CN105396109A - Traditional Chinese medicine preparation used for treating lung channel stasis heat-type allergic rhinitis - Google Patents
Traditional Chinese medicine preparation used for treating lung channel stasis heat-type allergic rhinitis Download PDFInfo
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- A61K36/185—Magnoliopsida (dicotyledons)
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Abstract
The invention provides a traditional Chinese medicine preparation used for treating lung channel stasis heat-type allergic rhinitis. The traditional Chinese medicine preparation comprises following bulk pharmaceutical chemicals: processed radix aconiti carmichaeli, cortex cinnamomi, radix morindae officinalis, herba cistanche, semen trigonellae, testudinis Carapacis et Plastri Colla, fried cortex eucommiae, semen cuscutae, stir-baked rhizoma dioscoreae, herba centipedae, quartz, fried fructus xanthii, radix angelicae, herba asari, herba schizonepetae, roasted herba ephedra, honey-fried licorice root, herba lycopi, fructus schisandrae chinensis, fresh ginger, radix saposhnikoviae, beesia calthaefolia, lysimachia grammica hance, and henbit deadnettle. The traditional Chinese medicine preparation is capable of improving symptoms of patients effectively, possesses no obvious toxic or side effect, and is capable of reducing recurrence rate of patients; comprehensive therapeutic effect of the traditional Chinese medicine preparation is better than that of positive control Western medicines and traditional Chinese medicines; and the advantages of the traditional Chinese medicine preparation are displayed fully.
Description
Technical field
The present invention relates to technical field of Chinese medicine, particularly relate to a kind of Chinese medicine preparation for the treatment of lung meridian stagnated heat type allergic rhinitis.
Background technology
Allergic rhinitis is equivalent to allergic rhinitis or the allergic rhinitis with sneezing of motherland's medical science also known as allergic rhinitis (allergicrhinitis).Being the allergic disease occurring in nasal mucosa, is also the common form of expression of allergic airway disease.With paroxysmal nasal obstruction, rhinocnesmus, sneeze, a large amount of thin nasal discharge of stream for main symptom, Shi Bi section commonly encountered diseases, frequently-occurring disease.What its outbreak was serious have impact on daily life and work.The features such as this disease has easily repeatedly, refractory is healed, if treatment not in time or method for the treatment of improper, can badly influence the quality of life of patient, the time-out of respiratory function when can occur time serious sleeping, this is a kind of stiff reaction blocking BITONG gas due to nasal mucous membranes edema and cause.For the allergic rhinitis of child, current western medical treatment only has by whole body or topical with the symptom palliated a disease, but when again running into this sick inducement and stimulating, the normal recurrent exerbation of primary disease, therefore from more later analysis, this disease is not well controlled.Therefore, the common concern of numerous medical personnel and society is caused for the treatment of primary disease and pre-Radix Stephaniae Tetrandrae.Although treatment by Chinese herbs allergic rhinitis is relatively long for the course for the treatment of, it is evident in efficacy, lasting, and side effect is low, in addition also greatly can reduce this sick relapse rate, therefore extensive patients is progressively accepting and approving this disease for the treatment of by Chinese herbs.
Lung opening at nose, therefore, the morbidity of allergic rhinitis and the function of lung have and directly contact, the living standard of modern people is become better and better, the diet of high heat, unsound living habit, as smoking, drink, Emotional disorder, particularly haze weather is multiple in recent years, ferritic is the excess of YANG originally, feel again exopathogen again from inner heat-transformation, cause lung meridian hot and suffocating, and then cause allergic rhinitis, Western medicine only has symptomatic treatment for the treatment of primary disease, there is no the concept of traditional Chinese medical science what is called card, therefore therapeutic effect can only improve symptom often, disease cannot be eradicated, therefore, increasing Chinese prescription is applied at clinical treatment primary disease.Chinese medicine preparation of the present invention, being exactly on the basis of clinical experience side, by simplifying medicine, removing and the medicine of toxic and side effects, remove quality not easily the medicine of control, after theory analysis research, the Chinese medicinal formulae drawn, is confirmed by relevant clinical research, experimentation and toxicological study, invention formulation has good curative effect, and have no side effect, therefore clinical expansion invention formulation, contributes to the thorough healing of primary disease.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of clinical manifestation according to lung meridian stagnated heat type allergic rhinitis, suit the remedy to the case for this pattern of syndrome, the side's of setting up medicine, find in clinical studies, it effectively can improve patients symptomatic, without obvious toxic-side effects, reduces the relapse rate of patient, comprehensive therapeutic effect is better than Western medicine and Chinese medicine positive control drug, fully shows advantage of the present invention.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation for the treatment of lung meridian stagnated heat type allergic rhinitis, its crude drug comprises Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Radix Morindae Officinalis, Herba Cistanches, Semen Trigonellae, Colla Plastri Testudinis, Cortex Eucommiae (parched), Semen Cuscutae, Rhizoma dioscoreae (parched), Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, Herba Ephedrae (processed), Radix Glycyrrhizae Preparata, Herba Lycopi, Fructus Schisandrae Chinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Rhizoma Beesiae Calthaefoliae, Herba Lysimachiae Grammicae and Herba Lamii Amplexicaulis.
Wherein, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 10 weight portion ~ 15 weight portion, Cortex Cinnamomi 15 weight portion ~ 30 weight portion, Radix Morindae Officinalis 15 weight portion ~ 30 weight portion, Herba Cistanches 15 weight portion ~ 30 weight portion, Semen Trigonellae 15 ~ 30 weight portion, Colla Plastri Testudinis 10 weight portion ~ 15 weight portion, Cortex Eucommiae (parched) 20 weight portion ~ 30 weight portion, Semen Cuscutae 15 weight portion ~ 20 weight portion, Rhizoma dioscoreae (parched) 15 weight portion ~ 20 weight portion, Herba Centipedae 15 weight portion ~ 20 weight portion, Quartz Album 10 weight portion ~ 15 weight portion, Fructus Xanthii (parched) 10 weight portion ~ 15 weight portion, the Radix Angelicae Dahuricae 10 weight portion ~ 15 weight portion, Herba Asari 5 weight portion ~ 10 weight portion, Herba Schizonepetae 10 weight portion ~ 15 weight portion, Herba Ephedrae (processed) 15 weight portion ~ 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion ~ 15 weight portion, Herba Lycopi 15 weight portion ~ 20 weight portion, Fructus Schisandrae Chinensis 10 weight portion ~ 15 weight portion, Rhizoma Zingiberis Recens 15 weight portion ~ 20 weight portion, Radix Saposhnikoviae 10 weight portion ~ 15 weight portion, Rhizoma Beesiae Calthaefoliae 15 weight portion ~ 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion ~ 15 weight portion, Herba Lamii Amplexicaulis 15 weight portion ~ 20 weight portion.
Wherein, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 10 weight portion ~ 15 weight portion, Cortex Cinnamomi 20 weight portion ~ 25 weight portion, Radix Morindae Officinalis 25 weight portion ~ 30 weight portion, Herba Cistanches 25 weight portion ~ 30 weight portion, Semen Trigonellae 15 weight portion ~ 20 weight portion, Colla Plastri Testudinis 10 weight portion ~ 15 weight portion, Cortex Eucommiae (parched) 25 weight portion ~ 30 weight portion, Semen Cuscutae 15 weight portion ~ 20 weight portion, Rhizoma dioscoreae (parched) 15 weight portion ~ 20 weight portion, Herba Centipedae 15 weight portion ~ 20 weight portion, Quartz Album 10 weight portion ~ 15 weight portion, Fructus Xanthii (parched) 10 weight portion ~ 15 weight portion, the Radix Angelicae Dahuricae 10 weight portion ~ 15 weight portion, Herba Asari 5 weight portion ~ 10 weight portion, Herba Schizonepetae 10 weight portion ~ 15 weight portion, Herba Ephedrae (processed) 15 weight portion ~ 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion ~ 15 weight portion, Herba Lycopi 15 weight portion ~ 20 weight portion, Fructus Schisandrae Chinensis 10 weight portion ~ 15 weight portion, Rhizoma Zingiberis Recens 15 weight portion ~ 20 weight portion, Radix Saposhnikoviae 10 weight portion ~ 15 weight portion, Rhizoma Beesiae Calthaefoliae 15 weight portion ~ 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion ~ 15 weight portion, Herba Lamii Amplexicaulis 15 weight portion ~ 20 weight portion.
Wherein, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 15 weight portion, Cortex Cinnamomi 25 weight portion, Radix Morindae Officinalis 30 weight portion, Herba Cistanches 30 weight portion, Semen Trigonellae 20 weight portion, Colla Plastri Testudinis 15 weight portion, Cortex Eucommiae (parched) 30 weight portion, Semen Cuscutae 20 weight portion, Rhizoma dioscoreae (parched) 20 weight portion, Herba Centipedae 15 ~ 20 weight portion, Quartz Album 10 weight portion, Fructus Xanthii (parched) 15 weight portion, the Radix Angelicae Dahuricae 15 weight portion, Herba Asari 10 weight portion, Herba Schizonepetae 10 weight portion, Herba Ephedrae (processed) 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion, Herba Lycopi 120 weight portion, Fructus Schisandrae Chinensis 15 weight portion, Rhizoma Zingiberis Recens 20 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Beesiae Calthaefoliae 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion, Herba Lamii Amplexicaulis 15 weight portion.
Wherein, described Chinese medicine preparation is prepared into powder, tablet, granule, capsule, pill, unguentum, mixture, syrup, oral liquid.
Wherein, described Chinese medicine preparation is prepared into oral liquid.
Present invention also offers the method that above-mentioned Chinese medicine preparation is prepared into oral liquid, it comprises:
The first step, get Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Rhizoma dioscoreae (parched), Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, Herba Ephedrae (processed), Fructus Schisandrae Chinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae and Rhizoma Beesiae Calthaefoliae to clean respectively, cutting, mix, with determining alcohol be 70 ~ 90% alcohol heating reflux extract 2 ~ 4 times, each quantity of solvent counts 5 ~ 7 times amount with the mixture weight that this step obtains, and each extraction time is 1 ~ 3 hour; Filter, merging filtrate, concentrated after filtrate recycling ethanol, obtain alcohol-extracted extract, for subsequent use;
Second step, medicinal residues mix with remaining crude drug, extracting in water 2 ~ 4 times, and each amount of water counts 8 ~ 10 times amount with the mixture weight that this step obtains, and each extraction time is 1 ~ 3 hour; Filter, merging filtrate, for subsequent use;
3rd step, the alcohol-extracted extract that the first step obtains is joined in filtrate prepared by second step, be heated to 30 DEG C ~ 40 DEG C, stirring and dissolving is complete, cool to room temperature, is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, gets the sucrose relative to each crude drug quality sum 0.03 ~ 0.06 times, be dissolved in water, join in the filtrate after the filtration of ultrafiltration post subsequently;
4th step, the product of the 3rd step is concentrated, remove portion water, obtaining crude drug concentration is the solution of 0.5g/ml ~ 1g/ml, refrigerated overnight at the temperature of 0 ~ 4 DEG C, filters, and obtains oral liquid, smooth out with the fingers the mode that the oral liquid after filtration adopts batch (-type) degassed, carry out degassed its vacuum-0.04mpa before filling the container;
5th step, smooth out with the fingers oral liquid at 50 DEG C of temperature, be filled with also capping in 10ml pipe-type bottles, aseptic washing is striven, hot blast drying row fill again to make the vacuum in the pipe-type bottles after filling solution >=0.01mpa require pipe-type bottles to adopt; Bottle cap uses by hygienic requirements; Sterilization, the oral liquid that filling and packing completes, adopts 105 DEG C, 30 minutes and carries out steam high temperature sterilization mode and carry out final products sterilization.
The present invention also provides a kind of Chinese medicine oral liquid for the treatment of lung meridian stagnated heat type allergic rhinitis, and its crude drug comprises Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Radix Morindae Officinalis, Herba Cistanches, Semen Trigonellae, Colla Plastri Testudinis, Cortex Eucommiae (parched), Semen Cuscutae, Rhizoma dioscoreae (parched), Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, Herba Ephedrae (processed), Radix Glycyrrhizae Preparata, Herba Lycopi, Fructus Schisandrae Chinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Rhizoma Beesiae Calthaefoliae, Herba Lysimachiae Grammicae and Herba Lamii Amplexicaulis.
Present invention also offers the application of above-mentioned Chinese medicine preparation in the medicine for the preparation for the treatment of lung meridian stagnated heat type allergic rhinitis.
Useful technique effect
The present invention is according to the clinical manifestation of lung meridian stagnated heat type allergic rhinitis, suit the remedy to the case for this pattern of syndrome, the side's of setting up medicine, find in clinical studies, it effectively can improve patients symptomatic, without obvious toxic-side effects, reduces the relapse rate of patient, comprehensive therapeutic effect is better than Western medicine and Chinese medicine positive control drug, fully shows advantage of the present invention.
Detailed description of the invention
The invention provides a kind of Chinese medicine preparation being used for the treatment of kidney yang deficiency allergic rhinitis, its crude drug comprises Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Radix Morindae Officinalis, Herba Cistanches, Semen Trigonellae, Colla Plastri Testudinis, Cortex Eucommiae (parched), Semen Cuscutae, Rhizoma dioscoreae (parched), Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, Herba Ephedrae (processed), Radix Glycyrrhizae Preparata, Herba Lycopi, Fructus Schisandrae Chinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Rhizoma Beesiae Calthaefoliae, Herba Lysimachiae Grammicae and Herba Lamii Amplexicaulis.
Further preferably, described Chinese medicine preparation is only prepared from by above-mentioned raw materials medicine.
Fang Zhongyong Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, the medicines such as Herba Ephedrae (processed), play expelling wind and cold pathogens, to induce sweat sensible effect, wherein Quartz Album, Herba Ephedrae (processed), Periostracum Cicadae, Herba Lysimachiae Grammicae, the medicines such as Herba Lamii Amplexicaulis, have and good alleviate allergic effect, patient's nasal mucosa high response can be reduced, lower inflammatory reaction, for its main clinical manifestation, select all medicines, add Radix Saposhnikoviae simultaneously, Rhizoma Beesiae Calthaefoliae, cold expelling consolidating superficial resistance, prevent from feeling in heresy again, patient's kidney yang virtual loss, water must not be changed, gather for YIN pathogen, many delays with the passing of time, must not fully recover, therefore Herba Lycopi is added, rush down turbid just wound, with Rhizoma Zingiberis Recens in while side, Herba Asari, Fructus Schisandrae Chinensis resolving fluid-retention with drugs of warm nature, diseases caused by retention of fluid must be changed, YIN pathogen must be fallen apart, kidney yang is more helped to recover, all medicines share, be adjuvant drug altogether, add Cortex Cinnamomi simply, both can warming and recuperating the kidney-YANG, again as making medicine guiding fire to origin.Full side share, warming and recuperating the kidney-YANG, cold expelling consolidating superficial resistance, sensible lung qi dispersing, promote the circulation of qi and water, plays treatment kidney yang deficiency allergic rhinitis.
Wherein, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 10 weight portion ~ 15 weight portion, Cortex Cinnamomi 15 weight portion ~ 30 weight portion, Radix Morindae Officinalis 15 weight portion ~ 30 weight portion, Herba Cistanches 15 weight portion ~ 30 weight portion, Semen Trigonellae 15 ~ 30 weight portion, Colla Plastri Testudinis 10 weight portion ~ 15 weight portion, Cortex Eucommiae (parched) 20 weight portion ~ 30 weight portion, Semen Cuscutae 15 weight portion ~ 20 weight portion, Rhizoma dioscoreae (parched) 15 weight portion ~ 20 weight portion, Herba Centipedae 15 weight portion ~ 20 weight portion, Quartz Album 10 weight portion ~ 15 weight portion, Fructus Xanthii (parched) 10 weight portion ~ 15 weight portion, the Radix Angelicae Dahuricae 10 weight portion ~ 15 weight portion, Herba Asari 5 weight portion ~ 10 weight portion, Herba Schizonepetae 10 weight portion ~ 15 weight portion, Herba Ephedrae (processed) 15 weight portion ~ 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion ~ 15 weight portion, Herba Lycopi 15 weight portion ~ 20 weight portion, Fructus Schisandrae Chinensis 10 weight portion ~ 15 weight portion, Rhizoma Zingiberis Recens 15 weight portion ~ 20 weight portion, Radix Saposhnikoviae 10 weight portion ~ 15 weight portion, Rhizoma Beesiae Calthaefoliae 15 weight portion ~ 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion ~ 15 weight portion, Herba Lamii Amplexicaulis 15 weight portion ~ 20 weight portion.
Wherein, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 10 weight portion ~ 15 weight portion, Cortex Cinnamomi 20 weight portion ~ 25 weight portion, Radix Morindae Officinalis 25 weight portion ~ 30 weight portion, Herba Cistanches 25 weight portion ~ 30 weight portion, Semen Trigonellae 15 weight portion ~ 20 weight portion, Colla Plastri Testudinis 10 weight portion ~ 15 weight portion, Cortex Eucommiae (parched) 25 weight portion ~ 30 weight portion, Semen Cuscutae 15 weight portion ~ 20 weight portion, Rhizoma dioscoreae (parched) 15 weight portion ~ 20 weight portion, Herba Centipedae 15 weight portion ~ 20 weight portion, Quartz Album 10 weight portion ~ 15 weight portion, Fructus Xanthii (parched) 10 weight portion ~ 15 weight portion, the Radix Angelicae Dahuricae 10 weight portion ~ 15 weight portion, Herba Asari 5 weight portion ~ 10 weight portion, Herba Schizonepetae 10 weight portion ~ 15 weight portion, Herba Ephedrae (processed) 15 weight portion ~ 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion ~ 15 weight portion, Herba Lycopi 15 weight portion ~ 20 weight portion, Fructus Schisandrae Chinensis 10 weight portion ~ 15 weight portion, Rhizoma Zingiberis Recens 15 weight portion ~ 20 weight portion, Radix Saposhnikoviae 10 weight portion ~ 15 weight portion, Rhizoma Beesiae Calthaefoliae 15 weight portion ~ 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion ~ 15 weight portion, Herba Lamii Amplexicaulis 15 weight portion ~ 20 weight portion.
Wherein, in described Chinese medicine preparation, the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 15 weight portion, Cortex Cinnamomi 25 weight portion, Radix Morindae Officinalis 30 weight portion, Herba Cistanches 30 weight portion, Semen Trigonellae 20 weight portion, Colla Plastri Testudinis 15 weight portion, Cortex Eucommiae (parched) 30 weight portion, Semen Cuscutae 20 weight portion, Rhizoma dioscoreae (parched) 20 weight portion, Herba Centipedae 15 ~ 20 weight portion, Quartz Album 10 weight portion, Fructus Xanthii (parched) 15 weight portion, the Radix Angelicae Dahuricae 15 weight portion, Herba Asari 10 weight portion, Herba Schizonepetae 10 weight portion, Herba Ephedrae (processed) 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion, Herba Lycopi 120 weight portion, Fructus Schisandrae Chinensis 15 weight portion, Rhizoma Zingiberis Recens 20 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Beesiae Calthaefoliae 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion, Herba Lamii Amplexicaulis 15 weight portion.
Each crude drug pharmacology is as follows:
Radix Aconiti Lateralis Preparata: acrid in the mouth, sweet, extremely hot in nature, enter the heart, kidney, spleen channel, have recuperating depleted YANG and rescuing the patient from collapse, mends fire supporing yang, dispelling cold by warming the meridian, the effect of removing damp and stopping pain, for excessive YIN keeping YANG externally, loss of YANG due to profuse perspiration, vomiting and diarrhoea is fainted inverse, cold extremities faint pulse, trusted subordinate's cold type of pain, cold-dysentery, beriberi edema, anemofrigid-damp arthralgia, sexual impotence, cold womb, deficiency and coldness is vomited and diarrhoea, YIN-cold edema, yang deficiency diseases caused by exogenous pathogenic factor, the cards such as the disease of carbuncle of yin nature skin infection and all chronic diseaseses.
Cortex Cinnamomi: extremely hot in nature, acrid in the mouth, sweet, return kidney, spleen, the heart, Liver Channel, have that to mend fire supporing yang, let the fire back to its origin, dispersing cold for relieving pain, effect of promoting blood circulation to restore menstrual flow, for warming the spleen and stomach, removing accumulated cold, promoting blood circulation.Control decline of the fire from the gate of life, cold extremities faint pulse, YANG-depletion is collapsed, and stomachache is had loose bowels, colic of cold type renal mass, chills and pain of the waist and kness, amenorrhea lump in the abdomen, carbuncle of yin nature, multiple abscess, and empty sun is more floating, the cards such as heat in the upper and cold in the lower.
Radix Morindae Officinalis: acrid in the mouth, sweet, slightly warm in nature, enters liver, kidney channel, has the effect of kidney-replenishing, bone and muscle strengthening, wind-damp dispelling, and for impotence due to deficiency of the kidney, seminal emission premature ejaculation, few abdomen cold type of pain, cold womb is infertile, the cards such as the muscles and bones flaccidity caused by deficiency of the liver and kindey is soft, chills and pain of the waist and kness.
Herba Cistanches: be the fleshy stem of Orobanchaceae Cistanche Hoffmgg. et Link plants Herba Cistanches and Cistanche Tubulosa, latin name herbacistanches is sweet in the mouth, salty, warm in nature, enter kidney, large intestine channel, have kidney-replenishing, benefiting essence-blood, the effect of loosening bowel to relieve constipation, for kidney yang deficiency, the impotence and premature ejaculation of asthenia of essence and blood, sterility and infertility, soreness of waist and knee joint, Hiccough and deaf, frequent micturition urine number, suffer from a deficiency of the kidney dryness of the intestine and puerperal blood deficiency, deficiency of body fluid after being ill the card such as constipation
Semen Trigonellae: warm in nature, bitter in the mouth, has kidney-replenishing, and effect of dispelling cold and dampness, cures mainly colic of cold type, abdomen side of body distension, the disturbance of lower legs due to pathogenic cold and dampness, the cards such as the soreness of waist, sexual impotence of suffering from a deficiency of the kidney.
Colla Plastri Testudinis: latin name TestudinisCarapacisetPlastriColla, salty in the mouth, sweet, cool in nature, return liver, kidney, heart channel, the effect of there is YIN nourishing, nourish blood, stopping blooding, cure mainly deficiency of YIN hectic fever, hectic fever due to YIN-deficiency night sweat, soreness of the waist and knees, blood deficiency and yellow complexion, the cards such as bleeding not during menses.
Cortex Eucommiae (parched): latin name EucommiaeFolium, taste is micro-pungent, warm in nature, returns liver, kidney channel, has invigorating the liver and kidney, bone and muscle strengthening, cure mainly deficiency of the liver and kindey, have a dizzy spell, waist knee joint ache, and muscles and bones flaccidity is soft waits card.
Semen Cuscutae: sweet in the mouth, pungent, property is put down, and enters liver,kidney,spleen warp, has the kidney invigorating and essence nourishing, the effect of nourishing the liver to improve visual acuity, be mainly used in the sexual impotence of insufficiency of kidney-YANG, seminal emission premature ejaculation, frequent micturition, dizziness and tinnitus; To suffer from a deficiency of the kidney pain in the lumbar region, married woman's leukorrhagia, nausea is solid; The binocular of both liver and kidney deficiency, deficiency of liver-blood is dim-sighted, blurring of vision; The loose stool stomachache of asthenia of both the spleen and kidney, the cards such as aqueous-grainy diarrhea.
Rhizoma dioscoreae (parched): latin name dioscoreaerhizoma, sweet in the mouth, property is put down, enter lung, spleen, kidney channel, there is strengthening the spleen and tonifying the lung, stomach reinforcing the kidney invigorating, benefit of reinforcing the kidney essence, hearing-improing and eyesight improving, help the five internal organs, bone and muscle strengthening, long will are calmed the nerves, effect of life lengthening, cure mainly that weakness of the spleen and stomach, lassitude, inappetence, chronic diarrhea and dysentery, insufficiency of lung-QI are dry, phlegm dyspnea cough, kidney qi loss, soreness of the waist and knees, lower limb flaccidity be weak, the red card such as swollen, fat of frequent micturition of quenching one's thirst, premature ejaculation of passing out semen, leukorrhagia nebulousurine, skin.
Herba Centipedae: latin name CentipedaeHebra, acrid in the mouth, warm in nature, enter lung, Liver Channel, there is cold-dispelling, clearing the nasal passage, eliminating phlegm and stopping cough, the effect of dissipating blood stasis for subsidence of swelling, for exterior syndrome due to wind-cold, nasal obstruction watery nasal discharge and nasal sinusitis, cough with copious phlegm, pertussis, the cards such as sore, carbuncle and painful swelling.
Quartz Album: Latin plant animal mineral name Quartz, sweet in the mouth, warm in nature, return through entering lung, kidney, heart channel.There is warming the lung kidney, tranquilizing mind, diuresis effect.Control lung cold cough with asthma, sexual impotence, quench one's thirst, irritability, palpitate with fear forgetful, dysuria, jaundice, stony edema, anemofrigid-damp arthralgia.
Fructus Xanthii (parched): latin name XanthiiFructus, acrid in the mouth, hardship, warm in nature, return lung meridian, there is the function of the dehumidifying of loose wind, understand things pain-stopping, cure mainly nasal sinusitis; Headche due to wind-cold; Rheumatic arthralgia; Rubella; Eczema; The cards such as scabies.
The Radix Angelicae Dahuricae: latin name AngelicaeDahuricaeRadix, acrid in the mouth, warm in nature, enter lung, spleen, stomach warp, there is the cold expelling that induces sweat, wind-expelling pain-stopping, clearing the nasal passage, dampness leukorrhagia stopping, effect of detumescence and apocenosis, cures mainly headache, supraorbital bone pain, toothache, nasal sinusitis, cold-damp is suffered from abdominal pain, hemorrhoidal hamorrhage anal fistula, leucorrhea with red and white discharge, ulcer sores, skin pruritus due to dryness, the cards such as scabies.
Herba Asari: latin name AsariRadixetRhizoma, acrid in the mouth, warm in nature, return lung, kidney channel, there is expelling wind and cold pain relieving, effect that warming the lung to resolve fluid-retention is sensible, cure mainly affection of exogenous wind-cold, headache, toothache, wind and cold temperature numbness, affection of exogenous wind-cold, in stop lung cold cough with asthma caused by cold fluid-retention, nasal obstruction nasal sinusitis, wind-eye corneal nebula, deafness pharyngalgia, the cards such as aphtha halitosis.
Herba Schizonepetae: acrid in the mouth, slightly warm in nature, returns lung, Liver Channel, has the loose wind that induces sweat, effect of rash.For flu, headache, measles, rubella, skin infection from the beginning of.Parch to black treating hematochezia, metrorrhagia, the cards such as puerperal blood faints.
Herba Ephedrae (processed): acrid in the mouth, micro-hardship, warm in nature, enter lung, urinary bladder channel, have and send out cold inducing sweat, depressed lung-energy dispersing, the effect of inducing diuresis to remove edema, is mainly used in the exterior excess syndromes such as the fever without perspiration of affection of exogenous wind-cold; Rheumatic arthralgia pain; Pathogenic cold attacking the lung or accumulation of heat in the lung to cough with asthma QI rising in reverse order, edema, the cards such as dysuria.
Radix Glycyrrhizae Preparata: sweet in the mouth, property put down, enter 12 warps, be in harmonious proportion the property of medicine, the effect of expelling phlegm for arresting cough, and can spleen invigorating and in, relieving spasm to stop pain, is mainly used in invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
Herba Lycopi: bitter in the mouth, pungent, slightly warm in nature, enters liver, spleen channel, has blood circulation promoting and blood stasis dispelling, line water detumescence, the effect of removing toxicity for eliminating carbuncles, for all cards of women's multiparity congestion, as blood stasis amenorrhea, dysmenorrhea etc., also for cards such as edema, ascites, traumatic injury, too fat to move skin infection.
Fructus Schisandrae Chinensis: warm in nature, sour in the mouth, sweet, return lung, the heart, kidney channel, there is convergence astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, effect of kidney calming, cure mainly chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, Tianjin wound is thirsty, deficient pulse of losing heart, the cards such as interior-heat is quenched one's thirst, palpitation and insomnia.
Rhizoma Zingiberis Recens: acrid in the mouth, slightly warm in nature, return lung, spleen, stomach warp, have appetizing preventing or arresting vomiting, preventing phlegm from forming and stopping coughing, effect of relieving the exterior syndrome by diaphoresis, cures mainly Deficiency and coldness of spleen and stomach, loss of appetite, nausea and vomiting, or vomiting due to fluid-retention, the vomiting of disorder of stomach-QI; Wind and cold or cold-phlegm cough; Cold, fever with aversion to wind, nasal obstruction headache waits card.
Radix Saposhnikoviae: acrid in the mouth, sweet, slightly warm in nature, enters lung, liver, spleen, urinary bladder channel, has expelling cold and relieving exterior syndrome, removing dampness to relieve pain, expelling wind and relieving convulsion, antipruritic effect, is mainly used in affection of exogenous wind-cold card and cold-evil's closing, the syndrome of superficies cold and interior heat of interior-heat pent-up.
Rhizoma Beesiae Calthaefoliae: latin name Beesiacalthaefolia, acrid in the mouth, warm in nature, enter lung meridian, large intestine channel, there is wind dispelling cold expelling, removing damp and stopping pain.Control affection of exogenous wind-cold, heating, headache, rheumatism, dysentery etc.
Herba Lysimachiae Grammicae: be the herb of Primulaceae Lysimachia plant Herba Lysimachiae Grammicae, bitter in the mouth, pungent, cool in nature, have vital energy regualting and blood circulation-promoting, effect of removing toxic substances diuresis, cures mainly intestinal colic in children, infantile convulsion, dysuria, innominate toxic swelling, the cards such as traumatic injury.
Herba Lamii Amplexicaulis: be the herb of Labiatae lamium plant Herba Lamii Amplexicaulis, acrid in the mouth, hardship, slightly warm in nature, has promoting blood circulation to remove obstruction in the collateral, and effect of removing toxic substances and promoting subsidence of swelling, cures mainly traumatic injury, bones and muscles pain, numb limbs and tense tendons, hemiplegia, facial paralysis, jaundice, nasal sinusitis, toxic swelling, the cards such as impetigo.
Chinese medicine preparation provided by the invention can be as required, make any one dosage form being suitable for Clinical practice, such as: powder, tablet, granule, capsule (soft capsule), pill (drop pill), unguentum, mixture, syrup, oral liquid etc., be preferably prepared into oral liquid.
Present invention also offers the method that above-mentioned Chinese medicine preparation is prepared into oral liquid, it comprises:
The first step, get Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Rhizoma dioscoreae (parched), Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, Herba Ephedrae (processed), Fructus Schisandrae Chinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae and Rhizoma Beesiae Calthaefoliae to clean respectively, cutting, mix, with determining alcohol be 70 ~ 90% alcohol heating reflux extract 2 ~ 4 times, each quantity of solvent counts 5 ~ 7 times amount with the mixture weight that this step obtains, and each extraction time is 1 ~ 3 hour; Filter, merging filtrate, concentrated after filtrate recycling ethanol, obtain alcohol-extracted extract, for subsequent use;
Second step, medicinal residues mix with remaining crude drug, extracting in water 2 ~ 4 times, and each amount of water counts 8 ~ 10 times amount with the mixture weight that this step obtains, and each extraction time is 1 ~ 3 hour; Filter, merging filtrate, for subsequent use;
3rd step, the alcohol-extracted extract that the first step obtains is joined in filtrate prepared by second step, be heated to 30 DEG C ~ 40 DEG C, stirring and dissolving is complete, cool to room temperature, is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, gets the sucrose relative to each crude drug quality sum 0.03 ~ 0.06 times, be dissolved in water, join in the filtrate after the filtration of ultrafiltration post subsequently;
4th step, the product of the 3rd step is concentrated, remove portion water, obtaining crude drug concentration is the solution of 0.5g/ml ~ 1g/ml, refrigerated overnight at the temperature of 0 ~ 4 DEG C, filters, and obtains oral liquid, smooth out with the fingers the mode that the oral liquid after filtration adopts batch (-type) degassed, carry out degassed its vacuum-0.04mpa before filling the container;
5th step, smooth out with the fingers oral liquid at 50 DEG C of temperature, be filled with also capping in 10ml pipe-type bottles, aseptic washing is striven, hot blast drying row fill again to make the vacuum in the pipe-type bottles after filling solution >=0.01mpa require pipe-type bottles to adopt; Bottle cap uses by hygienic requirements; Sterilization, the oral liquid that filling and packing completes, adopts 105 DEG C, 30 minutes and carries out steam high temperature sterilization mode and carry out final products sterilization.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.
Embodiment 1 oral liquid 1
Get Radix Aconiti Lateralis Preparata 15g, Cortex Cinnamomi 20g, Rhizoma dioscoreae (parched) 20g, Herba Centipedae 20g, Quartz Album 10g, Fructus Xanthii (parched) 15g, Radix Angelicae Dahuricae 15g, Herba Asari 10g, Herba Schizonepetae 10g, Herba Ephedrae (processed) 20g, Fructus Schisandrae Chinensis 15g, Rhizoma Zingiberis Recens 20g, Radix Saposhnikoviae 15g, Rhizoma Beesiae Calthaefoliae 20g clean respectively, cutting, mix, be that 80% alcohol heating reflux extracts 3 times with determining alcohol, each quantity of solvent is 1.5kg, and each extraction time is 2 hours, filter, merging filtrate, concentrated after filtrate recycling ethanol, obtain alcohol-extracted extract, for subsequent use, medicinal residues mix with Radix Morindae Officinalis 25g, Herba Cistanches 25g, Semen Trigonellae 20g, Colla Plastri Testudinis 15g, Cortex Eucommiae (parched) 30g, Semen Cuscutae 20g, Radix Glycyrrhizae Preparata 10g, Herba Lycopi 20g, Herba Lysimachiae Grammicae 10g, Herba Lamii Amplexicaulis 15g, extracting in water 3 times, add the water of 1.4kg, each extraction time is 2 hours at every turn, filter, merging filtrate, for subsequent use, the alcohol-extracted extract obtained above is joined in the filtrate of acquisition, be heated to 30 DEG C, stirring and dissolving is complete, cool to room temperature, through the ultrafiltration post ultrafiltration that the molecular weight that dams is 10000, get the sucrose relative to each crude drug quality sum 0.05 times, be dissolved in water, join in the filtrate after the filtration of ultrafiltration post subsequently, product is concentrated, remove portion water, obtaining crude drug concentration is the solution of 1g/ml, refrigerated overnight at the temperature of 0 DEG C, filter, obtain oral liquid, smooth out with the fingers the mode that the oral liquid after filtration adopts batch (-type) degassed, carry out degassed its vacuum-0.04mpa before filling the container, smooth out with the fingers oral liquid at 50 DEG C of temperature, be filled with also capping in 10ml pipe-type bottles, vacuum in pipe-type bottles after filling solution >=0.01mpa is required, and pipe-type bottles adopts aseptic washing to strive, hot blast drying row fill again, bottle cap uses by hygienic requirements, sterilization, the oral liquid that filling and packing completes, adopts 105 DEG C, 30 minutes and carries out steam high temperature sterilization mode and carry out final products sterilization.
Embodiment 2 oral liquid 2
Get Radix Aconiti Lateralis Preparata 10g, Cortex Cinnamomi 20g, Rhizoma dioscoreae (parched) 15g, Herba Centipedae 15g, Quartz Album 10g, Fructus Xanthii (parched) 10g, Radix Angelicae Dahuricae 10g, Herba Asari 5g, Herba Schizonepetae 10g, Herba Ephedrae (processed) 15g, Fructus Schisandrae Chinensis 10g, Rhizoma Zingiberis Recens 15g, Radix Saposhnikoviae 10g and Rhizoma Beesiae Calthaefoliae 15g to clean respectively, cutting, mix, be that 80% alcohol heating reflux extracts 3 times with determining alcohol, each quantity of solvent is 1.2kg, and each extraction time is 2 hours, filter, merging filtrate, concentrated after filtrate recycling ethanol, obtain alcohol-extracted extract, for subsequent use, medicinal residues mix with Radix Morindae Officinalis 25g, Herba Cistanches 25g, Semen Trigonellae 15g, Colla Plastri Testudinis 10g, Cortex Eucommiae (parched) 25g, Semen Cuscutae 15g, Radix Glycyrrhizae Preparata 10g, Herba Lycopi 15g, Herba Lysimachiae Grammicae 10g, Herba Lamii Amplexicaulis 15g, extracting in water 3 times, add the water of 1kg, each extraction time is 2 hours at every turn, filter, merging filtrate, for subsequent use, the alcohol-extracted extract obtained above is joined in the filtrate of acquisition, be heated to 30 DEG C, stirring and dissolving is complete, cool to room temperature, through the ultrafiltration post ultrafiltration that the molecular weight that dams is 10000, get the sucrose relative to each crude drug quality sum 0.05 times, be dissolved in water, join in the filtrate after the filtration of ultrafiltration post subsequently, product is concentrated, remove portion water, obtaining crude drug concentration is the solution of 1g/ml, refrigerated overnight at the temperature of 0 DEG C, filter, obtain oral liquid, smooth out with the fingers the mode that the oral liquid after filtration adopts batch (-type) degassed, carry out degassed its vacuum-0.04mpa before filling the container, smooth out with the fingers oral liquid at 50 DEG C of temperature, be filled with also capping in 10ml pipe-type bottles, vacuum in pipe-type bottles after filling solution >=0.01mpa is required, and pipe-type bottles adopts aseptic washing to strive, hot blast drying row fill again, bottle cap uses by hygienic requirements, sterilization, the oral liquid that filling and packing completes, adopts 105 DEG C, 30 minutes and carries out steam high temperature sterilization mode and carry out final products sterilization.
Embodiment 3 oral liquid 3
Get Radix Aconiti Lateralis Preparata 15g, Cortex Cinnamomi 25g, Rhizoma dioscoreae (parched) 20g, Herba Centipedae 20g, Quartz Album 15g, Fructus Xanthii (parched) 15g, Radix Angelicae Dahuricae 15g, Herba Asari 10g, Herba Schizonepetae 15g, Herba Ephedrae (processed) 20g, Fructus Schisandrae Chinensis 15g, Rhizoma Zingiberis Recens 20g, Radix Saposhnikoviae 15g and Rhizoma Beesiae Calthaefoliae 20g to clean respectively, cutting, mix, be that 80% alcohol heating reflux extracts 3 times with determining alcohol, each quantity of solvent is 1.5kg, and each extraction time is 2 hours, filter, merging filtrate, concentrated after filtrate recycling ethanol, obtain alcohol-extracted extract, for subsequent use, medicinal residues mix with Radix Morindae Officinalis 30g, Herba Cistanches 30g, Semen Trigonellae 20g, Colla Plastri Testudinis 15g, Cortex Eucommiae (parched) 30g, Semen Cuscutae 20g, Radix Glycyrrhizae Preparata 15g, Herba Lycopi 20g, Herba Lysimachiae Grammicae 15, Herba Lamii Amplexicaulis 20g, extracting in water 3 times, add the de water of 1.4, each extraction time is 2 hours at every turn, filter, merging filtrate, for subsequent use, the alcohol-extracted extract obtained above is joined in the filtrate of acquisition, be heated to 30 DEG C, stirring and dissolving is complete, cool to room temperature, through the ultrafiltration post ultrafiltration that the molecular weight that dams is 10000, get the sucrose relative to each crude drug quality sum 0.05 times, be dissolved in water, join in the filtrate after the filtration of ultrafiltration post subsequently, product is concentrated, remove portion water, obtaining crude drug concentration is the solution of 1g/ml, refrigerated overnight at the temperature of 0 DEG C, filter, obtain oral liquid, smooth out with the fingers the mode that the oral liquid after filtration adopts batch (-type) degassed, carry out degassed its vacuum-0.04mpa before filling the container, smooth out with the fingers oral liquid at 50 DEG C of temperature, be filled with also capping in 10ml pipe-type bottles, vacuum in pipe-type bottles after filling solution >=0.01mpa is required, and pipe-type bottles adopts aseptic washing to strive, hot blast drying row fill again, bottle cap uses by hygienic requirements, sterilization, the oral liquid that filling and packing completes, adopts 105 DEG C, 30 minutes and carries out steam high temperature sterilization mode and carry out final products sterilization.
Embodiment 4
Pharmacology's acute toxicity test
Object: when evaluating certain drug toxicity feature, first carry out acute toxicity test, provides contact in a short time may cause the data of harm to health.Reach and obtained median lethal dose(LD 50), observed the anxious poisonous effect feature of animal subject, for subacute, chronic toxicity test provide exposure dose level foundation.
Animal is selected: cleaning grade kunming mice, 30,20 ± 2g, male and female half and half.Buy rear adaptability to raise one week.
Prepared by medicine: medicine oral liquid 1 prepared by the embodiment of the present invention 1, is concentrated into containing crude drug 1.0g/ml, 4 DEG C of preservations, for subsequent use.Blank group: distilled water equal-volume gavage, all the other conditions are with medicine group of the present invention.
Administering mode is selected: what Chinese medicine preparation had cannot carry out injection administration, and therefore consider gastrointestinal administration, invention formulation takes gastric infusion.
Dosage: oral liquid dosage on the 1st prepared by the embodiment of the present invention 1 is 75g/kg/d, point 3 gavages, administration 0.5ml; Blank group is given and 0.5ml distilled water, 3 times/day, 0.5ml/ time, gavage, continuous gavage one week, and itemized record respectively organize mice behavior reaction, body weight, outward appearance, feed inflow.
Result judges: after gastric infusion, by the record to mice autonomic activities, fur, feed amount of drinking water.Through observation, oral liquid mice of the present invention without death, oral liquid group mice of the present invention and each physical signs of normal group mice basically identical, statistical analysis, no difference of science of statistics (P > 0.05).
The clinical plan consumption of oral liquid of the present invention is 5g/kg/d, and according to the anxious toxicity test of aqueous solution mice, mouse stomach 75g/kg/d calculates, and consumption intended by the clinical medical herbs of this dosis tolerata correspondence adult is 675g/kg/d (135 times).It is generally acknowledged maximum tolerated dose be equivalent to the clinical daily dosage more than 100 times of people and animal without death, when occurring without overt toxicity response situation, this medicine is safe.Therefore, can affirm, the application of this clinical drug is safe.
Rat chronic toxicity test of the present invention
Object: by repeating successive administration, observes toxic reaction, poisoning symptom and incidence rate that tested medicine produces.The target organ of toxic reaction and the reversibility of infringement thereof are provided, tentatively determine maximum dose level or the maximum no-effect dose of non-toxic reaction.Therefore the result of long term toxicity test and resin thereof have the meaning of Chinese medicine, provide scientific basis to new drug evaluation and for clinical trial design.
Animal is selected: cleaning grade Wistar rat, 220 ± 20g, male and female half and half, buys rear adaptability and raises one week.
Medication: cleaning grade Wistar rat, 40, male and female half and half, be divided into concentration group, low concentration group of the present invention in matched group, high concentration group of the present invention, the present invention at random by body weight, respective concentration is 1.25g/ml, 1.00g/ml, 0.75g/ml.Each administration group according to dosage gastric infusion 20mL/kg, 2 times/day, matched group gives distilled water 20mL/kg with method gavage.Claim 1 body weight weekly, and according to body weight adjustment dosage, drug withdrawal after successive administration 6 weeks (clinical application 1 course for the treatment of be 1 ~ 2 week), the recovery observation period is after drug withdrawal 2 weeks.
Result judges: calculate according to corresponding administration concentration, and oral liquid 1 dosage prepared by the rat oral gavage embodiment of the present invention 1 corresponds to 50g/kg/d, 40g/kg/d, 30g/kg/d, and amounting to into the clinical plan consumption of adult, is 90 times, 72 times, 54 times respectively.After gastric infusion, by the record to mice autonomic activities, fur, feed amount of drinking water.Through observation, oral liquid mice of the present invention without death, oral liquid group mice of the present invention and each physical signs of normal group mice basically identical, statistical analysis, no difference of science of statistics (P > 0.05).Anatomic observation is carried out to each group of Rats Organs and Tissues, has no obvious toxicity sensitive indicator and toxicity target organ.
Comprehensive analysis, oral liquid high concentration long-term taking of the present invention, has no and produces Delayed onset toxic reaction and cumulative toxicity reaction.Result of the test illustrates oral liquid prolonged application of the present invention to rat without obvious toxic-side effects, clinical adult's plan dosage and be in safety range the course for the treatment of.
Embodiment 5 zoopery
Experiment material
Laboratory animal
Cavia porcellus 30, male and female half and half, body weight (400 ± 50) g, raises at cleaning grade animal feeding room, is provided by Affiliated Hospital of Qingdao University.Cavia porcellus is divided into Normal group, positive controls, treatment group (oral liquid 1 gavage prepared by the embodiment of the present invention 1) 3 groups, often organizes 10.
Medicine
Chinese medicinal formulae
Oral liquid 1 prepared by the embodiment of the present invention 1, is concentrated into crude drug concentration 0.425g/ml, and again filter with compression filtration, obtain highly purified invention formulation high-purity fluid, concentration is 0.4g/ml, 4 DEG C of preservations, for subsequent use.
Other reagent
0.5% dexamethasone ephedrine, purchased from Hospital Attached to Shandong Chinese Medical Univ.
Fo Shi Freund's complete adjuvant (FCA), purchased from Hua Ying Bioisystech Co., Ltd
Freund's incomplete adjuvant (FIA), purchased from Hua Ying Bioisystech Co., Ltd
Ultrasonic Pulverization instrument, 150uSE, Japan
Tell refrigerated centrifuger, JZ-21BACKMAN, Germany
Experimental technique
Modeling mode
Immunity inoculation
Positive controls and treatment group every Cavia porcellus ragweed pollen Allergen 0.75mL and equivalent Fo Shi Freund's complete adjuvant (FCA) or Freund's incomplete adjuvant (FIA) carry out artificial immunization.Adopt for 1st time allergen to add Fo Shi Freund's complete adjuvant, in lumbar injection 0.5mL, extremity subcutaneous (oxter, groin) are injection 0.25mL 1.5mL altogether respectively.Change ragweed pollen allergen after 2 weeks into and add Freund incomplete adjunvant, 1 time weekly, continuous 2 weeks; Normal group replaces antigen with normal saline, the same positive controls of injecting method.
Excite
Carry out nasal cavity the 4th weekend to excite, the ragweed pollen allergen normal saline solution of model group preparation 0.5%, with sample injector instillation Cavia porcellus bilateral nostril (every side 10/L), every day 1 time, excites the next day of changing into 1 time (maintenance) after continuous 5d.Normal group replaces antigen collunarium with normal saline.There is the symptom such as obvious sneeze, snivel, scratching nose, face in experimental mice, and Normal group non-evident sympton and sign.
Therapeutic Method
Normal group, at treatment stage normal saline collunarium, every day 3 times, is total to 15d.Positive controls: the next day of changing into after exciting the 5th day, antigen collunarium excites 1 time (model maintenance), uses normal saline nose dropping treatment, every day 3 times simultaneously, altogether 15d.Medication therapy groups: the next day of changing into after exciting the 5th day, antigen collunarium excites 1 time, takes oral liquid 1 prepared by the embodiment of the present invention 1 simultaneously, after pressure filtration, and crude drug concentration 0.4g/ml, every day 3 times, altogether 15d.
Evaluation index
Mark by integration Superposition Method
Scratch nose: scratch and be 1 point for 3 times, 3 ~ 10 times 2 points, scratch more than 3 points; Sneeze: 1 ~ 3 is 1 point, 3 ~ 52 points, continuous sneeze 3 points; Thin nasal discharge: flow to anterior nares 1 point; Exceed anterior nares 2 points; Tears stream has one's face covered with 3 points.
Morphological observation
Light microscopic, the electron microscopic observation of the dynamic change of nasal mucosa pathology: by Cavia porcellus after last local excitation 1.5h 40mg/kg pentobarbital sodium anesthesia under respectively sacrificed by decapitation open bridge of the nose rapidly, get bilateral concha nasalis and mucous membrane of nasal septum, part nasal mucosa is put into 10% formalin and is fixed, paraffin sections, HE dyeing, light Microscopic observation.Part nasal mucosa puts into rapidly 2.5% glutaraldehyde solution, phosphate buffer embathes that rear use 1% osmic acid is fixed, serial dehydration of alcohol, Epon812 embedding, locate under the dyeing of semithin section, toluene two indigo plant, light microscopic, ultramicrotome ultrathin section, the dyeing of acetic acid uranium Chinese holly edge lead plumbate, TEM-100CX transmission electron microscope observing.
Evaluation index
Each administration group snivel animal is counted, every day 1 time, by the scoring of symptom improvement rate, compare group difference.(each treated animal sum-snivel number of animals)/each treated animal sum × 100%=symptom improvement rate.Each experimental group Cavia porcellus anoxia, after the 10th day, is put to death half by successive administration; After administration the 14th day, put to death remaining half; Get animal mucous membrane of nasal septum tissue, often organize and also get leaf texture under 2 Guinea pig lung, through decalcification, dehydration embedding, stained.The eosinophilic granulocyte of Microscopic observation all experimental group guinea-pig nasals mucosa, lymphoplasmacytic infiltrate, glandular hyperplasia and columnar epithelium squama degree, peribronchial, lung tissue inflammatory lesion situation, calculate each group of pathological observation average integral by Superposition Method.
Statistical procedures
Application SPSS15.0 software carries out statistical analysis, and measurement data is with mean scholar standard deviation
represent, result adopts the variance analysis method of completely randomized design data to carry out, and P < 0.05 thinks that difference has significance.
Experimental result
Oral liquid of the present invention causes the therapeutical effect of rat allergic rhinitis model to egg protein
Rhinitis Symptoms
From first sensitization the 7th day, antigen attacks the number of times that rear animal scratches nose, sneeze, and snivel degree increases by sky, egg protein sensitization the 14th day, animal model success (P < 0.01).Successful for modeling animal is divided into 3 groups of administrations at random.Medication the 7th day, the reaction of experimental group Rhinitis Symptoms has clear improvement (P < 0.05); Medication the 14th day, experimental group significantly can improve Rhinitis Symptoms (P < 0.01), medication the 21st day, each administration group Rhinitis Symptoms compares to still have with model group and alleviates trend, but there was no significant difference (P > 0.05).
IgE antibody level changes
After sensitization the 14th day, modeling animal serum sample IgE antibody was all positive, and the equal > 5mm of Intradermal locus coeruleus, serum IgE antibody reaches peak.Excite every day with 1%OVA collunarium, substantially can maintain stable IgE antibody and tire 1 between 14 ~ 28d; 1,1: 6,1: 18 and Rhinitis Symptoms, and normal group animal could not detect IgE all the time.After medication the 7th day, model control group serum sample IgE antibody tired scope 1: 1 ~ 1: 18; And experimental group increases along with administration time, IgE antibody titre reduces, and scope of tiring is in 1: 1 ~ 1: 6, and 1: 18 antiserum sample is negative.After medication the 14th day, model control group and the experimental group serum sample scope of tiring were 1: 1 ~ 1: 6.
Each group of table 1 on OVA cause rat allergic rhinitis symptoms impact (n=10,
)
Compare with model control group,
*p < < 0.01,
*p < 0.05; Compare with positive control drug group,
Δp > 0.05; Compare with normal group,
#p < 0.01.
Oral liquid of the present invention causes the therapeutical effect of Cavia porcellus allergic rhinitis model to egg protein
Rhinitis Symptoms
From first sensitization the 7th day, antigen attack after animal scratch the number of times of nose, sneeze, snivel degree increases by sky, OVA sensitization the 14th day, selects after modeling success animal is divided into 3 groups at random and starts administration.Each treatment group Rhinitis Symptoms alleviates gradually with administration time increase, and improvement rate improves gradually.Administration starts on the 4th day, and experimental group and BIYANKANG group symptom improvement rate start obvious rising; Administration the 7th day, the equal > 70% of the bright improvement rate of experimental group Rhinitis Symptoms; During administration the 11st day, the equal > more than 80% of experimental group Rhinitis Symptoms improvement rate; At successive administration after the 14th day, between group variable analysis result shows, and compares with model control group, and experimental group, BIYANKANG positive group all has significant difference, P < 0.05, F=3.85.
Nasal mucosal tissue is observed
Normal group animal almost infiltrates without nasal mucosa acidophil (EOS), after repeatedly giving the attack of OVA antigen, model group nasal mucosa ulcer, glandular hyperplasia and congestion and edema are obvious, especially infiltrate showed increased (P < 0.01) with EOS, show that EOS infiltrates and play an important role in OVA allergic rhinitis model pathogeny.Successive administration is after 10 days, above-mentioned pathological characteristics be improved significantly (P < 0.05), improve effect and be proportionate (P < 0.05).Successive administration is after 14 days, each experimental group pathological change and model control group more there was no significant difference (P > 0.05).To model control group and each experimental group guinea pig lung tissue, peribronchial histological observation, do not find that EOS increases, epithelial hyperplasia, the pathological changes such as alveolar septum narrows, contrafluxion.Show the antigen stimulation mode of via intranasal application, make allergy be confined to the nasal cavity of Cavia porcellus.
The scoring of table 2OVA Cavia porcellus allergic rhinitis model pathological observation (n=10,
)
Compare with model control group,
* *p < 0.01,
*p < 0.05,
*p > 0.05; Compare with positive controls,
Δp > 0.05; Compare with normal group,
#p < 0.01
Conclusion
Allergic rhinitis are also known as allergic rhinitis, and be a kind of allergic disease that is cardinal symptom feature with the rhinocnesmus of sudden and recurrent exerbation, sneeze, nose hypersecretion, tunica mucosa nasi swelling, belonging to the traditional Chinese medical science " allergic rhinitis " category, is department of otorhinolaryngology commonly encountered diseases, frequently-occurring disease.Allergic rhinitis pathogenesis is complicated, and wherein nasal mucosa acidophil (EOS) infiltration is the important pathological characteristics of allergic rhinitis.In recent years, sensitinogen detects and general immunity function point analysis comes into one's own in clinical diagnosis and treatment, and starts to select relative medicine for clinical treatment.
Modern pharmacological research confirms, oral liquid of the present invention is comparatively affirmed immune system effect, not only humoral immunization (IgE is reduced), monocyte-macrophage system table is revealed to obvious potentiation, and also has potentiation to erythrocyte immune.
This experiment is by showing rat and Cavia porcellus two kinds of allergic rhinitis animal model therapeutical effect researchs, the present invention obviously can improve the anaphylaxis of rat and Cavia porcellus, show as serum IgE level to reduce, allergic rhinitis symptoms is significantly alleviated, make guinea-pig nasal mucosa EOS infiltrate alleviate, nasal mucosa ulcer, glandular hyperplasia and congestion and edema be improved significantly, prompting the present invention desensitize by righting, immunity moderation reaction undertaking therapy allergic rhinitis, has good potential applicability in clinical practice.
The clinical research of embodiment 6 invention formulation treatment of allergic rhinitis
Clinical data
Physical data
In August, 2013 ~ in July, 2014 is included in this clinical research, in the Allergic Rhinitis of hospital admission, and 18 ~ 49 years old age; Medical history is all more than 3 years; Minimum 3 times/year of recurrence frequency, 1 time/February of severe one; Each disease time 7 ~ 14 days; Notably show effect the several months continuously.With reference to " (People's Republic of China's traditional Chinese medicine industry standard---TCM E.N.T. Dept. disease Standardization of diagnosis and curative effect (ZY/T001.6-94) " screening; Lung meridian stagnated heat type patient 207 example, is divided into treatment group 105 example at random, and matched group 102 example, treatment group, matched group be no significant difference (P > 0.05) in sex, age, the course of disease etc., has comparability.
Diagnostic criteria
Tcm diagnosis standard: according to " (People's Republic of China's traditional Chinese medicine industry standard---TCM E.N.T. Dept. disease Standardization of diagnosis and curative effect (ZY/T001.6-94) "
1, be that discontinuity nose is itched, repeatedly, BITONG gas is not smooth, and volume thin nasal discharge is cardinal symptom for sneeze.Have the performances such as anosmia, canthus and bottleneck throat pruritus concurrently simultaneously.
2, onset is rapid.Symptom can not maintain several points to tens of points not etc.Intermission is without sneeze and nasal obstruction.Can the disease such as concurrent urticaria, asthma.
3, usually fall ill because contact allergy is former (as flue dust, pollen, chemical substance etc.), even the change of ambient temperature also can bring out this disease.
4, nasal cavity inspection: mucosal pallor is congested, and concha nasalis swelling, secretions is more.
5, do nasal discharge inspection, anaphylactogen test, SERUM IgE detection if desired, help to clarify a diagnosis with this.
6, note with vasomotor rhinitis, catch cold have a stuffy nose, the disease such as stuffy nose differentiates mutually.
Syndrome differentiating diagnostic criteria:
Kidney yang deficiency: main manifestations is that nose is itched, nasal obstruction, and sneeze is more, runs into air-cooled easy outbreak.In time, has and is afraid of cold, cold limbs, clear urine in large amounts, and the stool pool is thin.Nasal membrane is pale, concha nasalis congestion and edema.Light red tongue, tongue is white, deep-thready pulse.
Therapeutic Method
In ill acute stage, the oral liquid 1 that treatment group gives the embodiment of the present invention 1 preparation is treated, 100ml/ time, 2 times/day.Matched group give Fructus Xanthii powder (purchased from the rich large pharmacy of state, composition: Fructus Xanthii, Flos Magnoliae, the Radix Angelicae Dahuricae, Herba Menthae; Effect: clearing the nasal passage, warming the lung) add JINGUI SHENQI WAN (purchased from the rich large pharmacy of state, effect: warming and recuperating the kidney-YANG, promote the circulation of qi and water), Fructus Xanthii powder 1 bag/time, takes after mixing it with water by 2 times/day, JINGUI SHENQI WAN 15 ball/time, 2 times/day.After remission, continue to take relative medicine consolidate curative effect, treatment group is given and oral liquid, is kept to 50ml/ time, 2 times/day; Matched group, to Fructus Xanthii powder 1 bag/time, 1 times/day, is taken after mixing it with water, JINGUI SHENQI WAN 10 ball/time, 1 times/day.More than treatment 2 weeks is the-individual course for the treatment of.Altogether 4 courses for the treatment of of treatment.Record each pattern of syndrome curative effect, statistics total effective rate.
At treatments period, allly connect subject affected children ranges and all want light diet, avoid the foods such as pungent, greasy, raw food is hard, excessively sweet, over-salty, fish shrimp crab etc. is avoided easily to cause irritated food as far as possible, avoid affected children ranges to contact pollen, wormwood, house pet, family, as far as possible without carpet, must be noted that clean, the moisturizing keeping affected children ranges living environment as far as possible, note warming, prevent flu.
Evaluation criterion
Short-term evaluation standard
After changing situation and treatment to symptom during 2 groups of patient treatments, recurrence is observed, and carry out evaluation curative effect from short term efficacy and long-term efficacy two aspect, concrete observation content is as follows: 1. the change of illness state before and after treatment; 2. remission status; 3. the change of nasal mucosa under conchoscope; 4. whether have the situation of palindromia, and during recurrence, whether the state of an illness changes compared with before treatment.
Table 3 standards of grading
Sign classification:
0 point: without concha nasalis inferior swelling;
1 point: concha nasalis inferior mild swelling.Nasal septum, middle nasal concha still can;
2 points: concha nasalis inferior has small―gap suture with at the bottom of nose or with nasal septum;
3 points: concha nasalis inferior is followed at the bottom of nose or nasal septum is close to, and cannot see middle nasal concha; Middle nasal concha Polypoid changes or formed polyp.
Efficacy evaluation
Curative effect scoring=[before (before treatment the rear total score of total score-treatment)/treatment total score] × 100%.
Be effective when curative effect scoring >=51%; Be effective when curative effect scoring is 50% ~ 21%; Be invalid when curative effect scoring≤20%.
In order to judge that whether curative effect relevant to the weight of the state of an illness, therefore according to above-mentioned standards of grading, thus this disease is divided into gently, in, heavy Three Estate (from intending).
Light: to mark as the patient being less than 7 points;
In: the patient marked as 8-11 divides;
Heavy: the patient marked as 12-15 divides.
Long-term efficacy evaluation criterion
Follow up a case by regular visits to after being applicable to all treatments, evaluate.Its long-term efficacy criterion is as follows: recovery from illness: half a year without recurrence, without any clinical manifestation; Effective: half a year, recurrent number reduced, and during outbreak, symptom alleviates; Invalid: half a year recurrent number and symptom with treatment before.
Result
Kidney yang deficiency allergic rhinitis curative effect
Two groups of clinical short term efficacies compare, in table 4
Table 4 short term efficacy compares (example)
Group | Number of cases | Cure | Effectively | Invalid | Total effective rate (%) |
Treatment group | 107 | 71 | 28 | 8 | 92.52% * |
Matched group | 102 | 39 | 40 | 23 | 77.45% |
Compare with matched group,
*p < 0.05
Two groups of clinical long-term efficacies compare, in table 5
Table 5 long-term efficacy compares (example)
Group | Number of cases | Cure | Effectively | Invalid | Total effective rate (%) |
Treatment group | 107 | 63 | 32 | 12 | 88.79% * |
Matched group | 102 | 38 | 36 | 28 | 72.55% |
Compare with matched group,
*p < 0.05
Conclusion
By this clinical observation, in kidney yang deficiency Allergic Rhinitis, treatment group and matched group compare analysis, two groups of curative effect no difference of science of statistics, P > 0.05, carries out Integrated comparative to curative effect, and short term efficacy treatment group curative effect is better than matched group, illustrate that treatment group can patients in remission faster, reduce anaphylaxis; In Long Term Clinical, treatment group curative effect is also better than matched group, illustrates that treatment group can significantly improve patient's stress state, reduces patient's hypersensitivity, reduces Patients on Recurrence.
Overall merit, Chinese medicine preparation of the present invention, short term efficacy can be good at alleviating kidney yang deficiency allergic rhinitis symptoms, and long-term efficacy has minimizing relapse rate, and improve the effect of the basic body constitution of patient, clinic is applied.
All above-mentioned this intellectual properties of primary enforcement, not setting restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (9)
1. treat a Chinese medicine preparation for lung meridian stagnated heat type allergic rhinitis, it is characterized in that: crude drug comprises Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Radix Morindae Officinalis, Herba Cistanches, Semen Trigonellae, Colla Plastri Testudinis, Cortex Eucommiae (parched), Semen Cuscutae, Rhizoma dioscoreae (parched), Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, Herba Ephedrae (processed), Radix Glycyrrhizae Preparata, Herba Lycopi, Fructus Schisandrae Chinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Rhizoma Beesiae Calthaefoliae, Herba Lysimachiae Grammicae and Herba Lamii Amplexicaulis.
2. the Chinese medicine preparation for the treatment of lung meridian stagnated heat type allergic rhinitis as claimed in claim 1, is characterized in that: the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 10 weight portion ~ 15 weight portion, Cortex Cinnamomi 15 weight portion ~ 30 weight portion, Radix Morindae Officinalis 15 weight portion ~ 30 weight portion, Herba Cistanches 15 weight portion ~ 30 weight portion, Semen Trigonellae 15 ~ 30 weight portion, Colla Plastri Testudinis 10 weight portion ~ 15 weight portion, Cortex Eucommiae (parched) 20 weight portion ~ 30 weight portion, Semen Cuscutae 15 weight portion ~ 20 weight portion, Rhizoma dioscoreae (parched) 15 weight portion ~ 20 weight portion, Herba Centipedae 15 weight portion ~ 20 weight portion, Quartz Album 10 weight portion ~ 15 weight portion, Fructus Xanthii (parched) 10 weight portion ~ 15 weight portion, the Radix Angelicae Dahuricae 10 weight portion ~ 15 weight portion, Herba Asari 5 weight portion ~ 10 weight portion, Herba Schizonepetae 10 weight portion ~ 15 weight portion, Herba Ephedrae (processed) 15 weight portion ~ 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion ~ 15 weight portion, Herba Lycopi 15 weight portion ~ 20 weight portion, Fructus Schisandrae Chinensis 10 weight portion ~ 15 weight portion, Rhizoma Zingiberis Recens 15 weight portion ~ 20 weight portion, Radix Saposhnikoviae 10 weight portion ~ 15 weight portion, Rhizoma Beesiae Calthaefoliae 15 weight portion ~ 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion ~ 15 weight portion, Herba Lamii Amplexicaulis 15 weight portion ~ 20 weight portion.
3. the Chinese medicine preparation for the treatment of lung meridian stagnated heat type allergic rhinitis as claimed in claim 1 or 2, is characterized in that: the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 10 weight portion ~ 15 weight portion, Cortex Cinnamomi 20 weight portion ~ 25 weight portion, Radix Morindae Officinalis 25 weight portion ~ 30 weight portion, Herba Cistanches 25 weight portion ~ 30 weight portion, Semen Trigonellae 15 weight portion ~ 20 weight portion, Colla Plastri Testudinis 10 weight portion ~ 15 weight portion, Cortex Eucommiae (parched) 25 weight portion ~ 30 weight portion, Semen Cuscutae 15 weight portion ~ 20 weight portion, Rhizoma dioscoreae (parched) 15 weight portion ~ 20 weight portion, Herba Centipedae 15 weight portion ~ 20 weight portion, Quartz Album 10 weight portion ~ 15 weight portion, Fructus Xanthii (parched) 10 weight portion ~ 15 weight portion, the Radix Angelicae Dahuricae 10 weight portion ~ 15 weight portion, Herba Asari 5 weight portion ~ 10 weight portion, Herba Schizonepetae 10 weight portion ~ 15 weight portion, Herba Ephedrae (processed) 15 weight portion ~ 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion ~ 15 weight portion, Herba Lycopi 15 weight portion ~ 20 weight portion, Fructus Schisandrae Chinensis 10 weight portion ~ 15 weight portion, Rhizoma Zingiberis Recens 15 weight portion ~ 20 weight portion, Radix Saposhnikoviae 10 weight portion ~ 15 weight portion, Rhizoma Beesiae Calthaefoliae 15 weight portion ~ 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion ~ 15 weight portion, Herba Lamii Amplexicaulis 15 weight portion ~ 20 weight portion.
4. the Chinese medicine preparation of the treatment lung meridian stagnated heat type allergic rhinitis as described in claims 1 to 3, it is characterized in that: the weight portion of each crude drug is respectively Radix Aconiti Lateralis Preparata 15 weight portion, Cortex Cinnamomi 25 weight portion, Radix Morindae Officinalis 30 weight portion, Herba Cistanches 30 weight portion, Semen Trigonellae 20 weight portion, Colla Plastri Testudinis 15 weight portion, Cortex Eucommiae (parched) 30 weight portion, Semen Cuscutae 20 weight portion, Rhizoma dioscoreae (parched) 20 weight portion, Herba Centipedae 15 ~ 20 weight portion, Quartz Album 10 weight portion, Fructus Xanthii (parched) 15 weight portion, the Radix Angelicae Dahuricae 15 weight portion, Herba Asari 10 weight portion, Herba Schizonepetae 10 weight portion, Herba Ephedrae (processed) 20 weight portion, Radix Glycyrrhizae Preparata 10 weight portion, Herba Lycopi 120 weight portion, Fructus Schisandrae Chinensis 15 weight portion, Rhizoma Zingiberis Recens 20 weight portion, Radix Saposhnikoviae 15 weight portion, Rhizoma Beesiae Calthaefoliae 20 weight portion, Herba Lysimachiae Grammicae 10 weight portion, Herba Lamii Amplexicaulis 15 weight portion.
5. the Chinese medicine preparation of the treatment lung meridian stagnated heat type allergic rhinitis as described in Claims 1-4, is characterized in that: described Chinese medicine preparation is prepared into powder, tablet, granule, capsule, pill, unguentum, mixture, syrup, oral liquid.
6. the Chinese medicine preparation of the treatment lung meridian stagnated heat type allergic rhinitis as described in claim 1 to 5, is characterized in that: described Chinese medicine preparation is prepared into oral liquid.
7. Chinese medicine preparation described in claim 1 to 6 is prepared into the method for oral liquid, it is characterized in that, comprising:
The first step, get Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Rhizoma dioscoreae (parched), Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, Herba Ephedrae (processed), Fructus Schisandrae Chinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae and Rhizoma Beesiae Calthaefoliae to clean respectively, cutting, mix, with determining alcohol be 70 ~ 90% alcohol heating reflux extract 2 ~ 4 times, each quantity of solvent counts 5 ~ 7 times amount with the mixture weight that this step obtains, and each extraction time is 1 ~ 3 hour; Filter, merging filtrate, concentrated after filtrate recycling ethanol, obtain alcohol-extracted extract, for subsequent use;
Second step, medicinal residues mix with remaining crude drug, extracting in water 2 ~ 4 times, and each amount of water counts 8 ~ 10 times amount with the mixture weight that this step obtains, and each extraction time is 1 ~ 3 hour; Filter, merging filtrate, for subsequent use;
3rd step, the alcohol-extracted extract that the first step obtains is joined in filtrate prepared by second step, be heated to 30 DEG C ~ 40 DEG C, stirring and dissolving is complete, cool to room temperature, is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, gets the sucrose relative to each crude drug quality sum 0.03 ~ 0.06 times, be dissolved in water, join in the filtrate after the filtration of ultrafiltration post subsequently;
4th step, the product of the 3rd step is concentrated, remove portion water, obtaining crude drug concentration is the solution of 0.5g/ml ~ 1g/ml, refrigerated overnight at the temperature of 0 ~ 4 DEG C, filters, and obtains oral liquid, smooth out with the fingers the mode that the oral liquid after filtration adopts batch (-type) degassed, carry out degassed its vacuum-0.04mpa before filling the container;
5th step, smooth out with the fingers oral liquid at 50 DEG C of temperature, be filled with also capping in 10ml pipe-type bottles, aseptic washing is striven, hot blast drying row fill again to make the vacuum in the pipe-type bottles after filling solution >=0.01mpa require pipe-type bottles to adopt; Bottle cap uses by hygienic requirements; Sterilization, the oral liquid that filling and packing completes, adopts 105 DEG C, 30 minutes and carries out steam high temperature sterilization mode and carry out final products sterilization.
8. treat a Chinese medicine oral liquid for lung meridian stagnated heat type allergic rhinitis, it is characterized in that: crude drug comprises Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Radix Morindae Officinalis, Herba Cistanches, Semen Trigonellae, Colla Plastri Testudinis, Cortex Eucommiae (parched), Semen Cuscutae, Rhizoma dioscoreae (parched), Herba Centipedae, Quartz Album, Fructus Xanthii (parched), the Radix Angelicae Dahuricae, Herba Asari, Herba Schizonepetae, Herba Ephedrae (processed), Radix Glycyrrhizae Preparata, Herba Lycopi, Fructus Schisandrae Chinensis, Rhizoma Zingiberis Recens, Radix Saposhnikoviae, Rhizoma Beesiae Calthaefoliae, Herba Lysimachiae Grammicae and Herba Lamii Amplexicaulis.
9. the application of Chinese medicine preparation described in claim 1 to 6 in the medicine for the preparation for the treatment of lung meridian stagnated heat type allergic rhinitis.
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CN101264190A (en) * | 2008-04-21 | 2008-09-17 | 北京中科仁和科技有限公司 | Chinese medicinal composition treating allergic rhinitis and preparation thereof |
CN103830564A (en) * | 2014-03-10 | 2014-06-04 | 宁波大学 | Oral medicine for treating chronic nasosinusitis |
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CN101264190A (en) * | 2008-04-21 | 2008-09-17 | 北京中科仁和科技有限公司 | Chinese medicinal composition treating allergic rhinitis and preparation thereof |
CN103830564A (en) * | 2014-03-10 | 2014-06-04 | 宁波大学 | Oral medicine for treating chronic nasosinusitis |
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