CN1785416A - Medicinal preparation for freating chololithiasis and its preparation method - Google Patents

Abstract

A Chinese medicine in the form of powder for treating cholelithiasis is prepared from 10 Chinese-medicinal materials including lysimachia, oriental wormwood, scutellaria root, rhubarb, etc. Its preparing process is also disclosed.

Description

Pharmaceutical preparation of treatment cholelithiasis and preparation method thereof

Technical field: the present invention relates to a kind of pharmaceutical preparation for the treatment of cholelithiasis and preparation method thereof, belong to technical field of medicaments.

Background technology: cholelithiasis is meant the disease of biliary system and stones in intrahepatic bile duct generation calculus, is human commonly encountered diseases and frequently-occurring disease, and this disease is distributed more widely, has crowd's place that the generation of cholelithiasis is just arranged.In recent years, along with the variation of China's dietary structure and social life, number of the infected is showed increased more in the past, and the trend that increases with age growth is arranged.Cholelithiasis causes very big misery to patient, causes shiver with cold, hyperpyrexia, severe pain, jaundice even life-threatening sometimes.In China, according to the reason of the traditional Chinese medical science " is usefulness to lead to ", based on calculus, getting to know in conjunction with China's bile duct is main characteristics, has formed characteristic Therapeutic Method from the fifties.

Cholagogic and lithagogue tablet is the good medicine of Chinese traditional treatment cholelithiasis, and cholagogic and lithagogue, anti-inflammatory analgesic effect are obvious, are clinical medicine commonly used, as national essential drugs by " each edition is recorded since the Chinese pharmacopoeia 85 editions, and is collected into much in the various famous-brand and high-quality Chinese patent medicine monographs.Through nearly 20 years clinical practice, prove that it has no side effect, good effect and use easy to carryly, but because its dosage form is a tablet, disintegrate is slow, be difficult for disperseing, bioavailability is relatively low and dosage is excessive, once need to take 10 more than, patient has saying of " eating tate ".

Summary of the invention: the objective of the invention is to: a kind of pharmaceutical preparation for the treatment of cholelithiasis and preparation method thereof is provided, and preparation disintegrate of the present invention is very fast, easily dispersion, bioavailability height and dosage are less, to overcome the deficiencies in the prior art.

The present invention is achieved in that according to weight and calculates that it is prepared into powder by Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, refining sodium sulphate 66g and refining Cortex Magnoliae Officinalis 132g; For yellowish-brown to tan powder, bitter in the mouth, salty.

The pharmaceutical preparation that the present invention treats cholelithiasis is preparation like this: weighting raw materials material Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, the Radix Aucklandiae, Radix Curcumae, Radix Et Rhizoma Rhei, Semen Arecae, Fructus Aurantii Immaturus (parched with bran), refining sodium sulphate and refining Cortex Magnoliae Officinalis, the Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate are ground into fine powder, standby; Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Curcumae, Semen Arecae, Fructus Aurantii Immaturus (parched with bran) and refining Cortex Magnoliae Officinalis are decocted with water 1～3 time, 1～3 hour for the first time, 0.5～2 hour for the second time, filter, the survey relative density was 1.32～1.35 clear paste when merging filtrate, filtrate were concentrated into 70～80 ℃, added the fine powder of the above-mentioned Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate, mixing, dry under 70～80 ℃ of conditions, be ground into fine powder, sieve, pack, promptly.

The best preparation method that the present invention treats the pharmaceutical preparation of cholelithiasis is: weighting raw materials material Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, refining sodium sulphate 66g and refining Cortex Magnoliae Officinalis 132g, the Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate are ground into fine powder, standby; Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Curcumae, Semen Arecae, Fructus Aurantii Immaturus (parched with bran) and refining Cortex Magnoliae Officinalis are decocted with water 2 times, 2 hours for the first time, 1 hour for the second time, filter, the survey relative density was 1.32～1.35 clear paste when merging filtrate, filtrate were concentrated into 70～80 ℃, added the fine powder of the above-mentioned Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate, mixing, dry under 70～80 ℃ of conditions, be ground into fine powder, the pack of sieving, make 1000 bags, promptly.

Cholelithiasis comprises cholelithiasis, hepatic calculus.That cholecystitis divides is anxious, slow two kinds, acute cholecystitis is based on acute calculus, cholelithiasis and acute cholecystitis all belong to disease scopes such as Chinese medicine " hypochondriac pain ", " jaundice ", " stomachache ", " addiction Huang ".It is many by disgruntled troubled thoughts, eating and drinking without temperance that the generation of cholelithiasis and acute cholecystitis, the traditional Chinese medical science are thought, or cold temperature is uncomfortable, or factor such as disturb on the ascarid, cause depression of liver-QI, strongly fragrant and fire-transformation, transporting and transforming function of the spleen and stomach mistake department, endogenous damp formation, damp-heat accumulation, liver lose to dredge and rush down, and gallbladder loses logical falling and forms, generally be divided into the stagnation of QI, damp and hot and fire-toxicity syndrome opinion is controlled, and wherein belongs to many with damp-heat syndrome.Clinical manifestation is with upper abdomen and middle part or upper right abdomen pain, nausea and vomiting, and fever with chills, or jaundice etc. is a cardinal symptom.Chinese traditional treatment mainly is conceived to depressed liver-energy dispersing and function of gallbladder promoting, purging FU-organs calculus, clearing away heat-damp and promoting diuresis except that by the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs.We are long as principle with the purging FU-organs cholagogic and lithagogue, and utilization we's basic indication is: right hypochondrial region, jaundice, the heat that occurs together shiver with cold, bitter taste xerostomia, constipation, red tongue with yellowish and greasy fur, wiry and frequent pulse or stringy and rolling pulse.Card belongs to damp-heat accumulation liver and gall person, doctor trained in Western medicine judgement cholelithiasis, and acute biliary infection has above-mentioned proposita, all can use this agent.

Herba Lysimachiae, Herba Artemisiae Scopariae are damp-resolving medicinal in this product side, are main effect with eliminating damp-heat, promoting the function of the gallbladder to alleviate jaundice.Cholelithiasis, biliary tract infection many with heresy from transconversion into heat.And heat is often in wet and existing, thereby uses Herba Lysimachiae, Herba Artemisiae Scopariae to reach the purpose of damp eliminating heat extraction.The traditional Chinese medical science thinks that gas is the machine of the whole body, qi as the commander of blood is arranged, the capable reason of the capable then blood of gas, biliary tract has the disease of Hepatic pent-up more, uses the qi-activating drug Radix Aucklandiae, Fructus Aurantii, Cortex Magnoliae Officinalis, be equipped with the Radix Curcumae of blood circulation promoting and blood stasis dispelling, current blood vessels again, reaching the strongly fragrant analgesic effect of separating, adopt Radix Et Rhizoma Rhei, Natrii Sulfas tonneau stool in the side, it is stagnant or lead excess-heat, expelling fluid-retention clearly to have got rid of gastrointestinal tract, capture to reach the hot down purpose of reality down with this method, better with antipyretic Radix Scutellariae compatibility effect.Use the Semen Arecae eliminating stagnated food and killing intestinal worms, to suffer from after the exhausted worm's ovum calculus.Simultaneously the effective ingredient according to modern pharmacology proof Herba Lysimachiae, Herba Artemisiae Scopariae have function of gallbladder promoting, diuresis, protect the liver, antibiotic and see virus function; Radix Et Rhizoma Rhei, Natrii Sulfas main component all have discharge function; That Radix Scutellariae has is antibiotic, antiviral, refrigeration function, for we's therapeutical effect provides rationale.

Make a general survey of full side, this product is a principal agent with Herba Lysimachiae, Herba Artemisiae Scopariae, eliminating damp-heat, the subcutaneous ulcer that disappears diuretic calculus; Radix Et Rhizoma Rhei, Radix Scutellariae, Natrii Sulfas heat clearing away purging FU-organs, hard masses softening and resolving makes its logical falling be accessory drugs altogether; Fructus Aurantii Immaturus, Cortex Magnoliae Officinalis, the Radix Aucklandiae, the wide intestinal of Semen Arecae logical the falling of regulating the flow of vital energy, to separate the pent-up of mechanism of qi, again can regulating QI to relieve pain; The Radix Curcumae vital energy regualting and blood circulation-promoting, the resolving depression pain relieving is adjuvant altogether.All medicines are harmonious, and play clearing away heat-damp and promoting diuresis altogether, promoting the circulation of QI to relieve pain, the effect of cholagogic and lithagogue.

This product has the effect of clearing away heat-damp and promoting diuresis, cholagogic and lithagogue, is used for Biliary Calculi, biliary tract infection, the treatment of gallbladder inflammation.Dosage form of the present invention is mainly powder, bigger specific surface area is arranged, easily dispersion, easy absorption, good effect, the bioavailability height is directly decomposed absorption by digestive tract behind the clothes, and is rapid-action, the development of acute cholecystitis onset acute disease feelings rapidly, the requirement drug effect is fast, and effect is strong, the most suitable requirement in this respect of this product.And little, the taking convenience of its dosage, do not contain any adjuvant in the medicine, the patient there is not taboo, be particularly suited for the gerontal patient.And this product impels polydipsia water when taking, so that digestive tract is full, strengthened the discharge of Biliary Calculi, and makes that acute and chronic biliary tract inflammation obtains in time, treatment efficiently.Therefore, compared with prior art, the present invention has easy dispersion, easy absorption, good effect, and bioavailability height and dosage are little, the advantage of taking convenience, do not contain any adjuvant in the medicine, and the patient is not had taboo, are particularly suited for the gerontal patient.

This product cholagogic and lithagogue Pharmacodynamic test of active extract of loosing:

Test objective: the research cholagogic and lithagogue looses to the rat bile flow, to the mice ear degree, to the influence of effect of mice pain and mice gall bladder emptying.

Material: (one) medicine: this product cholagogic and lithagogue looses, cholagogic and lithagogue tablet, and lot number: 930914, produce by the Qingdao pharmaceutical factory of traditional Chinese medicine.(2) animal: the wistar rat, body weight 200-250g, Kunming mouse, body weight 18～23g is provided by Shandong Medical University's Experimental Animal Center, and lot number is 930102.

Method: (one) is to the influence of rat bile flow: with 1% pentobarbital sodium ip anesthetized rat, be fixed on the plate, dig and open the abdominal cavity, expose ductus choledochus, cut a little otch, insert a polyethylene tube, ligation is fixed, and polyethylene tube is drawn the abdominal cavity, collects bile with the graduated centrifuge tube of 5ml, collect 1h before the medicine, irritate stomach (ig) administration then, matched group is given the equal volume excipient, continues to collect bile 4h, per hour write down the bile amount once, and ig 5% G/NS once.Observation index: per hour bile flow and 4h courage total amount.(2) to the influence of mice ear degree: get 50 of Kunming mouses, body weight 18～23g, male and female half and half, be divided into 5 groups at random, be diffusing high, normal, basic three the dosage groups of cholagogic and lithagogue, cholagogic and lithagogue tablet group and vehicle group, 10 every group, every day, ig was twice, continuous 14d, 30rain causes scorching liquid with mixing and drips in mouse right ear by 0.1ml/10g after last administration, puts to death behind the 15min, draws materials along left and right sides auricle same area with card punch, weigh respectively,, compare the difference of medication group and matched group, and obtain suppression ratio as swelling degree index with two ear weight differences.(3) to the influence of mice pain effect: get 50 of Kunming mouses, be divided into 5 groups at random, be diffusing high, normal, basic three the dosage groups of cholagogic and lithagogue, cholagogic and lithagogue tablet group and vehicle group, every group 10, every day, ig twice, continuously 14d, 30min lumbar injection 0.3% acetic acid 0.2ml/ only observes each treated animal in the 30min and turns round the body number by what acetic acid caused after last administration.(4) to the influence of mice gallbladder weight: get 50 of Kunming mouses, be divided into 5 groups at random, i.e. cholagogic and lithagogue high, normal, basic three dosage groups of loosing, cholagogic and lithagogue tablet group and vehicle group, every group 10, every day, ig twice, continuous 14d, 30min after last administration, put to death animal, the extraction gallbladder is weighed with analytical balance, calculates and respectively organizes gallbladder weight and carry out statistics relatively.

The result: (one) the results are shown in Table 1 to the influence of rat bile flow.

Table 1 cholagogic and lithagogue looses to the influence of rat bile flow

Group	Dosage mg/k g	Bile flow (ml/h)
								1h before the medicine	1h behind the medicine	2h	3h	4h	Total amount
		Cholagogic and lithagogue looses	2100	0.92±0.15	1.15±0.13*	1.45±0.14**	1.34±0.23**							0.96±0.23*	4.80±0.46*
1050	0.89±0.28							1.11±0.29*	1.12±0.26*	1.16±0.26*	0.93±0.23*	4.30±0.94*
			525	0.94±0.27	1.00±0.29	0.84±0.20	0.84±0.25						0.84±0.20	3.56±0.83
Cholagogic and lithagogue tablet	1050							0.89±0.25	1.10±0.24*	1.18±0.28*	0.95±0.10	0.90±0.10			4.15±0.79*
		The Veh group	/	1.02±0.28	0.85±0.33	0.87±0.34	0.88±0.26						0.74±0.15	3.34±0.84

(Mean ± SD), n=10, * p＜0.05, * * p＜0.01vs.veh group

Can draw from table 1,1h respectively organizes rat bile flow no significant difference before the medicine, and cholagogic and lithagogue looses and organizes after the medication, and the cholagogic and lithagogue tablet group all has the rat bile of promotion secretory action.The cholagogic and lithagogue 1050mg/kg dosage group of loosing all has remarkable promotion rat bile secretory action in 0～4h behind medicine, though and the bile total amount of 4h also facilitation is arranged apparently higher than veh group low dosage 525mg/kg group, compare no difference of science of statistics with the Veh group; The cholagogic and lithagogue tablet group is compared with the veh group, and effect is more obvious in 0～2h behind medicine.

(2) to the influence of mice ear degree, the results are shown in Table 2.

Table 2 cholagogic and lithagogue looses to the influence of mice ear degree

Group	Dosage mg/kg	Two auricle weight difference mg	Press down swollen rate %
				Cholagogic and lithagogue looses	3000	0.45±0.28**▲▲	68.53±19.29▲
1500	0.81±0.31**	43.36±21.47
			750		1.08±0.26	29.16±20.71
Cholagogic and lithagogue tablet	1500	0.66±0.31**					53.84±21.66▲
			The Veh group	/	1.43±0.61	/

(Mean ± SD), n=10, * p＜0.05, * * p＜0.01 vs.veh group, ▲ p＜0.05, ▲ ▲ the diffusing low dose group of the sharp cholagogic and lithagogue of p＜0.01vs..

The swelling of Veh group mouse right ear is obvious as can be seen from Table 2, and thickness increases, and two auricles differ greatly, and administration group mice two auricle differences are organized less than Veh, and the diffusing inflammatory reaction that can alleviate mice of cholagogic and lithagogue is described.

(3) to the influence of mice pain effect, see Table 3.

Table 3 cholagogic and lithagogue looses to the influence of mice pain effect

Group	Dosage mg/kg	Number of animals (only)	Turn round the body number of times in the 30min
				Cholagogic and lithagogue looses	3000	10	34.8±9.7**▲
1500	10	38.2±9.6**
			750		10	48.6±9.99
Cholagogic and lithagogue tablet	1500	10					43.6±7.31**
			The Veh group	/	10	53.3±6.34

(Mean ± SD), n=10, * p＜0.05, * * p＜0.01 vs.veh group, ▲ p＜0.05, ▲ ▲ the diffusing low dose group of the sharp cholagogic and lithagogue of p＜0.01vs..

As shown in table 3, can cause mouse peritoneal pain behind the injection acetic acid, writhing response appears.The cholagogic and lithagogue middle and high dosage group of loosing is compared with the Veh group with the cholagogic and lithagogue tablet group, effect obviously, significantly reduced mice the writhing response number of times, shown the pain effect that cholagogic and lithagogue looses and has obvious inhibition chemical substance to cause.

(4) to the influence of mice gallbladder weight, see Table 4.As can be seen from Table 4, high dose group was compared with the Veh group with the cholagogic and lithagogue tablet group during cholagogic and lithagogue loose, and effect has obviously significantly reduced the gallbladder weight of mice, illustrate that cholagogic and lithagogue is diffusing can quicken the mice gall bladder emptying.

Table 4 cholagogic and lithagogue looses to the influence of mice gallbladder weight

Group	Dosage mg/kg	Number of animals (only)	Gallbladder weight (mg)
				Cholagogic and lithagogue looses	3000	10	2.19±0.65**
1500	10	2.12±0.35**
			750		10	2.65±0.96
Cholagogic and lithagogue tablet	1500	10					2.47±0.62*
			The Veh group	/	10	3.07±0.65

(Mean ± SD), * P＜0.05, * * P＜0.01 VS.veh group

Conclusion (of pressure testing): above-mentioned results of pharmacodynamic test shows: this product cholagogic and lithagogue looses can significantly promote the anesthetized rat bile secretion, and obviously is longer than former dosage form contrast medicine cholagogic and lithagogue tablet its action time; Quicken the mice gallbladder to biliary Excretion, its effect slightly is better than former dosage form contrast medicine cholagogic and lithagogue tablet, but both compare no difference of science of statistics; Its mechanism may act on hepatocyte for this medicine, promotion is to biliary secretion, the interior bile of liver and gall is increased, intrinsic pressure increasing, Oddi's sphincter is loose, also may be the tensity that directly reduces Oddi's sphincter, strengthen many-sided effects such as gallbladder contraction, thereby make bile flow quickening in the unit interval.This product Dichlorodiphenyl Acetate induced mice abdominal cavity pain and mice auricular concha inflammation all have obvious inhibitory action, and its effect is similar to cholagogic and lithagogue tablet, illustrate that this medical instrument has inflammation-inhibiting reaction and analgesic effect.

This product cholagogic and lithagogue rat long term toxicity test that looses:

Material: 1, medicine: this product cholagogic and lithagogue looses: every gram is mixed with desired concn with 0.5% sodium carboxymethyl cellulose when being equivalent to crude drug 3.2g during administration.2, reagent: blood biochemical is learned the mensuration medicine box and is produced by Beijing Chemical Plant's clinical reagent subsidiary factory.Other chemical reagent is available from chemical reagent supply station, Jinan.3, instrument: the full-automatic hematimeter of 460310-0195 type, French Labover company produces; 4010 type semi-automatic biochemical analyzers, Beijing Analytical Instrument Factory produces.B2 one type rat feed cage tool, Feng Qiao radiation products factory in Wu County, Suzhou produces.4, animal and feedstuff: 60 of WiStar rats, body weight 160-180g, male and female half and half are provided by Shandong Province's Experimental Animal Center, the quality certification number: 930101.Granule Mus material is provided by Beijing China drug inspection office animal feeding breeding field.

Experimental technique: 1, animal feeding: after rat is bought, at first raise 1wk in advance in this center animal housing, body weight is 160 ± 20g when being used to test.♂ ♀ branch is supported during raising, and 10 in every cage is supplied with competent water and feedstuff, keeps 18-26 ℃ of room temperature.

2, animal grouping, dosage, cycle and medication: experimental animal is divided into high dose group, low dose group and blank group at random, 20 every group, male and female half and half.The diffusing clinical adult of cholagogic and lithagogue intends with dosage is: calculus: 2.3-3.8g/ time, and 2 times/day; Inflammation: 1.5-2.3g/ time, 2 times/day; The medication cycle is 10-15 days, because LD50 is not made in the low acute toxicity test of its toxicity, in conjunction with the maximum administration concentration that allows of this medicine, determine that high dose is the 6.5g/kg body weight, low dosage 1.3g/Kg, the ig administration is two months continuously, once-a-day, the administration volume is capacity tap waters such as 2ml/100g, matched group ig, and drug withdrawal rear section animal continues to observe for 2 weeks.Proportionately body weight for humans 60Kg calculates, and rat per kilogram of body weight high and low dose is about 50 and 10 times of the highest consumption of clinical adult respectively.

3, inspection item and method:

(1) general symptom and death condition: regularly observe animal activity, hair, feces situation and poisoning symptom that may occur and sign every day during the administration, confirms to have or not death.

(2) body weight change: reach every 2wk of drug withdrawal observation period during the administration and survey body weight once, compare, observe each treated animal body weight gain situation with matched group.

(3) hematology and biochemical analysis: respectively at 2wk after 8wk behind the medicine and the drug withdrawal, ether light anaesthesia lower tail is got blood, measures the every index of routine blood test, comprises hemoglobin (Hb), red blood cell count(RBC) (RBC), numeration of leukocyte (WBC) and classification (DC); Separation of serum, the biochemical every index of conventional determining blood comprises serum glutamic oxalacetic transaminase (GPT), glutamate pyruvate transaminase (GOT), alkali phosphatase (ALP), blood glucose (GLU), T-CHOL (TC), total protein (TP), albumin (ALB), creatinine (Cr) and blood urea nitrogen (BUN).

(4) histopathologic examination: the main organs that dead animal and administration is midway finished every group of 10 rats in back is carried out perusal, dissection is got brain, the heart, lung, liver,spleen,kidney, adrenal gland, testis, ovary, uterus and is weighed, with organ weight/body weight * 100 is organ coefficient, fix with 10% formalin then, cut into slices after the routine paraffin wax embedding, carry out H-E dyeing, microscopy.

(5) drug withdrawal is observed: heavy dose of group and matched group respectively stay 1/2 animal to continue to observe 2wk after the drug withdrawal, and observation index is the same.

Result of the test: 1, ordinary circumstance: in administration during two months, medication group and control rats are all movable normally, behavior is active, hair is smooth, in the high dose group animal-use drug began for two weeks loose and watery stools soft, animal does not see that other are unusual, each group is not seen animal dead during the administration.

2, to the influence of rat body weight: the results are shown in Table 5

Table 5 cholagogic and lithagogue looses to the influence of rat body weight

Group	Dosage (g/ kg)	Time
								Before the administration	2 weeks after the administration	4 weeks	6 weeks	8 weeks	2 weeks of observation period
		Matched group	/	164.00±17.8	183.89±23.12	204.05±26.24	220.37±29.20							239.64±26.52	258.00±30.12
Cholagogic and lithagogue looses	6.5							163.05±22.4	172.39±20.44	196.38±21.32	212.12±20.76	232.14±23.8	250.24±32.58
		1.3	166.5±14.3	177.9±16.56	198.37±18.38	218.10±25.70	237.21±23.69							/

(n＝20，x±SD)

As can be seen from Table 5, except that the administration phase the 2nd, all high dose group the weight of animals increased a little less than matched group (but not statistically significant), each administration treated animal of all the other times and control animals body weight gain situation basically identical, no significant difference between group (P＞0.05).

3, rat blood is learned the influence of checking: the results are shown in following table

Table 6 cholagogic and lithagogue looses to the influence of rat Hb (g/dl)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	12.22±1.25	13.70±0.58
Cholagogic and lithagogue looses	6.5	11.98±0.95	14.77±1.79
				1.3	12.32±0.89	/

(n＝20，x±SD)

Table 7 cholagogic and lithagogue looses to rat RBC (* 10 ¹²/ l) influence

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	9.28±0.71	10.07±1.34
Cholagogic and lithagogue looses	6.5	9.10±2.47	11.96±2.06
				1.3	8.28±0.68	/

Table 8 cholagogic and lithagogue looses to rat WBC (* 10 ⁹/ l) and the classification influence

Group	Dosage (g/kg)	The cell classification	Administration 8wk	Drug withdrawal 2wk (n=10)
					Matched group	/	WBC(％) N(％) L(％) M(％)	14.4±3.09 30.3±3.55 69.1±12.58 1.2±0.42	13.28±2.42 29.82±2.32 68.2±11.99 2.06±12.98
Cholagogic and lithagogue looses	6.5	WBC(％) N(％) L(％) M(％)	15.4±3.99 27.4±2.14 70.9±13.55 1.1±0.35	14.82±4.32 30.4±2.15 68.3±14.15 1.3±0.55
					1.3	WBC(％) N(％) L(％) M(％)	14.2±3.39 29.1±2.55 68.3±12.95 1.2±0.46	/ / / /

(n＝20，x±SD)

As can be seen from the above table, administration finishes and the observation period finishes back administration group and control animals content of hemoglobin, erythrocyte, numeration of leukocyte and classification all in normal range, are learned by statistics and are handled there was no significant difference (P＞0.05) between administration group and the matched group.

4, the influence that blood biochemistry of rats is checked: the results are shown in following table

Table 9 cholagogic and lithagogue looses to the influence of rat blood serum GPT (u)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	37.63±7.88	34.53±9.41
Cholagogic and lithagogue looses	6.5	37.79±11.62	34.32±9.45
				1.3	39.27±12.71	/

Table 10 cholagogic and lithagogue looses to the influence of rat blood serum GOT (u)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	72.14±24.21	61.60±22.09
Cholagogic and lithagogue looses	6.5	62.12±28.45	66.44±10.28
				1.3	62.82±14.84	/

(n＝20，x±SD)

Table 11 cholagogic and lithagogue looses to the influence of rat blood serum BUN (mg/dl)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	16.12±3.03	14.2±3.24
Cholagogic and lithagogue looses	6.5	16.29±4.99	12.69±6.18
				1.3	15.13±2.78	/

(n＝20，x±SD)

Table 12 cholagogic and lithagogue looses to the influence of rat blood serum ALP (g/dl)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	2.41±0.89	3.92±0.50
Cholagogic and lithagogue looses	6.5	2.89±0.71	3.28±1.27
				1.3	2.59±0.71	/

(n＝20，x±SD)

Table 13 cholagogic and lithagogue looses to the influence of rat blood serum GLU (mg/dl)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	72.91±22.10	83.77±23.46
Cholagogic and lithagogue looses	6.5	75.31±25.86	80.71±17.92
				1.3	79.23±14.8	/

(n＝20，x±SD)

Table 14 cholagogic and lithagogue looses to the influence of Serum TC (mg/dl)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	1.04±0.30	1.82±0.32
Cholagogic and lithagogue looses	6.5	1.02±0.33	2.04±0.83
				1.3	1.56±0.31	/

(n＝20，x±SD)

Table 15 cholagogic and lithagogue looses to the influence of rat blood serum TP (g/dl)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	8.81±3.94	10.17±1.78
Cholagogic and lithagogue looses	6.5	7.86±1.56	10.28±3.02
				1.3	9.41±1.05	/

(n＝20，x±SD)

Table 16 cholagogic and lithagogue looses to the influence of rat blood serum ALB (g/dl)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	4.82±0.89	5.25±0.55
Cholagogic and lithagogue looses	6.5	5.69±0.71	4.86±0.83
				1.3	5.06±0.71	/

(n＝20，x±SD)

Table 17 cholagogic and lithagogue looses to the influence of rat blood serum Cr (mg/dl)

Group	Dosage (g/kg)	Administration 8wk	Drug withdrawal 2wk (n=10)
				Matched group	/	1.40±0.48	1.38±0.57
Cholagogic and lithagogue looses	6.5	1.49±0.18	1.30±0.26
				1.3	1.09±0.58	/

(n＝20，x±SD)

Last table result shows and respectively organizes serum glutamic oxalacetic transaminase (GPT) behind the rat medicine, glutamate pyruvate transaminase (GOT), alkali phosphatase (ALP), blood glucose (GLU), T-CHOL (TC), total protein (TP), albumin (ALB), creatinine (Cr), blood urea nitrogen (BUN) measured value all in normal range, no significant difference (P＞0.05) between each group.

5, to the influence of Rats Organs and Tissues coefficient: the results are shown in Table 18.

Group n=5	Dosage (g/k g)		Organ coefficient (%, X ± SD)
													The heart	Liver	Spleen	Lung	Kidney	Brain	The adrenal gland	Ovary n=5	Uterus n=5	Testis
			8 weeks of administration
Matched group	/	0.39± 0.08														3.45± 0.32	0.34± 0.11	0.70± 0.009	0.78± 0.10	0.74± 0.07	0.03± 0.01	0.05± 0.02	0.12± 0.12	1.11± 0.11
				Cholagogic and lithagogue looses	6.5	0.46± 0.1		3.94± 0.90	0.45± 0.11	0.86± 0.17	0.94± 0.16	0.82± 0.13	0.04± 0.03	0.08± 0.06	0.34± 0.07										1.35± 0.28
1.3	0.35± 0.05		3.02± 0.39													0.39± 0.04	0.62± 0.10	0.70± 0.05	0.76± 0.06	0.03± 0.01	0.06± 0.02	0.25± 0.04	1.07± 0.34
					2 weeks of drug withdrawal
Matched group	/	0.34± 0.03		3.61± 0.54														0.32± 0.06	0.75± 0.08	0.69± 0.09	0.74± 0.07	0.03± 0.01	0.07± 0.01	0.11± 0.06	1.31± 0.22
					Cholagogic and lithagogue looses	6.5	0.35± 0.06		3.56± 0.48	0.29± 0.06	0.73± 0.05	0.71± 0.10	0.76± 0.071	0.03± 0.01	0.06± 0.02	0.22± 0.04	1.26± 0.12

(n＝10，X±SD)

As can be seen from Table 18, the variation of each group of administration and control rats organ coefficient all in normal range, is learned by statistics and is handled there was no significant difference (P＞0.05) between each group.

6, rat main organs histopathologic examination:

Gross examination of skeletal muscle: each is organized the rat heart, liver, spleen, lung, kidney, stomach and duodenum and cuts open inspection substantially and there is no unusual.

Histological examination: the intracardiac adventitia of control rats, matter is not all looked into and is seen abnormal change between the cardiac muscle fiber of cardiac muscular tissue and cardiac muscle.The lobules of liver of liver, sinus hepaticus organizational structure are normal, do not see hepatocellular degeneration or necrosis.The bronchus at different levels of lung and alveolar tissue structure no abnormality seen, it is focal hemorrhage only to see that a rat pulmonary has.The glomerule of kidney, renal tubules and interstitial tissue of kidney's structure are all normal.

Each administration treated animal main organs histological examination; Relatively there is no notable difference with matched group.But also see the minority animal lung focal bleeding is arranged, this situation may with individual animal careless manipulation in the gastric infusion process or when putting to death, pulmonary is subjected to.Due to the crush injury, matched group also has this situation to occur, and therefore gets rid of due to the drug toxicity.

Experiment conclusion: experimental study shows: this product cholagogic and lithagogue looses 6.5,1.3g/kg, once a day, two weeks is not seen animal ordinary circumstance, body weight gain, hematology, blood biochemical analysis ANOMALOUS VARIATIONS after ig rat 2 months and the drug withdrawal continuously, does not also see main organs histopathology ANOMALOUS VARIATIONS.Above-mentioned dosage is respectively 50,10 times of clinical adult's dosage, proves that this product toxicity is lower, and clinical practice is safe.

This product cholagogic and lithagogue chmice acute toxicity research that looses:

Material: 1. medicine: this product cholagogic and lithagogue looses, usage and consumption: oral, and calculus: 2.30-3.80g/ time, 2 times/day; Inflammation: 1.50-2.30g/ time, 2 times/day; It is 2.89g that every gram contains the crude drug amount.Provide by the applicant.Its maxima solubility is 0.5g/ml.

2. animal and feedstuff: Kunming mouse is provided the quality certification number: 930102 by Shandong Medical University's Experimental Animal Center.Granule Mus material is provided by Ministry of Public Health drug inspection office laboratory animal breeding field.

Method: trial test shows that this product toxicity is lower, is subjected to the restriction of administration volume and concentration, is difficult to measure LD50, so carry out maximum tolerance determination in a day of its mice.Get 20 of healthy Kunming mouses, ♂ ♀ half and half, body weight 19-22g, water is can't help in experiment fasting in evening the previous day, and second with function of gallbladder promoting powder medicine for discharging calculus stone 0.4ml/10g, in 8:00,14:00,17:00 ig respectively once observe 7d continuously, observe the reaction of animals situation, record animal appearance, behavioral activity, the mental status, large and small just character and color, fur, breathing, nose, be movable, the mental status, large and small just character and color, fur, breathing, nose, eye, oral secretion and death condition.

The result: observe 7d after the administration, none death of mice, outward appearance health, behavior is active, and the mental status is good, the fur smoothness, breathing and defecation are normal, nose, the no abnormal secretions in eye oral cavity.

Conclusion: originally experimental results show that, mice diffusing 60g/kg of ig cholagogic and lithagogue on the one, animal does not have any untoward reaction, can think that the maximum oral tolerance amount on the one of the diffusing mice of cholagogic and lithagogue is 60g/kg, being equivalent to the crude drug amount is 192g/kg, be 526 times of clinical calculus dosage, 870 times of inflammation dosage show that thus this product clinical application is safe.

This product stability study:

One, room temperature test down: this product is carried out study on the stability under the room temperature, getting three batch samples tests by the quality standard of being formulated, under the listing terms of packing, when room temperature is placed 1,2,3,6,12,18 month its quality to be investigated, its investigation the results are shown in following table:

Preparation stability is investigated test report ()

The sample title: this product cholagogic and lithagogue looses

Result's standing time (date) project	0 month (95.3.17)	January (95.4.17)	February (95.5.17)	March (95.6.17)	June (95.4.17)	December (96.3.17)	18 months (96.9.17)
								Character	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder
Differentiate (1) (2) (3) (4) (5)	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result
								Moisture (%) uniformity fineness of powder assay (%) bacterium (individual/g) mould is (individual/g) the pathogenic bacteria mite that lives	4.32 0.0427＜10＜10 do not detect	4.80 qualified 0.0434＜10＜10 do not detect	4.92 qualified 0.0428＜10＜10 do not detect	4.50 qualified 0.0432＜10＜10 do not detect	6.07 qualified 0.0434＜10＜10 do not detect	6.01 qualified 0.0421＜10＜10 do not detect	6.08 qualified 0.0425＜10＜10 do not detect

Preparation stability is investigated test report (two)

The sample title: this product cholagogic and lithagogue looses

Result's standing time (date) project	0 month (95.3.17)	January (95.4.17)	February (95.5.17)	March (95.6.17)	June (95.4.17)	December (96.3.17)	18 months (96.9.17)
								Character	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder
Differentiate (1) (2) (3) (4) (5)	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result
								Moisture (%) uniformity fineness of powder assay (%) bacterium (individual/g) mould is (individual/g) the pathogenic bacteria mite that lives	4.35 qualified 0.0460＜10 10 does not detect	4.82 qualified 0.0467＜10＜10 do not detect	5.20 qualified 0.0456＜10＜10 do not detect	5.10 qualified 0.0464＜10＜10 do not detect	6.26 qualified 0.0447＜10＜10 do not detect	6.04 qualified 0.0451＜10＜10 do not detect	6.50 qualified 0.0458＜10＜10 do not detect

Preparation stability is investigated test report (three)

The sample title: this product cholagogic and lithagogue looses

Result's standing time (date) project	0 month (95.3.17)	January (95.4.17)	February (95.5.17)	March (95.6.17)	June (95.4.17)	December (96.3.17)	18 months (96.9.17)
								Character	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder	The yellowish-brown powder
Differentiate (1) (2) (3) (4) (5)	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result	Be positive result
								Moisture (%) uniformity fineness of powder assay (%) bacterium (individual/g) mould is (individual/g) the pathogenic bacteria mite that lives	4.53 qualified 0.0492＜10＜10 do not detect	4.86 qualified 0.0495＜10＜10 do not detect	5.01 qualified 0.0486＜10＜10 do not detect	5.22 qualified 0.0489＜10＜10 do not detect	5.84 qualified 0.0480＜10＜10 do not detect	5.86 qualified 0.0490＜10＜10 do not detect	6.80 qualified 0.0488＜10＜10 do not detect

Two, conclusion: investigate the result according to above cold test, this product room temperature was placed after 18 months, and significant change all takes place for its character and chemical constituent, and the physicochemical property that this product is described is more stable.The effect duration of this product is tentative to be 2 years.

Technical study:,, selecting for use of index components done design investigated test with screening in order to optimize reasonable process conditions in the Study on Preparation stage.At first monarch drug Herba Lysimachiae and Herba Artemisiae Scopariae carry out the thin layer chromatography test as the index object in the side of choosing, and result of the test shows that the separating effect of ingredient and specificity are all not really desirable, and is also undesirable to the thin layer chromatography separation of Radix Scutellariae.Consider that decoction can take out of such as invalid components such as tannin, phlegmatic temperaments, these compositions are dissolved in organic solvent hardly, and the Quercetin in some effective ingredient such as the Herba Lysimachiae, mountain naphthol, capillin in the Herba Artemisiae Scopariae, baicalin in the Radix Scutellariae, p one sitosterol, thick in the Cortex Magnoliae Officinalis are pounced on phenol etc. and are to dissolve in organic solvent by liposoluble substance, with the organic solvent is that the extractum that solvent is measured should be the effective ingredient mixture, can react extraction effect substantially.Decide with the extractum to be testing index preferred for preparation process conditions.The comparative efficacy test result of sample has also proved the feasibility of this technology, thus extraction time and solvent multiple preferably to make index with extractum be rational substantially.

The physicochemical property of each flavour of a drug in the prescription:

1. Herba Lysimachiae: contain materials such as CAMP/GAMP sample material, quercetin glycoside, ursolic acid, kaempferol, sodium chloride.

2. Herba Artemisiae Scopariae: contain materials such as coumarin, chlorogenic acid, caffeic acid, fatty acid, oleic acid, arachidic acid, furfural, hutanal

3. Radix Scutellariae: contain baicaligenin, baicalin, baicalin, benzoic acid, B one sitosterol etc.

4. the Radix Aucklandiae: contain volatile oil 0.3-3%, wherein composition has aplotaxene, a-ionoionone, 6-selinene, costunolide, costic acid etc., contains stigmasterol, inulin, saussurine etc. in addition.

5. Radix Curcumae: contain camphene, sesquiterpene, Camphora, curcumin, turmerone, sesquiterpene alcohols, fatty oil, Eucarvone, phellandrene etc.

6. Radix Et Rhizoma Rhei: contain anthraquinone derivative: chrysophanol, emodin, chrysophanic acid, Aloe Radix Et Rhizoma Rhei contain tannin, fatty acid, Palmic acid, oleic acid, cinnamic acid etc. in addition.

7. Semen Arecae: areca alkaloids content 0.3-0.6%: arecoline, arecaidine, fatty oil, lauryl aldehyde, Palmic acid, oleic acid, stearic acid etc.

8. Fructus Aurantii Immaturus: contain flavonoid glycoside, alkaloid, vitamin c, naringin, Saponin etc.

The pharmacologically active of each medicine and preparation technology's dependency in the prescription: modern pharmacology studies have shown that except that Radix Et Rhizoma Rhei, the Radix Aucklandiae, Natrii Sulfas three flavors were given birth to and used, it was rational that all the other seven flavor medicine materials adopt decocting methods to extract pharmacological component in the side.Relevant documents and materials are discussed and are theed contents are as follows:

1. Herba Lysimachiae: water decoction in vitro tests in 1: 1, staphylococcus aureus there is stronger inhibitory action, diphtheria corynebacterium, Bacillus typhi, escherichia coli, Hemolytic streptococcus all there are stronger inhibitory action; Water decoction is to cerebral blood flow, and heart coronary flow all is significantly increased effect, and myocardial ischemia, cerebral vascular resistance are all had the improvement effect; Water decoction gavages rat, dog duodenal administration, and biliary drainage proof has significant promotion bile secretion and Excretion, can obvious loose Oddi's sphincter, silt shape calculus is easily discharged, in addition water decoction also have diuresis and expelling stone, protect the liver, effect such as anticancer.

2. Herba Artemisiae Scopariae: the water decoction 100% usefulness flat board method of skidding.To golden yellow Portugal bacterium, block its coccus, bacillus pyocyaneus, enteritis liver bacterium, meningococcus not unison inhibitory action all arranged, 10% decoct can suppress Bacillus tuberculosis's growth safely, 5% decoct effect 3 days, 8 kinds of leptospira are all dissolved, water decoction has effect of obvious promotion bile secretion and the effect of row's gallbladder, and the effect of obviously lax Oddi's sphincter is arranged; Protect the liver in addition in addition, effect such as anti-tumor, blood vessel dilating.

3. Radix Scutellariae: decoct tube dilution method, 1: 1 280 pairs of alpha streptococcus, Bacillus typhi, 1: the 640 pair of diphtheria corynebacterium, streptococcus pneumoniae, tubercule bacillus; 1: 320 pair of staphylococcus aureus, vibrio cholera, dysentery bacterium have inhibitory action, in vitro tests, and decoct has inhibitory action to leptospira, and killing action is arranged during high concentration; In addition decoct spasmolytic function of gallbladder promoting, analgesic calmness are arranged, to allergic regulating action etc.

4. Radix Curcumae: 50% decoct has inhibitory action with dull and stereotyped ditch method to Bacillus typhi, leprosy bacillus.

5. Semen Arecae: in vitro tests 30% Semen Arecae decoct can make the dog dwarf tapeworm tetanic to dead in 40 minutes, and mice schistosomicide experimental therapy shows, oral Semen Arecae decoct after 1.5 hours visible 98% schistosoma liver move.

6. Fructus Aurantii Immaturus: decoct is used for numb sour rabbit dog obvious boosting; But experiment and clinical observation discovery microcirculation improvement.Influential to brain, kidney and arteria coronaria flow, and can be used for shock treatment.

7. Cortex Magnoliae Officinalis: the decoct tube dilution method, 1: 320 pair of streptococcus pneumoniae, 1: 160 pair of alpha streptococcus, 1: the 80 pair of group B streptococcus and dysentery bacterium all have inhibitory action; Decoct has excitation to the rabbit intestinal under test dose, causes the saliva gastric secretion, and gastrointestinal peristalsis is accelerated and promoted the gastrointestinal absorption that diet is increased.

This product is a benchmark with the Natrii Sulfas inventory, cholagogic and lithagogue after the conversion looses to write out a prescription: 1000 bags of amounts, Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, Natrii Sulfas (making with extra care) 66g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 132g, the ratio that prescription is respectively distinguished the flavor of between medicine so this product cholagogic and lithagogue looses is consistent with the prescription ratio of former dosage form cholagogic and lithagogue tablet.Use for convenience, the diffusing specification of cholagogic and lithagogue is decided to be the 0.76g/ bag.Dosage: oral calculus 3-5 bag/time, 2 times on the one.Inflammation 2-3 bag/time, 2 times on the one.

The research of process rationality: because good effect, safe and reliable, cholagogic and lithagogue tablet is as national essential drugs, and " each edition recorded since the Chinese pharmacopoeia by 85 editions.This medicine preparation technology is simple and easy to do, equipment is conventional, with low cost glad accepted by producer, the effective in cure again prerequisite of doing well, in line with this principle, we do not change extracting method, but our emphasis has carried out research to extraction process condition, intermediate control parameter and stability of formulation etc. and investigated; The selection of these technical data then is creative place of the present invention.

The preparation technology of cholagogic and lithagogue tablet is based on Chinese medical theory, and reasonability is strong, and the traditional Chinese medical science is thought " the Radix Et Rhizoma Rhei person's character is fallen and rushed down; be good at assigning, and gives birth to the property rise and have ", gives birth to stagnant with rushing down, again can removing the relative excess heat, to rush down clearly, cooperate the mutual reinforcement between mutual-assistance with Natrii Sulfas, Radix Et Rhizoma Rhei is attacked partially, Natrii Sulfas moistens partially, two medicines share attacks profit and helps mutually, plays clearing heat and moistening dryness altogether and rushes down purgation and imitate cholagogic and lithagogue Fang Zesheng Radix Et Rhizoma Rhei.The Radix Aucklandiae is given birth to the effective ingredient that can keep its regulating QI to relieve pain fully.The fecula content that can increase again in the prescription is easy to production operation.

The research of intermediate control parameter: 95 editions " the control parameter of no clear paste in the Chinese pharmacopoeia cholagogic and lithagogue tablet method for making, for making things convenient for production control, we investigate this.

Determining of relative density measured value: the mode of the concentrated the most normal employing of decocting liquid is a concentrating under reduced pressure in productions, and temperature is 70～80 ℃, measures the clear paste relative density for convenience, and we will measure temperature and be decided to be 70～80 ℃.

Relative density is surveyed its value group and imitated: make that to mix cream even, sticking cream do not occur, discharging is convenient, the applicant is defined as 1.32～1.35 through 10 batches of investigations of lab scale, again through 3 batches of amplifications, mixes cream and the discharging situation conforms to lab scale.

The investigation of decocting time and number of times:

Decoct number of times: get seven flavor medicine material 437.5g such as Herba Lysimachiae, amount of water 6562.5ml, decocting time are 2 hours, fry in shallow oil 2 times, 3 times respectively and test.The results are shown in Table 19.

Table 19

Decoct number of times		Quantity of solvent (ml)	Dried cream must be measured (g)
				Divide 2 times	For the second time for the first time	4000 2562.5	74.8
Divide 3 times	For the third time for the second time for the first time	3000 2000 1562.5	77.3

The result shows that 3 times extraction extractum amount is many slightly, but the long width of cloth is very little, in order to reduce energy resource consumption, reduces production costs, so this technology extraction time is selected 2 times.

Decocting time: get seven flavor medicine material 350g such as Herba Lysimachiae, amount of water 5250ml decocts 2 times, tests, and the results are shown in Table 20.

Table 20

For the first time decocting time (minute)	Dried cream must be measured (g)	For the second time decocting time (minute)	Dried cream must be measured (g)
				90 120 150	30.7 38.4 39.9	40 60 90	19.8 24.3 26.5

The result shows, from extracting gained dry extract amount relatively, 120 minutes for the first time comparatively suitable, 60 minutes for the second time comparatively suitable, though 150 minutes first time, 90 minutes for the second time are some more,, consider energy resource consumption and production cycle with institute's time-consuming measurement, decocting time is decided to be 120 minutes for the first time, 60 minutes for the second time.

The specific embodiment:

Embodiments of the invention 1: weighting raw materials material Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, refining sodium sulphate 66g and refining Cortex Magnoliae Officinalis 132g, the Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate are ground into fine powder, standby; Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Curcumae, Semen Arecae, Fructus Aurantii Immaturus (parched with bran) and refining Cortex Magnoliae Officinalis are decocted with water 2 times, 2 hours for the first time, 1 hour for the second time, filter, merging filtrate, the survey relative density was 1.32～1.35 clear paste when filtrate was concentrated into 70～80 ℃, the fine powder that adds the above-mentioned Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate, mixing, dry under 70～80 ℃ of conditions, be ground into fine powder, cross sieve No. 6, pack is made 1000 bags, every bag of 0.76g, promptly.This product is oral, calculus: one time 3～5 bags, 2 times on the one; Inflammation: one time 2～3 bags, 2 times on the one.

Embodiments of the invention 2: weighting raw materials material Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, refining sodium sulphate 66g and refining Cortex Magnoliae Officinalis 132g, the Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate are ground into fine powder, standby; Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Curcumae, Semen Arecae, Fructus Aurantii Immaturus (parched with bran) and refining Cortex Magnoliae Officinalis are decocted with water 1 time, each 3 hours, merging filtrate, the survey relative density was 1.32～1.35 clear paste when filtrate was concentrated into 70～80 ℃, the fine powder that adds the above-mentioned Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate, mixing, dry under 70～80 ℃ of conditions, be ground into fine powder, cross sieve No. 6, pack is made 1000 bags, promptly.

Embodiments of the invention 3: weighting raw materials material Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, refining sodium sulphate 66g and refining Cortex Magnoliae Officinalis 132g, the Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate are ground into fine powder, standby; Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Curcumae, Semen Arecae, Fructus Aurantii Immaturus (parched with bran) and refining Cortex Magnoliae Officinalis are decocted with water 2 times, 1 hour for the first time, 0.5 hour for the second time, filter, merging filtrate, the survey relative density was 1.32～1.35 clear paste when filtrate was concentrated into 70～80 ℃, the fine powder that adds the above-mentioned Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate, mixing, dry under 70～80 ℃ of conditions, be ground into fine powder, cross sieve No. 6, pack is made 1000 bags, promptly.

Embodiments of the invention 4: weighting raw materials material Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, refining sodium sulphate 66g and refining Cortex Magnoliae Officinalis 132g, the Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate are ground into fine powder, standby; Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Curcumae, Semen Arecae, Fructus Aurantii Immaturus (parched with bran) and refining Cortex Magnoliae Officinalis are decocted with water 3 times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, filter merging filtrate, the survey relative density was 1.32～1.35 clear paste when filtrate was concentrated into 70～80 ℃, added the fine powder of the above-mentioned Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate, mixing, dry under 70～80 ℃ of conditions, be ground into fine powder, cross sieve No. 6, pack, make 1000 bags, promptly.

Claims (3)

1. pharmaceutical preparation for the treatment of cholelithiasis, it is characterized in that: calculate according to weight, it is prepared into powder by Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, refining sodium sulphate 66g and refining Cortex Magnoliae Officinalis 132g; For yellowish-brown to tan powder, bitter in the mouth, salty.

2. treat the preparation method of the pharmaceutical preparation of cholelithiasis according to claim 1, it is characterized in that: weighting raw materials material Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, the Radix Aucklandiae, Radix Curcumae, Radix Et Rhizoma Rhei, Semen Arecae, Fructus Aurantii Immaturus (parched with bran), refining sodium sulphate and refining Cortex Magnoliae Officinalis, the Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate are ground into fine powder, standby; Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Curcumae, Semen Arecae, Fructus Aurantii Immaturus (parched with bran) and refining Cortex Magnoliae Officinalis are decocted with water 1～3 time, 1～3 hour for the first time, 0.5～2 hour for the second time, filter, the survey relative density was 1.32～1.35 clear paste when merging filtrate, filtrate were concentrated into 70～80 ℃, added the fine powder of the above-mentioned Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate, mixing, dry under 70～80 ℃ of conditions, be ground into fine powder, sieve, pack, promptly.

3. according to the preparation method of the pharmaceutical preparation of the described treatment cholelithiasis of claim 2, it is characterized in that: weighting raw materials material Herba Lysimachiae 660g, Herba Artemisiae Scopariae 660g, Radix Scutellariae 198g, Radix Aucklandiae 198g, Radix Curcumae 198g, Radix Et Rhizoma Rhei 330g, Semen Arecae 330g, Fructus Aurantii Immaturus (parched with bran) 132g, refining sodium sulphate 66g and refining Cortex Magnoliae Officinalis 132g, the Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate are ground into fine powder, standby; Herba Lysimachiae, Herba Artemisiae Scopariae, Radix Scutellariae, Radix Curcumae, Semen Arecae, Fructus Aurantii Immaturus (parched with bran) and refining Cortex Magnoliae Officinalis are decocted with water 2 times, 2 hours for the first time, 1 hour for the second time, filter, the survey relative density was 1.32～1.35 clear paste when merging filtrate, filtrate were concentrated into 70～80 ℃, added the fine powder of the above-mentioned Radix Aucklandiae, Radix Et Rhizoma Rhei, refining sodium sulphate, mixing, dry under 70～80 ℃ of conditions, be ground into fine powder, the pack of sieving, make 1000 bags, promptly.