A kind of antianaphylactic medicine and preparation method thereof
Invention field
The present invention relates to a kind of antianaphylactic medicine.Specifically, relating to a kind of is the Claritin made of raw material and the preparation method of this medicine with the Chinese herbal medicine.
Background technology
Allergy is a kind of special pathologic immunoreation, show as when body by suck, eat, inject or approach contact allergy such as contact former after, a certain tissue or organ can appear, even the kickback of general, cause various dysfunctions or tissue injury.Be characterized in that this anaphylaxis to particular matter only appears on one's body the minority receiver, and cause that material hypersensitive is harmless for most of receivers.
Generalized allergy can be divided into two types, and a kind of is the low reaction type, promptly reactive low excessively type; Another kind is high response type, that is alleged anaphylaxis usually.According to statistics, be subjected to the influence of factors such as environmental pollution and life style, the anaphylaxis that various anaphylactogens cause is in rising trend year by year in the world.In China, anaphylactoid sickness rate accounts for 10%, and anaphylaxis has belonged to multiple commonly encountered diseases.Though allergic diseases causes the serious side of body that becomes to human health unlike cancer and cardiovascular disease, its can bring long-term puzzlement to the patient, causes multiple complications, even threat to life.
At present, it all is according to the principle that desensitizes, suppresses basically that anaphylactoid medicine is treated in countries in the world, adopts medicines such as promethazine hydrochloride (promethazine) PROMETHAZINE HYDROCHLORIDE, chlorphenamine (chlorphenamine) CHLORPHENIRAMINE MELEATE, diphhydramine hydrochloride DIPHENHYDRAMINEHYDROCHLORIDE, this imidazoles (hismanal) ASTEMIZOLE.But, take the medicine of these chemosynthesis after, dizzy, weak, drowsiness, xerostomia occurs easily, feel sick, side effect such as vomiting, also can occur when heavy dose of suffering from diarrhoea, hypotension, ataxia, convulsions is gone into a coma even the reaction of heart condition.Therefore, these chemicalses are for suffering from cardiovascular diseases, bronchial asthma, acute asthma, pylorus or duodenal obstruction, prostate hyperplasia, neck of bladder obstruction, renal insufficiency, glaucoma, hyperthyroidism, and special populations such as the patient of vascular hypertension and anemia of pregnant woman belong to careful usefulness or forbidden drugs; Belong to the duration of work forbidden drugs for work posts such as work high above the ground person, mechanically actuated person, drivers.And, when using simultaneously, other medicines and these medicines also cause untoward reaction easily, and this has also limited the use of this class medicine.In addition, should be pointed out that existing treatment anaphylaxis medicine does not have preventive effect.
Along with the raising of people's living standard, natural plant more and more is subjected to liking of people, but the antiallergic plant amedica of pure natural is few, does not also find the antiallergic plant amedica that can substitute traditional Western medicine, have prevention and therapeutical effect so far.
Summary of the invention
An object of the present invention is to provide a kind of is the Claritin of raw material with the Chinese herbal medicine.
Another object of the present invention provides the preparation method of the above-mentioned Claritin of preparation.
According to theory of Chinese medical science, any disease all is the result of imbalance of YIN and YANG, internal organs disorder.The basic cause of disease of allergic disease can be divided into inside and outside two aspects, and exopathogenic factor mainly is to be affected by the cold or pathogenic heat, and endogenous cause of ill mainly is yin or yang excess due to the vital organs of the human body functional disorder or declines partially, and give birth in the fire, expectorant, the stasis of blood etc.In the internal organs pathological changes, be many with lung, spleen, kidney especially.Lung governing qi, department breathes, lead in outside, main again fur, a surname's row is defended the gas of sun, lung drops to suitablely with respectful clearly, is jammed for contrary; Spleen department fortuneization is source of generating QI and blood; Gas is the root of gas in the kidney master.
The present invention is based on the theory of traditional medicine and the achievement of modern medicines research, lose void at the anaphylaxis yang-energy, instability of surface, the disease of susceptible wind and cold exopathogen as the Therapeutic Principle, selects for use multiple natural Chinese medicine to prepare medicine with " tonifying the lung consolidating superficial resistance, the spleen invigorating benefit is defended ".Realize that technical scheme of the present invention is as follows:
The present invention relates to a kind of antianaphylactic medicine, it is made up of the following weight proportion raw material basically:
Radix Astragali 30-60 part Rhizoma Atractylodis Macrocephalae 20-45 part Fructus Mume 10-30 part Radix Saposhnikoviae 8-20 part
Radix Glycyrrhizae 5-15 part Poria 5-15 part Pheretima 4-12 part Fructus Xanthii 4-10 part
Preferably, medicine of the present invention is made up of the following weight proportion raw material basically:
Radix Astragali 35-50 part Rhizoma Atractylodis Macrocephalae 25-40 part Fructus Mume 15-25 part Radix Saposhnikoviae 10-18 part
Radix Glycyrrhizae 8-12 part Poria 8-12 part Pheretima 5-10 part Fructus Xanthii 5-8 part
More preferably, medicine of the present invention is made up of the following weight proportion raw material basically:
15 parts of 20 parts of Radix Saposhnikoviaes of 30 portions of Fructus Mumes of 40 parts of Rhizoma Atractylodis Macrocephalaes of the Radix Astragali
6 parts of 8 portions of Fructus Xanthii of 10 parts of Pheretimas of 10 parts of Poria of Radix Glycyrrhizae
Medicine of the present invention can also contain 10-20 part Cortex Mori and 4-10 part Rhizoma Chuanxiong (weight ratio).
In the pharmaceutical composition of the present invention:
Radix Astragali sweet in the mouth, slightly warm in nature is apt to into spleen channel, the energy tonifying Qi and lifting yang, benefit is defended consolidating superficial resistance.The sweet temperature of the Radix Astragali is gone into lung, but replenishing and restoring lung-QI is breathed with department again." book on Chinese herbal medicine converges and says " said: " arresting sweating is defended in the tonifying the lung spleen invigorating in fact, and the medicine of wind dispelling fortune poison also.”
Rhizoma Atractylodis Macrocephalae hardship, sweet, warm is returned spleen, stomach warp, air making-up and spleen enlivening is arranged, the effect of dampness diuretic." explaining abstruseness of the canon of materia medica " said: " Rhizoma Atractylodis Macrocephalae, the medicine of tonifying the spleen and stomach, more unequalled person.”
Liver, spleen, lung, large intestine channel are returned in Fructus Mume acid, puckery, flat, and astringing lung-QI and relieving cough is alleviated phlegm dyspnea, thick kind the holding back of gas." medication heart method " says it can " receive lung qi." can be used for the disease of few expectorant of chronic cough of deficiency lung or dry cough without phlegm.
Radix Saposhnikoviae acrid in the mouth, sweet, warm in nature, return bladder, liver, spleen channel, inducing diaphoresis to dispel wind, removing dampness to relieve pain.This product rise to be sent out and to be loose, and is general for controlling wind, by the sign that ailment said due to cold or exposure causes, no matter hold under the arm cold, hold heat under the arm or hold under the arm wet, all can be by the suitable compatibility of Radix Saposhnikoviae, with the exopathogen that looses, the releasing sign.
Radix Glycyrrhizae property is sweet, flat, returns liver, spleen, lung meridian, lung moistening detoxifcation and middle emergency.But coordinating the actions of various ingredients in a prescription cures mainly vital organs of the human body cold and heat pathogen, infirmities and diseases.
But Poria strengthening the spleen and stomach, a muscles and bones, sharp joint, stopping leak rush down, remove four coldness of the body to wet.
Pheretima distinguishes the flavor of, and is cold in nature, is the dry body of huge earthworm section's animal Pheretima aspergillum or thin white silk used in ancient China earthworm, the effect of have heat clearing away, endogenous wind stopping, relievining asthma.
More than all medicine compatibilities, can nurse one's health the spleen lung, QI invigorating consolidates, and drives away ailment said due to cold or exposure.The not empty then fur of lung is solid, and exopathogen is difficult to invade; Spleen must be good for that to transport then water wet as to change, and expectorant can not be spontaneous.So all medicines share, giving consideration to both the incidental and fundamental, reinforcement and elimination in combination is played its merit altogether.
Medicine of the present invention can combine with any pharmaceutically acceptable carrier or excipient, and be made into various suitable dosage forms, for example powder, granule (comprising dry syrup, electuary), tablet, capsule, pill (comprising drop pill), injection, syrup, Emulsion, water preparation, aerosol etc.Wherein, preferred particulates agent and capsule.More preferably capsule.Capsule comprises hard capsule, soft capsule, enteric coated capsule, double-deck capsule, slow releasing capsule etc.
The invention still further relates to a kind of method for preparing antianaphylactic medicine, comprising:
Get 30-60 part Radix Astragali, 20-45 part Rhizoma Atractylodis Macrocephalae, 10-30 part Fructus Mume, 8-20 part Radix Saposhnikoviae, 5-15 part Radix Glycyrrhizae, 5-15 part Poria, 4-12 part Pheretima, 4-10 part Fructus Xanthii, perhaps add 10-20 part Cortex Mori and/or 4-10 part Rhizoma Chuanxiong again, dry, pulverize the back and cross 100 order dusting covers,, make powder various loose powder mix homogeneously.
Preferably, the weight proportion of each raw material is as follows in the preparation method of the present invention:
Radix Astragali 35-50 part Rhizoma Atractylodis Macrocephalae 25-40 part Fructus Mume 15-25 part Radix Saposhnikoviae 10-18 part
Radix Glycyrrhizae 8-12 part Poria 8-12 part Pheretima 5-10 part Fructus Xanthii 5-8 part
More preferably, the weight proportion of each raw material is as follows in the preparation method of the present invention:
15 parts of 20 parts of Radix Saposhnikoviaes of 30 portions of Fructus Mumes of 40 parts of Rhizoma Atractylodis Macrocephalaes of the Radix Astragali
6 parts of 8 portions of Fructus Xanthii of 10 parts of Pheretimas of 10 parts of Poria of Radix Glycyrrhizae
The Radix Astragali in this method is good with Radix Astragali, and Radix Glycyrrhizae should be selected Radix Glycyrrhizae Preparata for use, the Fructus Xanthii that Fructus Xanthii was preferably fried.
Advantage of the present invention and characteristics are: (1) produce effects is fast, and duration of efficacy is long; (2) adopt the pure natural plant medicine composition, safety, stable, without any side effects; (3) have the broad-spectrum anti-allergic effects, should (as bronchial asthma, allergic rhinitis) have remarkable result abnormal the sending out of respiratory tract; (4) has the effect that Polyglucan reacts.
Brief description of drawings
Patient's subjective symptom total mark changed before and after Fig. 1 was to use.
Patient's objective sign total mark changed before and after Fig. 2 was to use.
The specific embodiment
Embodiment one:
All Chinese crude drug raw materials are all available from Beijing's medical material company.
Take by weighing raw material (kilogram) by following proportioning:
The Radix Astragali 60 Rhizoma Atractylodis Macrocephalaes 40 Fructus Mumes 30 Radix Saposhnikoviaes 18
Radix Glycyrrhizae 12 Poria 15 Pheretimas 10 Fructus Xanthii 8
Above-mentioned various raw material washs through extracing foreign material, and in-10 ℃ of dryings, the moisture in the medicine is approximately less than 5% to use YZC-1000 type cold drying case (the Changjiang river pharmaceutical equipment company limited product) respectively.(Changshu Chinese traditional medicine machine factory) pulverizes with SF-250 type pulverizer, crosses 100 order dusting covers, adopts VQT-200 type batch mixer (luxuriant source pharmaceutical machine factory) with various fine powder mix homogeneously, to make powder.Powder is fallow powder, and sealing is stored in shady and cool dry place.
Embodiment two:
Take by weighing raw material (kilogram) by following proportioning:
The Radix Astragali 40 Rhizoma Atractylodis Macrocephalaes 30 Fructus Mumes 20 Radix Saposhnikoviaes 15
Radix Glycyrrhizae 10 Poria 10 Pheretimas 8 Fructus Xanthii 6
Above-mentioned various raw material washs through extracing foreign material, and cold drying is pulverized, and crosses 100 order dusting covers, and processing such as mix homogeneously are made into powder, are fallow, is stored in shady and cool dry locating.
Embodiment three:
Take by weighing raw material (kilogram) by following proportioning:
The Radix Astragali 30 Rhizoma Atractylodis Macrocephalaes 22 Fructus Mumes 15 Radix Saposhnikoviaes 10 Radix Glycyrrhizaes 8
Poria 8 Pheretimas 4 Fructus Xanthii 5 Cortex Mori 15 Rhizoma Chuanxiongs 5
Above-mentioned various raw material washs through extracing foreign material, and cold drying is pulverized, and crosses 100 order dusting covers, and processing such as mix homogeneously are made into powder, are fallow, is stored in shady and cool dry locating.
Embodiment four:
Adopt FLG-60 type granulator (luxuriant source pharmaceutical machine factory product), the powder of embodiment two gained is made single-size.The sterilization back is filled into Capsules (meeting ministry standard) with NJP-400 type capsule filler (Ruian, Zhejiang China reaches pharmaceutical machine factory product) with it, makes capsule.
Preserve in shady and cool dry place capsule bottling back, and every capsules contains 0.35 gram granule.
Embodiment five:
1. case
Checking treatment 34 examples, male's 9 examples wherein, women's 25 examples, age 12-63 year, average 32.7 years old, morbidity course of disease 2-40 did not wait, average 8.9 years, typical bronchial asthma of the equal tool of patient or allergic rhinitis Sx, and the patient all is positive to specificity allergy tuerculoderma, and the patient is all in stage of attack during treatment.Wherein, have 8 examples to show as simple allergic rhinitis, have 2 examples to show as simple bronchial asthma, all the other 24 examples show as the allergic rhinitis bronchial asthma that occurs together.
2. method
Oral capsule, every day secondary, each four balls, every ball 0.35 gram rises and service once just before going to bed morning.
The each patient is an one and a half months whole courses of treatment, is divided into three observation stages.First observation stage schedules to last two weeks, and in this stage, every day is by the doctor's advice oral capsule; Second observation stage also schedules to last two weeks, the capsule of stopping using in this stage; The 3rd observation stage still schedules to last two weeks, and interior during this period patient takes capsule by former method.At viewing duration other medicines of stopping using, remove asthma attack and allow when serious the patient to take over the suppressing panting calming medicine of using always on a small quantity.
3. the standard of efficacy evaluation
The methods analyst curative effect that adopts symptom integral and sign integration to combine.Before the begin treatment according to patient's subjective symptom and objective sign, by symptom, the sign the set standard of keeping the score, patient's basic integration before the itemized record treatment.In the patient first behind the medication two weeks, midway behind the drug withdrawal two weeks and behind the secondary medication two weeks, write down the sings and symptoms integration in each stage respectively, observe untoward reaction or other variations that the patient occurs simultaneously during medication then.
The integration of sings and symptoms is divided into 0,1,2,3 grades, respectively representative do not have, light, in, heavy.Concrete standard is as follows:
The table 1. symptom standard of keeping the score
1 minute | Paroxysm 1 time/day | On a small quantity | Idol is stifled | Idol is itched | Idol is uncomfortable in chest | Idol is coughed | The idol paroxysm | One side is gently red | One side idol is itched | One side is a small amount of |
2 minutes | Paroxysm 2-4 time/day | Need wipe away clearly | Alternately stifled | Paroxysm is itched | Activity is felt oppressed | Hacking cough | Frequently breathe heavily | Bilateral is gently red | Bilateral is itched | Bilateral is a small amount of |
3 minutes | Paroxysm is more than 5 times/day | Ooze | Bilateral is stifled | Need rub nose | Static to feeling oppressed | The influence sleep | Can not put down for sleeping in | Bilateral is red | Often rub one's eyes | The bilateral tear that overflows |
The table 2. sign standard of keeping the score
4. efficacy evaluation result
(1) integration of patient's symptom and sign changes before and after the medication
Through medication and observation on schedule continuously, each stage before and after treatment, 34 routine patients' subjective symptom and the variation of objective sign such as table 3 and table 4, and illustrated in figures 1 and 2.
Patient's subjective symptom integration changes before and after table 3. medication
Integration | Sneeze | Snivel | Nasal obstruction | Rhinocnesmus | The sense of feeling suffocated | Cough | Asthma | Furious | Ophthalmic pruritus | Shed tears | Total mark |
Basic symptom before the treatment | ????91 | ????89 | ????67 | ????75 | ????46 | ??28 | ??31 | ??18 | ???39 | ???27 | ????511 |
When the phase I, treatment finished | ????45 | ????36 | ????28 | ????37 | ????15 | ??9 | ??7 | ??4 | ???12 | ???7 | ????200 |
Behind the drug withdrawal two weeks | ????50 | ????46 | ????38 | ????30 | ????21 | ??14 | ??10 | ??9 | ???13 | ???9 | ????240 |
When the second stage treatment finishes | ????31 | ????27 | ????28 | ????19 | ????11 | ??6 | ??3 | ??7 | ???7 | ???2 | ????141 |
Patient's objective sign integration changes before and after table 4. medication
Integration | The nasal mucosa edema | Nasal mucosa is pale | The nose secretion | Venting quality | Wheezing sound | Wet gong sound | Conjunctival congestion | Chemosis | The eye secretion | Total mark |
Basic symptom before the treatment | ????86 | ????84 | ????56 | ????51 | ???20 | ???1 | ????24 | ????20 | ???15 | ????357 |
When the phase I, treatment finished | ????43 | ????44 | ????29 | ????28 | ???5 | ???0 | ????4 | ????3 | ????5 | ????161 |
After the drug withdrawal ten months | ????52 | ????47 | ????31 | ????30 | ???9 | ???0 | ????7 | ????13 | ????7 | ????196 |
When the phase I, treatment finished | ????35 | ????32 | ????17 | ????20 | ???3 | ???0 | ????3 | ????6 | ????2 | ????118 |
From table 3 and table 4, Fig. 1 and Fig. 2 as seen: after (1) patient took the capsule two weeks first, every subjective symptom and objective sign all had improvement in various degree; (2) discontinue medication behind the two weeks, symptom and sign are slightly gone up, but medicine is still kept certain curative effect; (3) take medicine once more behind the two weeks, patient's sings and symptoms take a favorable turn again.
(2) efficacy analysis
Total mark decline with symptom, sign before and after the treatment is being significant effective more than 15 minutes, total mark descends and is divided into well at 10-14, and total mark descends and is divided into effectively at 5-9, and it is not obvious that total mark decline less than 5 is divided into curative effect, the patient is analyzed one by one, and the result is as follows:
The analysis of cases one by one of symptom, sign integration before and after table 5. treatment
| Curative effect is not obvious | Effectively | Well | Significant effective |
| The example number | ????% | The example number | ????% | The example number | ????% | The example number | ????% |
After the phase I medication | ????5 | ????15 | ????15 | ????44 | ????11 | ????32 | ???3 | ????9 |
Behind the drug withdrawal two weeks | ????8 | ????24 | ????19 | ????56 | ????6 | ????18 | ???0 | ????0 |
After the second stage medication | ????5 | ????15 | ????5 | ????15 | ????15 | ????44 | ???9 | ????26 |
By table 5 as seen: behind (1) allergic airway disease stage of attack patient medication two weeks, there is patient's symptom and sign of 9% to alleviate substantially, patient's symptom and sign of 32% obviously alleviates, and patient's symptom and sign of 44% takes a turn for the better to some extent, and other has 15% patient's symptom and sign and the preceding no significant change of treatment; (2) behind the drug withdrawal two weeks, patient's symptom body weight all increases the weight of to some extent; (3) once more behind the medication two weeks, patient's symptom and sign further takes a turn for the better again, and symptom and sign basic controlling person increases to 26%, and obviously the alleviator increases to 44%, and symptom and sign improvement person to some extent reduces to 15%, but does not relatively have significant change before still having 15% patient and treatment.
5. the Wright peakology before and after the bronchial asthma patient medication
To the patient of 24 examples, with Wright peak velocity instrument, the peak velocity before and after the detection patient takes medicine, with the relatively variation of its respiratory function with bronchial asthma.It is as follows to reach the peak velocity observed result in each stage of treatment before the medication:
The average peak velocity ratio before and after table 6. treatment
Treatment previous peaks flow velocity | The peak velocity when phase I finishes | Peak velocity behind the drug withdrawal two weeks | Peak velocity when second stage finishes |
394 liters/minute | 498 liters/minute | 426 liters/minute | 473 liters/minute |
By table 6 as seen: before the treatment of (1) 24 routine asthmatic patient the average peak flow velocity be 394 liters/minute; (2) take medicine first behind the two weeks, the average peak flow velocity increase to 498 liters/minute; (3) behind the drug withdrawal two weeks peak value drop to 426 liters/minute, but still be higher than the treatment before level; (4) once more behind the medication two weeks, peak velocity increase again to average 473 liters/minute.
Embodiment five: 1. crowd on probation
For detection of drugs to anaphylactoid preventive effect, select 24 volunteers and participate in test.Wherein, special anaphylactogen (ethanol, seafood) is had people's 17 examples of allergies, because of job demand go on business throughout the year, to the strange land being not acclimatized person that produces the allergic symptom (dermatitis is scratched where it itches, rhinitis) 6 people.2. method
The people who special anaphylactogen (ethanol, seafood) is had allergies took capsule, dosage in two hours before contact allergy is former: each 4, and every 0.35 gram.
Because of the being not acclimatized person that produces the allergic symptom (dermatitis is scratched where it itches, rhinitis) in twice test, after taking medicine continuously and reach the destination in 2nd before reaching the destination, took medicine every day twice, each 4, every 0.35 gram continuously 2.3. pharmacodynamic analysis
As shown in table 7, special anaphylactogen (ethanol, seafood) people hypersensitive was taken medicine before contact allergy is former in two hours, contact allergy is former and do not produce responder totally 13 examples thereafter, and only 4 examples are invalid;
Person's contact in 2 days is in advance taken medicine and was taken medicine continuously after reaching the destination 2 because of being not acclimatized produces the allergic symptom, and symptoms of allergic does not all appear in 6 volunteers.
The reagentia of table 7. Polyglucan
Anaphylactogen because of | Medicine time | Effective routine number |
Ethanol | Former 2 hours before of contact allergy | ????8 |
Seafood | Former 2 hours before of contact allergy | ????5 |
Being not acclimatized (dermatitis is scratched where it itches) | Reached the destination 2 days before | ????2 |
After reaching the destination | ????2 |
Being not acclimatized (rhinitis) | Reached the destination 2 days before | ????4 |
After reaching the destination | ????4 |
Above-mentioned studies show that, medicine of the present invention have the effect of Polyglucan reaction.Because IgE is the allergic main medium of mediation, has the intravital IgE concentration of allergies person obviously higher, infer that medicine of the present invention reaches prevention and alleviates allergic effect by the level of IgE in the control agent.