CN1879843A - A Chinese medicinal composition for treating chronic cholecystitis and method for preparing same - Google Patents

Abstract

Disclosed is a Chinese medicinal composition for treating chronic cholecystitis which is prepared from lysimachia christinae, corydalis tuber, toosendan fruit, curcuma aromatica, banksia rose, and rhubarb horsetails by a predetermined weight proportions, and can be prepared into any of the conventional oral administration dosage forms.

Description

A kind of Chinese medicine composition for the treatment of chronic cholecystitis and preparation method thereof

Technical field:

The invention belongs to the field of Chinese medicines, especially relate to a kind of Chinese medicine composition for the treatment of chronic cholecystitis and preparation method thereof.

Background technology:

Chronic cholecystitis is a kind of common clinical, frequently-occurring disease, the chronic inflammatory disease that refers to gallbladder, can cause the characteristics of have course of disease delay, easily showing effect repeatedly by calculus stimulation, bacterial infection, viral hepatitis, chemical lesion, parasitic infection or acute cholecystitis delay.Statistical information in recent years shows that its sickness rate has the trend that rises year by year, and this may have higher diagnosis relevant with the change and the ultrasonic image learning aid of people's dietary structure.Therefore, prevention and treatment primary disease are particularly important.Primary disease belongs to Chinese medicine " hypochondriac pain ", " gallbladder-distention " category.How to treat chronic cholecystitis, make great efforts the unique advantage of exploitation Chinese medicine on the treatment primary disease, be subjected to experts and scholars' attention just day by day.The Chinese medicine primary disease at function of gallbladder promoting, to improve aspect the symptom curative effect obvious, has unique advantage for improving clinical efficacy.At present, the western medical treatment primary disease mainly adopts antiinflammatory, function of gallbladder promoting and support symptomatic treatment, and the extensive use of antibacterials, being on the increase of Resistant strain, the continuous appearance of New-type wide-spectrum high-efficiency antimicrobial element brings some new drawbacks again, as: consumption is crossed roughly dysbacteriosis, superinfection etc.Though operation can be effected a radical cure, there are sequela or complication unavoidably and are difficult for being accepted by the patient.

Summary of the invention:

Technical problem to be solved by this invention provides Chinese medicine composition of a kind of treatment chronic cholecystitis evident in efficacy and preparation method thereof.

The crude drug of Chinese medicine composition of the present invention is formed and proportioning following (by weight):

Herba Lysimachiae 1500-3000 weight portion Rhizoma Corydalis 1000-2000 weight portion

Fructus Toosendan 1000-2000 weight portion Radix Curcumae 1000-2000 weight portion

Radix Aucklandiae 700-1000 weight portion Radix Et Rhizoma Rhei 300-600 weight portion.

The crude drug of Chinese medicine composition of the present invention is formed and proportion optimization following (by weight):

Herba Lysimachiae 2000-3000 weight portion Rhizoma Corydalis 1500-2000 weight portion

Fructus Toosendan 1500-2000 weight portion Radix Curcumae 1000-1500 weight portion

Radix Aucklandiae 700-900 weight portion Radix Et Rhizoma Rhei 400-500 weight portion.

The crude drug of Chinese medicine composition of the present invention is formed and proportioning the best is (by weight):

Herba Lysimachiae 2500 weight portion Rhizoma Corydalis 1667 weight portion Fructus Toosendans 1667 weight portions

The Radix Curcumae 1250 weight portion Radix Aucklandiae 833 weight portion Radix Et Rhizoma Rhei 416 weight portions.

The preparation method of Chinese medicine composition of the present invention:

Radix Curcumae, the Radix Aucklandiae add 4～8 times of water gagings, and vapor distillation extracted volatile oil 3～6 hours, and aqueous solution after the distillation and medicinal residues device are in addition collected, and volatile oil is made clathrate with 2～5 times of amount beta-schardinger dextrin-application grinding methods; Rhizoma Corydalis adds 4～6 times of amount 70～90% alcohol reflux 1～3 time, each 1～3 hour, merge extractive liquid,, filter, filtrate recycling ethanol also is evaporated to mutually 80 ℃ to density 1.20～1.45, Radix Curcumae behind medicinal residues and the distillating extracting oil, Radix Aucklandiae medicinal residues merge, add Herba Lysimachiae, Fructus Toosendan, Radix Et Rhizoma Rhei residue three flavors, adding 6～9 times of water gagings immersions decocted 2～5 times after 3～5 hours, each 0.5～1.5 hour, aqueous solution after collecting decoction and the distillation, filter, filtrate decompression is concentrated into 80 ℃ of relative density 1.00-1.25, add ethanol make contain alcohol 50～70%, fully stir, static 20～25 hours, filter, filtrate recycling ethanol also is evaporated to 80 ℃ of relative density 1.25-1.40, merges with the Rhizoma Corydalis ethanol extract, adds starch, mixing, 80 ℃ of drying under reduced pressure are ground into fine powder, with the B-cyclodextrin clathrate mixing of volatile oil of Radix Aucklandiae, excipient direct through conventional operation or that adding is pharmaceutically accepted is made tablet, capsule, granule, oral liquid, the subcutaneous administration preparation, in the suppository any, preferred tablet.

The present invention has clearing away heat-damp and promoting diuresis, the merit of regulating QI to relieve pain, and at the cause of disease and the characteristics of incidence of chronic cholecystitis, the dialectical treatment primary disease that combines of differential diagnosis of diseases, clinical efficacy is reliable and stable.

Description of drawings:

Fig. 1 is the extraction process route map of Radix Curcumae, Radix Aucklandiae medical material;

Fig. 2 is the extraction process route map of Rhizoma Corydalis;

Fig. 3 is the extraction process route map of Herba Lysimachiae, Fructus Toosendan, Radix Et Rhizoma Rhei;

Fig. 4 is preferred Radix Curcumae, volatile oil of Radix Aucklandiae extraction conditions result schematic diagram.

Below further set forth the beneficial effect of medicine of the present invention by testing example, these are tested examples and have comprised that the pharmacodynamics test of medicine of the present invention (to call the peaceful sheet of flank in the following text) and clinical observation on the therapeutic effect test.

[test example 1] medicine of the present invention is to the therapeutical effect of rat chronic cholecystitis

Test material:

Anthology invention medicine flank is peaceful, specification 0.8g/ sheet (containing crude drug amount 8.33g).JINDAN PIAN, Yangtze River pharmaceutical Co. Ltd, lot number: 0002211-5.

1, the peaceful sheet of flank is to the influence of rat liver choleresis

Experimental technique:

50 of rats, male, be divided into 5 groups at random, both normal saline matched groups, JINDAN PIAN matched group, the high, medium and low dosage group of the peaceful sheet of flank.Every group 10.

Experimental rat is through gastric infusion, and dosage is respectively: the peaceful sheet administration of flank high dose group, 2.5g/kg; Dosage group during flank is peaceful, 2g/kg; Low dose group, 1.5g/kg; Positive controls (JINDAN PIAN) 1.6g/kg; Matched group is with the volume normal saline.Successive administration 3 days,

Rat fasting 12 hours (can't help water) after the last administration is tested and was administered once in preceding 30 minutes.Then with urethanes (20%) intraperitoneal injection of anesthesia (5ml/kg).The rat dorsal position is fixed on the rat platform, and the abdominal part median incision is opened the abdominal cavity, finding stomachus pyloricus, is standard with the pyloric part, the upset duodenum, find vater's papilla portion, find common bile duct along pars papillaris, isolate common bile duct, the ligation lower end with mosquito forceps, carefully cut an osculum with eye scissors, do common bile duct intubate (plastic tube about 1mm) with 15 centimeters long plastic tubes, form biliary drainage, treat that bile flow stablized 15-20 minute.Writing down after the administration each cowardly juice secretory volume in 240 minutes respectively, is observation index with the choleresis of each group rat, represents that with mean plus-minus standard deviation significance test is checked with t between group.

Experimental result:

The selection of animal, rat be not owing to there is a gallbladder, so but in the experiment direct observation medicine be not subjected to gallbladder to store the interference of bile function to the influence of liver bile secretion.Help observing the biliary variation of hepatic secretion.Animal is selected buck for use, because estrogen has certain influence to the liver bile secretion, so select buck for use, reduces the influence of endocrine factors to experiment.Urethanes is adopted in anesthesia, because of the barbiturates anaesthetic also has tangible influence to animal bile, in order to get rid of this type of interference, so select urethanes for use.

The result shows, compare with matched group, the peaceful sheet administration of flank animal bile secretory volume all is significantly increased trend, and 1 group of rat of the peaceful sheet administration of flank after administration 120,180 minutes, bile flow is apparently higher than the concurrent control group 180 minutes the time after administration for 2 groups of rats of the peaceful sheet administration of flank, and the peaceful sheet of prompting flank has obvious facilitation to the rat liver bile secretion.The positive control drug JINDAN PIAN after administration 120,180 minutes the time bile flow be higher than matched group.Show that the peaceful sheet of flank has the effect of the bile secretion of promotion.Its mechanism of action awaits further research.

The peaceful sheet of table 1 flank is to the influence (x+s) of rat liver choleresis

Group	Matched group	The JINDAN PIAN group	1 group of high dose	2 groups of middle dosage	3 groups of low dosages
						30min	0.348±0.102	0.310±0.094	0.372±0.069	0.342±0.065	0.313±0.061
60min	0.318±0.111	0.310±0.116	0.350±0.081	0.345±0.101	0.332±0.089
						120min	0.308±0.027	0.381±0.078*	0.416±0.061**	0.353±0.068	0.348±0.082
180min	0.346±0.060	0.415±0.036**	0.417±0.046**	0.445±0.044**	0.375±0.054
						240min	0.400±0.280	0.414±0.053	0.407±0.054	0.415±0.081	0.355±0.076

Compare with matched group: * P＜0.05 * * P＜0.01.

2, the peaceful sheet of flank is to the influence of animal intestine wriggling

Experimental technique:

(1) laboratory animal and grouping

Get 50 of kunming mices, male and female half and half, body weight 20-22g is divided into matched group, positive drug control group, the high, medium and low dosage group of the peaceful sheet administration of flank at random.Every group 10.

(2) animal subject is prepared and dosage

Animal subject is in experiment beginning in preceding 3 days gastric infusion, experiment proxima luce (prox. luc) laboratory animal 24 hours on an empty stomach, experiment peaceful sheet of flank on the same day and charcoal end are mixed into suspension (charcoal end concentration 5%) gastric infusion, and dosage is respectively: the peaceful sheet administration of flank high dose group, 4g/kg; Dosage group during flank is peaceful, 2g/kg; Low dose group, 1g/kg; Positive controls (JINDAN PIAN) 2g/kg; Matched group is with the volume normal saline.

(3) observational technique and index

30min behind the filling stomach takes off vertebra and puts to death animal, cuts the abdominal cavity, takes out gastrointestinal, is tiled on the glass plate, measures the displacement of the last head end of small intestinal total length and charcoal in intestinal tube, calculates the propulsive percentage rate in charcoal end.

The charcoal end advances distance/small intestinal total length * 100% of %=charcoal end front end and pylorus

(4) observation index and statistical procedures

With the propulsive percentage rate in boneblace end is observation index.Observe the influence of the peaceful sheet of flank to the experimental animal models enterokinesia, data are added and subtracted standard deviation with mean, and (x ± s) expression, the significance test of group difference is checked with t.

Experimental result: this test is the index agent with the charcoal end, observed of the influence of the peaceful sheet of flank to the experimental animal models enterokinesia, the result shows that each treated animal charcoal end of administration advances percentage rate all obviously greater than matched group (P＜0.001), and the peaceful sheet of prompting flank can obviously increase the animal intestine wriggling.The results are shown in Table 2.

The percentile comparison of each treated animal charcoal end propelling of table-2 experiments (x ± s)

Group	The example number	Dosage	The charcoal end advances percentage rate (%)
				Matched group (normal saline)	10	------	57.15±8.74
Positive controls	10	2g/kg	72.31±14.17**
				The peaceful high dose group of flank	10	4g/kg	81.03±12.13***
Dosage group during flank is peaceful	10	2g/kg	75.57±10.45***
				The peaceful low dose group of flank	10	1g/kg	69.69±12.56**

Compare with matched group: * * * P＜0.001, * * P＜0.01, * P＜0.05.

[test example 2] present composition Study on extraction experiment

1, according to the contained composition of prescription Chinese crude drug, we can be divided three classes it.

Contain the volatile ingredient medical material: Radix Curcumae, the Radix Aucklandiae,

Liposoluble constituent medical material: Rhizoma Corydalis

Contain the water soluble ingredient medical material: Herba Lysimachiae, Fructus Toosendan, Radix Et Rhizoma Rhei

More than three class medical materials, the extraction that contains volatile oil in the volatile ingredient medical material generally has two kinds of methods: promptly applying high density ethanol extraction and vapor distillation extract.Consider the simplicity of production cost and operation, through prerun, we select for use steam distillation to extract volatile oil in this part medical material, for fear of other composition loss, the medicinal residues that we will extract behind the volatile oil together extract with decocting decoct medicinal herbs material again, so the extraction process route of Radix Curcumae, Radix Aucklandiae medical material as shown in Figure 1.

Rhizoma Corydalis: this medical material ingredient is that solvent is difficult to stripping with water, still to intend adopting with ethanol be that solvent extracts it, also the medicinal residues after the alcohol extraction are together extracted with the decocting medical material more simultaneously, to avoid wherein water soluble ingredient loss.So the extraction process route map of Rhizoma Corydalis as shown in Figure 2.

Herba Lysimachiae, Fructus Toosendan, rhubarb medicinal material: because its ingredient is water solublity, still adopt decocting method to extract its composition, it extracts route as shown in Figure 3.

2, the selection of prescription Chinese crude drug extraction solvent and method:

(1) use steam distillation and extract the preferred of volatile oil technical conditions in Radix Curcumae, the Radix Aucklandiae:

Use steam distillation and extract operation, through prerun, the principal element that the volatile oil effect is extracted in influence has distillation hourly water consumption and distillation time.At these two factors, we have carried out following test on the trial test basis:

Get Radix Curcumae 30g, Radix Aucklandiae 20g mixing according to the prescription ratio, totally 4 parts, put respectively in the volatile oil extractor, add 4,5,6,7 times of water of medical material respectively, soak after 2 hours, the heating distillation extraction, own backflow picks up counting when producing, and controls identical back-flow velocity, writes down different time volatile oil respectively and carries to such an extent that measure, the results are shown in Table 3, Fig. 4.

The preferred Radix Curcumae of table 3, volatile oil of Radix Aucklandiae extraction conditions be table as a result

	1 hour	2 hours	3 hours	4 hours	5 hours	6 hours
							7 times of water of 6 times of water of 5 times of water of 4 times of water	0.08 0.08 0.11 0.08	0.1 0.1 0.15 0.1	0.12 0.12 0.16 0.13	0.14 0.14 0.18 0.14	0.15 0.15 0.19 0.15	0.15 0.15 0.19 0.16

Above result shows, the extraction conditions of volatile oil is preferably medical material and adds 6 times of water gagings, distillation extraction 5 hours in Radix Curcumae, the Radix Aucklandiae two flavor medical materials.

(2) liposoluble constituent extractive technique condition preferred in the Rhizoma Corydalis:

The main component of Rhizoma Corydalis is an alkaloid, uses alcohol reflux more, and through prerun, we have determined to influence four factors of extraction effect, A when promptly extracting: used concentration of alcohol; B: extraction time; C: each extraction time; D: at every turn add amount of alcohol, and in conjunction with practical situation, we have determined three levels for each factor, see Table 4.

Table 4 Rhizoma Corydalis is used alcohol reflux and is investigated the factor level table

We use orthogonal test is index with the extracted amount of tetrahydropalmatine in the Rhizoma Corydalis, presses L ₉(3 ⁴) orthogonal table tests

The concrete operations step: get Rhizoma Corydalis 40g respectively, totally 9 parts, add alcohol reflux by table 3 condition, extract reclaims ethanol and the dry total extractives that gets, and measures the wherein content of tetrahydropalmatine, the results are shown in Table 5, and variance analysis as a result sees Table 6.

Table 5: Rhizoma Corydalis ethanol extraction orthogonal experiments table

	Factor				Total extractives amount (g)	Tetrahydropalmatine extracted amount (mg)
							A	B	C	D
	1 2 3 4 5 6 7 8 9 I II III SS	1 1 1 2 2 2 3 3 3 2.200 8.602 4.751 6.952	1 2 3 1 2 3 1 2 3 3.793 6.729 5.031 1.448	1 2 3 2 3 1 3 1 2 7.244 3.752 4.557 2.229							1 2 3 3 1 2 2 3 1 4.211 5.068 6.264 0.702	3.221 3.810 4.460 2.500 3.236 2.424 2.020 1.305 1.952	0.635 0.732 0.833 2.286 2.852 3.464 0.872 3.145 0.734

Table 6 Rhizoma Corydalis ethanol extraction orthogonal experiments analysis of variance table

Soruces of variation	From the sum of squares of deviations	Degree of freedom	Variance	The F value	Significance
						A B C D	6.925 1.448 2.229 0.702	2 2 2 2	3.463 0.724 1.115 0.351	9.865 2.063 3.175 1	*

F _0.10(2，2)＝9.00 F _0.05(2，2)＝19.00

Above result shows that the A factor level changes has appreciable impact to experimental result, and in conjunction with intuitive analysis, Rhizoma Corydalis alcohol reflux condition is preferably A ₂B ₂C ₁D ₁, promptly adding 75% ethanol, reflux, extract, 2 times was extracted 1.5 hours at every turn, used 5 times of medical material amount ethanol at every turn.

The clinical observation of [test example 3] Drug therapy chronic cholecystitis of the present invention

1. physical data

Accept clinic case totally 90 examples for medical treatment, wherein male 40 examples, 50 examples.18～29 years old 9 age example, 30～39 years old 26 example, 40～49 years old 29 example, 50～59 years old 21 example, 60～65 years old 5 example.Wherein the course of disease is the shortest 1 year, and is the longest 21 years.

2. diagnostic criteria

(1) Syndrome in TCM marquis diagnostic criteria

1. demonstrate,prove the marquis: syndrome of accumulated dampness-heat (with reference to issue " tcm clinical practice diagnosis and treatment term part " GB/T16751.2-1997 of State Bureau of Technical Supervision and regular higher education Chinese medicine class planning teaching material " Diagnostics of Chinese Medicine " reference " the clinical research guideline of new Chinese medicine treatment syndrome of dampness-heat stagnating in spleen ").

2. primary symptom: right side of body pain, bitter taste in the mouth and dry throat

Inferior disease: pain is drawn the shoulder back of the body, the tending to vomit of feeling sick, and indigestion and loss of appetite abdominal distention, anorexia is greasy, gallbladder district tenderness, it is not well or constipated to defecate, yellowish or reddish urine.

Tongue arteries and veins: red tongue with yellow fur or yellow greasy, wiry and frequent pulse or sliding number.

Syndrome of accumulated dampness-heat primary symptom indispensability, and tool time disease, three above persons of tongue arteries and veins, promptly diagnosable.

(2) Western medicine diagnose standard

1. the upper right abdomen pain of persistence or discomfort is arranged or accompany right omoplate district pain.

2. indigestion symptoms such as nauseating, belch, acid regurgitation, abdominal distention and stomach be scorching hot are arranged, the postemphasis of feed greasy food.

3. the course of disease is long, more than 3 months, has the characteristics of outbreak repeatedly.

4. can there be tenderness and percussion pain in the gallbladder district.

5. the visible thickening of capsule wall of gallbladder of ultrasound diagnosis, crude, gallbladder dwindles or enlargement, gallbladder contraction function is bad.

(3) chronic cholecystitis ultrasound diagnosis state of an illness calibration standard sees Table 7

	Normally (0)	Light level (3)	Middle rank (6)	Heavy duty (9)
					The gallbladder situation	The normal wall of gallbladder size is smooth or owe smooth, and thick＜0.3cm contractile function is normal.	Normally only wall is crude or thicken for the gallbladder size, about 0.3-0.5cm, contractile function is relatively poor.	Slightly enlargement or dwindle of gallbladder, wall is crude or thicken, about 0.4-0.8 cm, contractile function is poor.	The obvious enlargement of gallbladder or dwindle, wall is crude to be thickened, 0.6～1.2cm, contractile function are seriously bad.

Annotate: the normal meter of gallbladder ultrasound diagnosis 0 minute, light level meter 3 minutes, middle rank meter 6 minutes, heavy duty meter 9 minutes.

3. Therapeutic Method

Oral 3 times of every day, 3 times on the one, one time 1 or follow the doctor's advice, took for 4 weeks continuously.

4. efficacy assessment standard

Judge curative effect according to integration method.

(1) clinical cure: symptom, sign integration reduce 〉=95%, and imaging examination is normal.

(2) produce effects: symptom, sign integration reduce 〉=70%, and basic imaging examination meets the produce effects standard.

(3) effective: the sings and symptoms integration reduces 〉=30%, and imaging examination reaches effective standard.

(4) invalid: symptom, sign integration reduce＜30%, and imaging examination does not all have improvement.

5. therapeutic outcome (seeing Table 8,9)

Table 8 total effects analysis (%)

Group	The example number	Clinical cure	Produce effects	Effectively	Invalid	Total effective rate
							Treatment group matched group	60 30	43(71.67) 14(46.67)	8(13.33) 7(23.33)	5(8.33) 3(10)	4(6.67) 6(20)	93.3 80

Analyze through Ridit, u=2.0527, P＜0.05 illustrates that two groups of total effectses have significant difference, the treatment group obviously is better than matched group.

Symptom relatively before and after table 9 treatment

Symptom	Group	Before the treatment (n=60)				Treatment back (n=30)				Compare in the group		Compare between group
														-	+	++	+++	-	+	++	+++	X 2	P	X 2	P
		Right side of body pain	Matched group before the treatment	0 0	19 11	29 14	12 5	50 16	3 5	3 5	4 4	7.6685 3.3168	＜0.01 ＜0.01													2.2549	＜0.05
The xerostomia dry pharynx	Treatment group matched group													0 0	21 10	14 15	5 5	43 14	9 7	6 6	2 3	7.2653 3.3914	＜0.01 ＜0.01	2.0699	＞0.05
		Pain is drawn the shoulder back of the body	Treatment group matched group	5 0	19 16	26 10	10 4	48 5	5 13	7 10	0 2	7.1072 2.6386	＜0.01 ＜0.01													2.7283	＜0.05
Nausea and vomiting	Treatment group matched group													13 8	24 10	17 9	6 3	46 16	9 9	5 5	0 0	5.5261 2.3330	＜0.01 ＜0.05	1.8074	＞0.05
		Indigestion and loss of appetite abdominal distention	Treatment group matched group	6 3	13 20	7 25	4 12	40 13	13 7	4 7	4 3	4.6250 1.2224	＜0.01 ＞0.05													1.9736	＜0.05
Anorexia is greasy	Treatment group matched group													3 1	20 13	25 8	12 8	41 14	10 5	5 5	4 6	6.4036 2.3777	＜0.01 ＜0.05	2.0010	＜0.05
		It is not well or constipated to defecate	Treatment group matched group	21 9	12 7	10 11	7 3	49 19	5 4	3 6	3 1	3.6000 2.3404	＜0.01 ＜0.05													1.4029	＞0.05
Yellowish or reddish urine	Treatment group matched group													9 4	17 10	24 10	9 6	45 15	7 6	8 6	0 3	6.8098 2.5491	＜0.01 ＜0.05	2.1043	＜0.05

Annotate: going up performance is relatively to analyze through Ridit in two groups of symptom groups before and after the treatment, difference is (P＜0.01) extremely significantly, compare between group, two groups in nauseating tending to vomit, stool aspect character improves, not remarkable (P＞0.05) remainder of difference all has significant difference (P＜0.05), illustrates that the treatment group is better than matched group.

In a word, in the treatment of 4 weeks, treat 60 examples with the peaceful sheet of flank, clinical cure 43 examples, produce effects 8 examples, effective 5 examples, invalid 4 examples, total effective rate 93.3%.

The preparation tablets of embodiment 1 medicine of the present invention

Herba Lysimachiae 2500g Rhizoma Corydalis 1667g Fructus Toosendan 1667g

Radix Aucklandiae 833g Radix Curcumae 1250g Radix Et Rhizoma Rhei 416g

Radix Curcumae, the Radix Aucklandiae add 6 times of water gagings, and vapor distillation extracted volatile oil 5 hours, and aqueous solution after the distillation and medicinal residues device are in addition collected, and volatile oil is made clathrate with 4 times of amount beta-schardinger dextrin-application grinding methods; Rhizoma Corydalis adds 5 times of amount 75% alcohol reflux 2 times, each 1.5 hours, merge extractive liquid, filtered, filtrate recycling ethanol also is evaporated to 80 ℃ of relative densities 1.30～1.35, Radix Curcumae behind medicinal residues and the distillating extracting oil, Radix Aucklandiae medicinal residues merge, and add Herba Lysimachiae, Fructus Toosendan, residue such as Radix Et Rhizoma Rhei three flavors add 8 times of water gagings immersions and decoct 4 times after 4 hours, each 1 hour, aqueous solution after collecting decoction and the distillation filters, and filtrate decompression is concentrated into 80 ℃ of relative density 1.10-1.15, add ethanol make contain alcohol 60%, fully stir, static 24 hours, filter, filtrate recycling ethanol also is evaporated to 80 ℃ of relative density 1.30-1.35, merge with the Rhizoma Corydalis ethanol extract, add starch, mixing, 80 ℃ of drying under reduced pressure, being ground into fine powder, with the B-cyclodextrin clathrate mixing of volatile oil of Radix Aucklandiae, is wetting agent system granule with 90% ethanol, under 40 ℃ of-50 ℃ of conditions, spray drying, granulate, tabletting is made 1000 in tablet through conventional technology.

The granule preparation of embodiment 2 medicines of the present invention

Herba Lysimachiae 2000g Rhizoma Corydalis 1500g Fructus Toosendan 1500g

Radix Aucklandiae 700g Radix Curcumae 1000g Radix Et Rhizoma Rhei 400g

Radix Curcumae, the Radix Aucklandiae add 4 times of water gagings, and vapor distillation extracted volatile oil 4 hours, and aqueous solution after the distillation and medicinal residues device are in addition collected, and volatile oil is made clathrate with 4 times of amount beta-schardinger dextrin-application grinding methods; Rhizoma Corydalis adds 4 times of amount 75% alcohol reflux 2 times, each 1 hour, merge extractive liquid,, filter, filtrate recycling ethanol also is evaporated to 80 ℃ of relative density 1.30-1.35, the Radix Curcumae behind medicinal residues and the distillating extracting oil, Radix Aucklandiae medicinal residues merge, add Herba Lysimachiae, Fructus Toosendan, Radix Et Rhizoma Rhei residue three flavors, add 6 times of water gagings immersions and decoct 2 times after 4 hours, each 1 hour, the aqueous solution after collecting decoction and the distillation, filter, filtrate decompression is concentrated into mutually 80 ℃ to density 1.10-1.15, adds ethanol and makes and contain alcohol 60%, fully stirs, static 20 hours, filter, filtrate recycling ethanol also is evaporated to 80 ℃ of relative density 1.30-1.35, merges with the Rhizoma Corydalis ethanol extract, add starch, mixing, 80 ℃ of drying under reduced pressure are ground into fine powder, B-cyclodextrin clathrate mixing with volatile oil of Radix Aucklandiae, with 90% ethanol is wetting agent system granule, and spray drying is made the finished particle agent through conventional technology.

The capsule preparation of embodiment 3 medicines of the present invention

Herba Lysimachiae 3000g Rhizoma Corydalis 2000g Fructus Toosendan 2000g

Radix Aucklandiae 900g Radix Curcumae 1500g Radix Et Rhizoma Rhei 500g

Radix Curcumae, the Radix Aucklandiae add 8 times of water gagings, and vapor distillation extracted volatile oil 5 hours, and aqueous solution after the distillation and medicinal residues device are in addition collected, and volatile oil is made clathrate with 5 times of amount beta-schardinger dextrin-application grinding methods; Rhizoma Corydalis adds 5 times of amount 75% alcohol reflux 2 times, each 1.5 hours, merge extractive liquid,, filter, filtrate recycling ethanol also is evaporated to 80 ℃ of relative densities 1.30～1.35, the Radix Curcumae behind medicinal residues and the distillating extracting oil, Radix Aucklandiae medicinal residues merge, add Herba Lysimachiae, Fructus Toosendan, Radix Et Rhizoma Rhei residue three flavors, add 8 times of water gagings immersions and decoct 4 times after 5 hours, each 1.5 hours, the aqueous solution after collecting decoction and the distillation, filter, filtrate decompression is concentrated into 80 ℃ of relative density 1.10-1.15, adds ethanol and makes and contain alcohol 60%, fully stirs, static 24 hours, filter, filtrate recycling ethanol also is evaporated to 80 ℃ of relative density 1.30-1.35, merges with the Rhizoma Corydalis ethanol extract, add starch, mixing, 80 ℃ of drying under reduced pressure are ground into fine powder, B-cyclodextrin clathrate mixing with volatile oil of Radix Aucklandiae, with 90% concentration ethanol is the wetting agent granule, and spray drying is made capsule through conventional technology.

Claims (6)

1, a kind of Chinese medicine composition for the treatment of chronic cholecystitis, it is characterized in that: this Chinese medicine composition is made by following bulk drugs:

Herba Lysimachiae 1500-3000 weight portion Rhizoma Corydalis 1000-2000 weight portion

Fructus Toosendan 1000-2000 weight portion Radix Curcumae 1000-2000 weight portion

Radix Aucklandiae 700-1000 weight portion Radix Et Rhizoma Rhei 300-600 weight portion.

2, a kind of Chinese medicine composition for the treatment of chronic cholecystitis as claimed in claim 1, it is characterized in that: this Chinese medicine composition is made by following bulk drugs:

Herba Lysimachiae 2000-3000 weight portion Rhizoma Corydalis 1500-2000 weight portion

Fructus Toosendan 1500-2000 weight portion Radix Curcumae 1000-1500 weight portion

Radix Aucklandiae 700-900 weight portion Radix Et Rhizoma Rhei 400-500 weight portion.

3, a kind of Chinese medicine composition for the treatment of chronic cholecystitis as claimed in claim 1, it is characterized in that: this Chinese medicine composition is made by following bulk drugs:

Herba Lysimachiae 2500 weight portion Rhizoma Corydalis 1667 weight portion Fructus Toosendans 1667 weight portions

The Radix Curcumae 1250 weight portion Radix Aucklandiae 833 weight portion Radix Et Rhizoma Rhei 416 weight portions.

4, as claim 1 or 2 or 3 described a kind of Chinese medicine compositions for the treatment of chronic cholecystitis, it is characterized in that: the dosage form of this Chinese medicine composition is any in tablet, capsule, granule, oral liquid, subcutaneous administration preparation, the suppository.

5, a kind of preparation method for the treatment of the Chinese medicine composition of chronic cholecystitis as claimed in claim 4, it is characterized in that: this method is:

Radix Curcumae, the Radix Aucklandiae add 4～8 times of water gagings, and vapor distillation extracted volatile oil 3～6 hours, and aqueous solution after the distillation and medicinal residues device are in addition collected, and volatile oil is made clathrate with 2～5 times of amount beta-schardinger dextrin-application grinding methods; Rhizoma Corydalis adds 4～6 times of amount 70～90% alcohol reflux 1～3 time, each 1～3 hour, merge extractive liquid,, filter, filtrate recycling ethanol also is evaporated to mutually 80 ℃ to density 1.20～1.45, Radix Curcumae behind medicinal residues and the distillating extracting oil, Radix Aucklandiae medicinal residues merge, add Herba Lysimachiae, Fructus Toosendan, Radix Et Rhizoma Rhei residue three flavors, adding 6～9 times of water gagings immersions decocted 2～5 times after 3～5 hours, each 0.5～1.5 hour, aqueous solution after collecting decoction and the distillation, filter, filtrate decompression is concentrated into 80 ℃ of relative density 1.00-1.25, add ethanol make contain alcohol 50～70%, fully stir, static 20～25 hours, filter, filtrate recycling ethanol also is evaporated to 80 ℃ of relative density 1.25-1.40, merge with the Rhizoma Corydalis ethanol extract, add starch, mixing, 80 ℃ of drying under reduced pressure, be ground into fine powder, with the B-cyclodextrin clathrate mixing of volatile oil of Radix Aucklandiae, excipient direct through conventional operation or that adding is pharmaceutically accepted is made tablet, capsule, granule, oral liquid, the subcutaneous administration preparation, in the suppository any.

6, a kind of preparation method for the treatment of the Chinese medicine composition of chronic cholecystitis as claimed in claim 5, it is characterized in that: the method for preparing tablet is:

Radix Curcumae, the Radix Aucklandiae add 6 times of water gagings, and vapor distillation extracted volatile oil 5 hours, and aqueous solution after the distillation and medicinal residues device are in addition collected, and volatile oil is made clathrate with 4 times of amount beta-schardinger dextrin-application grinding methods; Rhizoma Corydalis adds 5 times of amount 75% alcohol reflux 2 times, each 1.5 hours, merge extractive liquid, filtered, filtrate recycling ethanol also is evaporated to 80 ℃ of relative densities 1.30～1.35, Radix Curcumae behind medicinal residues and the distillating extracting oil, Radix Aucklandiae medicinal residues merge, and add Herba Lysimachiae, Fructus Toosendan, Radix Et Rhizoma Rhei residue three flavors add 8 times of water gagings immersions and decoct 4 times after 4 hours, each 1 hour, aqueous solution after collecting decoction and the distillation filters, and filtrate decompression is concentrated into 80 ℃ of relative density 1.10-1.15, add ethanol make contain alcohol 60%, fully stir, static 24 hours, filter, filtrate recycling ethanol also is evaporated to 80 ℃ of relative density 1.30-1.35, merge with the Rhizoma Corydalis ethanol extract, add starch, mixing, 80 ℃ of drying under reduced pressure, being ground into fine powder, with the B-cyclodextrin clathrate mixing of volatile oil of Radix Aucklandiae, is wetting agent system granule with 90% ethanol, under 40 ℃ of-50 ℃ of conditions, spray drying, granulate, tabletting is made tablet through conventional technology.

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