CN101879302A - Compound traditional Chinese medicine for treating slow arrhythmia and preparation method thereof - Google Patents

Abstract

The invention discloses a compound traditional Chinese medicine for treating slow arrhythmia, which is prepared from the following Chinese medicinal materials by weight: 24 to 36 grams of astragalus, 12 to 18 grams of cassia twig, 12 to 18 grams of desalted aconite accessory root, 24 to 36 grams of root of red-rooted salvia, 7 to 11 grams of szechuan lovage rhizome, 9 to 15 grams of malaytea scurfpea fruit, 4 to 8 grams honey-fried liquorice root, 4 to 8 grams of dried ginger and 1 to 3 grams of manchurian wildginger. A preparation method comprises the following steps of: extracting volatile oil in the cassia twig, the szechuan lovage rhizome, the dried ginger and the manchurian wildginger by using a steam distillation method, and performing the inclusion of beta-cyclodextrin to obtain an volatile oil inclusion compound; decocting the inclusion compound independently in water; decocting the remaining medicinal materials in the water for extracting, and depositing the extracted medicinal materials by using alcohol for refining; and merging extract, performing spray drying, adding the inclusion compound into dry powder, palletizing and packaging. The preparation method has the advantages of extracting volatile components in the compound traditional Chinese medicine effectively, retaining active ingredients of the compound traditional Chinese medicine farthest, improving the stability of the volatile components and greatly improving the solubility of the volatile components simultaneously, facilitating the implementation of a sequent preparation process, and improving the stability of preparations and the effect of clinical application, along with reasonability and simplicity.

Description

A kind of herbal mixture for the treatment of slow arrhythmia and preparation method thereof

Technical field

The present invention relates to herbal mixture for the treatment of slow arrhythmia and preparation method thereof.Belong to technical field of Chinese medicines.

Background technology

China is about to enter aging society at present, and old people's health problem will become one of key factor that influences family and social stability fast development.For the health that ensures the old people, promote quality of life, research old people's disease is developed all kinds of preventions, medicine is the important topic that important researcher faces.

Slow arrhythmia is the disease that a kind of heart abnormality is beaten, and is common senile disease, and long-term slow arrhythmia is that wherein common traditional Chinese medical science sign is sick sinus syndrome (being called for short " sick sinus syndrome "), and pathogenesis is not clear.Sick hole is the sinuatrial node pathological changes of chronic progressive external, good sending out in middle-aged and elderly people.But the cause of disease is very complicated, and the course of disease is also quite long, thereby the syndrome of clinical manifestation, light then dizzy, weak, cardiopalmus, breathes hard or the confused Mongolian of transience, when severe bradycardia and/or low level occurring and restrain slowly, can faint, even die suddenly.This type of sign belongs to the deficiency-cold syndrome that traditional Chinese medical science internal organs void declines basically.

Medically still do not have at present the clear and definite Therapeutic Method that can cure slow arrhythmia, except that pacemaker is installed, still do not have ideal medicine.According to " interior warp " " treatment of deficiency-syndrome by reinforcement's, cold person's using warming therapy " principle, the domestic report treated primary disease with warming YANG and invigorating QI method and warming the meridian and reinforcing YANG method curative effect preferably arranged.Based on the traditional Chinese medical science pathomechanism of sick hole, to advocate to rule together with heart kidney, QI and blood is taken into account and is the Therapeutic Principle, and the herbal mixture of research and development treatment slow arrhythmia has the important research value and the value of practical application.

Summary of the invention

The purpose of this invention is to provide a kind of herbal mixture for the treatment of bradyarrhythmia and preparation method thereof.

The herbal mixture of treatment slow arrhythmia of the present invention is to be made by the Chinese crude drug of following weight proportioning:

The Radix Astragali 24～36g Ramulus Cinnamomi 12～18g RADIX ACONITI LATERALIS PREPARATA 12～18g Radix Salviae Miltiorrhizae 24～36g Rhizoma Chuanxiong 7～11g

Fructus Psoraleae 9～15g Radix Glycyrrhizae Preparata 4～8g Rhizoma Zingiberis 4～8g Herba Asari 1～3g.

The optimum weight proportioning of treatment slow arrhythmia herbal mixture of the present invention is:

Radix Astragali 30g Ramulus Cinnamomi 15g RADIX ACONITI LATERALIS PREPARATA 15g Radix Salviae Miltiorrhizae 30g Rhizoma Chuanxiong 9g Fructus Psoraleae 12g Radix Glycyrrhizae Preparata 6g

Rhizoma Zingiberis 6g Herba Asari 2g

Treatment slow arrhythmia herbal mixture of the present invention is a granule, and its preparation method may further comprise the steps:

1) takes by weighing Ramulus Cinnamomi, Rhizoma Chuanxiong, Rhizoma Zingiberis and Herba Asari by the medical material proportioning, place round-bottomed flask, and add the water of 8 times of Ramulus Cinnamomi, Rhizoma Chuanxiong, Rhizoma Zingiberis and Herba Asari gross weight, soaked 1 hour;

2) with the round-bottomed flask of step 1) connection volatile oil extractor suitable for reading, adopt vapor distillation to extract 2～8 hours, filter the extracting solution in the round-bottomed flask, filtering residue keeps, and it is that 1.0 concentrated medicament is standby that filtrate is concentrated into relative density;

3) volatile oil in separation, the collection volatile oil extractor is also weighed, and places tool plug test tube, and the dehydrated alcohol that adds 2 times of volatile oil weight fully dissolves, and gets the volatile oil alcoholic solution, and close plug is standby;

4) take by weighing the beta-schardinger dextrin-of 9 times of volatile oil weight, add 60 ℃ water, be mixed with the beta-schardinger dextrin-saturated aqueous solution;

5) under 60 ℃ of constant temperature and magnetic agitation condition, get the volatile oil alcoholic solution of step 3), speed with 1ml/min, be added dropwise in the beta-schardinger dextrin-saturated aqueous solution of step 4), drip and finish back continuation constant temperature stirring 2 hours, obtain the Benexate Hydrochloride of volatile oil, after the cold preservation, take out, constant temperature stirred 1 hour for 60 ℃.Leave standstill, filter, the clathrate filtrate for later use, clathrate filtering residue vacuum drying is standby.

6) take by weighing RADIX ACONITI LATERALIS PREPARATA, Radix Salviae Miltiorrhizae, Fructus Psoraleae and Radix Glycyrrhizae Preparata according to the medical material proportioning, add the water of 12 times of RADIX ACONITI LATERALIS PREPARATAs, Radix Salviae Miltiorrhizae, Fructus Psoraleae and Radix Glycyrrhizae Preparata gross masses, soak after 1 hour, decoct and extracted 2 hours, filter; Filtering residue and step 2) filtering residue merge, add the water of 8 times of filtering residue gross weights again, decoct and extracted 1 hour, filter; The clathrate filtrate of merging filtrate and step 5), the concentrated medicament that to be evaporated to 40 ℃ of following relative densities be 1.05-1.06;

7) take by weighing the Radix Astragali by the medical material proportioning, add the water of 10 times of Radix Astragali quality, soak after 1 hour, decoct and extracted 2 hours, filter; Filtering residue adds the water of 8 times of Radix Astragali quality again, decocts to extract 1 hour, filters; Merging filtrate, the medicinal liquid that to be evaporated to 40 ℃ of following relative densities be 1.05-1.06 is standby;

8) with the concentrated medicament and the step 2 of step 6)) concentrated medicament merge, the ethanol that slowly adds mass concentration 95% under the stirring, make that to contain alcohol amount volume ratio be 70%, fully stir, filter after the cold preservation standing over night, the medicinal liquid that it is 1.08-1.10 that filtrate decompression is recycled to 40 ℃ of following relative densities is standby;

9) medicinal liquid of step 8) and the medicinal liquid of step 7) are merged, centrifugal, centrifugal liquid adds the adjuvant of medical material gross mass 22%, said medical material is a medical material whole in the herbal mixture, said adjuvant is that mass ratio is 1: 1 dextrin and a lactose, after 60 ℃ of constant temperature stirred, spray drying obtained spray drying powder;

10) the dry clathrate filtering residue of step 5) gained and the spray drying powder of step 9) are mixed, as wetting agent, cross 12 eye mesh screens and make granule, according to every bag 10g packing with mass concentration 95% ethanol.

The invention has the advantages that:

1, herbal mixture advance.The medical material proportioning of herbal mixture of the present invention is formed and is met traditional Chinese traditional treatment principle, forms after clinical verification, has suitable therapeutical effect, for the treatment of bradyarrhythmia rehabilitation of patients provides new medicament selection.

2, extraction process is rationally advanced.Ramulus Cinnamomi is the dry twig of canella Cortex Cinnamomi Ramulus cinnamomi, and main chemical compositions has cinnamic aldehyde, cinnamic acid and coumarin kind compound etc., has the effect that temperature is held up kidney yang; Rhizoma Chuanxiong is a samphire Rhizoma Chuanxiong Ligusticum chuanxiong Hort. rhizome, contains compositions such as ligustilide, new Fructus Cnidii lactone, has the effect of blood-activating and qi-promoting, wind-expelling pain-stopping; Rhizoma Zingiberis is the dried root of zingiber Zingiberaceae, contains compositions such as shogaol, Rhizoma Zingiberis Recens aldehyde, zingiberol, zingiberone, lauro lene, has the cold removing of invigorating blood circulation to effect; Herba Asari is the root and rhizome of aristolochiaceae plant Herba Asari Asarum heterot ropoi des Fr.Schmidt var.mandshuricum (Maxim.) Kitag., Seoul Herba Asari A.S iebol dii Miq.var.seoulense Nakai or magnificent Herba Asari A.siebol di i Miq., contain main components such as methyleugenol, australene, nopinene and limonene, therapeutic effect with heart tonifying, spasmolytic all contains more volatile oil in above-mentioned 4 kinds of Chinese medicines.Conventional water boiling and extraction process can't keep the volatile ingredient in the Chinese crude drug because of long-time open decoction, concentrated.And the present invention adopts the volatile ingredient in the vapor distillation extraction medical material, uses beta-cyclodextrin inclusion compound then, increases volatile oil stability and the dissolubility in water thereof, to satisfy the deliquescent needs of granule; Through medicinal residues and medicinal liquid and other decoctings extraction medical material merging processing that volatile oil extracts, further extract the water soluble ingredient in the medical material.Reach the purpose of efficient reservation medical material active component.

Other contained compositions in the medical material extract in the water boiling and extraction mode simultaneously.Radix Salviae Miltiorrhizae contains the diterpene quinones, other Diterpenes, compositions such as phenolic acids, RADIX ACONITI LATERALIS PREPARATA contains alkaloid, aminoacid and glucosides class etc., Fructus Psoraleae mainly contains Coumarins, flavonoid, monoterpene phenols etc., and Radix Glycyrrhizae contains organic acid, saponin etc., above-mentioned main component also contains the part liposoluble constituent simultaneously based on water soluble ingredient; Its most of effective ingredient can obtain by hot water extraction, therefore said components is merged with water boiling and extraction, and then the alcohol precipitation is removed impurity.The Radix Astragali contains active stronger triterpene saponin in the side, flavonoid, polysaccharide, aminoacid and trace element, composition can boil composition by decocting and extract, consider that simultaneously astragalus polysaccharides has definite raising immunity, the curative effect of strengthening the body resistance, for avoid this effective ingredient that runs off in the precipitate with ethanol process, the Radix Astragali is taked independent water boiling and extraction.

3, the present invention has improved ingredient stability and preparation process feasibility.Volatile oil is because volatile, easy oxidation, be difficult for preserving, simultaneously in follow-up preparation process research, there are application of sample difficulty, the poorly soluble problem of finished product, therefore volatile oil must be carried out character improvement, the preparation method of herbal mixture provided by the invention has improved stability and technology operability.

4, dosage form advance.Need not to decoct, granule had both met the medicine law of this treatment disease, and taking convenience, mouthfeel are good; The more important thing is that the crude drug carrying capacity is bigger, meet the needs of prescription total amount tcm development bigger than normal.

The specific embodiment

Embodiment 1

Take by weighing Chinese crude drug by following proportioning:

Radix Astragali 30g Ramulus Cinnamomi 15g RADIX ACONITI LATERALIS PREPARATA 15g Radix Salviae Miltiorrhizae 30g Rhizoma Chuanxiong 9g Fructus Psoraleae 12g Radix Glycyrrhizae Preparata 6g

Rhizoma Zingiberis 6g Herba Asari 2g

1) takes by weighing Ramulus Cinnamomi 15g, Rhizoma Chuanxiong 9g, Rhizoma Zingiberis 6g and Herba Asari 2g by the medical material proportioning, place round-bottomed flask, add 256g water, soaked 1 hour;

2) with the round-bottomed flask of step 1) connection volatile oil extractor suitable for reading, adopt vapor distillation to extract 7 hours, filter the extracting solution in the round-bottomed flask, filtering residue keeps, and it is that 1.0 concentrated medicament is standby that filtrate is concentrated into relative density;

3) volatile oil in separation, the collection volatile oil extractor is also weighed, and places tool plug test tube, and the dehydrated alcohol that adds 2 times of volatile oil weight fully dissolves, and gets the volatile oil alcoholic solution, and close plug is standby;

4) take by weighing the beta-schardinger dextrin-of 9 times of volatile oil weight, add 60 ℃ water, be mixed with the beta-schardinger dextrin-saturated aqueous solution.

5) under 60 ℃ of constant temperature and magnetic agitation condition, get the volatile oil alcoholic solution of step 3), speed with 1ml/min, be added dropwise in the beta-schardinger dextrin-saturated aqueous solution of step 4), drip and finish back continuation constant temperature stirring 2 hours, obtain the Benexate Hydrochloride of volatile oil, after the cold preservation, take out, constant temperature stirred 1 hour for 60 ℃.Leave standstill, filter clathrate filtrate for later use, clathrate filtering residue vacuum drying.

6) take by weighing RADIX ACONITI LATERALIS PREPARATA 15g, Radix Salviae Miltiorrhizae 30g, Fructus Psoraleae 12g and Radix Glycyrrhizae Preparata 6g according to the medical material proportioning, add 756g water, soak after 1 hour, decoct and extracted 2 hours, filter; Filtering residue and step 2) filtering residue merge, add the water of 8 times of filtering residue gross weights again, decoct and extracted 1 hour, filter; The clathrate filtrate of merging filtrate and step 5), the concentrated medicament that to be evaporated to 40 ℃ of following relative densities be 1.05-1.06;

7) take by weighing Radix Astragali 30g by the medical material proportioning, add 300g water, soak after 1 hour, decoct and extracted 2 hours, filter; Filtering residue adds 240g water again, decocts to extract 1 hour, filters; Merging filtrate, the medicinal liquid that to be evaporated to 40 ℃ of following relative densities be 1.05-1.06 is standby;

8) with the concentrated filtrate and the step 2 of step 6)) concentrated medicament merge, the ethanol that slowly adds mass concentration 95% under the stirring, make that to contain alcohol amount volume ratio be 70%, fully stir, filter after the cold preservation standing over night, the medicinal liquid that it is 1.08-1.10 that filtrate decompression is recycled to 40 ℃ of following relative densities is standby;

9) medicinal liquid of step 8) and the medicinal liquid of step 7) are merged, centrifugal, centrifugal liquid adds 27.5g dextrin and lactose, and dextrin and lactose respectively are 13.75g, and after 60 ℃ of constant temperature stirred, spray drying obtained spray drying powder;

10) the dry clathrate filtering residue of step 5) gained and the spray drying powder of step 9) are mixed, as wetting agent, cross 12 eye mesh screens and make granule with mass concentration 95% ethanol.According to every bag 10g packing.

Herbal mixture of the present invention is in the clinical practice example of treatment slow arrhythmia.

Patient's 46 examples, male's 29 examples, women's 17 examples; Age is 1 example below 20 years old, 21-40 year 5 examples, 41-50 year 7 examples, 51-60 year 22 examples, 61-70 year 10 examples, 1 example more than 71 years old, 54.0 ± 10.4 years old mean age.Occupation: workman's 20 examples, cadre's 14 examples, teacher's 4 examples, peasant's 2 examples, other 6 examples.This group patient makes a definite diagnosis all and meets " the diagnosis reference standard of sick sinus syndrome " that " CHINESE JOURNAL OF INTERNAL MEDICINE " 1977 formulated, sick sinus syndrome 41 examples wherein, suspicious sick sinus syndrome 5 examples.Press the Rubenstein classification method, this group belongs to I type person 28 examples, II type 12 examples, III type 6 examples." the common arrhythmia cause of disease, the order of severity and the curative effect reference standard " that the national prevention and treatment in Chinese and western coronary heart disease of reference, angina pectoris, arrhythmia research forum are formulated, this group case is carried out the cause of disease to be judged, belong to coronary heart disease 16 examples, hypertension and hypertensive heart disease 3 examples, viral myocarditis (containing sequela) 5 examples, cardiomyopathy 1 example, agnogenio 21 examples.The order of severity: belong to slight 3 examples, moderate 35 examples, severe 8 examples.The course of disease: fall ill 6 months with interior person's 9 examples, 1～3 year 6 example, 3～5 years 3 examples, 5～10 years 7 examples, 10～20 years 16 examples, 4 examples more than 20 years, not quite clear 1 example.Chinese medical discrimination typing: belong to the deficiency of vital energy 22 examples, yang deficiency 4 examples, gas sun two empty 5 examples, the deficiency of YIN 3 examples, deficiency of both QI and YIN 2 examples, deficiency of both YIN and YANG 2 examples, dialectical not quite clear 8 examples.

Therapeutic Method: at every turn take herbal mixture 10g, 3 times on the one.Taking medicine continuously 1 month was 1 course of treatment, and wherein 4 examples are obeyed 2 courses of treatment.

Observational technique:

1) heart rate: adopt auscultation and electrocardiogram method of determining and calculating to carry out record simultaneously, calculate average heart rate, compare before and after treating.

2) symptom curative effect: the common sympton of primary disease is meant dizziness, cardiopalmus, uncomfortable in chest, out of breath, weak etc., all adds up integrated value before and after the treatment respectively by the symptom integral method, calculates the percentage ratio that reduces the symptom integral value before controlling after the treatment with following formula then:

Symptom integral subtracts proportion by subtraction=(control preceding integrated value-Zhi after integrated value)/control preceding integrated value * 100%

The symptom curative effect is passed judgment on: symptom reduces 100% for disappearing, and it is produce effects that symptom reduces 〉=80%, and reducing 〉=60% is that effectively＜60% is invalid, and controlling the back instead increases more than 20% to worsening.

3) therapeutic effect of syndrome: the Chinese medical discrimination therapeutic effect of syndrome also adopts the integrated value before and after the treatment of integration method statistics, calculates integration by above-mentioned formula then and subtracts proportion by subtraction, and pass judgment on curative effect in view of the above.

4) ECG curative effect: Electrocardioscopy result routinely, carry out cross-reference, judge therapeutic effect.

5) control the comprehensive judgement of effect:, comprehensively judge according to common ARR curative effect reference standard in 1979.

Therapeutic outcome:

1) to the influence of heart rate

Average before the treatment of auscultation heart rate (inferior/minute) be 51.0 ± 7.1, be 61.9 ± 8.6 after the treatment, P＜0.001; Electrocardiogram measuring and calculating heart rate: average is 49.7 ± 5.5 before the treatment, is 58.1 ± 7.9 after the treatment, P＜0.001.

2) to the curative effect of common sympton

This is organized in 46 examples and totally 8 makes an exception except that the not quite clear person of registration symptom in asymptomatic or the treatment observation, all the other 38 routine subjective symptomss judges: 20 examples that disappear, produce effects 6 examples, effective 10 examples, invalid 2 examples.

3) to the curative effect of differentiation of symptoms and signs for classification of syndrome syndrome

This is organized in 46 examples and to remove dialectical not quite clear person 8 exceptions, the clear and definite person of all the other 38 routine differentiation of symptoms and signs for classification of syndrome syndromes, and after treatment, syndrome 9 examples that disappear, produce effects 7 examples, effective 21 examples, invalid 1 example.

4) to Electrocardiographic curative effect

Reduce some types by the performance of the electrocardiogram before and after the treatment.After taking medicine, electrocardiogram recovers normal person's 18 examples, improves 7 examples, and total effective rate is 54.35% (table 1).

Patient's electrocardiogram changes before and after table 1 treatment

5) to the influence of atropine provocative test

Observe atropine provocative test 26 examples before the treatment, positive 23 examples, negative 3 examples; Treatment is checked 12 examples after January, 7 examples of turning out cloudy, and 5 examples are still positive.Negative conversion rate is 58.33%.

6) to the effect of sinus node function

Do the atrium through esophagus and transfer the patient fight to count 28 examples, sinus node dysfunction 25 examples wherein, 23 examples of checking after 1 course of treatment, the most cases of every index all have improvement in various degree.See table 2 for details.

7) therapeutic effect is comprehensively judged

According to common ARR curative effect reference standard in 1979, comprehensive judged result: produce effects 16 examples, effective 23 examples, invalid 6 examples worsen 1 example, and total effective rate is 84.78%.

8) relation of differentiation of symptoms and signs for classification of syndrome and curative effect

In the dialectical 38 clear and definite examples, the inclined to one side deficiency of vital energy, yang deficiency are 33 main examples before the treatment, account for 86.8%.The deficiency of vital energy 22 examples wherein, produce effects 11 examples (holding the stasis of blood 3 examples under the arm), effective 8 examples, invalid 2 examples worsen 1 example; Yang deficiency 4 examples, effective 3 examples, invalid 1 example (holding stasis of blood type under the arm); Gas sun two empty 5 examples, produce effects 2 examples (hold the stasis of blood under the arm, hold each 1 example of phlegm-damp under the arm), effective 3 examples; Deficiency of both YIN and YANG 2 examples, produce effects, effective each 1 example.The inclined to one side deficiency of YIN is main person's 5 examples before the treatment, accounts for 13.2%..Produce effects 1 example, effective 4 examples (hold the stasis of blood under the arm, hold each 2 example of phlegm-damp under the arm).The former obvious effective rate is 42.42%, and the latter is 20%, points out this medicine that inclined to one side gas, yang deficiency person's curative effect are better than inclined to one side deficiency of YIN person.But deficiency of YIN person's example number is few partially, waits to confirm.

9) relation of sick hole typing and curative effect

I type 28 examples, produce effects 10 examples, effective 16 examples, invalid 2 examples; II type 12 examples, produce effects 2 examples, effective 7 examples, invalid 2 examples worsen 1 example; III type 6 examples, produce effects 4 examples, invalid 2 examples.Electrocardiogram typing and curative effect do not have the evident regularity variation.

Claims (4)

1. herbal mixture for the treatment of slow arrhythmia is characterized in that it is to be made by the Chinese crude drug of following weight proportioning:

The Radix Astragali 24～36g Ramulus Cinnamomi 12～18g RADIX ACONITI LATERALIS PREPARATA 12～18g Radix Salviae Miltiorrhizae 24～36g Rhizoma Chuanxiong 7～11g

Fructus Psoraleae 9～15g Radix Glycyrrhizae Preparata 4～8g Rhizoma Zingiberis 4～8g Herba Asari 1～3g.

2. by the herbal mixture of the described treatment slow arrhythmia of claim 1, it is characterized in that the weight proportion of each Chinese crude drug is:

Radix Astragali 30g Ramulus Cinnamomi 15g RADIX ACONITI LATERALIS PREPARATA 15g Radix Salviae Miltiorrhizae 30g Rhizoma Chuanxiong 9g Fructus Psoraleae 12g Radix Glycyrrhizae Preparata 6g

Rhizoma Zingiberis 6g Herba Asari 2g

3. by the herbal mixture of claim 1 or 2 described treatment slow arrhythmias, it is characterized in that said Chinese medicine is granule.

4. want the preparation method of the herbal mixture of 1 described treatment slow arrhythmia by right, it is characterized in that may further comprise the steps:

1) takes by weighing Ramulus Cinnamomi, Rhizoma Chuanxiong, Rhizoma Zingiberis and Herba Asari by the medical material proportioning, place round-bottomed flask, and add the water of 8 times of Ramulus Cinnamomi, Rhizoma Chuanxiong, Rhizoma Zingiberis and Herba Asari gross weight, soaked 1 hour;

2) with the round-bottomed flask of step 1) connection volatile oil extractor suitable for reading, adopt vapor distillation to extract 2～8 hours, filter the extracting solution in the round-bottomed flask, filtering residue keeps, and it is that 1.0 concentrated medicament is standby that filtrate is concentrated into relative density;

3) volatile oil in separation, the collection volatile oil extractor is also weighed, and places tool plug test tube, and the dehydrated alcohol that adds 2 times of volatile oil weight fully dissolves, and gets the volatile oil alcoholic solution, and close plug is standby;

4) take by weighing the beta-schardinger dextrin-of 9 times of volatile oil weight, add 60 ℃ water, be mixed with the beta-schardinger dextrin-saturated aqueous solution;

5) under 60 ℃ of constant temperature and magnetic agitation condition, get the volatile oil alcoholic solution of step 3), speed with 1ml/min, be added dropwise in the beta-schardinger dextrin-saturated aqueous solution of step 4), drip and finish back continuation constant temperature stirring 2 hours, obtain the Benexate Hydrochloride of volatile oil, after the cold preservation, take out, constant temperature stirred 1 hour for 60 ℃.Leave standstill, filter, the clathrate filtrate for later use, clathrate filtering residue vacuum drying is standby.

6) take by weighing RADIX ACONITI LATERALIS PREPARATA, Radix Salviae Miltiorrhizae, Fructus Psoraleae and Radix Glycyrrhizae Preparata according to the medical material proportioning, add the water of 12 times of RADIX ACONITI LATERALIS PREPARATAs, Radix Salviae Miltiorrhizae, Fructus Psoraleae and Radix Glycyrrhizae Preparata gross masses, soak after 1 hour, decoct and extracted 2 hours, filter; Filtering residue and step 2) filtering residue merge, add the water of 8 times of filtering residue gross weights again, decoct and extracted 1 hour, filter; The clathrate filtrate of merging filtrate and step 5), the concentrated medicament that to be evaporated to 40 ℃ of following relative densities be 1.05-1.06;

7) take by weighing the Radix Astragali by the medical material proportioning, add the water of 10 times of Radix Astragali quality, soak after 1 hour, decoct and extracted 2 hours, filter; Filtering residue adds the water of 8 times of Radix Astragali quality again, decocts to extract 1 hour, filters; Merging filtrate, the medicinal liquid that to be evaporated to 40 ℃ of following relative densities be 1.05-1.06 is standby;

8) with the concentrated medicament and the step 2 of step 6)) concentrated medicament merge, the ethanol that slowly adds mass concentration 95% under the stirring, make that to contain alcohol amount volume ratio be 70%, fully stir, filter after the cold preservation standing over night, the medicinal liquid that it is 1.08-1.10 that filtrate decompression is recycled to 40 ℃ of following relative densities is standby;

9) medicinal liquid of step 8) and the medicinal liquid of step 7) are merged, centrifugal, centrifugal liquid adds the adjuvant of medical material gross mass 22%, said medical material is a medical material whole in the herbal mixture, said adjuvant is that mass ratio is 1: 1 dextrin and a lactose, after 60 ℃ of constant temperature stirred, spray drying obtained spray drying powder;

10) the dry clathrate filtering residue of step 5) gained and the spray drying powder of step 9) are mixed, as wetting agent, cross 12 eye mesh screens and make granule, according to every bag 10g packing with mass concentration 95% ethanol.