CN103432377B - Preparation method of Wenxin Formulation - Google Patents

Abstract

The invention discloses a preparation method of Wenxin Formulation, which relates to a preparation method of a traditional Chinese medicinal composition for treating the syndrome of heart-qi insufficiency and solves the problem in the prior art that there is no a pharmaceutical preparation process for Wenxin Formulation. The method comprises (1) taking white ginseng, cassia twig, Trichosanthes kirilowii, Allium macrostemon, Ternate pinellia, Paeonia lactiflora, Ophiopogon japonicas and Coptis chinensis, reflux-extracting with ethanol, and cooling and then filtering the extraction liquid; (2) adding ethanol into the extraction residues for reflux-extraction, cooling and then filtering the extraction liquid, adding ethanol into the extraction residues again for reflux-extraction, mixing all the filtrates, recovering the filtrates under reduced pressure, concentrating until no ethanol smell is detected, evaporate to dryness in an evaporating dish, and then vacuum-drying. The preparation method of Wenxin Formulation (a traditional Chinese medicinal composition for treating the syndrome of heart-qi insufficiency), disclosed in the invention, has a simple and convenient process, conforms to the requirements in real production, and solves the problem in the prior art that there is no a pharmaceutical preparation process for Wenxin Formulation. The prepared Wenxin Formulation has definite efficacy on the syndrome of heart-qi insufficiency, and the total effectiveness reaches 90.8%.

Description

A kind of preparation method of Chinese medicine composition

Technical field

The present invention relates to the preparation method of the Chinese medicine composition for the treatment of syndrome of deficiency of heart qi.

Background technology

Wen Xinfang by Radix Ginseng, Ramulus Cinnamomi, Fructus Trichosanthis, Bulbus Allii Macrostemonis, Rhizoma Pinelliae, Radix Paeoniae Rubra, Radix Ophiopogonis, Rhizoma Coptidis form, be the Empirical formula of the glad Experience in Treating syndrome of deficiency of heart qi of Cao Hong; The party is for the pathogenic characteristic of coronary heart disease deficiency of heart-YANG, phlegm and blood stasis, sanctionization is added and subtracted on " Gualou Xiebai Banxia Tang " basis, through long-term clinical practice and lot of experiments, show syndrome of deficiency of heart qi, syndrome of deficiency of heart-YANG determined curative effect, total effective rate 90.9%.But, because it is clinical experience side, lack medicine preparation technology and the quality standard of applicable actual production, constrain Wen Xinfang quality control evaluation Establishing and industrialization Production requirement.

Summary of the invention

The object of the invention is to solve the problem that existing Wen Xinfang does not have the medicine preparation technology of actual production, and the preparation method of Wen Xinfang is provided.

The preparation method of Wen Xinfang is carried out as follows:

One, 8 ~ 12g Radix Ginseng, 8 ~ 12g Ramulus Cinnamomi, 13 ~ 17g Fructus Trichosanthis, 13 ~ 17g Bulbus Allii Macrostemonis, 8 ~ 12g Rhizoma Pinelliae, 13 ~ 17g Radix Paeoniae Rubra, 13 ~ 17g Radix Ophiopogonis and 3 ~ 7g Rhizoma Coptidis is got, adding the mass concentration accounting for said medicine gross mass 8 times amount is 70% ethanol, then reflux, extract, 3 times, each 1 ~ 2 hour, merge extractive liquid, also cools 10 ~ 15min, then through 16 layers of filtered through gauze;

Two, adding the mass concentration accounting for filtering residue gross mass 8 times amount in the filtering residue after filtering to step one is 70% ethanol, reflux, extract, 1 hour, extracting solution cooling 10 ~ 15min, then through 16 layers of filtered through gauze, it is 70% ethanol that filtering residue after filtration adds the mass concentration accounting for filtering residue quality 8 times amount again, reflux, extract, 1 hour, all filtrate in combining step one and step 2, reclaim under reduced pressure filtrate, be concentrated into without alcohol taste, then proceed in evaporating dish, 70 DEG C of heating in water bath evaporates to dryness, then be placed in vacuum drying oven dry, namely complete the preparation of Wen Xinfang.

The preparation method of Wen Xinfang in the present invention, Wen Xinfang is the Chinese medicine composition for the treatment of syndrome of deficiency of heart qi, in its preparation technology, Extraction solvent ethanol water used is cheap and easy to get, technological operation is easy and the content of flour extraction and main component can be made to reach optimum state, realistic production requirement, perfectly solves the problem that existing Wen Xinfang does not have the medicine preparation technology of actual production.By the finger printing of Wen Xinfang quality control, demonstrating the present invention can carry out quality control to Wen Xinfang xeraphium all sidedly; With main component adenosine, cinnamic acid, berberine hydrochloride for index, carry out novel composing prescription multicomponent assay simultaneously, supplement the deficiency of finger printing reflection stoichiometric information, meet the feature of middle medical drugs globality, further prove its active constituent content conformance with standard of Wen Xinfang prepared by the present invention.

Gained Wen Xinfang is prepared in the present invention, to syndrome of deficiency of heart qi determined curative effect, effectively can eliminate spontaneous perspiration, cardiopalmus, breathe hard, the common disease of uncomfortable in chest, pallor light red tongue and deficient pulse, total effective rate is 90.8%, and have no side effect, long-term taking also can not damage internal organs, and drug dependence is less, and medication is safer.

Accompanying drawing explanation

Each group rat body weight variation diagram during Fig. 1 is Treated with Chinese Decoction; In figure, 1 is blank group, and 2 is low dose group, and 3 is natural recovering group, and 4 is high dose group;

Fig. 2 is the intrinsic pressure figure of blank group rat cardiac ventricular;

Fig. 3 is the intrinsic pressure figure of natural recovering group rat cardiac ventricular;

Fig. 4 is the intrinsic pressure figure of high dose group rat cardiac ventricular;

Fig. 5 is the intrinsic pressure figure of low dose group rat cardiac ventricular;

Fig. 6 is the cardiac myocytes tissue morphology microscopy figure of normal rat;

Fig. 7 is the muscle fiber microscopy figure of natural recovering group rat heart;

Fig. 8 is the interstitial blood capillary microscopy figure of natural recovering group rat heart;

Fig. 9 is the interstitial microscopy figure of natural recovering group rat heart;

Figure 10 is natural recovering group rat heart microscopy figure;

Figure 11 is the tissue morphology microscopy figure of high dose group rat heart;

Figure 12 is the blood capillary microscopy figure of high dose group rat heart;

Figure 13 is the interstitial microscopy figure of high dose group rat heart;

Figure 14 is the blood capillary microscopy figure of high dose group rat heart;

Figure 15 is the interstitial microscopy figure of low dose group rat heart;

Figure 16 is the tissue morphology microscopy figure of low dose group rat heart;

Figure 17 is the blood capillary microscopy figure of low dose group rat heart;

Figure 18 is the interstitial microscopy figure of low dose group rat heart;

Figure 19 is the myocardial ultrastructure figure that blank group rat amplifies 6000 times;

Figure 20 is the myocardial ultrastructure figure that blank group rat amplifies 11500 times;

Figure 21 is the myocardial ultrastructure figure that natural recovering group rat amplifies 6000 times;

Figure 22 is the myocardial ultrastructure figure that natural recovering group rat amplifies 11500 times;

Figure 23 is the myocardial ultrastructure figure that high dose group rat amplifies 6000 times;

Figure 24 is the myocardial ultrastructure figure that high dose group rat amplifies 11500 times;

Figure 25 is the myocardial ultrastructure figure that low dose group rat amplifies 6000 times;

Figure 26 is the myocardial ultrastructure figure that low dose group rat amplifies 11500 times.

Detailed description of the invention

Technical solution of the present invention is not limited to following cited detailed description of the invention, also comprises the combination in any between each detailed description of the invention.

The preparation method of detailed description of the invention one: present embodiment Wen Xinfang is carried out as follows:

One, 8 ~ 12g Radix Ginseng, 8 ~ 12g Ramulus Cinnamomi, 13 ~ 17g Fructus Trichosanthis, 13 ~ 17g Bulbus Allii Macrostemonis, 8 ~ 12g Rhizoma Pinelliae, 13 ~ 17g Radix Paeoniae Rubra, 13 ~ 17g Radix Ophiopogonis and 3 ~ 7g Rhizoma Coptidis is got, adding the mass concentration accounting for said medicine gross mass 8 times amount is the ethanol of 70%, then reflux, extract, 3 times, each 1 ~ 2 hour, merge extractive liquid, also cools 10 ~ 15min, then through 16 layers of filtered through gauze;

Two, adding the mass concentration accounting for filtering residue gross mass 8 times amount in the filtering residue after filtering to step one is the ethanol of 70%, reflux, extract, 1 hour, extracting solution cooling 10 ~ 15min, then through 16 layers of filtered through gauze, it is the ethanol of 70% that filtering residue after filtration adds the mass concentration accounting for filtering residue quality 8 times amount again, reflux, extract, 1 hour, all filtrate in combining step one and step 2, reclaim under reduced pressure filtrate, be concentrated into without alcohol taste, then proceed in evaporating dish, 70 DEG C of heating in water bath evaporates to dryness, then be placed in vacuum drying oven dry, namely complete the preparation of Wen Xinfang.

Wen Xinfang prepared by present embodiment, it is the Chinese medicine composition for the treatment of syndrome of deficiency of heart qi, adopts oral administration; Usage and dosage: adult every day 2 times, a 9-13g 4 weeks is a course for the treatment of.

Wen Xinfang prepared by present embodiment, it is the pharmaceutical composition for the treatment of syndrome of deficiency of heart qi, and its Chinese crude drug effect is resolved as follows:

Sweet, the micro-hardship of monarch drug Radix Ginseng nature and flavor, tepor, returns spleen lung, the heart, kidney channel.Function is strongly invigorating primordial QI, and multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid and nourish blood, Fructus Alpiniae Oxyphyllae of calming the nerves; Be rich in Ginsenosides, ginseng polysaccharide, volatile oil, sterols and aminoacid, vitamin etc., wherein Ginsenosides is main active.Large quantity research shows, ginsenoside can protecting myocardial cell, reduces blood pressure and blood lipoid level, resists myocardial ischemia.

Monarch drug Ramulus Cinnamomi nature and flavor acrid, sweet, warm.GUIXIN, lung, urinary bladder channel.Function is diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.Containing a large amount of volatile oil in Ramulus Cinnamomi, take cinnamic aldehyde as main component, also comprise cinnamic acid, cinnamyl alcohol, syringic aldehyde, coumarin, 2-methoxybenzoic acid, protocatechuic acid etc.In addition steroidal compounds is also had as crossed cupreol, daucosterol, 5 α, 8 α-Ergosterol Peroxide etc.Research shows that Ramulus Cinnamomi ethanol extraction has discharged vasodilator effect by suppressing Ca2+ influx and calcium.Wherein syringic aldehyde and cinnamic acid can have antioxidant activity, have protective effect to gastric mucosa injury.

Ministerial drug Bulbus Allii Macrostemonis nature and flavor are pungent, bitter, temperature.GUIXIN, lung, stomach, large intestine channel.Function is activating YANG and eliminating stagnation, circulation of qi promoting intestinal stasis relieving.Have the compositions such as furostanol, volatile oil, nitrogen-containing compound, aminoacid from the compound be wherein separated, wherein Furost saponine is its main active, and what have now found that has macrostemonoside A, E, F, G, J, L, H, I etc.The human blood platelets activation that macrostemonoside can suppress adenosine diphosphate (ADP) (ADP) to be induced and gathering, to the cytotoxic activity of different tumor cell line.Macrostemonoside A can blood sugar lowering, can raise peroxisome proliferators activated receptor γ and express, and increase the activity of lipase in visceral adipocytes and obesity, the structure of its steroid has the effect of potential protection cardiovascular system.

Sweet, the micro-hardship of ministerial drug Fructus Trichosanthis nature and flavor, cold.Return lung, stomach, large intestine channel.Function is clearing away heat and eliminating phlegm, and relieving stuffiness of the chest by dispersing aggregation of pathogens, moisturizes laxation.Containing abundant fatty oil in Semen Trichosanthis, wherein there are the unsaturated fatty acids such as linolenic acid, Palmic acid, myristic acid, stearic acid, trichosanic acid, and the pentacyclic triterpene such as sterol, karounidiol and cucurbitacine tetracyclic triterpene etc.Report research report, unsaturated fatty acid can reduce triglyceride and mean arterial blood pressure, and in diet, the picked-up of unsaturated fatty acid can reduce the probability suffering from cardiovascular disease.Linoleic acid can suppress macrophage adhesion activity can atherosclerosis, reduces serum LDL cholesterol level, because this reducing incidence of coronary heart disease probability.

Ministerial drug Rhizoma Pinelliae nature and flavor are pungent, temperature.Return spleen, stomach, lung meridian.Function is drying dampness to eliminate phlegm, and for cough due to damp-phlegm, gastral cavilty feeling of fullness, sputum condenses, and coughs up and can not tell.Now from the Rhizoma Pinelliae, isolated main component has volatile oil, fatty acid, nucleoside, amino acid and protein etc.Wherein fatty acid is based on unsaturated fatty acids such as linoleic acids.Large quantity research shows, the adenosine in nucleoside, can pass through specific adenosine receptor, have direct protective effect to myocardial cell, is also the active drug for the treatment of paroxysmal supraventricular tachycardia simultaneously.

Ministerial drug Radix Paeoniae Rubra nature and flavor are bitter, are slightly cold.Return Liver Channel.Function is clearing away heat and cooling blood, eliminating stasis to stop pain.From Radix Paeoniae Rubra in isolated chemical composition, with monoterpene and monoterpene glycosides content more, be secondly triterpene and glycoside thereof, flavonoid, tannin class, sterols, organic acid and several amino acids and trace element.Monoterpene glycosides in Radix Paeoniae Rubra is usually by aromatic acid esterifications such as benzoic acid, P-hydroxybenzoic acid and gallic acids.Modern pharmacological research shows; peoniflorin suppresses the growth of human colon cancer cell; Human Umbilical Vein Endothelial Cells apoptosis has protective effect; by alleviating inflammatory cell infiltration and the penetrating protection acute lung injury of blood capillary; its antiinflammatory action can reduce cerebral infarction and the neurologic impairment of ischemical reperfusion injury rat, the myocardial ischemia/reperfusion injury of cardioprotection.The rat heart function of gallic acid to diabetes-induced does not have cardioprotection entirely, the heart lysosome damage preventing isoproterenol from causing.

Sweet, the micro-hardship of adjuvant drug nature and flavor Radix Ophiopogonis, is slightly cold.GUIXIN, lung, stomach warp.Function is YIN nourishing and the production of body fluid promoting, and lung moistening clears away heart-fire.Radix Ophiopogonis, main chemical compositions was steroidal saponin, polysaccharide and flavone compound.More than 40 kind of steroidal saponin has been got, as ophiopogonin B, C, D, E, F, G from the Radix Ophiopogonis of separate sources.It is active that ophiopogonin and Radix Ophiopogonis polysaccharide have extensive prevention and cure of cardiovascular disease, and the human umbilical vein endothelial cell damage of ophiopogonin D to hydrogen peroxide modeling has protective effect, and Radix Ophiopogonis polysaccharide can resist myocardial ischemia.

Adjuvant drug Rhizoma Coptidis nature and flavor bitter cold, GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel.Heat clearing and damp drying, eliminating fire and detoxication ^[41].The effective ingredient mainly multiple alkaloid of Rhizoma Coptidis, wherein content of berberine is the highest.Berberine is remarkable in the pharmacological action of cardiovascular system, antiatherogenic effect may with adjusting blood lipid, inflammation-inhibiting, blood pressure lowering, blood sugar lowering, suppresses vascular smooth muscle cell curing relevant; Resist the arrhythmia of II type rat diabetes myocardial infarction model; Protective effect is had to the cardiac toxicity that amycin in Mice Body causes; By alleviating the lipid accumulation of heart and promoting that the Cardiac Function in Rat that glucose transport protection hyperglycemia and hypercholesterolemia are brought out is incomplete; Effectively can regulate the sympathetic activity of experimental rat cardiac hypertrophy, there are the potentiality for the treatment of myocardial hypertrophy and chronic heart failure patients.

In side with Radix Ginseng, Ramulus Cinnamomi for monarch drug warmly nourishing Yangqi, warming the meridian and promoting blood circulation; Fructus Trichosanthis, Bulbus Allii Macrostemonis, the Rhizoma Pinelliae are regulated the flow of vital energy the chest stuffiness relieving, and clearing away phlegm eliminating stagnation of activating yang, is equipped with Radix Paeoniae Rubra promoting flow of QI and blood, makes perfect square tonify without causing stagnation; The product easily impairment of YIN of a specified duration of warm-dryness syndrome, therefore with Radix Ophiopogonis, Rhizoma Coptidis helps it, Rhizoma Coptidis heat clearing away, Radix Ophiopogonis moisturizes YIN nourishing.

Detailed description of the invention two: the difference of present embodiment and detailed description of the invention one is: get 10g Radix Ginseng, 10g Ramulus Cinnamomi, 15g Fructus Trichosanthis, 15g Bulbus Allii Macrostemonis, 10g Rhizoma Pinelliae, 15g Radix Paeoniae Rubra, 15g Radix Ophiopogonis and 5g Rhizoma Coptidis in step one.Other step and parameter identical with detailed description of the invention one.

Detailed description of the invention three: the difference of present embodiment and detailed description of the invention one or two is: merge extractive liquid, in step one also cools 12min.Other step and parameter identical with detailed description of the invention one or two.

Embodiment:

The preparation method of Wen Xinfang is carried out as follows:

One, 10g Radix Ginseng, 10g Ramulus Cinnamomi, 15g Fructus Trichosanthis, 15g Bulbus Allii Macrostemonis, 10g Rhizoma Pinelliae, 15g Radix Paeoniae Rubra, 15g Radix Ophiopogonis and 5g Rhizoma Coptidis is got, adding the mass concentration accounting for said medicine gross mass 8 times amount is the ethanol of 70%, then reflux, extract, 3 times, each 1 hour, merge extractive liquid, also cools 12min, then through 16 layers of filtered through gauze;

Two, adding the mass concentration accounting for filtering residue gross mass 8 times amount in the filtering residue after filtering to step one is the ethanol of 70%, reflux, extract, 1 hour, extracting solution cooling 12min, then through 16 layers of filtered through gauze, it is the ethanol of 70% that filtering residue after filtration adds the mass concentration accounting for filtering residue quality 8 times amount again, reflux, extract, 1 hour, all filtrate in combining step one and step 2, reclaim under reduced pressure filtrate, be concentrated into without alcohol taste, then proceed in evaporating dish, 70 DEG C of heating in water bath evaporates to dryness, then be placed in vacuum drying oven dry, namely complete the preparation of Wen Xinfang.

The value of concentration of alcohol, addition, extraction time, return time 4 factors in the present embodiment preparation method, and to be finally defined as optimum extraction process be by adopting 10 batch samples of high performance liquid chromatography to novel composing prescription to carry out finger printing research, determine 20 total peaks, formulate the finger printing of novel composing prescription.Between collection of illustrative plates, correlation coefficient process calculates similarity in 0.97 ~ 0.99 scope, and cosine angle-off set calculates similarity between 0.98 ~ 0.99, shows that the finger printing set up may be used for the quality control of novel composing prescription; Process is as follows:

With flour extraction, cinnamic acid and berberine hydrochloride for Testing index, high spot reviews concentration of alcohol, addition, extraction time, return time 4 factors, each selecting factors 3 levels, L9 (3) 4 orthogonal table is adopted to carry out the preferred Wen Xinfang optimum extraction process of EXPERIMENTAL DESIGN, the results are shown in Table 1, variance analysis is in table 2.For the ease of calculating, standardization being carried out to experimental result, eliminating dimension, result of the test being converted into percentage score and calculating.As can be seen from table 1, table 2, factor index for the significance sequence of flour extraction is: A>D>B>C; Variance analysis shows, concentration of alcohol has the impact of significance to flour extraction, P<0.05; For cinnamic acid, the significance sequence of each factor is followed successively by: A>C>B>D, variance analysis show each factor on Determination of cinnamic acid there are no significant impact; For berberine hydrochloride, each factor significance sequence is followed successively by: D>B>C>A, and variance analysis shows each factor also to be affected without significance its content.Although flour extraction is the highest under A1 condition, but the Determination of cinnamic acid of monarch drug Ramulus Cinnamomi is minimum at which level, the content of berberine hydrochloride of same adjuvant drug Rhizoma Coptidis is also minimum under this level conditions, therefore comprehensive flour extraction and active constituent content measuring result are thought and should be selected A2 level, and namely concentration of alcohol 70% is Extraction solvent.Factor B when the 2nd level cinnamic acid and content of berberine hydrochloride the highest, flour extraction is there was no significant difference under B2, B3 condition, therefore selects the second level of B factor to be the extraction conditions optimized.Monarch drug in the Ramulus Cinnamomi side of being, C factor is only second to A factor to Determination of cinnamic acid impact, and the 3rd level therefore selecting C factor is extraction conditions.Factor D is non-significant factors, but it can be seen from the table can be, Determination of cinnamic acid reduces along with the prolongation of return time, but flour extraction increases along with the prolongation of return time, owing to containing the compound such as adenosine, guanosine in side, cross long heating and can accelerate its decomposition, and D factor is concerning the influence factor flour extraction being non-limiting, therefore D factor 1 level is selected to be extraction conditions, namely the optimum extraction process of Wen Xinfang is A2B2C3D1, i.e. 8 times amount 70% ethanol, extract 3 times, each 1h.

Prepare gained Wen Xinfang dried powder in the present embodiment, take 40mg, be placed in 2ml volumetric flask, add mass concentration be the methanol dilution of 70% to scale, weighed weight, ultrasonic 15min under room temperature, take out, let cool, more weighed weight, supply weightlessness with 70% methanol, repeat mixing, cross 0.22 μm of microporous filter membrane, get subsequent filtrate, obtain the testing sample of 20mg/mL.With berberine hydrochloride peak for reference peak, between each peak, correlation coefficient is in 0.97 ~ 0.99 scope as can be seen from Table 3, and cosine angle, between 0.98 ~ 0.99, therefore illustrates to have high similarity between each batch sample.Can finding out that each step process is stable by table 3 similarity-rough set result to repeat, showing by setting up finger printing and standard practice, what can realize warm heart formula extraction preparation quality is stable and controlled.

Table 1 Wen Xinfang optimum extraction process L9 (3) 4 orthogonal experiments intuitive analysis

The variance analysis of table 2 Wen Xinfang optimum extraction process multi objective

(note: F0.05 (2,2)=19.0, " * " representative have a significant impact)

Table 3 Wen Xinfang fingerprint similarity evaluation table

Take HPLC as core technology, with main component adenosine, cinnamic acid, berberine hydrochloride for index, set up the method for assay while of novel composing prescription multicomponent.Show that precision, accuracy all can meet the needs of assay through methodological study result.Multicomponent is measured to the feature making the method for quality control of this prescription more meet middle medical drugs globality.

Determining Wen Xinfang optimum extraction process, on the basis of Criterion finger printing, multicomponent assay is simultaneously being carried out to Wen Xinfang; Adopt high performance liquid chromatography to the main component cinnamic acid in Ramulus Cinnamomi, the main component adenosine in Bulbus Allii Macrostemonis, the Rhizoma Pinelliae, and the effective ingredient berberine hydrochloride in Rhizoma Coptidis carries out assay, and carry out Method validation.Under 280nm, measure peak area, the content (table 4) of adenosine, berberine hydrochloride, cinnamic acid in calculation sample, through scaling results is: every gram of medicated powder contains adenosine 12.24mg, containing cinnamic acid 0.42mg, and hydrochloric berberine 15.88mg.Medical material flour extraction is 23%, calculates raw medicinal herbs content to be: every gram of raw medicinal herbs is containing adenosine 2.82mg, cinnamic acid 0.096mg, berberine hydrochloride 3.65mg.

Table 4 warm heart quadrat sampling product multi objective assay result

Sample number	Adenosine (A)	Cinnamic acid (A)	Berberine hydrochloride (A)
				1	316991	822226	11272319
2	315201	810102	11002689
				3	317754	810225	10912942
4	313834	806478	10961499
				5	310346	810329	10989577
Meansigma methods	314825.2	811872	11027805
				RSD(%)	0.83	1.1	0.66
Content (mg/mL)	0.245	0.00837	0.318

The Wen Xinfang prepared in the present embodiment, it is the Chinese medicine composition for the treatment of syndrome of deficiency of heart qi, and its demonstration test step is as follows: adopt Wistar rat, buy from Heilongjiang University of Chinese Medicine's Experimental Animal Center.

One, 64 rats are divided into four groups at random, often organize 16, be respectively: blank group, natural recovering group, high dose group and low dose group; Wherein, natural recovering group, high dose group and low dose group are modeling group;

Two, 1st ~ 21 days, modeling group rat set up insufficiency of heart-QI model, blank group rat feeding every day Mus grain 30g; 22nd ~ 35 days, high dose group gavages Wen Xinfang medicinal liquid 1.0ml/100g(by body weight and namely give crude drug 3.42g/100g every day), low dose group gavages Wen Xinfang medicinal liquid 1.0ml/100g(by body weight every day and low dosage gives crude drug 0.855g/100g), natural recovering group and the every daily weight 1.0ml/100g of blank group gavage normal saline, and each group rat all gives 30g Mus grain simultaneously;

Three, the 36th day each group rat carries out index determining: each group rat is early 6:00 collection 12h urine at night from the 1st day, collects 1 time every 1 day, and urine is in pvc pipe, and 13000r/min, 4 DEG C of centrifugal 10min, get supernatant, put in-20 DEG C of refrigerators and preserve standby inspection.

Result of the test is as follows:

1. novel composing prescription is on the impact of rat sign

Blank group rat is submissive smooth at whole experimental session chaeta, is quick on the draw.All the other each group after duplicating model success, show weak weak, weak breath lazy dynamic, nose color is light, hair dries up, rare soft, state of looking for food of defecating.22nd day (i.e. administration the 1st day) starts, and each group rat state is recovered all to some extent, and the weak state of novel composing prescription high dose group is eliminated very fast, within the 24th day, shows more active.The undesirable condition of the 32nd day (i.e. administration the 11st day) the respectively mental status of group rat, skin and hair, nose color is all clearly better, the rat of high dose group and low dose group comparatively natural recovering group and blank group more active.The rat of the 35th day (i.e. administration the 14th day) novel composing prescription high dose group and low dose group is more pink compared with the nose color of natural recovering group.

2. novel composing prescription is on the impact of rat body weight

At the end of modeling, blank group rat body weight is 325.6 ± 14.6g, and natural recovering group rat body weight is 193.3 ± 5.9g, and novel composing prescription high dose group rat body weight is 193.1 ± 9.6g, and novel composing prescription low dose group rat body weight is 198.5 ± 13.4g, as shown in Figure 1.After entering treatment/convalescent period, all have increase faster with blank group more each modeling group rat body weight, group difference without significant, but terminates each modeling group rat body weight still lower than blank group to laboratory, and difference has significant.

3. novel composing prescription is on the impact of rat cardiac ventricular hemodynamic index

Compare with natural recovering group rat, administration group rat heart rate is faster, and wherein the difference of low dose group has significant, compares with blank group, and each group rat heart rate is still comparatively slow, and difference has significant.Compare with natural recovering group rat, administration group left ventricle maximum collapse pressure obviously increases, and wherein the difference of high dose group has significant; Compare with blank group, administration group ventricle maximum internal pressure is also higher, but no significant difference.Compare with natural recovering group, the most careful intraventricular pressure of administration group obviously reduces, and wherein the difference of high dose group has statistical significance.The maximum climbing speed of systolic pressure of administration group and the maximum fall off rate absolute value of diastolic pressure all have and increase, and significantly more than natural recovering group and blank group, difference has statistical significance.As shown in Fig. 2, Fig. 3, Fig. 4, Fig. 5 and table 5.

Table 5 novel composing prescription is on insufficiency of heart-QI rat model ventricular hemodynamics impact (Mean+SD)

Note: compare * P ﹤ 0.05, * * P ﹤ 0.01 with blank group; ▲ P ﹤ 0.05 is compared, ▲ ▲ P ﹤ 0.01 with natural recovering group.

4. novel composing prescription is on the impact of rat biochemical indicator

4.1 cyclic adenosine monophosphate cAMP and cyclic guanosine monophosphate cGMP changes of contents

As shown in table 6, after treatment, cAMP and the cGMP content in novel composing prescription high dose, low dosage and natural recovering group rat plasma increases all to some extent, compares, no significant difference with blank group.

Table 6 novel composing prescription is on insufficiency of heart-QI rat model plasma cAMP, cGMP content impact (Mean+SD)

Group	n	cAMP(nmol/L)	cGMP(nmol/L)
				Blank group	8	16.96±4.65	14.05±2.36
Recovery group	10	17.04±4.25	16.33±4.05
				High dose	10	15.53±1.78	15.11±4.30
Low dosage	9	18.31±4.49	15.18±2.87

4.2 atrial natriuretic peptide ANF changes of contents

As shown in table 3, after treatment, novel composing prescription high dose group rat plasma ANF content increases, and compare with natural recovering group, difference has significant; High dose group and low dose group compare with blank group, no significant difference.

4.3 myocardium calcium cTn-I changes of contents

As shown in table 7, after treatment, novel composing prescription high dose group and low dose group rat plasma cTn-I content decline, but compare with natural recovering group, no significant difference; High dose group and low dose group compare with blank group, no significant difference.

Table 7 novel composing prescription is on insufficiency of heart-QI rat model plasma ANF, cTn-I content impact (Mean+SD)

Group	n	ANF（ng/ml)	cTn-I（ng/ml)
				Blank group	8	0.291±0.072	6.59±0.45
Recovery group	10	0.272±0.053	7.45±1.76
				High dose	10	0.353±0.092▲	6.98±0.54

Low dosage

9

0.271±0.064

6.61±0.70

Note: compare ▲ P ﹤ 0.05 with natural recovering group.

4.4 lipid peroxide MDA content and SOD activity change

As shown in table 4, after treatment, novel composing prescription high dose group and low dose group Content of MDA decline, and compare with natural recovering group, difference has significant; SOD activity increases, and compares with natural recovering group, and difference has significant; High dose group MDA content is lower than blank group, and difference has significant; Natural recovering group SOD vigor is lower than blank group, and difference has significant.

Table 8 novel composing prescription is on insufficiency of heart-QI rat model serum MDA, SOD content impact (Mean+SD)

Group	n	MDA（nmol/ml）	SOD（NU/ml）
				Blank group	8	5.55±0.54	1.45±0.08
Recovery group	10	6.16±0.91	1.09±0.11**
				High dose	10	4.87±0.66*▲▲	1.47±0.07▲▲
Low dosage	9	5.33±0.68▲	1.41±0.06▲▲

Note: compare with blank group, * P<0.05, * * P<0.01; Compare with natural recovering group, ▲ P ﹤ 0.05, ▲ ▲ P ﹤ 0.01.

5. rat heart muscle pathology are affected

As shown in Fig. 6, Fig. 7, Fig. 8 and Fig. 9.Natural recovering group rat heart microscopy is normal, and volume etc. are large, smooth surface, and each room, cell structure are normal, high-visible; Microscopy visible part muscle fiber atrophy, swelling, between part flesh, vasodilation is congested, visible stove myolysis.After treatment, novel composing prescription high dose group, low dose group rat cardiac tissue structure recovery are better, and under mirror, visible muscle fiber is comparatively neat in bundle arrangement, and nucleus is complete, but the slight congested and a small amount of interstitial edema of visible part blood vessel.

6. on the impact of myocardial ultrastructure

As shown in Figure 10, natural recovering group myocardial ultrastructure fibres visible myofilament intercalated disc is broadening, and partial mitochondrial film is damaged, dissolving, and ridge is disorderly, and visible endoplasmic reticulum is vacuolation.After novel composing prescription treatment, high dose group, low dose group myocardial ultrastructure make moderate progress, and visible cardiac muscle fiber arrangement is comparatively neat, and muscle segment is respectively with comparatively clear, and mitochondrion peplos is comparatively complete, and endoplasmic reticulum cavity is less, and high dose group is better than low dose group.

In order to show the therapeutic effect of the Wen Xinfang (namely treating the Chinese medicine composition of syndrome of deficiency of heart qi) prepared in the present embodiment, through 98 routine system clinical observations, in the process of above-mentioned clinical observation, record is carried out to the medical history of above-mentioned patient, the state of an illness and curative effect.

Clinical therapeutic efficacy criterion is:

Cure: common sign as spontaneous perspiration, cardiopalmus, breathe hard, uncomfortable in chest, dynamicly then to increase the weight of, pallor light red tongue, deficient pulse all disappears.

Take a turn for the better: subjective symptoms as cardiopalmus, breathe hard, uncomfortable in chest, spontaneous perspiration disappears substantially, complexion and pulse condition are tending towards normal.

Invalid: symptom, sign are not improved.

Therapeutic effect: a kind of Chinese medicine novel composing prescription for the treatment of insufficiency of heart-QI of the present invention is treated through 98 routine motive deficient syndrome patients, 79 example recoveries from illness, 10 examples take a turn for the better, and 9 examples are invalid, and total effective rate reaches 90.8%.

Model case:

Case 1: patient Liu, female, 47 years old, suffers from motive deficient syndrome 2 years, long-term cardiopalmus, breathe hard, uncomfortable in chest, pale complexion, take Chinese medicine of the present invention after 5 months, symptom disappears completely, and pulse condition is normal, follows up a case by regular visits to and does not recur for 1 year.

Case 2: patient Lee, female, 52 years old, suffer from motive deficient syndrome 3 years, long-term discomfort uncomfortable in chest, shortness of breath and fatigue, after activity more so, take Chinese medicine of the present invention after 6 months, symptom disappeared completely, and pulse condition is normal, follows up a case by regular visits to and does not recur for 1 year.

Case 3: patient Zhang, female, 34 years old, suffer from syndrome of deficiency of heart qi, conscious severe palpitation, take Chinese medicine of the present invention after 2 months, symptom disappeared completely, and pulse condition is normal, follows up a case by regular visits to and does not recur for 1 year.

Case 4: patient is in so-and-so, and man, 58 years old, suffer from syndrome of deficiency of heart qi 1 year, long-term discomfort uncomfortable in chest, shortness of breath and fatigue, Mental fatigue spontaneous perspiration, take Chinese medicine of the present invention after 6 months, symptom disappeared completely, and pulse condition is normal, follows up a case by regular visits to and does not recur for 1 year.

Case 5: patient Zhang, female, 48 years old, suffer from motive deficient syndrome 2 years, long-term discomfort uncomfortable in chest, shortness of breath and fatigue, Mental fatigue spontaneous perspiration, multi-treatment was invalid, and take Chinese medicine of the present invention after 7 months, symptom disappears completely, and pulse condition is normal, follows up a case by regular visits to and does not recur for 1 year.

Case 6: patient Pan so-and-so, female, 46 years old, suffers from syndrome of deficiency of heart qi, cardiopalmus, breathe hard, pale tongue with thin fur, take Chinese medicine of the present invention after 2 months, symptom disappears completely, and pulse condition is normal, follows up a case by regular visits to and does not recur for 1 year.

Case 7: patient Yang, female, 52 years old, suffers from syndrome of deficiency of heart qi 1 year, for a long time uncomfortable in chest, breathe hard, take Chinese medicine of the present invention after 5 months, symptom disappears completely, and pulse condition is normal, follows up a case by regular visits to and does not recur for 1 year.

Case 8: patient Lin, man, 53 years old, suffer from syndrome of deficiency of heart qi, discomfort uncomfortable in chest, shortness of breath and fatigue, after activity more so, take Chinese medicine of the present invention after 4 months, symptom disappeared completely, and pulse condition is normal, follows up a case by regular visits to and does not recur for 1 year.

Claims (3)

1. a preparation method for Chinese medicine composition, is characterized in that it carries out as follows:

One, 8 ~ 12g Radix Ginseng, 8 ~ 12g Ramulus Cinnamomi, 13 ~ 17g Fructus Trichosanthis, 13 ~ 17g Bulbus Allii Macrostemonis, 8 ~ 12g Rhizoma Pinelliae, 13 ~ 17g Radix Paeoniae Rubra, 13 ~ 17g Radix Ophiopogonis and 3 ~ 7g Rhizoma Coptidis is got, adding the mass concentration accounting for said medicine gross mass 8 times amount is 70% ethanol, then reflux, extract, 3 times, each 1 ~ 2 hour, merge extractive liquid, also cools 10 ~ 15min, then through 16 layers of filtered through gauze;

Two, adding the mass concentration accounting for filtering residue gross mass 8 times amount in the filtering residue after filtering to step one is 70% ethanol, reflux, extract, 1 hour, extracting solution cooling 10 ~ 15min, then through 16 layers of filtered through gauze, it is 70% ethanol that filtering residue after filtration adds the mass concentration accounting for filtering residue quality 8 times amount again, reflux, extract, 1 hour, all filtrate in combining step one and step 2, reclaim under reduced pressure filtrate, be concentrated into without alcohol taste, then proceed in evaporating dish, 70 DEG C of heating in water bath evaporates to dryness, then be placed in vacuum drying oven dry, namely complete the preparation of described Chinese medicine composition.

2. the preparation method of a kind of Chinese medicine composition according to claim 1, is characterized in that getting 10g Radix Ginseng, 10g Ramulus Cinnamomi, 15g Fructus Trichosanthis, 15g Bulbus Allii Macrostemonis, 10g Rhizoma Pinelliae, 15g Radix Paeoniae Rubra, 15g Radix Ophiopogonis and 5g Rhizoma Coptidis in step one.

3. the preparation method of a kind of Chinese medicine composition according to claim 1 and 2, is characterized in that merge extractive liquid, in step one and cools 12min.