CN115105564A - Traditional Chinese medicine composition for treating arrhythmia and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating arrhythmia and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating arrhythmia and a preparation method and application of a preparation thereof. The traditional Chinese medicine composition for treating arrhythmia is prepared from the following traditional Chinese medicines in parts by mass: 3-6 parts of angelica, 5-8 parts of rehmannia root, 5-8 parts of coptis root, 6-9 parts of rhizoma anemarrhenae and 2-4 parts of honey-fried licorice root. The invention also provides application of the medicine in preparing medicines for treating and preventing arrhythmia, including application in preparing medicines for treating or preventing premature ventricular contraction, ventricular tachycardia, ventricular fibrillation and cardiac arrest.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating arrhythmia and a preparation method and application of a preparation thereof.
Background
Arrhythmia refers to the abnormality of the frequency, rhythm, origin, conduction and speed or activation sequence of heart impulse, and is manifested clinically as palpitation, chest distress, shortness of breath, and too fast, slow or irregular pulse. Clinically, the arrhythmia can be classified into tachyarrhythmia and chronic arrhythmia according to the heart rate at the onset; tachyarrhythmia refers to arrhythmia in which the cardiac pacing point is in or outside the sinoatrial node, the ventricular rate is greater than 100 times/min, and is commonly seen in various organic heart diseases such as coronary heart disease, cardiomyopathy, myocarditis, rheumatic heart disease and the like, which often affect blood circulation, induce and aggravate cardiac insufficiency, and even cause death. Clinically common tachyarrhythmias include premature beats, paroxysmal tachycardia (supraventricular, ventricular), flutter and tremor (atrial, ventricular), pre-excitation syndrome, and the like. The etiology of the heart disease is complex, and heart diseases, non-heart diseases, drug side effects and the like can cause problems in a certain link of a cardiac pacing conduction system (sinus node, node bundle, atrioventricular node, atrioventricular bundle and the like), so that arrhythmia is caused.
At present, the incidence rate of arrhythmia has no definite statistics. The comparison of the incidence rates of various arrhythmias according to related data shows that the incidence rate of sinus arrhythmia is 25-27%, the incidence rate of sinus arrhythmia is 20-22%, the incidence rate of sinus tachycardia is 13-15%, the incidence rate of ventricular premature beat is 14-16%, the incidence rate of atrial premature beat is 5-7%, the incidence rate of atrial fibrillation is 11-15%, the incidence rate of atrioventricular conduction block is 5-7%, and the incidence rate of other arrhythmia is 5-8%. Clinically, various kinds of arrhythmia can occur singly or simultaneously, and the manifestation is complex.
Tachyarrhythmia is a common cardiovascular disease, and seriously affects the quality of life and life health of patients. An investigation and research in China discovers that the incidence rate of the tachyarrhythmia screened by the common people through the dynamic electrocardiogram is up to 40-75%. 2019 consensus of EHRA: management of asymptomatic arrhythmias indicates that arrhythmias may be indirect or persistent, and may be asymptomatic in many individuals, meaning that the actual number of arrhythmias is far above the clinical statistics. The clinical diagnosis of arrhythmia requires a detailed inquiry of medical history, symptoms and lifestyle habits, and then a detailed physical examination and electrocardiographic examination to help the analysis and diagnosis of the disease and type of the patient.
The treatment of arrhythmia can be long-term drug treatment, and intervention treatment and operation treatment such as electrical defibrillation, electrical cardioversion or artificial cardiac pacemaker can be carried out in severe cases; or catheter radiofrequency ablation to treat tachyarrhythmia. Although great progress has been made in treating tachyarrhythmia in a non-drug manner, such as radical atrioventricular nodal reentry tachycardia, atrioventricular reentry tachycardia, atrial flutter, ventricular tachycardia with normal cardiac structure and the like by radiofrequency catheter ablation, the success rate is high, but complications such as cardiac sack filling, atrioventricular conduction block and bleeding are easy to occur; an embedded automatic cardioversion defibrillator (ICD) can obviously improve prognosis of malignant ventricular arrhythmia, but the radiofrequency catheter ablation of atrial fibrillation has uncertain curative effect, the radiofrequency catheter ablation success rate of malignant ventricular arrhythmia is low, or even the ICD is treated, long-term administration is needed, so that the drug treatment is still the main method for treating tachyarrhythmia.
Currently, the common western medicines for treating arrhythmia mainly comprise: lidocaine, flecainide, sotalol, amiodarone, dofetilide, mexiletine, quinidine, verapamil and diltiazem. However, western medicines have great side effects and may induce more serious arrhythmia, so that clinicians are very alert. The commonly used traditional Chinese medicines for treating arrhythmia include: heart stabilizing granules, ginseng pine heart nourishing capsules and the like, but the medicines are mainly tonifying and nutritional ingredients and are suitable for people with poor constitution and malnutrition. More people with strong physique appear arrhythmia clinically, and no proper traditional Chinese medicine is available.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a traditional Chinese medicine composition for treating arrhythmia; the invention also aims to provide a preparation method and application of the traditional Chinese medicine composition.
The traditional Chinese medicine composition for treating arrhythmia is prepared from the following traditional Chinese medicinal materials in parts by mass: 3-6 parts of angelica sinensis, 5-8 parts of rehmannia root, 5-8 parts of coptis chinensis, 6-9 parts of rhizoma anemarrhenae and 2-4 parts of honey-fried licorice root.
Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by mass: 3 angelica, 5 rehmannia root, 5 coptis root, 6 rhizoma anemarrhenae and 2 honey-fried licorice root.
Preferably, the traditional Chinese medicine composition is prepared by taking the following traditional Chinese medicinal materials in parts by mass as raw materials: 5 parts of angelica sinensis, 6 parts of rehmannia root, 6 parts of coptis chinensis, 7 parts of rhizoma anemarrhenae and 3 parts of honey-fried licorice root.
Preferably, the traditional Chinese medicine composition is prepared by taking the following traditional Chinese medicinal materials in parts by mass as raw materials: 6 angelica, 8 rehmannia root, 8 coptis root, 9 rhizoma anemarrhenae and 4 honey-fried licorice root.
The traditional Chinese medicine composition for treating arrhythmia is prepared into any pharmaceutically acceptable oral dosage forms, and the dosage forms comprise: tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, buccal agents, granules, medicinal granules, pills, powder and the like.
The pharmaceutical composition can be used alone or further added with other pharmaceutical excipients to prepare various clinically used formulations, such as one or more of diluents, disintegrants, binders, wetting agents, lubricants, hydrophilic polymer materials, medicinal oil, flavoring agents and sustained-release materials, and can be prepared into oral liquid, tablets, pellets, granules, capsules, soft capsules, dripping pills, sustained-release tablets, sustained-release pellets or sustained-release capsules.
The preparation method of the preparation comprises the following steps: (1) extracting raw medicinal materials: taking the raw medicinal materials in the mass ratio, adding 10 times of water to extract for two times, each time for 1.5 hours, filtering, combining the decoction, standing for 12 hours, concentrating the supernatant into thick paste with the relative density of 1.20-1.25 (70 ℃), drying under reduced pressure, and crushing into fine powder. (2) And preparing the oral preparation according to a pharmaceutical method.
Wherein the granules are: mixing the above fine powder with dextrin, lactose and aspartame, granulating to 1000g, and packaging.
The traditional Chinese medicine composition for treating arrhythmia has the following characteristics:
(1) the formula is wonderful: rehmannia is a monarch drug with sweet and cold nature and flavor, enters heart, liver and kidney meridians, cools blood and nourishes yin, can nourish heart yin and tonify kidney yin to clear deficiency fire, and is a monarch drug. The angelica sinensis can enrich and activate blood, help the monarch to nourish yin and blood of the heart, and also has the effect of activating blood, and can prevent deficiency fire from burning yin and blood to stasis. The coptis root, rhizoma coptidis, rhizoma anemarrhenae, radix glycyrrhizae, an adjuvant drug and a guiding drug are used for treating the syndrome of fire excess, and the whole formula has the effects of nourishing blood, nourishing yin, purging fire and calming the heart.
(2) The extraction method is scientifically investigated: the invention considers the content of berberine hydrochloride and the paste yield of the coptis component as indexes and examines the solvent dosage, the extraction time, the times and the paste yield of the water extraction method by an orthogonal design method.
(3) The preparation is reasonable: the composition has high extraction rate, and the dosage is large if the composition is prepared into capsules and tablets; the granule not only keeps the characteristics of quick absorption, quick effect and the like of the decoction, but also overcomes the defects of easy mildewing of the decoction caused by temporary preparation and decoction before taking.
(4) The curative effect is remarkable: composition of the invention to CaCl 2 The arrhythmia of the mouse caused by the traditional Chinese medicine composition has obvious inhibiting effect; has intervention effect on rat arrhythmia caused by aconitine; it has inhibitory and prophylactic effects on arrhythmia of guinea pig caused by ouabain. The details will be described in detail in the examples.
Detailed Description
Example 1
Weighing the following raw materials in parts by mass: 150g of angelica, 250g of rehmannia root, 250g of coptis root, 300g of rhizoma anemarrhenae and 100g of honey-fried licorice root. Extracting with 10 times of water twice each for 1.5 hr, filtering, and mixing decoctions. Standing for 12 hr, concentrating the supernatant to obtain soft extract with relative density of 1.20-1.25 (70 deg.C), drying under reduced pressure, pulverizing into fine powder, adding dextrin, lactose and aspartame, mixing, and making into granule.
Example 2
Weighing the following raw materials in parts by mass: 250g of angelica, 300g of rehmannia root, 300g of coptis root, 350g of rhizoma anemarrhenae and 150g of honey-fried licorice root. Extracting with 10 times of water twice (each for 1.5 hr), filtering, and mixing decoctions. Standing for 12 hr, concentrating the supernatant to obtain soft extract with relative density of 1.20-1.25 (70 deg.C), drying under reduced pressure, pulverizing into fine powder, adding dextrin, lactose and aspartame, mixing, and granulating.
Example 3
Weighing the following raw materials in parts by mass: 300g of angelica, 400g of rehmannia root, 400g of coptis root, 450g of rhizoma anemarrhenae and 200g of honey-fried licorice root. Extracting with 10 times of water twice (each for 1.5 hr), filtering, and mixing decoctions. Standing for 12 hr, concentrating the supernatant to obtain soft extract with relative density of 1.20-1.25 (70 deg.C), drying under reduced pressure, pulverizing into fine powder, adding dextrin, lactose and aspartame, mixing, and making into granule.
Example 4
Weighing the following raw materials in parts by mass: 200g of angelica, 350g of rehmannia root, 350g of coptis root, 400g of rhizoma anemarrhenae and 150g of honey-fried licorice root. Extracting with 10 times of water twice (each for 1.5 hr), filtering, and mixing decoctions. Standing for 12 hr, concentrating the supernatant to obtain soft extract with relative density of 1.20-1.25 (70 deg.C), drying under reduced pressure, pulverizing into fine powder, adding dextrin, lactose and aspartame, mixing, and making into granule.
Example 5
Weighing the following raw materials in parts by mass: 300g of angelica, 200g of rehmannia root, 400g of coptis root, 300g of rhizoma anemarrhenae and 150g of honey-fried licorice root. Extracting with 10 times of water twice (each for 1.5 hr), filtering, and mixing decoctions. Standing for 12 hr, concentrating the supernatant to obtain soft extract with relative density of 1.20-1.25 (70 deg.C), drying under reduced pressure, pulverizing into fine powder, adding dextrin, lactose and aspartame, mixing, and making into granule.
Example 6
Taking the fine powder of any one of the embodiments 1-5, adding dextrin, pregelatinized starch and aspartame, mixing well, granulating, and filling into capsules.
Example 7
Taking the fine powder of any one of the embodiments 1-5, adding aspartame and sodium benzoate, adding water to make 1000ml, stirring, subpackaging, and sterilizing to obtain the oral liquid.
Example 8
Taking the fine powder of any one of the embodiments 1-5, adding starch and lactose, mixing uniformly, granulating, drying, tabletting, and coating film-coated tablets.
Example 9
In this example, the content and the extraction rate of berberine hydrochloride, which is a component of coptis chinensis, are used as indexes, and the solvent dosage, the extraction time and the extraction times of the water extraction method are determined through orthogonal experimental design.
An orthogonal test method is adopted, berberine hydrochloride content and cream yield are used as indexes, extraction solvent A, extraction time B and extraction frequency C in the extraction process are used as investigation factors, each factor is selected from three levels (shown in the following table 1), and experimental design is carried out according to a four-factor three-level orthogonal test table (shown in the following table 2).
TABLE 1 Water extraction factor table for rehmannia root and other herbs
| Level of factor | A extraction coal dissolving (double) | B extraction time (hours) | C number of times of extraction |
| 1 | 8 | 1 | 1 |
| 2 | 10 | 1.5 | 2 |
| 3 | 12 | 2 | 3 |
1 preparation of test solution
9 parts of radix rehmanniae recen 12g, angelica sinensis 10g, coptis chinensis 12g, rhizoma anemarrhenae 14g and radix glycyrrhizae preparata 6 g. According to the conditions listed in the orthogonal test table, the extracted liquid medicines are respectively combined, filtered, concentrated and prepared into solution containing 0.12g of coptis root per 1 ml.
2 determination of content of berberine hydrochloride
Precisely measuring sample solution 5ml, extracting with water saturated n-butanol solution for 2 times (20 ml each time), mixing n-butanol solutions, evaporating, dissolving residue with methanol, metering to 25ml, and shaking. Another 2ml of the solution was precisely transferred and placed in a 10ml measuring flask, methanol was added to the solution to a constant volume, the solution was shaken up and filtered through a 0.45 μm microporous membrane, and 20 μ l of the filtrate was sampled and measured, and the results are shown in table 2.
3 determination of cream yield
Precisely measuring each 20ml of the above extractive solution, placing in evaporating dish, evaporating to dryness in water bath, oven drying in oven at 105 deg.C for 3 hr, taking out, placing in desiccator, cooling, weighing rapidly, and calculating the paste yield (see Table 2).
TABLE 2 Water extraction orthogonal test result table for crude drugs such as Sheng Di Huang
TABLE 3 analysis of variance in berberine hydrochloride content extraction
| Factors of the design | Sum of squares of deviation | Degree of freedom | F ratio | Critical value of F | Significance of |
| Error of A | 82.889 | 2 | 1.000 | 19.000 | |
| B extraction time | 187.556 | 2 | 2.263 | 19.000 | |
| Number of C extractions | 29872.889 | 2 | 360.396 | 19.000 | ** |
*F 0.05 （2,2）=19.00 **F 0.01 （2,2）=99.00
TABLE 4 analysis of variance in extraction of cream yield
| Factors of the fact | Sum of squares of deviation | Degree of freedom | F ratio | Critical value of F | Significance of |
| A extraction solvent | 21.660 | 2 | 1.638 | 19.000 | |
| Error of B | 13.220 | 2 | 1.000 | 19.000 | |
| Number of C extractions | 460.940 | 2 | 34.867 | 19.000 | * |
*F 0.05 （2,2）=19.00 **F 0.01 （2,2）=99.00
4 orthogonal test results and results analysis
The results of visual analysis (see table 2) using berberine hydrochloride as the index show that C, B, A are important factors in order among the factors influencing berberine hydrochloride extraction, A is the factor A 2 ＞A 3 ＞A 1 Among the factors B, B 2 ＞B 3 ＞B 1 Among the factors C, C 3 ＞C 2 ＞C 1 The most preferred combination is A 2 B 2 C 3 . The results of the anova (see Table 3) show that (A is an error term), the B factor has no significant influence, the C factor has a very significant influence, and the optimal combination is A 2 B 2 C 3 . The results of visual analysis (see table 2) using the cream yield as the index show that the factors influencing the cream yield are C, A, B in turn, and among the factors A, A 3 ＞A 2 ＞A 1 Among the factors B, B 3 ＞B 2 ＞B 1 Among the factors C, C 3 ＞C 2 ＞C 1 The most preferred combination is A 3 B 3 C 3 . The results of the anova (see Table 4) show that (B is an error term), the factor A has no significant influence, the factor C has extremely significant influence, and the optimal combination is A 3 B 3 C 3 . Combining the analysis results and actual production, the preparation process of crude rehmannia root and other medicinal materials is determined as A 2 B 2 C 2 : that is, 10 times of water was added and extracted 2 times for 1.5 hours each time.
Example 10
The evaluation of the curative effect of the composition on the arrhythmia of the mice caused by calcium chloride is examined through a mouse model.
Medicament and apparatus
1.1 medicaments
The composition of the invention is extracted by water to obtain extract powder, 2.8g of crude drug/g of powder, and is provided by Suzhou Yusen New drug development Co. The invention relates to a formula A (radix rehmanniae, angelica, coptis and rhizoma anemarrhenae) dismantling powder with 2.5g of crude drugs/g, and a formula B (radix rehmanniae, angelica, coptis and radix glycyrrhizae preparata) dismantling powder with 2.1g of crude drugs/g. Prescription for heart disease: 30g of radix rehmanniae, 20g of angelica, 9g of coptis chinensis, 9g of scutellaria baicalensis, 15g of radix paeoniae alba, 15g of rhizoma anemarrhenae, 9g of ginseng, 15g of platycladi seed, 30g of amethyst, 30g of jujube kernel, 3g of liquorice, water extract powder and 3g of crude drug per g of powder. It is from the literature "the therapeutic effect and action mechanism discussion of the prescription for treating yin deficiency and fire excess type tachyarrhythmia" (bush, Zhang Hui, huiying. Chinese medicine pharmacology and clinic, 2020; 36 (3): 231).
Amiodarone hydrochloride tablets, 0.2 g/tablet, sunofil (hang state) pharmaceutical ltd, product lot number: 8HG 0451. Calcium chloride (Calcium chloride dihydrate, CaCl 2), minium 99%, SIGMA-ALDRICH product, cat #: C7902-500G, batch number: 058k 06941. 0.9% sodium chloride injection, 500 ml/bag, supplied by Beijing Huarun Shuanghe pharmaceutical industry Co., Ltd., lot number: D201905305.
1.2 instruments
Electrographic analysis system (Softron SP-2006), Beijing Soulong Biotechnology Ltd.
Test method
2.1 animals
60 ICR mice, SPF grade, male, weight 18-20g Beijing Wintolite laboratory animal technology Limited, license number: SCXK (Jing) 2016-. The certification number is as follows: 110011191106628.
2.2 grouping
Animals were randomly divided into 6 groups of 10 animals each, each: control group (normal saline 20 ml/kg), amiodarone hydrochloride group (80 mg/kg), the composition group of the invention (8 g crude drug/kg), the formula A group (7.1 g crude drug/kg), and the group B (6 g crude drug/kg); xinjiening group (8.6 g crude drug/kg). The intervention drugs adopted by the groups are prepared to the required concentration by normal saline, and are continuously administrated by intragastric administration for 3 days, and the amiodarone hydrochloride group is administrated by intragastric administration for 1 day, and the volume of the drugs is 20 ml/kg.
2.3 Molding and administration
CaCl 2 The concentration of the extract was 1.5g/100ml in physiological saline. 30 minutes after the last administration of each group of mice, 3.5 percent chloral hydrate is adopted for intraperitoneal injection anesthesia; then, an electrocardiogram analysis system is connected to record a standard II-lead electrocardiogram. Then injecting CaCl into mouse tail vein 2 (225 mg/kg, 15mg/ml, constant speed feed in 10 seconds), observing whether arrhythmia electrocardiogram is induced, recording arrhythmia incidence rate (%), arrhythmia duration (seconds), and calculating logarithm (Log); the results were statistically processed.
2.4 statistical analysis
The results are expressed as mean ± standard deviation (± S) and the differences between groups are compared using the t-test.
3 results of the test
The test result shows that the tail of the control group mice is injected with CaCl intravenously 2 Then, the heart rhythm goes from fast to slow, the cardiac arrest appears, and then arrhythmia electrocardiograms such as ventricular premature beat, ventricular tachycardia and spontaneous rhythm appear, and the normal electrocardiograms are gradually recovered. Tail vein injection of CaCl 2 The post-occurrence rate was 100%. Wherein the control group was injected with CaCl in tail vein 2 3 post-mortalities with a mortality rate of 30%. The results are shown in Table 5.
TABLE 5 inventive CaCl 2 Influence of incidence and duration of mouse arrhythmogenesis (± S)
| Group of | n | Incidence (%) | Duration (second) | Log(duration) |
| Control group | 7 | 100 | 275.0±40.9 | 2.44±0.06 |
| Amiodarone group | 10 | 100 | 91.3±25.4** | 1.94±0.12** |
| Square-disassembling A group | 10 | 100 | 251.0±34.5 | 2.39±0.11 |
| Group B of detachable squares | 10 | 100 | 248.2±59.2 | 2.38±0.18 |
| Compositions of the invention | 10 | 100 | 203.0±58.1* | 2.29±0.18* |
| Heart disease treating group | 10 | 100 | 208.8±46.2* | 2.21±0.16* |
Note: p <0.05, P <0.01, compared to control group
4 conclusion
In this experiment, it was observed that mouse tail was injected with CaCl intravenously 2 Then arrhythmia of different degrees appears, and the incidence rate of arrhythmia of the control group is 100 percent. Amiodarone significantly reduced the duration of arrhythmia (P) compared to the control group<0.01), the invention group and the heart disease treating group can obviously inhibit CaCl 2 The duration of the arrhythmia is obviously shortened (P)<0.05), may be associated with calcium channel blocking effects.
Example 11
The evaluation of the curative effect of the aconitine-induced rat arrhythmia by the composition disclosed by the invention and the related composition is examined through a rat model.
Medicaments and agents
1.1 medicaments
The water extract powder, the formula A, the formula B, the perhexiline powder, the amiodarone hydrochloride tablet and the 0.9% sodium chloride injection of the composition are the same as the first embodiment. Aconitine (Aconitine), C34H47NO11 the batch number is: 17120715, Shanghai Fengshi Biotech, Inc.
Instrument for measuring the position of a moving object
Electrocardiographic analysis system (Softron SP-2006), beijing glong biotechnology limited.
2 test method
2.1 animals
SD rats, SPF grade, 70, healthy, male, weight 160~180g, Beijing Witonglihua laboratory animal technology Limited, license number: SCXK (Kyoto) 2016-. The certification number is as follows: no. 1100111911007298.
2.2 grouping
SD rats were randomly divided into 6 groups of 10 animals each, each of which was: a control group (3 ml/kg of physiological saline), a western medicine amiodarone hydrochloride group (40 mg/kg), the composition of the invention (8 g of crude drug/kg), the formula-disassembled group A (7.1 g of crude drug/kg), the group B (6 g of crude drug/kg) and the heart disease treating group (8.6 g of crude drug/kg). The intervention drugs adopted by the groups are prepared to the required concentration by normal saline, the continuous intragastric administration is carried out for 3 days, the intragastric administration is carried out for 1 day by the amiodarone hydrochloride group, and the administration volume is 10 ml/kg.
2.3 method
Preparing aconitine: after dissolving a little with 1% diluted hydrochloric acid, the solution is prepared to 50 mug/ml with physiological saline, and diluted to 2.5 mug/ml with physiological saline before the test.
After the animals in each group are orally administered with corresponding intervention drugs for the last time, 1% sodium pentobarbital is used for intraperitoneal injection and anesthesia (50 mg/kg), and an electrocardiogram analysis system is connected to record a standard II-lead electrocardiogram. The left external jugular vein of the rat was then isolated and cannulated for external jugular vein. 2.5 mu g/mL aconitine solution is pumped into the external jugular vein at a constant speed of 0.083 mL/min. The time of appearance of ventricular premature beats (PVBs), Ventricular Tachycardia (VT), Ventricular Fibrillation (VF) and Cardiac Arrest (CA) was observed and recorded during the constant infusion of aconitine. And calculating the amount of aconitine consumed when the electrocardiogram appears. The results were statistically processed.
2.4 statistical analysis
The results are expressed as mean ± standard deviation (± S) and the differences between groups are compared using the t-test. P <0.05 is statistically significant.
3 results of the test
3.1 Aconitine-induced arrhythmia model in rats
By utilizing a Softron SP-2006 rat electrocardiogram analysis system, the electrocardiogram change of rats before and after aconitine-induced arrhythmia is monitored by taking II-lead electrocardiogram change of rats as an index. Electrocardiogram performance of the model group proves that aconitine intravenous injection can induce stable induction of arrhythmia of rats, and the severity of arrhythmia increases synchronously with the increase of dosage. After aconitine is injected into rats in a control group, electrocardiogram shows ventricular premature beat at first, then shows ventricular tachycardia and ventricular tachycardia, and finally records ventricular fibrillation and cardiac arrest, and the change of the electrocardiogram indicates that the aconitine induces the arrhythmia model of the rats to be successful.
3.2 Effect of the composition of the invention on Aconitine-induced arrhythmia in rats
Compared with the control group rats, the amiodarone group rats have obviously increased arrhythmia time of PVBs, VT and VF (P < 0.01). Party a group VT time increase (P < 0.05); the VT and VF time of the invention group and the Xinjining group is obviously increased (P <0.05 or P < 0.01). See table 6.
TABLE 6 Effect of the compositions of the present invention on Aconitine-induced arrhythmia time (+ -S) in rats PVBs, VT and VF
Note: p <0.05, P <0.01, compared to control group
3.3 Effect of the composition of the present invention on different arrhythmia tolerance levels in Aconitine-induced rats
Compared with the control group rats, the consumption of aconitine is obviously increased when the electrocardiograms of the amiodarone group rats have PVBs, VT and VF arrhythmia (P is less than 0.01). The aconitine consumption is obviously increased when the prescription B is dismantled into VF (P is less than 0.05); the aconitine consumption is obviously increased when the arrhythmia of VT and VF appears on the electrocardiogram of rats of the invention (P is less than 0.05); the aconitine consumption of rats in the Xinjiening group is obviously increased only when the electrocardiogram shows VT arrhythmia (P < 0.05). See table 7.
TABLE 7 Effect of the present invention on the amount of tolerance (+ -S) to aconitine-induced PVBs, VT and VF arrhythmias in rats
Note: p <0.05, P <0.01, compared to control group
4 conclusion
In this experiment, it was observed that the severity of arrhythmia increased synchronously with the increase in the intravenous dose of aconitine in rats in the control group. The composition of the invention can obviously prolong the time of different types of arrhythmia of rats, and simultaneously, the injection dosage of aconitine is increased to a certain extent. The composition has a certain intervention effect on arrhythmia caused by aconitine, and can inhibit myocardial cells Na + The internal flow is related.
Example 12
The inhibitory effect of the composition on the rapid arrhythmia of guinea pigs induced by the intravenous injection of ouabain is observed.
1 drugs and agents
1.1 medicaments
The water extract powder, the formula A, the formula B, the perhexiline powder, the amiodarone hydrochloride tablet and the 0.9% sodium chloride injection of the composition are the same as the first embodiment. Ouabain (Ouabain octahydrate), SIGMA-ALDRICH product, lot number: 029K 1076. Pentobarbital sodium, imported and separately packaged in Germany, Beijing chemical reagent company, product batch number: 020402.
1.2 instruments
Electrocardiographic analysis system (Softron SP-2006), beijing glong biotechnology limited. ALC-IP800LB microinjection Pump (ALC-IP 800LB Syring Pump), Older Biotechnology, Inc., Shanghai.
2 test method
2.1 animals
60 common-grade guinea pigs, male, weight 240-: SCXK (Jing) 2009-0014.
2.2 grouping
The guinea pigs are randomly divided into 6 groups, each group comprises 10 guinea pigs, a control group (distilled water is 3 ml/kg), a control western medicine amiodarone hydrochloride (30 mg/kg), intervention medicines adopted by the composition (8 g crude medicines/kg), the prescription A group (7.1 g crude medicines/kg), the B group (6 g crude medicines/kg) and the prescription for treating heart diseases (8.6 g crude medicines/kg) are all prepared to required concentration by normal saline, the administration is continuously performed for 3 days by intragastric administration, the administration is performed for 1 day by intragastric administration for the amiodarone hydrochloride group, and the administration volume is 10 ml/kg.
2.3 method
And (3) preparation of ouabain: the concentration of the solution was 100. mu.g/ml in physiological saline. 30 minutes after each group of guinea pigs are administered with the last dose, the guinea pigs are anesthetized by pentobarbital sodium intraperitoneal injection (35 mg/kg), and are connected with an electrocardiogram analysis system to record standard II-lead electrocardiogram; subsequently, the guinea pigs were isolated from the left external jugular vein and were administered ouabain (100. mu.g/ml, 0.1 ml/min) at a constant rate using a micro syringe pump, and the animals were observed for the time of ventricular premature beats (PVBs), Ventricular Tachycardia (VT), Ventricular Fibrillation (VF) and Cardiac Arrest (CA) to calculate ouabain consumption (. mu.g/kg). The results were statistically processed.
2.4 statistical analysis
Results are expressed as mean ± standard deviation (± s), and comparisons of differences between groups were performed using the t-test. P <0.05 is statistically significant.
3 results of the test
3.1 ouabain-induced rat arrhythmia model
By utilizing a Softron SP-2006 rat electrocardiogram analysis system, the electrocardiogram change of rats before and after the arrhythmia induced by ouabain is monitored by taking the II-lead electrocardiogram change of rats as an index. After intravenous injection of ouabain, the electrocardiogram of the rats in the control group shows ventricular premature beat, then shows ventricular tachycardia and ventricular tachycardia, and finally records ventricular fibrillation and cardiac arrest, and the change of the electrocardiogram indicates that the ouabain induces the guinea pig arrhythmia model to be successful.
3.2 Effect of the composition of the present invention on ouabain-induced arrhythmia in Guinea pigs
Compared with the control group rats, the amiodarone group rats have obvious increase of PVBs, VT, VF and CA time in electrocardiogram and have statistical significance (P < 0.01). The composition of the invention has obvious increase of PVBs, VT, VF and CA time (P < 0.05) on the electrocardiogram of rats. See table 8.
TABLE 8 influence of 'Anxin' granules on PVBs and VT arrhythmic time (. + -. S) in guinea pigs induced by ouabain
Note: p <0.05, P <0.01, compared to control group
3.3 Effect of the composition of the present invention on the amount of different arrhythmia tolerance in Ouabain rats
Test results show that compared with a control group, the consumption of ouabain is obviously increased when rats in the amiodarone group have PVBs, VT, VF and CA arrhythmia (P is less than 0.01); the consumption of ouabain is obviously increased when the rats develop VT and VF (P < 0.05). The results are shown in Table 9.
TABLE 9 Effect of the present invention on Wabayin-induced PVBs and VT arrhythmia tolerance in guinea pigs (+ -S)
Note: p <0.05, P <0.01, compared to control group
4 conclusion
The composition of the invention has certain inhibition and prevention effects on guinea pig arrhythmia caused by ouabain, and can partially reduce ouabain consumption which is induced arrhythmia. The possible mechanism of action is membrane stabilization, inhibition of Na + 、Ca 2+ Influx thus antagonizing the arrhythmia.
Example 13
This example examines the efficacy of the compositions of the present invention in a rat ischemia reperfusion injury model.
1 drugs and agents
1.1 medicaments
The water extract powder, the formula A, the formula B, the perhexiline powder, the amiodarone hydrochloride tablet and the 0.9% sodium chloride injection of the composition are the same as the first embodiment.
1.2 instruments
ALC-V8 model Small animal ventilator, Shanghai Orkets Biotechnology Ltd. Electrocardiographic analysis system (Softron SP-2006), beijing Softron biotechnology limited.
2 test method
2.1 animals
SD rats, SPF grade, 70 male, weight 180-200 g, provided by Sibefu (Beijing) laboratory animal science and technology Limited, license number: SCXK (Jing) 2019-.
2.2 grouping
SD rats were randomly divided into 6 groups of 10 animals each, each of which was: compared with a control group (3 ml/kg of normal saline) and a western medicine amiodarone hydrochloride group (40 mg/kg), intervention medicines adopted by the composition (8 g of crude drugs/kg), the disassembled prescription A group (7.1 g of crude drugs/kg), the disassembled prescription B group (6 g of crude drugs/kg) and the Xinjiening group (8.6 g of crude drugs/kg) are all prepared to required concentration by normal saline, and are continuously administered for 3 days by intragastric administration, and the amiodarone hydrochloride group is administered for 1 day by intragastric administration, and the administration volume is 10 ml/kg.
2.3 method
After the animals in each group were individually gazed with the corresponding intervention drugs, they were anesthetized by intraperitoneal injection with 1% sodium pentobarbital (50 mg/kg). Rats were fixed to the rat plate in supine position. Separating the skin and subcutaneous tissue in the center of the neck, cutting the gap between the 3 rd and 4 th tracheal cartilages, inserting a simple tracheal catheter, and connecting a small animal respirator for auxiliary respiration. The chest was then opened along the left intercostal 4 th, the muscles and ribs were bluntly separated, the pericardium carefully teased out after the ribs were separated, the heart was exposed and pressed against the thoracico-abdominal to squeeze out the heart, and a thread (suture No. 0) was threaded between the pulmonary artery cone and the left atrial appendage at the root of the left anterior descending coronary artery in preparation for ligation. And meanwhile, an electrocardiogram analysis system is connected to record a standard II-lead electrocardiogram as a baseline electrocardiogram. And (5) ligating the left anterior descending branch of the coronary artery after the rat is stable for 10 min. The change of the reddish complexion of the heart surface to pale complexion is observed under the direct vision of the heart, which is the success of the myocardial infarction model. The rat was observed for respiration and heartbeat. After 15min of ligation of the left anterior descending branch of the coronary artery, the ligature is cut off to realize reperfusion of the anterior descending branch. After reperfusion, the animals generally develop arrhythmia of different degrees such as ventricular premature beats (PVBs), Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) within about 1 minute immediately. The number of PVBs and the total VT + VF time course (in seconds) were observed within 10 minutes after reperfusion.
3 results
Test results show that arrhythmia of different degrees occurs within 1 minute immediately after reperfusion of the control group. Compared with the control group, the total time course of the amiodarone group rats in myocardial ischemia reperfusion within 10min is obviously reduced, and the amiodarone group rats have statistical significance (P < 0.01). The number of PVBs and the total VT + VF time course of the group of the invention are obviously reduced (P < 0.05). The results are shown in Table 10.
TABLE 10 Effect of the invention on the number of PVBs and the total time course of (VT + VF) after myocardial ischemia-reperfusion injury in rats (+ -S)
| Group of | n | PVBs（n） | （VT+VF）(s) |
| Control group | 10 | 10.82±5.42 | 320±62 |
| Amiodarone group | 10 | 6.28±1.25** | 242±45** |
| Square-disassembling A group | 10 | 12.28±4.54 | 324±84 |
| Group B of detachable squares | 10 | 11.74±5.25 | 306±62 |
| Group of the invention | 10 | 7.58±6.36* | 284±48* |
| Heart disease treating group | 10 | 10.78±4.54 | 299±35 |
Note: p <0.05, P <0.01, compared to control group
4 conclusion
The PVBs number and the total time course (VT + VF) of the group are obviously shortened, which shows that the invention has obvious inhibiting and preventing effects on arrhythmia induced by rat ischemia-reperfusion injury.
Claims (10)
1. A traditional Chinese medicine composition for treating arrhythmia is characterized by being prepared from the following traditional Chinese medicinal materials in parts by mass: 3-6 parts of angelica, 5-8 parts of rehmannia root, 5-8 parts of coptis root, 6-9 parts of rhizoma anemarrhenae and 2-4 parts of honey-fried licorice root.
2. The traditional Chinese medicine composition as claimed in claim 1, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by mass: 3 parts of angelica sinensis, 5 parts of rehmannia glutinosa, 5 parts of coptis chinensis, 6 parts of rhizoma anemarrhenae and 2 parts of honey-fried licorice root.
3. The traditional Chinese medicine composition as claimed in claim 1, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by mass: 5 parts of angelica sinensis, 6 parts of rehmannia root, 6 parts of coptis chinensis, 7 parts of rhizoma anemarrhenae and 3 parts of honey-fried licorice root.
4. The traditional Chinese medicine composition as claimed in claim 1, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by mass: 6 angelica, 8 rehmannia root, 8 coptis root, 9 rhizoma anemarrhenae and 4 honey-fried licorice root.
5. A traditional Chinese medicine composition preparation for treating arrhythmia, which is characterized in that the traditional Chinese medicine composition preparation is any pharmaceutically acceptable oral dosage form prepared by taking the traditional Chinese medicine composition as the raw material according to claim 1 or 2 or 3 or 4.
6. The Chinese medicinal composition preparation as claimed in claim 5, which is in the form of granules.
7. The method for preparing the Chinese medicinal composition preparation of claim 5, which comprises the following steps: the preparation method of the preparation comprises the following steps: (1) extracting raw medicinal materials: taking the raw medicinal materials in the mass ratio, adding 10 times of water to extract twice, each time for 1.5 hours, filtering, combining the decoctions, standing for 12 hours, concentrating the supernatant into thick paste with the relative density of 1.20-1.25 (70 ℃), drying under reduced pressure, crushing into fine powder (2), and preparing into an oral preparation according to a pharmaceutical method.
8. The method for preparing a granular formulation of a Chinese medicinal composition according to claim 6, wherein the fine powder prepared according to claim 7 is added with dextrin, lactose and aspartame, and then the mixture is uniformly mixed and prepared into granules.
9. Use of the Chinese medicinal composition of claim 1 or 2 or 3 or 4 in the preparation of a medicament for treating or preventing arrhythmia.
10. The use of the Chinese medicinal composition of claim 9 in the preparation of medicaments for the treatment or prevention of ventricular premature beats (PVBs), Ventricular Tachycardia (VT), Ventricular Fibrillation (VF) and Cardiac Arrest (CA).
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| CN1650917A (en) * | 2004-12-01 | 2005-08-10 | 山东中医药大学附属医院 | Medicine for treating arrhythmia and its preparation method |
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