver damage
Experiment material is as follows:
Medicine:Suspension oral liquid suspension medicinal extract of the present invention, 3.27g/ml containing crude drug amount, during gavage with 5% Arab
Gum-solution is made into required concentration.
Reagent:Carbon tetrachloride (analysis is pure):Import dispenses, the packing of Guangzhou Medical Depot chemical reagents corporation, lot number:
930519:Glutamic-pyruvic transaminase kit, Chongqing east chemical reagent work product, lot number:940519
Animal:NIH systems mouse, provided by Department of Health of Guangdong Province experimental animal field, quality certification number:93022, body weight 20-
22g, male and female half and half.
Experimental method:Mouse is taken, is randomly divided into blank group, model group and the high, medium and low dosage of suspension oral liquid of the present invention
Group, every group of 10-11 only, gastric infusion (normal group and model group to isometric 5% my Ah 's gum-solution), daily one
It is secondary, continuous three days, 5 hours, the carbon tetrachloride peanut oil solution 10ml/kg of each group mouse peritoneal injection 0.1% after administration in the 3rd day,
Once, (injection carbon tetrachloride 36 hours) fasting in the 5th day 12 hours, orbital venous plexus takes for 4th the sky, each continuous gavage in afternoon
Blood, serum is separated, serum glutamic pyruvic transminase is determined by Lai Shi.Mouse is put to death after taking blood, it is appropriate to liver, routinely carry out tissue
Section, the pathological change situation of more each liver of microscopy.As a result as shown in table 2-5, table 2-6.
Influences of the table 2-5 to carbon tetrachloride induced mice acute liver damage serum glutamic pyruvic transminase
Note:The * P compared with model group<0.05 **P<0.01, the △ P compared with model group<0.05.
Table 2-5 shows, mouse after carbon tetrachloride moulding, serum glutamic pyruvic transminase it is significantly raised (compared with normal group, P<
0.01), illustrate that model is established.Rise of the suspension oral liquid high dose of the present invention to serum glutamic pyruvic transminase activity has reduction effect
(P<0.05)。
Influences of the table 2-6 to Acute Liver Injury Induced by carbon tetrachloride Mouse Liver pathological change
Note:Pathological change degree evaluation standard.
"-" is shown normally;"+" shows that lesion is confined to the 1/3 of lobuli hepatis;
" ++ " shows that lesion is confined between the 1/3-2/3 of lobuli hepatis;
" +++ " shows lesion more than the 2/3 of lobuli hepatis.
Table 2-6 shows, after model group mouse peritoneal injection carbon tetrachloride, different degrees of pathological change, liver occurs in liver
Cell cloudy swelling is denatured, steatosis, downright bad and hepatic parenchymal cell infiltration.Suspension oral liquid heavy dose of the present invention is to liver cell
Cloudy swelling denaturation, steatosis, necrosis and cell infiltration have a mitigation effect, it is low dose of then only to liver cell it is downright bad and scorching carefully
Born of the same parents' is impregnated with mitigation effect.
Test the conclusion of (2):Suspension oral liquid heavy dose 21.68g/kg gastric infusions of the present invention, to anxious caused by chlorination carbon
Property liver harm mouse serum glutamic pyruvic transminase activity rise have inhibitory action, it is cloudy swelling denaturation, steatosis to liver cell, bad
Dead and liver parenchyma cell infiltration has improvement result;Pathology of the middle dosage 10.84g/kg and low dose of 2.71g/kg to liver
Change also has slight improvement result, therefore this composition suspension oral liquid has certain liver protection effect.
Test (3) immunological enhancement
Experiment material is as follows:
Medicine:Suspension oral liquid medicinal extract of the present invention, it is 3.27g/ml containing crude drug amount, with distilled water diluting into three before experiment
Concentration (108mg/ml, 216mg/ml, 432mg/ml);Endoxan, Shanghai No.12 Pharmaceutical Factory's product, matched somebody with somebody with preceding distilled water
Into 1mg/ml;Levamisole hydrochloride, guilin pharmacy factory, 1mg/ml is made into distilled water with preceding.
Instrument:721 spectrophotometers, Shanghai analytical instrument factory.
Animal:NIH mouse inbred lines, Guangdong Province medical experimental animal field provide, quality certification number:93022, body weight 20-22g,
Male and female half and half.
Experimental method:1. the influence to normal mouse boosting cell haemolysis OD values;Mouse is taken, is randomly divided into normal control
Group, levamisol group and the high, medium and low dosage group of suspension oral liquid of the present invention, every group 12, gastric infusion, in experiment the 6th day
Mianyang red blood cell (SRBC) 0.4ml/ to each group mouse peritoneal injection 5% is only (equivalent to 4*108SRBC/), the 11st day eye
Ball takes blood, draws neck to put to death animal, takes spleen that splenocyte suspension is made, splenocyte is washed twice with cold Gey liquid, and adjustment cell number is
5*106/ml.Often pipe adds splenocyte suspension 1ml, 1%SRBC 1ml and 1:20 fresh guinea pig complements (through SRBC) absorb) 1ml
Fully mix, put 37 DEG C of water-baths 1 hour, supernatant, is drawn at centrifugation with stopped reaction per Guan Jialeng Gey test solutions 3ml after taking-up
Liquid reads optical density (OD) value at 721 type spectrophotometer 413nm.It the results are shown in Table 2-7
Influence of the table 2-7 suspension oral liquids of the present invention to normal mouse boosting cell haemolysis OD values
Note:Compared with normal group, * P>0.05.
Table 2-7 illustrates, nothing is substantially with normal group compared with for the haemolysis OD values of the high, medium and low dosage group of suspension oral liquid of the present invention
Difference (P>0.05), illustrate this composition suspension oral liquids of these three dosage to normal mouse boosting cell antibody tormation without obvious
Influence.
2. the influence to suppressed mouse boosting cell haemolysis OD values are immunized:Mouse is taken, is randomly divided into Normal group, ring phosphinylidyne
Amine+high, medium and low the dosage group of suspension of the present invention oral liquid, every group 12, gastric infusion, mouse peritoneal injection is given within the 8th day in experiment
Endoxan 10mg/kg, remaining the results are shown in Table 2-8 with 1 operation
Influence of table 2-8 this composition suspension oral liquids to immune suppressed mouse boosting cell haemolysis OD values
Note:Compared with endoxan group, * * P<0.01.
Table 2-8 illustrates, the haemolysis OD values of ring+middle and high low dose group of suspension of the present invention oral liquid respectively with endoxan group
Compare P<0.01, the P compared with normal group>0.05, illustrate high dose suspension oral liquid of the present invention have obvious enhancing immune by
Press down mouse boosting cell and produce the effect of antibody, and can be allowed to close to normal level.Effect no significant difference (the P of middle and high dosage>
0.05), low dosage has no significant effect to this index.
3. the influence to normal mouse peripheral blood ANAE (+) lymphocyte percentage:Mouse is taken, is randomly divided into normal control
Group and the high, medium and low dosage group of present composition suspension oral liquid, every group 12, gastric infusion, in experiment the 11st day, take small
Rat-tail portion blood film, rapid 37 DEG C of drying immersion educate liquid and (are proportionally added into six azos with M/15pH7.6 phosphate buffers, magenta
Liquid and 2% α-acetic acid naphthalene solution, 6.4) final pH, which should be, takes out slide water flushing sediment after 3 hours, filter paper blots;Use again
1% peacock green is redyed the 5-10 seconds, is washed, drying, oil mirror inspection.A Blood piece is checked per mouse, 100 lymphs is counted, tries to achieve
ANAE (+) T lymphocyte percentages.It the results are shown in Table 2-9.
The influence of table 2-9 suspension Oral Liquid On Mice peripheral blood ANAE (+) lymphocyte percentages of the present invention
Note:Compared with normal group, * P>0.05.
Table 2-9 illustrate, ANAW (+) lymphocyte percentage of high, medium and low three dosage groups of suspension oral liquid of the present invention with
Normal group compares P>0.05, this composition suspension oral liquid is prompted to normal mouse peripheral blood ANAE (+) lymphocyte percentage
Have no significant effect, the levamisol as positive control drug is also without obvious effect.
4. the influence to suppressed mouse peripheral blood ANAE (+) lymphocyte percentage is immunized;Mouse is taken, is randomly divided into normal
Control group, the high, medium and low dosage group of suspension oral liquid (low dosage 2.71g/kg, middle dosage 5.42g/kg, high dose of the present invention
10.84g/kg), gastric infusion, once a day, continuous 10 days, mouse peritoneal injection endoxan 10mg/ is given within the 8th day in experiment
ml;In experiment the 10th day, mouse tail blood film is taken, rapid 37 DEG C of drying immersion is educated liquid and (pressed with M/15pH7.6 phosphate buffers
Ratio add six azos, pinkish red liquid and 2% α-acetic acid naphthalene solution, final pH should be 6.4) after 3 hours take out slide rinsed with water
Sediment, filter paper blot;Redyed the 5-10 seconds, washed with 1% peacock green again, drying, oil mirror inspection.A Blood piece, meter are checked per mouse
100 lymphs of number, try to achieve ANAE (+) T lymphocyte percentages, the results are shown in Table 2-10.
Shadow of the table 2-10 suspension oral liquids of the present invention to immune suppressed mouse peripheral blood ANAE (+) lymphocyte percentage
Ring
Note:Compared with endoxan group, * * P<0.01.
Table 2-10 explanations, ring+suspension oral liquid (i.e. endoxan+suspension of the present invention oral liquid) middle and high dosage group
ANAE (+) lymphocyte percentage P compared with endoxan group<0.01;The P compared with normal group respectively again>0.05, in prompting,
The suspension oral liquid of the present invention of high dose, which has, is remarkably reinforced immune suppressed mouse peripheral blood ANAE (+) lymphocyte percentage
Effect, and can be allowed to close to normal level.The effect no significant difference P of middle and high dosage>0.05, low dosage is to this index without bright
Development rings.
Test the conclusion of (3):The middle and high dosage of suspension oral liquid of the present invention is remarkably reinforced immune suppressed mouse boosting cell
Produce antibody and improve the effect of periphery blood T lymphocyte percentage, inhibitory action of the cycli phosphate amine to immunocyte can be prevented,
To improve humoral immunity and Immunomodulating effects in low state.And it can be allowed to show its immune increasing close to normal level
Strong and Immunomodulating effects.Middle and high dosage has no significant effect to normal mouse.The above results are prompted, and the present invention is suspended oral
The Immune-enhancing effect and Immunomodulating effects of liquid and the immune functional state residing for body are closely related, with theory of traditional Chinese medical science on " empty
Person mends it, damage person's benefit " viewpoint match.Low dosage suspension oral liquid of the present invention is to normal and immune suppressed mouse without bright
Aobvious effect.
Levamisol is the immunopotentiator of affirmative, and this experiment is using it as positive control drug.Result of the test shows the present invention
Suspension oral liquid has the humoral immunity and cellular immune function for being remarkably reinforced immune suppressed mouse, produces and can be allowed to close to normal water
It is flat, normal mouse is then had no significant effect.These results are consistent with the rabbit epidemic disease pharmacological action feature of levamisol.
3rd, toxicologic study
1. acute toxicity mouse by 0.4ml/10g/ days (equivalent to crude drug amount 30g/kg) continuous servo, observe 1 week, be no different
Normal death condition, LD50, or LD50 are not measured>130g/kg (clinical recommend dosage 150 times of 70kg adults), the MTD measured exists
Between 500~800 times of the clinical recommendation dosage of 70kg adults, illustrate that this product is safe, toxicity is extremely low.
2. long term toxicity this product presses low dosage 10g/kg, high dose 60g/kg had no animal to the continuous servo of rat 90 days
There is the toxicity change of outward appearance, appetite, body weight increase, blood routine, hepatic and renal function and organs and tissues.
Although reference be made herein to invention has been described for multiple explanatory embodiments of the invention, however, it is to be understood that
Those skilled in the art can be designed that a lot of other modifications and embodiment, and these modifications and embodiment will fall in this Shen
Please be within disclosed spirit and spirit.More specifically, can be to master in the range of disclosure and claim
The building block and/or layout for inscribing composite configuration carry out a variety of variations and modifications.Except what is carried out to building block and/or layout
Outside variations and modifications, to those skilled in the art, other purposes also will be apparent.