CN102973883A - Traditional Chinese medicine preparation for treatment of gallstones and cholecystitis and preparation method thereof - Google Patents
Traditional Chinese medicine preparation for treatment of gallstones and cholecystitis and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a traditional Chinese medicine preparation for treatment of gallstones and cholecystitis and a preparation method thereof. The raw materials of the traditional Chinese medicine preparation include 165 parts of radix bupleuri, 165 parts of pericarpium citri reticulatae viride, 165 parts of scutellaria baicalensis, 165 parts of white peony root, 66 parts of rhubarb, 165 parts of radix curcumae, 165 parts of lysimachia christinae hance, 165 parts of lygodium japonicum, 165 parts of endothelium corneum gigeriae galli, 165 parts of oriental wormwood, 165 parts of rhizoma curcumae longae, 110 parts of rhizoma sparganii, and 165 parts of radix clematidis. The traditional Chinese medicine preparation is prepared by extracting and purifying according to a certain process, and added with a pharmacy-acceptable accessory. The traditional Chinese medicine preparation of the invention has the characteristics of simple preparation process, safety and effectiveness, and significant pharmacological effects.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation for the treatment of cholelithiasis, cholecystitis and preparation method thereof, belong to the pharmaceutical preparations technology field.
Background technology
Raising along with the social life level, the quickening of rhythm of life, the incidence rate of cholecystitis, gallstone disease is in rising trend, and the multiple 35-55 middle age in year of being born in, and belongs to the category of the diseases such as Chinese medicine " hypochondriac pain ", " abdominal distention ", " gallbladder-distention ", " jaundice ".What Chinese medicine was thought its morbidity is because feelings will is uncomfortable, eating and drinking without temperance, and damp and hot interior life is due to cannot not penting up loosely.Disease is defended mainly in liver and gall, relates to spleen, stomach, large intestine, and main pathogenesis is that liver and gall are lost and dredged, retention of damp-heat in the interior, and incoordination between the liver and stomach, bile excretion is not smooth, and calculus is blocked, and the gallbladder internal organs is obstructed, and its pathological product forms cholelithiasis.The passages through which vital energy circulates of liver and gall is distributed in that the side of body is lower, and QI stagnation of the liver and galibladder, vim and vigour are not smooth, stagnation of QI and blood may bring about pain, so see the right flank distending pain, the time heavy when light, in time, end when sending out; Damp-heat accumulation is loose, generates calculus, so persistence distending pain or angor under your upper right abdomen or the xiphoid-process; Sick at gallbladder, contrary at stomach, QI depression of the liver and gallbladder, perverse and unreasonable manner is violated stomach, and the disease of seeing the adverse rising of stomach-QI such as nausea and vomiting; If bile is not smooth, jaundice then appears in excessive skin, bitter taste, oliguria with reddish urine, red tongue with yellowish and greasy fur, stringy and rolling pulse and number average belongs to resembling of dampness-heat in the liver and gallbladder.Control suitable depressed liver-energy dispersing and function of gallbladder promoting calculus, Qinghua is damp and hot, the method for promoting the circulation of QI to relieve pain.
The invention provides a kind of Chinese medicine preparation for the treatment of cholelithiasis, cholecystitis, its prescription is comprised of 13 flavor Chinese medicines, for QI stagnation of the liver and galibladder, the cards such as damp-heat blocking in the body, calculus block, and the gallbladder internal organs is obstructed have the very clinical treatment effect of produce effects, between this, we have successively applied for following 2 patents of invention for this Chinese medicine composition, and its publication number is respectively CN1418682A, CN1562178A, and open day is respectively 2002.11.29 and 2004.03.17; Above patent of invention file discloses, protects from aspects such as different amounts of components, different preparation technology and dosage forms; and the application's patent is to carry out on this basis a large amount of experimentatioies; with further replenishment of process preparation method; improving preparation stability and bioavailability is purpose, and creationary a kind of Chinese medicine preparation for the treatment of cholelithiasis, cholecystitis of succeeding in developing.
Summary of the invention
The object of the invention is to provide a kind of steady quality, and curative effect is reliable, the treatment cholelithiasis that bioavailability is high, the Chinese medicine preparation of cholecystitis.
Another object of the present invention is to provide the preparation method of the Chinese medicine preparation of this treatment cholelithiasis, cholecystitis, the method is simple and feasible, meet absorption process in the oral medicine object, the Chinese medicine preparation good stability that finally makes, and curative effect is reliably remarkable.
Technical solution of the present invention is realized by following step:
A. prescription forms: 165 parts of Radix Bupleuri, 165 parts on Pericarpium Citri Reticulatae Viride, 165 parts of Radix Scutellariaes, 165 parts of the Radix Paeoniae Albas, 66 parts of Radix Et Rhizoma Rhei, 165 parts of Radix Curcumaes, 165 parts of Herba Lysimachiaes, 165 parts of Spora Lygodii, 165 parts of Endothelium Corneum Gigeriae Galli, 165 parts of Herba Artemisiae Scopariaes, 165 parts in Rhizoma Curcumae Longae, 110 parts of rhizoma sparganic, 165 parts of Radix Clematidis;
B. preparation method: with above-mentioned 13 flavor Chinese crude drugs, in the steps below operations:
⑴ continue to employ after the Endothelium Corneum Gigeriae Galli pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Curcumae, Rhizoma Curcumae Longae, Herba Artemisiae Scopariae, rhizoma sparganic medical material, and adding with the medical material weight ratio is that 6～12 times of amounts, concentration are 50%～80% ethanol, heating extraction 1～3 time, and each 1～2 hour, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with the Radix Paeoniae Alba, Radix Et Rhizoma Rhei, Herba Lysimachiae, Spora Lygodii, clematis chinensis medicinal materials, adding with the medical material weight ratio is that 5～10 times of amounts, pH value are 3.0～5.5 water, heating extraction 1～3 time, each 1～2 hour, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 50%～80%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, and behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, the adjuvant commonly used that adds on the pharmaceutics is made various oral formulations.
Technical solution of the present invention is specifically realized by following steps:
A. prescription forms: 165 parts of Radix Bupleuri, 165 parts on Pericarpium Citri Reticulatae Viride, 165 parts of Radix Scutellariaes, 165 parts of the Radix Paeoniae Albas, 66 parts of Radix Et Rhizoma Rhei, 165 parts of Radix Curcumaes, 165 parts of Herba Lysimachiaes, 165 parts of Spora Lygodii, 165 parts of Endothelium Corneum Gigeriae Galli, 165 parts of Herba Artemisiae Scopariaes, 165 parts in Rhizoma Curcumae Longae, 110 parts of rhizoma sparganic, 165 parts of Radix Clematidis;
B. preparation method: with above-mentioned 13 flavor Chinese crude drugs, in the steps below operations:
⑴ continue to employ after the Endothelium Corneum Gigeriae Galli pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Curcumae, Rhizoma Curcumae Longae, Herba Artemisiae Scopariae, rhizoma sparganic medical material, and adding with the medical material weight ratio is that 8 times of amounts, concentration are 65% ethanol, heating extraction 2 times, and each 1.5 hours, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with the Radix Paeoniae Alba, Radix Et Rhizoma Rhei, Herba Lysimachiae, Spora Lygodii, clematis chinensis medicinal materials, adding with the medical material weight ratio is that 8 times of amounts, pH value are 4.5 water, heating extraction 2 times, each 1.5 hours, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 65%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, and behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, the adjuvant commonly used that adds on the pharmaceutics is made various oral formulations.
The oral formulations of finally making in the above technical scheme can be: tablet, granule, pill or hard capsule, and its further preparation scheme of each preparation is as follows:
Pill: be that mixed-powder with gained among the such scheme step ⑷ sieves, use water pill, drying is made pill.
Tablet: be with among the such scheme step ⑷ with the mixed-powder of gained, granulate, compacting in flakes, coating, and get final product.
Hard capsule: be with among the such scheme step ⑷ with the mixed-powder of gained, granulate, encapsulated.
Granule: be with among the such scheme step ⑷ with the mixed-powder of gained, drying, and get final product.
Chinese medicine preparation of the present invention cures mainly the cards such as cholelithiasis, cholecystitis and belongs to QI stagnation of the liver and galibladder, damp-heat blocking in the body person.Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI in the prescription, the disease of kind treating the liver gallbladder; The Herba Lysimachiae eliminating damp-heat, cholagogic and lithagogue is treating the liver cholelithiasis key medicine.Two medicines match, and the depressed liver-energy dispersing and function of gallbladder promoting calculus is monarch drug altogether.Radix Scutellariae clearing gallbladder heat and dampness; The Radix Et Rhizoma Rhei heat clearing and blood circulation promoting pushes away Chen Zhixin, helps altogether Herba Lysimachiae to clear away the dampness and heat, and cholagogic and lithagogue is with being ministerial drug.The Spora Lygodii clearing away heat and promoting diuresis, it is damp and hot to disappear; The treating stranguria fossil of Endothelium Corneum Gigeriae Galli, the kind cholelithiasis of controlling; The Herba Artemisiae Scopariae clearing away heat-damp and promoting diuresis is logical yellow; Rhizoma Curcumae Longae, rhizoma sparganic, Radix Clematidis promoting flow of QI and blood, removing obstruction in the collateral to relieve pain; Radix Paeoniae Alba relieving spasm to stop pain, above-mentioned seven flavor medicine material is assisted the monarch and his subjects' promoting the circulation of QI to relieve pain altogether, and Qinghua is damp and hot, and cholagogic and lithagogue is adjuvant drug altogether.Radix Bupleuri draws all medicines and enters liver and gall, the double usefulness that makes medicine of doing.All medicines match, and are total to long memorial liver cholagogic and lithagogue, and Qinghua is damp and hot, the merit of promoting flow of QI and blood pain relieving.
We are in the middle of the research process of reality, and than 2 patents of invention in first to file, its main creation point is the extraction purification aspect of medical material, has brought thus significant technological progress, and its main beneficial effect is as follows.
Chinese medicine preparation of the present invention is comprised of the pure Chinese medicine of 13 flavors such as Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, the Radix Paeoniae Alba, Radix Et Rhizoma Rhei, Endothelium Corneum Gigeriae Galli is the dry gizzard inwall of family chicken in the side, it contains a large amount of protein, trace element and vitamins chemical constituent, these compositions are easily destroyed by High Temperature High Pressure, being difficult for long-time heating extracts, therefore among the present invention it is adopted and entirely beat the mode that powder is used as medicine and prepare, can either protect significantly the active component in the medical material not to be destroyed; So that process for producing is easy, feasible, can comprehensively utilize active substance again; In Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Curcumae, Rhizoma Curcumae Longae, Herba Artemisiae Scopariae, the rhizoma sparganic 7 flavor medical materials, contain a large amount of pure dissolubilities and water solublity active component, therefore, we carry out first the ethanol extraction liposoluble constituent to it, the medical material that medicinal residues is contained the water-soluble components such as peoniflorin, emodin with the Radix Paeoniae Alba, Radix Et Rhizoma Rhei, Herba Lysimachiae, Spora Lygodii and Radix Clematidis again mixes, adopt acid extraction, the refining method of precipitate with ethanol to process, so both extracted comprehensively and kept effective ingredient, can make with extra care again, simplify the operation course, thereby energy savings, dwindle production cost.Therefore in conjunction with the extracting method of above-mentioned medical material, we finally are made into oral formulations evident in efficacy by the creative work of hardships.In a word, the technical scheme of extraction purification of the present invention, molding is that we are in the research process of reality, by unremitting groping and accidental discovery, and the clinical practice demand of the said preparation of comprehensively having investigated, reasonably plan as a whole, comparison and the process route that draws, thereby guaranteed science, the high efficiency of the Chinese medicine preparation finally made.
It below is the pharmacodynamic study test to technical solution of the present invention, because core innovative point of the present invention is the extraction and purification process aspect of medical material, and with we previous disclosed publication number CN1418682A, after the patent document contrast of CN1562178A, we are take the technical scheme of publication number CN1418682A as correlation technique, therefore we in pharmacodynamic experiment take the two technology contents as contrast, research level in conjunction with modern pharmacology, and pass through in the body, outer lithodialysis test, impact on the rat bile secretion, the antagonism cholelithiasis of medicine of the present invention has been illustrated in the tests such as anti-inflammatory and antalgic fully, the pharmacodynamics curative effect of cholecystitis.In order to simplify experimental implementation, save research expenditure, follow the experiment principle of parallel control, get rid of the Different therapeutical effect that each medicine group is brought because of dosage form itself, thereby the creativeness of the outstanding technical solution of the present invention of science more, we study take the middle product group of one of them disclosed technical scheme as representative, right this can be derived for those skilled in the art fully thus, understand the beneficial effect of other parameter point technical scheme among the application, so the technology of the present invention content and drug effect result never are limited to this scope.
1 test material and result processing method:
1.1 the preparation of trial drug:
The preparation of A trial drug of the present invention:
⑴ continue to employ after Endothelium Corneum Gigeriae Galli 165g pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri 165g, Pericarpium Citri Reticulatae Viride 165g, Radix Scutellariae 165g, Radix Curcumae 165g, Rhizoma Curcumae Longae 165g, Herba Artemisiae Scopariae 165g, rhizoma sparganic 110g medical material, adding with the medical material weight ratio is that 8 times of amounts, concentration are 65% ethanol, heating extraction 2 times, each 1.5 hours, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with Radix Paeoniae Alba 165g, Radix Et Rhizoma Rhei 66g, Herba Lysimachiae 165g, Spora Lygodii 165g, Radix Clematidis 165g medical material, adding with the medical material weight ratio is that 8 times of amounts, pH value are 4.5 water, heating extraction 2 times, each 1.5 hours, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 65%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, namely gets total mixture; Before use, adding distil water is mixed with medicinal liquid, namely gets the middle product group of medicine of the present invention.
The preparation of product group in the middle of the B.CN1418682A contrast:
⑴ it is for subsequent use that be ground into fine powder with Radix Et Rhizoma Rhei 66g;
⑵ extract volatile oil with Herba Artemisiae Scopariae 165g, Radix Curcumae 165g, Pericarpium Citri Reticulatae Viride 165g, Rhizoma Curcumae Longae 165g, rhizoma sparganic 110g, for subsequent use; Aqueous solution after the distillation filters, and filtrate in addition device is collected; Medicinal residues decoct with water 2 times with Radix Bupleuri 165g, Radix Scutellariae 165g, Radix Paeoniae Alba 165g, Herba Lysimachiae 165g, Spora Lygodii 165g, Endothelium Corneum Gigeriae Galli 165g, Radix Clematidis 165g again, and each 1.5h filters, filtrate after filtrate and the distillation merges, and is condensed into clear paste, adds ethanol and makes and contain the alcohol amount and reach 50%, stir evenly, cold preservation 24 hours filters, decompression filtrate recycling ethanol continues to be condensed into thick paste, vacuum drying, get dry extract, be ground into fine powder, with Radix Et Rhizoma Rhei fine powder and volatile oil mixing, namely get total mixture; Before use, adding distil water is mixed with the medicinal liquid identical with product group concentration in the middle of the invention described above, namely gets the middle product group of CN1418682A contrast.
1.2 experimental animal: Kunming mouse, SD rat and rabbit are provided by The Fourth Military Medical University's Experimental Animal Center.
1.3 test method: observe the test of the inside and outside dissolving cholelithiasis of each medicine group body, on tests such as the impact of rat bile secretion and anti-inflammatory and analgesic effects.
1.4 statistical procedures: experimental result with
Expression adopts the t check to measure the significance of group difference.
2 test methods and result:
2.1 external lithodialysis test
With the dry pigment complex stone of shape, size, similar weight, be divided at random 3 groups, 10 every group.Every group of cholelithiasis placed the ground test tube with ground stopper that fills 6ml tested material solution, and every pipe l grain places test tube 37 ℃ of constant temperature water baths again, and every 24h observes 1 time, and every 24h changes liquid 1 time, Continuous Observation 15 days.Take out cholelithiasis on the 16th day, weigh after to be dried, calculate the difference of the forward and backward cholelithiasis weight of lithodialysis, the results are shown in Table 1.
The external litholytic effect research of table 1 (n=10,
)
Annotate: compare with the normal saline group,
* *P＜0.001; Compare with CN1418682A medicine group,
△P＜0.05.
By the experimental data of table 1 as can be known: in the middle of the medicine of the present invention in the middle of product group and the CN1418682A contrast product group and normal saline group relatively, both all can reduce the weight of cholelithiasis significantly in external lithodialysis test, and have reached extremely significantly statistical significance; Compare with product group in the middle of the CN1418682A contrast, the product group is larger to the weight differential of external cholelithiasis before and after effect in the middle of the present invention, also has outstanding diversity effect, the result of study prompting: product can reduce the volume and weight of external cholelithiasis significantly in the middle of of the present invention, and it is had obvious therapeutical effect.
2.2 lithodialysis experimental study in the body
Get 30 of rabbit, with containing 6 weeks of 1% dihydrocholesterol forage feed.Be divided at random 3 groups in the 3rd week: be respectively normal saline matched group, the middle product group of the present invention and the middle product group of CN1418682A.Each test group is with gastric infusion, and successive administration under narcotism, is cut the rabbit abdominal cavity open after 3 weeks, and the ligation bile duct takes out and the incision gallbladder, allows bile flow in the filter cloth, has flowed rear visible a plurality of cholelithiasis until liquid.Filter cloth is put dry 12h in 60 ℃ of baking ovens, take out filter cloth, accurately weigh and deduct former filter cloth dry weight, be the gross weight of cholelithiasis, experimental result sees Table 2.
The research of litholytic effect in table 2 body (
)
Annotate: compare with the normal saline group,
* *P＜0.001; Compare with CN1418682A medicine group,
△P＜0.05.
By the experimental data of table 2 as can be known: product group and normal saline group be relatively in the middle of product group, the CN1418682A contrast in the middle of the medicine of the present invention, both all can obviously reduce the weight of cholelithiasis in the rabbit body, and compare with the cholelithiasis weight of normal saline group and to have reached significant diversity; Compare with product group in the middle of the CN1418682A contrast, the product group makes the weight reducing of proper inner bag stone in the middle of the present invention, has also reached statistical meaning.
2.3 the impact on the rat bile secretory volume
Get 30 of SD rats, water is can't help in the 12h fasting before the experiment, after weighing during experiment, is divided at random 3 groups: be respectively normal saline matched group, the middle product group of the present invention and the middle product group of CN1418682A.Then every Mus with pentobarbital sodium 40mg/kg intraperitoneal injection of anesthesia after, open the abdominal cavity, find bile duct, do " V " shape to the liver direction and cut bile duct, insert plastic tube and fixing, visible pistac bile flows out subsequently.After stablizing 20min, collect first 30min bile, then respectively organize rat is given respectively above grouping by duodenum saline or medicinal liquid.Collect a bile every 30min after the administration, totally 3 times, the record choleresis the results are shown in Table 3.
Table 3 on the impact of rat bile secretory volume (n=10,
)
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with CN1418682A medicine group,
△P＜0.05,
△ △P＜0.01.
As shown in Table 3: compare with the normal saline group, in the middle of the medicine of the present invention in the middle of product group, the CN1418682A contrast product group for administration after 30min, 60min, 90min rat bile secretory volume has and significantly increases effect, and in above-mentioned 3 time periods potentiation is arranged all, and reached significant diversity effect; Compare with product group in the middle of the CN1418682A contrast, product group above-mentioned 3 time points after administration in the middle of the present invention all have the effect of significant enhancing rat bile secretion, and have reached statistical significance.Results suggest: medicine group of the present invention is of value to the treatment of gallbladder class disease for the choleresis showed increased of rat, and relatively has more excellent therapeutical effect with the CN1418682A contrast groups.
2.4 antiinflammatory experimental study
2.4.1 xylol causes the impact of chmice acute inflammation:
Get 30 of mices, be divided at random 3 groups, be administered once every day, gastric infusion 7d, behind last administration lh, be coated with dimethylbenzene 0.05ml in the mouse right ear positive and negative, to 2h behind the dimethylbenzene, put to death animal, cut ear, sweep away auricle in corresponding site with the 8mm steel drift, weigh, take the difference of left and right sides ear weight as the swelling degree, the results are shown in Table 4.
Table 4 xylol cause mice ear impact (
)
Annotate: compare with the normal saline group,
* *P＜0.001; Compare with CN1418682A medicine group,
△ △P＜0.01.
2.4.2 the impact on the mice granuloma induced by implantation of cotton pellets: get 30 mices, be divided at random 3 groups, every group 10, implant each 1 of 5mg sterilized cotton ball, gastric infusion respectively at oxter, the mice left and right sides, every day 1 time, 7d puts to death animal behind last administration lh altogether, gets granuloma induced by implantation of cotton pellets, weigh (weight in wet base), the results are shown in Table 5.
Table 5 on the granulomatous impact of mice cotton balls number (
, mg)
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01; Compare with CN1418682A medicine group,
△P＜0.05.
Result of the test by table 4 and 5 shows: compare with the normal saline matched group, product group, the middle product group of CN1418682A contrast all have good antiinflammatory action, and have reached significant diversity effect in the middle of the medicine of the present invention in above-mentioned antiinflammatory experiment; In the middle of the medicine of the present invention in the middle of product group and the CN1418682A contrast product group relatively count the antiinflammatory such as granuloma at acute inflammation, mice cotton balls and all have significant diversity in testing, obvious statistical significance is arranged; Results suggest: the product group has good therapeutical effect to the inflammatory model of mice in the middle of the medicine group of the present invention, and significantly is better than the drugs compared group.
2.5 analgesic experiment
2.5.1 mice acetic acid is caused the effect of writhing response: 30 of mices, be divided at random 3 groups, be administered once every day, gastric infusion is 5 days continuously, and behind last gastric infusion lh, lumbar injection 0.6% glacial acetic acid 0.2ml/ only, observe mouse writhing number of times in the 20min, the results are shown in Table 6.
The analgesic activity of table 6 pair mice acetic acid twisting reaction (
)
Annotate: compare with the normal saline group,
*P＜0.01,
* *P＜0.001; Compare with CN1418682A medicine group,
△P＜0.05.
2.5.2 the impact on mice electricity irritation whipping pain threshold: 30 of mices, be divided at random 3 groups, be administered once every day, gastric infusion is 5 days continuously, behind last gastric infusion lh, an electrode is put on the mice foot, another electrode stimulating afterbody, after the energising, the pain threshold when observing the mice whipping the results are shown in Table 7.
Electricity irritation suppression ratio=(administration group pain threshold-matched group pain threshold)/matched group pain threshold * 100%.
Table 7 is on the impact of mice electricity irritation whipping pain threshold
Annotate: compare with the normal saline group,
*P＜0.01; Compare with CN1418682A medicine group,
△P＜0.05.
Show that from table 6 and table 7 result the analgesic effect of product group in the middle of product group and the CN1418682A contrast more all has significant difference with the normal saline matched group in the middle of the medicine of the present invention; The middle product group of product group and CN1418682A contrast relatively can obviously reduce the writhing number of times in the middle of the medicine of the present invention in the mice acetic acid twisting, can significantly improve pain threshold in the experiment of mice electricity irritation whipping pain threshold, and the significant difference effect is all arranged.Results suggest: medicine group of the present invention has better analgesic activity effect.
In above-mentioned pharmacodynamic experiment, we are by the improvement effect of the different animal experiment evaluation index of examination, no matter the product group is external in the middle of can finding out medicine of the present invention, all has good therapeutical effect in the lithodialysis test in the body, obviously can improve the secretory volume of bile, to anti-inflammatory, strengthen analgesic activity, results suggest: pharmaceutical preparation of the present invention can have good treatment cholelithiasis, the effect of cholecystitis, and can alleviate the pain of this type of Disease, its whole curative effect has more excellent therapeutical effect than the technical scheme of previous disclosed correlation technique CN1418682A group, outstanding embodiment the useful technique effect of medicine of the present invention.
The specific embodiment
Below be the specific embodiment of content of the present invention, be used for setting forth the technical scheme that present specification is wanted the technical solution problem, help those skilled in the art to understand content of the present invention, but the realization of technical solution of the present invention is not limited to these embodiment.
Embodiment 1
⑴ continue to employ after Endothelium Corneum Gigeriae Galli 165g pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri 165g, Pericarpium Citri Reticulatae Viride 165g, Radix Scutellariae 165g, Radix Curcumae 165g, Rhizoma Curcumae Longae 165g, Herba Artemisiae Scopariae 165g, rhizoma sparganic 110g medical material, adding with the medical material weight ratio is that 8 times of amounts, concentration are 65% ethanol, heating extraction 2 times, each 1.5 hours, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with Radix Paeoniae Alba 165g, Radix Et Rhizoma Rhei 66g, Herba Lysimachiae 165g, Spora Lygodii 165g, Radix Clematidis 165g medical material, adding with the medical material weight ratio is that 8 times of amounts, pH value are 4.5 water, heating extraction 2 times, each 1.5 hours, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 65%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, namely get total mixture, the total mixture of gained is sieved, use water pill, drying is made 1000g.
Embodiment 2
⑴ continue to employ after Endothelium Corneum Gigeriae Galli 165g pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri 165g, Pericarpium Citri Reticulatae Viride 165g, Radix Scutellariae 165g, Radix Curcumae 165g, Rhizoma Curcumae Longae 165g, Herba Artemisiae Scopariae 165g, rhizoma sparganic 110g medical material, adding with the medical material weight ratio is that 12 times of amounts, concentration are 80% ethanol, heating extraction 1 time, each 2 hours, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with Radix Paeoniae Alba 165g, Radix Et Rhizoma Rhei 66g, Herba Lysimachiae 165g, Spora Lygodii 165g, Radix Clematidis 165g medical material, adding with the medical material weight ratio is that 5 times of amounts, pH value are 3.0 water, heating extraction 3 times, each 1 hour, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 50%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, with the total mixture of gained, granulate, compacting in flakes, coating is made 1000.
Embodiment 3
⑴ continue to employ after Endothelium Corneum Gigeriae Galli 165g pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri 165g, Pericarpium Citri Reticulatae Viride 165g, Radix Scutellariae 165g, Radix Curcumae 165g, Rhizoma Curcumae Longae 165g, Herba Artemisiae Scopariae 165g, rhizoma sparganic 110g medical material, adding with the medical material weight ratio is that 6 times of amounts, concentration are 50% ethanol, heating extraction 3 times, each 1 hour, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with Radix Paeoniae Alba 165g, Radix Et Rhizoma Rhei 66g, Herba Lysimachiae 165g, Spora Lygodii 165g, Radix Clematidis 165g medical material, adding with the medical material weight ratio is that 10 times of amounts, pH value are 5.5 water, heating extraction 1 time, each 2 hours, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 80%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, with the total mixture of gained, granulates, encapsulated, makes 1000 hard capsules.
Embodiment 4
⑴ continue to employ after Endothelium Corneum Gigeriae Galli 165g pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri 165g, Pericarpium Citri Reticulatae Viride 165g, Radix Scutellariae 165g, Radix Curcumae 165g, Rhizoma Curcumae Longae 165g, Herba Artemisiae Scopariae 165g, rhizoma sparganic 110g medical material, adding with the medical material weight ratio is that 10 times of amounts, concentration are 70% ethanol, heating extraction 2 times, each 1.5 hours, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with Radix Paeoniae Alba 165g, Radix Et Rhizoma Rhei 66g, Herba Lysimachiae 165g, Spora Lygodii 165g, Radix Clematidis 165g medical material, adding with the medical material weight ratio is that 8 times of amounts, pH value are 4.5 water, heating extraction 3 times, each 1 hour, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 70%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, with the total mixture of gained, granulates, and drying is made the 1000g granule.
In order further to verify the curative effect of finished product preparation of the present invention, we have carried out corresponding clinical trial with the medicine for preparing among the above-mentioned specific embodiment 1-4, and are existing that report the test is as follows.
⑴ object of study: choose tested case 278 examples in year JIUYUE step-length hospital of traditional Chinese hospital, in April, 2006～2008,5 examples that come off, person's 273 examples of including the statistical analysis in midway.Adopt parallel control, method for designing at random, be divided at random 5 groups, 1 group of 54 example of embodiment wherein, male's 30 examples wherein, women's 24 examples, mean age (40.2 ± 1.2) year; 2 group of 51 example of embodiment, male's 30 examples wherein, women's 21 examples, year mean age (39.6 ± 2.0); 3 group of 55 example of embodiment, male's 34 examples wherein, women's 21 examples, year mean age (41.5 ± 0.9); 4 group of 54 example of embodiment, male's 29 examples wherein, women's 25 examples, year mean age (41.2 ± 1.6); Matched group (XIAOYAN LIDAN PIAN group) 59 examples, male's 35 examples wherein, women's 24 examples, average (40.8 ± 1.6) year.
⑵ case is selected:
A tcm diagnosis standard main symptom: the right flank distending pain is often involved right shoulder, or epigastric fullness, stringy pulse; Inferior card: pain, vexed swollen because the variation of feelings will increases and decreases, uncomfortable in chest easypro, sighing frequently, bitter taste is felt sick, and the decreased food intake of receiving is few, and belch is done frequently, and it is uncomfortable to defecate.
B Western medicine diagnose standard: 1. continue upper right abdomen dull pain or sense of discomfort or omoplate district pain; 2. the indigestion symptoms such as nauseating, belch, pantothenic acid, abdominal distention and scorching hot are arranged, the postemphasis of feed greasy food; 3. the course of disease is longer, and the course of disease is through having acute attack and alleviating characteristics alternately; 4. gallbladder area has mild tenderness or percussion pain; 5. the visible gallbladder wall of B ultrasonic crude, thicken, gallbladder dwindles or is out of shape or with cholelithiasis; 6. the visible gallbladder of cholecystography dwindles or is out of shape, and gallbladder contraction function is bad or the gallbladder development is thin, visible cholelithiasis.All according to above-mentioned 5., 6. add 1. one of in-4. in 2 above persons can make a definite diagnosis.
⑶ method:
With prepared granule group, pill group, tablet group, hard capsule and in the following manner administration of matched group among the invention described above embodiment 1-4: the patient takes medicine 3 every day, each 6 measurement units (being granule group 6g, pill group 6g, 6 of tablet groups, 6 of hard capsule groups, 6 of positive controls), after 15 skies are 1 course for the treatment of, judge efficacy result 2 courses for the treatment of.
⑷ criterion of therapeutical effect:
1. recovery from illness: symptom, sign disappear, and haemanalysis and liver function are normal, and image check shows that the wall thickness of gallbladder or bile duct wall, crude, 3 of entrant sounds recover normal, and calculus is all discharged; 2. produce effects: symptom, sign disappear, and haemanalysis and liver function are normal, and image check shows that 2 are recovered normal in the wall thickness of gallbladder or bile duct wall, crude, the entrant sound, calculus is most of discharge or the calculus decreased number greater than original 1/3; 3. effective: symptom, sign are most of to disappear, and haemanalysis is normal, and liver function takes a turn for the better, and image check shows in the wall thickness of gallbladder or bile duct wall, crude, the entrant sound and be improved more than 1, calculus is most of discharge or the calculus decreased number less than original 1/3; 4. invalid: unchanged before and after the treatment.
⑸ statistical method:
1. ranked data are with Ridit check, rank test; 2. enumeration data X 2 test; 3. measurement data is with t check, variance analysis.
⑹ results and analysis:
1 group of 20 example of fully recovering of embodiment, produce effects 15 examples, effective 12 examples, invalid 7 examples, cure-remarkable-effectiveness rate 64.8%, total effective rate 87.0%; 2 groups of 16 examples of fully recovering of embodiment, produce effects 19 examples, effective 10 examples, invalid 6 examples, cure-remarkable-effectiveness rate 68.6%, total effective rate 88.2%; 3 groups of 17 examples of fully recovering of embodiment, produce effects 18 examples, effective 11 examples, no effect 9, cure-remarkable-effectiveness rate 63.6%, total effective rate 83.6%; 4 groups of 18 examples of fully recovering of embodiment, produce effects 19 examples, effective 10 examples, invalid 7 examples, cure-remarkable-effectiveness rate 68.5%, total effective rate 87.0%; Matched group 15 examples of fully recovering, produce effects 16 examples, effective 7 examples, invalid 21 examples, cure-remarkable-effectiveness rate 52.5%, total effective rate 64.4%.
Above clinical efficacy results suggest: the medicine of technical solution of the present invention preparation is aspect treatment cholecystitis, cholelithiasis, and each dosage form all has the curing protrusion effect, and curative effect is better than matched group.Results suggest Chinese medicine preparation of the present invention has the advantages such as preparation technology is efficiently feasible, drug effect is clear and definite, stable curative effect is reliable, its beneficial effect is no matter from the extraction and purification process of medicine, or on the forming technique of finished product preparation, all effectively guaranteed the excellent results of preparation of the present invention, this will bring for the clinical practice of this Chinese medicine preparation huge potentiality and development space.
Claims (9)
1. Chinese medicine preparation for the treatment of cholelithiasis, cholecystitis is characterized in that it is to be prepared from by following technique:
A. prescription forms: 165 parts of Radix Bupleuri, 165 parts on Pericarpium Citri Reticulatae Viride, 165 parts of Radix Scutellariaes, 165 parts of the Radix Paeoniae Albas, 66 parts of Radix Et Rhizoma Rhei, 165 parts of Radix Curcumaes, 165 parts of Herba Lysimachiaes, 165 parts of Spora Lygodii, 165 parts of Endothelium Corneum Gigeriae Galli, 165 parts of Herba Artemisiae Scopariaes, 165 parts in Rhizoma Curcumae Longae, 110 parts of rhizoma sparganic, 165 parts of Radix Clematidis;
B. preparation method: with above-mentioned 13 flavor Chinese crude drugs, in the steps below operations:
⑴ continue to employ after the Endothelium Corneum Gigeriae Galli pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Curcumae, Rhizoma Curcumae Longae, Herba Artemisiae Scopariae, rhizoma sparganic medical material, and adding with the medical material weight ratio is that 6～12 times of amounts, concentration are 50%～80% ethanol, heating extraction 1～3 time, and each 1～2 hour, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with the Radix Paeoniae Alba, Radix Et Rhizoma Rhei, Herba Lysimachiae, Spora Lygodii, clematis chinensis medicinal materials, adding with the medical material weight ratio is that 5～10 times of amounts, pH value are 3.0～5.5 water, heating extraction 1～3 time, each 1～2 hour, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 50%～80%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, and behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, the adjuvant commonly used that adds on the pharmaceutics is made various oral formulations.
2. the Chinese medicine preparation for the treatment of cholelithiasis as claimed in claim 1, cholecystitis is characterized in that it is to be prepared from by following technique:
A. prescription forms: 165 parts of Radix Bupleuri, 165 parts on Pericarpium Citri Reticulatae Viride, 165 parts of Radix Scutellariaes, 165 parts of the Radix Paeoniae Albas, 66 parts of Radix Et Rhizoma Rhei, 165 parts of Radix Curcumaes, 165 parts of Herba Lysimachiaes, 165 parts of Spora Lygodii, 165 parts of Endothelium Corneum Gigeriae Galli, 165 parts of Herba Artemisiae Scopariaes, 165 parts in Rhizoma Curcumae Longae, 110 parts of rhizoma sparganic, 165 parts of Radix Clematidis;
B. preparation method: with above-mentioned 13 flavor Chinese crude drugs, in the steps below operations:
⑴ continue to employ after the Endothelium Corneum Gigeriae Galli pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Curcumae, Rhizoma Curcumae Longae, Herba Artemisiae Scopariae, rhizoma sparganic medical material, and adding with the medical material weight ratio is that 8 times of amounts, concentration are 65% ethanol, heating extraction 2 times, and each 1.5 hours, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with the Radix Paeoniae Alba, Radix Et Rhizoma Rhei, Herba Lysimachiae, Spora Lygodii, clematis chinensis medicinal materials, adding with the medical material weight ratio is that 8 times of amounts, pH value are 4.5 water, heating extraction 2 times, each 1.5 hours, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 65%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, and behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, the adjuvant commonly used that adds on the pharmaceutics is made various oral formulations.
3. such as the Chinese medicine preparation of claim 1 or 2 described treatment cholelithiasis, cholecystitis, it is characterized in that this Chinese medicine preparation is tablet, granule, pill or hard capsule.
4. preparation method for the treatment of the Chinese medicine preparation of cholelithiasis, cholecystitis is characterized in that:
A. prescription forms: 165 parts of Radix Bupleuri, 165 parts on Pericarpium Citri Reticulatae Viride, 165 parts of Radix Scutellariaes, 165 parts of the Radix Paeoniae Albas, 66 parts of Radix Et Rhizoma Rhei, 165 parts of Radix Curcumaes, 165 parts of Herba Lysimachiaes, 165 parts of Spora Lygodii, 165 parts of Endothelium Corneum Gigeriae Galli, 165 parts of Herba Artemisiae Scopariaes, 165 parts in Rhizoma Curcumae Longae, 110 parts of rhizoma sparganic, 165 parts of Radix Clematidis;
B. preparation method: with above-mentioned 13 flavor Chinese crude drugs, in the steps below operations:
⑴ continue to employ after the Endothelium Corneum Gigeriae Galli pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Curcumae, Rhizoma Curcumae Longae, Herba Artemisiae Scopariae, rhizoma sparganic medical material, and adding with the medical material weight ratio is that 6～12 times of amounts, concentration are 50%～80% ethanol, heating extraction 1～3 time, and each 1～2 hour, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with the Radix Paeoniae Alba, Radix Et Rhizoma Rhei, Herba Lysimachiae, Spora Lygodii, clematis chinensis medicinal materials, adding with the medical material weight ratio is that 5～10 times of amounts, pH value are 3.0～5.5 water, heating extraction 1～3 time, each 1～2 hour, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 50%～80%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, behind Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, namely gets total mixture, and the adjuvant commonly used that adds on the pharmaceutics is made various oral formulations.
5. the preparation method of the Chinese medicine preparation for the treatment of cholelithiasis as claimed in claim 4, cholecystitis is characterized in that:
⑴ continue to employ after the Endothelium Corneum Gigeriae Galli pulverizing medicinal materials is become fine powder;
⑵ get Radix Bupleuri, Pericarpium Citri Reticulatae Viride, Radix Scutellariae, Radix Curcumae, Rhizoma Curcumae Longae, Herba Artemisiae Scopariae, rhizoma sparganic medical material, and adding with the medical material weight ratio is that 8 times of amounts, concentration are 65% ethanol, heating extraction 2 times, and each 1.5 hours, filter, filtrate, medicinal residues are continued to employ;
⑶ mix the medicinal residues among the above-mentioned ⑵ with the Radix Paeoniae Alba, Radix Et Rhizoma Rhei, Herba Lysimachiae, Spora Lygodii, clematis chinensis medicinal materials, adding with the medical material weight ratio is that 8 times of amounts, pH value are 4.5 water, heating extraction 2 times, each 1.5 hours, filter, add ethanol in the filtrate so that contain the alcohol amount and reach 65%, leave standstill, filter, filtrate is continued to employ;
⑷ mix the filtrate of continuing to employ at two places among above-mentioned ⑵ and the ⑶, and Recycled ethanol is to without behind the alcohol flavor, concentrated, dry and be ground into dried cream powder, with Endothelium Corneum Gigeriae Galli fine powder mixing among the ⑴, namely gets total mixture, and the adjuvant commonly used that adds on the pharmaceutics is made various oral formulations.
6. such as the preparation method of the Chinese medicine preparation of claim 4 or 5 described treatment cholelithiasis, cholecystitis, it is characterized in that: the total mixture of gained is sieved, use water pill, drying is made pill.
7. such as the preparation method of the Chinese medicine preparation of claim 4 or 5 described treatment cholelithiasis, cholecystitis, it is characterized in that: with the total mixture of gained, granulate, compacting in flakes, coating is made tablet.
8. such as the preparation method of the Chinese medicine preparation of claim 4 or 5 described treatment cholelithiasis, cholecystitis, it is characterized in that: with the total mixture of gained, granulate, encapsulated, make hard capsule.
9. such as the preparation method of the Chinese medicine preparation of claim 4 or 5 described treatment cholelithiasis, cholecystitis, it is characterized in that: the total mixture of gained is granulated drying, granulation agent.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1418682A (en) * | 2002-11-29 | 2003-05-21 | 张慧芳 | Medicine compositions for treating biliary calculus, and its prepn. method |
| CN1562178A (en) * | 2004-03-17 | 2005-01-12 | 北京奇源益德药物研究所 | Preparation of Chinese traditional medicine for curing gallstone and preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1418682A (en) * | 2002-11-29 | 2003-05-21 | 张慧芳 | Medicine compositions for treating biliary calculus, and its prepn. method |
| CN1562178A (en) * | 2004-03-17 | 2005-01-12 | 北京奇源益德药物研究所 | Preparation of Chinese traditional medicine for curing gallstone and preparation method |
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