CN101007157A - Traditional Chinese medicine compound preparation for treating chronic cholecystitis - Google Patents
Traditional Chinese medicine compound preparation for treating chronic cholecystitis Download PDFInfo
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Abstract
The invention relates to a kind of Chinese traditional medicine compound preparation which can treat chronic cholecystitis, its ingredients, extracting technology, preparing technology, function and indication are also disclosed in the invention. The ingredients of the invention include green tangerine peel, Curcuma aromatica, nut grass galingale rhizome, white mustard seed, danshen root, radix astragali and sedi,herba. The preparation in the invention can treat chronic cholecystitis, stagnation of liver-QI with deficiency of the spleen and humid heat heaping. It has the function of dispersing the depressed liver-energy, invigorating the spleen, cholagogue and getting through the collaterals. The preparing procedure of the invention includes the following steps: pulverizing the Chinese traditional medicine properly; steam distillation; enveloping with beta-cyclodextrin; recirculation with water or alcohol; condensing and drying the extracted solution; adding certain accessories to made pellets, capsules, granules, guttates and other medically acceptable dosages. The advantages of the invention include: sufficient drug sources, simple preparing technologies, obvious curative effect, safe and low toxicity; it's safe and medically reliable.
Description
Technical field:
The present invention relates to a kind of compound Chinese medicinal preparation for the treatment of chronic cholecystitis.Specifically, be to be the Chinese patent medicine that raw material is made with the Chinese herbal medicine, its prescription composition, extraction process, preparation process thereof and function cures mainly and indication.
Background technology:
Chronic cholecystitis is a kind of high morbidity, the commonly encountered diseases of Digestive System Department.Modern study shows, cholelithiasis be the main diseases that causes chronic cholecystitis because of.Doctor trained in Western medicine except that operation, does not still have effective Therapeutic Method to the treatment of chronic cholecystitis at present, and therapeutic method of surgery is not accepted by most of patients as yet, Western medicine oral medicine also has diarrhoea and Liver and kidney toxic side effects except that unsatisfactory curative effect, bring very big painful and burden to extensive patients.Motherland's medical science thinks that chronic cholecystitis belongs to the traditional Chinese medical science " gallbladder-distention ", " hypochondriac pain " category, mainly because of due to the factors such as eating and drinking without temperance, internal damage by the excessive seven emotions, being invaded by exogenous pathogen, its clinical manifestation is that right side of body distending pain and gastral cavity abdomen painful abdominal mass expand not relax and be cardinal symptom, often accompanies belch sigh, dry mouth with bitter taste, anorexia, tired, loose stool, whenever increases the weight of because of feelings will or eating and drinking without temperance.The tradition Chinese medicine is demanded further excavation, exploitation, arrangement, raising urgently to these sick diagnosis and treatment existing long history and abundant clinical experience and more complete theory.We excavate on the basis of TCM Document ancient books in arrangement for this reason, according to the tcm clinical practice curative effect, and filter out in conjunction with modern science and technology and a series of experimental study and to have depressed liver-energy dispersing and function of gallbladder promoting, invigorating the spleen and regulating the stomach, the dampness removing heat clearing away, the pharmaceutical composition of the merit of eleminating phlegm and freeing channels has reached good medicinal effects and use value.
Summary of the invention:
One of purpose of the present invention provides a kind of compound Chinese medicinal preparation (1000 preparation units) for the treatment of chronic cholecystitis.Be primarily characterized in that the Chinese crude drug that it includes following weight proportion makes:
Pericarpium Citri Reticulatae Viride 200～1000 weight portion Radix Curcumaes 150～1000 weight portions
Rhizoma Cyperi 150～1200 weight portion Semen Sinapis Albaes 150～600 weight portions
Radix Salviae Miltiorrhizae 300～1500 weight portion Radixs Astragali 300～1500 weight portions
Herba Sedi 120～1500 weight portions
Described a kind of compound Chinese medicinal preparation (1000 preparation units) for the treatment of chronic cholecystitis, its best raw material weight proportioning is: Pericarpium Citri Reticulatae Viride 400 weight portion Radix Curcumaes 400 weight portions
Rhizoma Cyperi 480 weight portion Semen Sinapis Albaes 240 weight portions
The Radix Salviae Miltiorrhizae 600 weight portion Radixs Astragali 600 weight portions
Herba Sedi 600 weight portions
Two of purpose of the present invention provides a kind of extraction process for preparing above-mentioned compound Chinese medicinal preparation, it is characterized in that:
Pericarpium Citri Reticulatae Viride is ground into coarse powder, adds 8 times of water gagings and soaks 4 hours, extracts volatile oil 6 hours with the way of distillation, and the aqueous solution after the distillation concentrates, and is standby; Volatile oil is standby;
Above-mentioned medicinal residues contain the 50% alcohol reflux secondary of NaOH0.1% with 10 times of amounts, each 1.5 hours; Merge extractive liquid, filters, decompression filtrate recycling ethanol, and 80 mesh sieves were pulverized in oven dry, and were standby.
Radix Curcumae, Rhizoma Cyperi two flavors add 10 times of water gagings and soaked 2 hours, extract volatile oil 5 hours with the way of distillation, and 8 times of water gagings of medicinal residues reuse extracted 1 hour, collected extracting solution, concentrated, and are standby.Volatile oil mixes with Pericarpium Citri Reticulatae Viride volatile oil with 6 times of amount beta-schardinger dextrin-s, 50 ℃ of following enclose 2 hours.
Radix Salviae Miltiorrhizae, the Radix Astragali add 8 times of amount 70% alcohol reflux secondaries, and each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and 80 mesh sieves were pulverized in oven dry.
Herba Sedi, Semen Sinapis Albae and Radix Salviae Miltiorrhizae, Radix Astragali alcohol extraction medicinal residues add 10 times of water gagings and extract secondary, and each 1 hour, merge extractive liquid, filtered, and concentrates.Merge concentrated solution, add ethanol and make and contain the alcohol amount and reach 70%, 80 mesh sieves are filtered, concentrated, dry, pulverized to alcohol deposit fluid.Merge with the dry powder of Pericarpium Citri Reticulatae Viride alcohol extraction, promptly.
Three of purpose of the present invention provides extract of the above and the medicament that mix to form of acceptable pharmaceutical carrier pharmaceutically, and said medicament is an acceptable dosage form on the various pharmaceuticss such as tablet, capsule, pill, powder, syrup, soft extract, mixture, drop pill, granule, oral liquid, drop.
The function that four of purpose of the present invention provides aforementioned pharmaceutical compositions cures mainly and indication.The function of described pharmaceutical composition cures mainly with indication and it is characterized by: soothing liver and strengthening spleen, the function of gallbladder promoting collateral dredging cures mainly chronic cholecystitis.Stagnation of liver-QI with deficiency of the spleen, syndrome of accumulated dampness-heat, card is seen: right side of body distending pain and gastral cavity abdomen are the spleen-distension not to relax, and often accompanies belch sigh, dry mouth with bitter taste, anorexia, tired, loose stool, whenever increases the weight of because of feelings will or eating and drinking without temperance.
For achieving the above object, prove its therapeutic effect and safety non-toxic, adopt following technical scheme:
One, pharmacodynamics test:
(1) choleretic effect:
1. to the influence of rabbit in the test of body function of gallbladder promoting:
50 of New Zealand rabbits, male and female half and half, body weight 1.8～2.5kg, random packet.Press the volume gastric infusion of 5ml/kg body weight, for three days on end.Employing is tested in the body biliary drainage.Collect bile in preceding 1 hour of medicine, distinguish every group of rat then and inject the medicine of equal-volume, various dose, and collect 1,2,3,4 hour choleresis behind the medicine respectively through duodenum.
Table 1. drug extract of the present invention to the influence of rabbit bile flow (
N=10)
| Group | Before the administration | Behind the medicine 60 minutes | Behind the medicine 180 minutes | Behind the medicine 240 minutes | Bile secretion increment rate (%) |
| Blank group | 0.51±0.06 | 0.58±0.13 | 0.49±0.07 | 0.51±0.03 | |
| High dose | 0.50±0.07 | 0.84±0.13 | 0.70±0.08 | 0.54±0.07 | 88.73±31.96 |
| Middle dosage | 0.51±0.08 | 0.75±0.08 | 0.63±0.10 | 0.52±0.04 | 64.24±26.77 |
| Low dosage | 0.54±0.07 | 0.73±0.04 | 0.58±0.10 | 0.53±0.05 | 51.45±20.82 |
| Cholagogic tablet | 0.53±0.07 | 0.80±0.09 | 0.63±0.08 | 0.50±0.04 | 66.96±17.92 |
The result shows: 60 minutes, 120 minutes high, medium and low dosage and blank group more all have significant difference in various degree behind medicine, 180 fens high, middle dosage and blank group more all have significant difference in various degree behind medicine, and low dosage and blank group relatively present certain effect trend.High, medium and low dosage 1 hour bile secretion increment rate (%) is respectively 88.73%, 64.24% and 51.45%.
2., to the influence of guinea pig in vitro gallbladder systolic and diastolic function:
2.1. guinea pig in vitro gallbladder bar preparation:
Get 50 of Cavia porcelluss, male and female half and half, body weight 300.0～350.0g, random packet.Tested preceding 8 hours, water is can't help in fasting, after Cavia porcellus anesthesia, rapid row epigastrium side straight cut, fully expose gallbladder, respectively wear a fine rule ligation cystic duct at what cervical region of gallbladder bottom, cut off along the outside with small size suture needle, take out gallbladder, put into the culture dish that fills 4 ℃ of Krebs liquid rapidly, flush away blood and bile are two with eye scissors with the gallbladder vertical profile, obtain two gallbladder flesh bar specimen, length * wide about 10～15mm * 3～5mm stays in the culture dish of 4 ℃ of Krebs liquid logical mixture of oxygen and preserves standby.
2.2. influence to the normal systolic and diastolic function of gallbladder that exsomatizes:
A gallbladder flesh bar is worn silk thread one end to be fixed on the L type glass hook, the other end be fixed in the tracing device that exsomatizes the record end on, in Magnus' bath, inject the nutritional solution of 20ml, constant temperature is 37 ℃ in the bath, regulates mixture of oxygen, makes oxygen bubbles tiny, even, 8～10/minute, after stablizing 20～30 minutes, trace the normal motion collection of illustrative plates that contracts that relaxes of one section gallbladder flesh bar, measure its shrinkage amplitude and frequency; The medicinal liquid that adds the high, medium and low dosage of medicine of the present invention then respectively.Trace the easypro motion collection of illustrative plates that contracts of one section gallbladder flesh bar, measure its shrinkage amplitude and frequency, observe influence normal gallbladder systolic and diastolic function.
Table 2. medicine of the present invention to the influence of the normal systolic and diastolic function of guinea pig in vitro gallbladder (
N=8)
| Group | Final concentration mg/ml | Influence to the normal gallbladder shrinkage amplitude that exsomatizes | ||
| Gallbladder normal baseline shrinkage amplitude (cm) exsomatizes | Gallbladder shrinkage amplitude (cm) exsomatizes after the medication | Own control difference (cm) | ||
| High dose | 0.165 | 1.007±1.122 | -4.490±2.023*** | 5.497±1.802*** |
| Middle dosage | 0.083 | 1.155±0.388 | -0.875±0.594*** | 2.030±0.653*** |
| Low dosage | 0.042 | 2.211±2.720 | -0.278±2.544** | 4.990±3.217** |
| Group | Final concentration mg/ml | Influence to the normal gallbladder contraction frequency that exsomatizes | ||
| Gallbladder normal baseline contraction frequency (inferior/4 minute) exsomatizes | Gallbladder contraction frequency (inferior/4 minute) exsomatizes after the medication | Own control difference (inferior/4 minute) | ||
| High dose | 0.165 | 2.454±0.769 | 1.138±0.886** | 1.316±0.841 |
| Middle dosage | 0.083 | 1.720±0.953 | 0.543±0.877 | 0.471±1.080 |
| Low dosage | 0.042 | 2.138±0.512 | 1.667±0.626 | 0.471±0.701* |
The result shows: medicine high dose of the present invention with in, low dosage all can obviously suppress the normal systolic and diastolic function of guinea pig in vitro gallbladder, shows that medication after-contraction amplitude reduces, medication after-contraction frequency deceleration.
2.3 the enhanced influence of stripped gallbladder contraction function that Ach is caused:
A gallbladder flesh bar is worn silk thread one end to be fixed on the L type glass hook, the other end be fixed in the tracing device that exsomatizes the record end on, in Magnus' bath, inject the nutritional solution of 20ml, constant temperature is 37 ℃ in the bath, regulates mixture of oxygen, makes oxygen bubbles tiny, even, 8～10/minute, after stablizing 20～30 minutes, trace the normal motion collection of illustrative plates that contracts that relaxes of one section gallbladder flesh bar, measure its shrinkage amplitude and frequency; Add Ach then and cause the gallbladder contraction function that exsomatizes to strengthen, trace its contractile motion collection of illustrative plates, measure its shrinkage amplitude and frequency; And then add the medicinal liquid of the high, medium and low dosage of medicine of the present invention respectively.Trace its motion collection of illustrative plates that contracts that relaxes, measure its shrinkage amplitude and frequency, observe Ach is caused the enhanced inhibitory action of gallbladder contraction function that exsomatizes.
Table 3. medicine of the present invention to Ach cause the enhanced influence of guinea pig in vitro gallbladder contraction function (
N=8)
| Group | Final concentration mg/ml | Influence to the normal gallbladder shrinkage amplitude that exsomatizes | |||
| Normal baseline shrinkage amplitude (cm) | With Ach after-contraction amplitude (cm) | Medication after-contraction amplitude (cm) | Own control difference (cm) | ||
| High dose | 0.165 | 0.950±0.459 | 5.440±3.659* | 0.839±3.813** | 4.601±2.884 |
| Middle dosage | 0.083 | 0.613±0.393 | 6.534±3.992** | -0.359±5.573* | 6.893±6.951 |
| Low dosage | 0.042 | 1.082±1.010 | 3.951±3.433 | 0.460±1.672** | 3.491±0.666 |
| Group | Final concentration mg/ml | Influence to the normal gallbladder contraction frequency that exsomatizes | |||
| Normal baseline contraction frequency (inferior/4 minute) | With Ach after-contraction frequency (inferior/4 minute) | Medication after-contraction frequency (inferior/4 minute) | Own control difference (inferior/4 minute) | ||
| High dose | 0.165 | 2.526±0.771 | 2.296±1.343 | 2.176±1.317 | 0.120±1.388** |
| Middle dosage | 0.083 | 2.696±1.056 | 2.799±1.534 | 2.363±0.981 | 0.436±0.783*** |
| Low dosage | 0.042 | 3.171±1.565 | 2.513±0.459 | 2.318±0.872 | 0.095±1.007*** |
The result shows: cause the enhancing of guinea pig in vitro gallbladder contraction function behind the dropping Ach, show that medication after-contraction amplitude increases, medication after-contraction frequency is accelerated; Medicine high dose of the present invention with in, low dosage can cause the guinea pig in vitro gallbladder contraction function to strengthen to Ach the obvious suppression effect is arranged, show that medication after-contraction amplitude reduces, medication after-contraction frequency deceleration.
2.4. the influence that the stripped gallbladder contraction function that Atropine is caused suppresses;
A gallbladder flesh bar is worn silk thread one end to be fixed on the L type glass hook, the other end be fixed in the tracing device that exsomatizes the record end on, in Magnus' bath, inject the nutritional solution of 20ml, constant temperature is 37 ℃ in the bath, regulates mixture of oxygen, makes oxygen bubbles tiny, even, 8～10/minute, after stablizing 20～30 minutes, trace the normal motion collection of illustrative plates that contracts that relaxes of one section gallbladder flesh bar, measure its shrinkage amplitude and frequency; Add Atropine then and cause the gallbladder contraction function that exsomatizes to suppress, trace its contractile motion collection of illustrative plates, measure its shrinkage amplitude and frequency; The medicinal liquid that adds high, medium and low dosage then respectively.Trace its motion collection of illustrative plates that contracts that relaxes, measure its shrinkage amplitude and frequency, observe the synergism of the stripped gallbladder contraction function inhibition that Atropine is caused, all data are organized a t check, see Table 4.
Table 4. medicine of the present invention to Atropine cause the enhanced influence of guinea pig in vitro gallbladder contraction function (
N=8)
| Group | Final concentration (mg/ml) | Influence to the normal gallbladder shrinkage amplitude that exsomatizes | |||
| Normal baseline shrinkage amplitude (cm) | With Atropine after-contraction amplitude (cm) | Medication after-contraction amplitude (cm) | Own control difference (cm) | ||
| High dose | 0.165 | 1.021±0.423 | -2.189±1.638*** | -4.383±2.290*** | -5.404±2.174*** |
| Middle dosage | 0.083 | 0.776±0.209 | -2.856±1.483*** | -6.178±2.625** | -6.954±2.724*** |
| Low dosage | 0.042 | 0.960±0.363 | -0.432±1.412* | -0.890±2.513 | -1.850±2.653 |
| Group | Final concentration (mg/ml) | Influence to the normal gallbladder contraction frequency that exsomatizes | |||
| Normal baseline contraction frequency (inferior/4 minute) | With Atropine after-contraction frequency (inferior/4 minute) | Medication after-contraction frequency (inferior/4 minute) | Own control difference (inferior/4 minute) | ||
| High dose | 0.165 | 2.825±1.201 | 1.781±1.134* | 1.978±1.197 | -0.848±1.124** |
| Middle dosage | 0.083 | 2.525±0.625 | 2.428±0.764 | 1.995±0.766 | -0.530±1.107*** |
| Low dosage | 0.042 | 2.450±0.687 | 2.350±0.371 | 2.499±0.707 | 0.049±0.907*** |
The result shows: cause the inhibition of guinea pig in vitro gallbladder contraction function behind the dropping Atropine, show that medication after-contraction amplitude reduces, medication after-contraction frequency deceleration; High dose with in, low dosage can cause the guinea pig in vitro gallbladder contraction function to suppress that the obvious synergistic effect is arranged to Atropine, shows that medication after-contraction amplitude further reduces, medication after-contraction frequency further slows down.
(2), to the antagonism of inflammation different phase:
1. the influence that rat paper disk method granuloma is formed:
Get 60 of Wistar kind rats, body weight 180-220g, random packet.After stablizing three days, the quantitative scraps of paper of the prior disinfectant of embedding are tucked in down by rat partly sterilised, and performing the operation began to irritate stomach in back 4 hours, successive administration 10 days, behind the last medicine 1 hour, rat was put to death in dislocation, cuts off local skin, the granulomatous cyst wall of careful separation keeps it complete as far as possible, weighs.Calculate the ratio of granuloma and body weight, the results are shown in Table 5.
The influence that table 5. medicine of the present invention forms rat paper disk method granuloma (
N=10)
| Project | Dosage (g/kg) | Body weight (g) | Granuloma weight (mg) | Granuloma/body weight (mg/100g) |
| Blank group | - | 254.0±16.2 | 151.0±28.0 | 0.59±0.10 |
| High dose | 11.95 | 255.7±11.4 | 104.0±18.3 *** | 0.41±0.07 *** |
| Middle dosage | 5.98 | 253.2±22.0 | 115.3±10.0 **## | 0.46±0.06 **## |
| Low dosage | 2.99 | 257.3±15.9 | 124.6±13.0 *@@### | 0.49±0.07 *@### |
| Cholagogic tablet | 0.95 | 255.4±27.0 | 120.2±13.9 **@## | 0.47±0.07 *@## |
| Diclofenac | 0.018 | 265.3±17.5 | 89.1±23.8 *** | 0.34±0.10 *** |
The result shows: the high, medium and low dosage group of medicine of the present invention all can suppress rat granuloma weight.Prompting this product obviously antagonism rat chronic inflammation and the hypertrophy in inflammation late period sexually revises.
2. to the granulomatous influence of mice agar:
Get 60 of above-mentioned healthy mices, female, body weight 20-22g is divided into 5 groups at random, before the administration, the agar 0.2ml of every mouse back subcutaneous injection 2% causes the solution-air capsule, gastric infusion, continuous 10 days, fasting is 12 hours before the last medicine, behind the medicine 1 hour, the animal dislocation is put to death, operation is cutd open and is got granulation tissue, weighs.
The influence that table 6. medicine of the present invention forms mice agar granuloma (
N=10)
| Group | Dosage (g/kg) | Agar granuloma weight (g) | Agar granuloma/body weight (mg/100g) |
| Blank | - | 0.209±0.031 | 1.034±0.145 |
| High dose | 17.26 | 0.135±0.032*** | 0.665±0.163*** |
| Middle dosage | 8.63 | 0.149±0.055** | 0.733±0.278** |
| Low dosage | 4.32 | 0.170±0.045*## | 0.835±0.206$$ |
| Cholagogic tablet | 2.7 | 0.163±0.023**@### | 0.814±0.150*&&@ |
| Diclofenac | 0.026 | 0.114±0.028*** | 0.560±0.144*** |
The result shows: the high, medium and low dosage of medicine of the present invention all can significantly suppress the granulomatous formation of mice agar, and prompting this product obviously antagonism mice chronic inflammatory disease and the hypertrophy in inflammation late period sexually revises.
3. the influence of xylol induced mice capillary of skin permeability:
Get above-mentioned mice and be divided into 5 groups at random, continuous irrigation stomach three days, 1h tail vein is given 0.5%Evean-Blue-NS liquid 0.1mL/10g behind the last medicine, hit exactly melted paraxylene 0.03mL on the skin of unhairing of position in every mouse peritoneal immediately, taking off cervical vertebra behind the 20min puts to death, peel skin of abdomen, every skin locus coeruleus shreds with operating scissors, places in the tool plug teat glass, adds acetone-normal saline (3: 7) 10mL, putting the dark place places, jolting every day test tube 2～3 times, the centrifugal 10min of 2000r/min behind the 3d gets supernatant in 590nm place colorimetric, measure absorbance, proofread and correct with acetone-normal saline.The results are shown in Table 7.
Table 7. medicine xylol of the present invention cause the mouse skin capillary permeability influence (
N=10)
| Group | Dosage (g/kg) | Dyestuff seepage discharge (mg/mL) | Suppress percentage rate (%) |
| Blank | - | 1.071±0.410 | - |
| High dose | 17.26 | 0.637±0.214 ** | 40.55 |
| Middle dosage | 8.63 | 0.734±0.281 * | 31.47 |
| Low dosage | 4.32 | 0.760±0.356 | 29.08 |
| Diclofenac | 0.026 | 0.550±0.164 ** | 48.66 |
The result shows: medicine height of the present invention, middle dosage all can significantly suppress increasing of mice caused by dimethylbenzene xylene capillary of skin permeability, and low dosage can not significantly suppress increasing of mice caused by dimethylbenzene xylene capillary of skin permeability, only present certain effect trend.The obviously exudative change of antagonism chmice acute inflammation of prompting this product.
(3), to the analgesic activity of mice hot plate analgesic test:
Get some of the female healthy mices of 18--20g, hot plate filters out pain threshold 5-30 50 of persons between second, with dividing 5 groups before the test.Each group is all by the volume gastric infusion of 0.25ml/10g body weight, for three days on end, measures behind the last medicine 0.5,1,1.5,2,4 hour pain threshold respectively.
Table 8. medicine of the present invention to the analgesic activity of hot plate method mice (
N=10)
| Group | Dosage (g/kg) | Pain threshold (s) before the medicine | 30 fens pain thresholds (s) behind the medicine | 60 fens pain thresholds (s) behind the medicine | 90 fens pain thresholds (s) behind the medicine | 120 fens pain thresholds (s) behind the medicine | 240 fens pain thresholds (s) behind the medicine |
| The water contrast | - | 18.3±3.8 | 21.5±6.4 | 22.3±7.1 | 21.7±4.8 | 21.9±4.6 | 21.5±5.7 |
| High dose | 17.26 | 18.5±4.1 | 29.2±6.2 | 83.5±45.6 | 97.3±50.9 | 34.6±6.1 | 63.9±44.7 |
| Middle dosage | 8.63 | 18.6±4.6 | 25.1±14.2 | 40.1±14.3 | 63.8±34.2 | 32.7±8.8 | 58.0±52.9 |
| Low dosage | 4.32 | 18.1±6.7 | 24.5±7.2 | 34.3±12.1 | 47.8±30.1 | 30.9±11.0 | 26.1±7.9 |
| Diclofenac | 0.026 | 18.1±5.7 | 38.9±18.6 | 108.9±65.8 | 101.2±61.2 | 37.4±8.7 | 37.3±16.4 |
The result shows: significant difference is in various degree more all arranged before the pain threshold of different time and the medicine behind the medicine medicine of the present invention; Its analgesic activity behind medicine 30 minutes the beginning onset, analgesic activity behind medicine 1-2 hour the strongest, analgesic activity weakens along with the reduction of dosage.Compare there was no significant difference before and after the water contrast self, point out medicine of the present invention that significant analgesia role is arranged.
(4), immunoregulation effect
1. the mice carbon granule is cleaned up the test of experiment:
Get 50 of mices, male and female half and half are divided into 5 groups at random, and gastric infusion every day 1 time, administration is 10 days altogether, and after the last administration 1 hour, each Mus iv india ink 0.2ml/20g injected and got blood 0.02ml from the eye socket venous plexus respectively in back 2 minutes, 18 minutes and add 0.1%Na
2CO
3In the solution 2ml test tube, left standstill 1 hour, 650nm measures the A value, the results are shown in Table 10.
Table 10. medicine of the present invention to the mice carbon granule clean up ability influence (
N=10)
| Group | Dosage (g/kg) | Trap (A) value 2 minutes | Trap (A) value 18 minutes |
| Blank | - | 0.600±0.116 | 0.180±0.096 |
| High dose | 17.26 | 0.314±0.120*** | 0.076±0.038** |
| Middle dosage | 8.63 | 0.451±0.122* | 0.104±0.047* |
| Low dosage | 4.32 | 0.516±0.088@@@ | 0.141±0.106 |
| Cholagogic tablet | 2.73 | 0.494±0.097*@@ | 0.133±0.111 |
The result shows: medicine height of the present invention, middle dosage and cholagogic tablet all can significantly improve the carbon granule of mice and clean up ability.
2. to the influence of the low temperature swimming with a load attached to the body ability of mice:
Get 50 of Kunming mouses, male and female half and half, random packet, each organizes mice gastric infusion according to dosage, once a day, totally 10 days.Behind the last medicine 1 hour, mice is put into the water box that fills 0 ℃ of frozen water, and (the bear a heavy burden test of low temperature swimming ability of 1g of 60cm * 40cm * 50cm) was write down it and is begun to swim the time into water-bed of sinking to, and the result organizes a t check and handles, and sees Table 11.
Table 11. medicine of the present invention to the influence of mice low temperature swimming with a load attached to the body ability (
N=10)
| Group | Dosage (g/kg) | The low temperature swimming with a load attached to the body time (S) |
| Blank | - | 295.6±53.0 |
| High dose | 17.26 | 370.0±46.5 ** |
| Middle dosage | 8.63 | 355.3±43.3 * |
| Low dosage | 4.32 | 350.7±33.5 * |
| Cholagogic tablet | 2.73 | 323.4±30.9@ |
The result shows: the high, medium and low dosage of medicine of the present invention all can significantly improve mice low temperature swimming with a load attached to the body ability, and low temperature swimming with a load attached to the body ability all is better than cholagogic tablet.
The main pharmacodynamics result of study shows: medicine of the present invention has significant function of gallbladder promoting, antiinflammatory, analgesia and immunoregulatory effect.
Two, acute toxicity test:
The oral LD that do not make of mice
50, be calculated as 248.4g/kg by containing the crude drug amount in one day mouse stomach drug extract of the present invention, be equivalent to more than 523.73 times of clinical 70kg people's per kilogram of body weight consumption per day, observed seven days continuously, mice generally in order, none death illustrates this product low toxicity, safety.
Three, long term toxicity test:
Weigh for rat oral gavage drug extract of the present invention (to contain the crude drug amount) 33.2g/kg, 16.6g/kg, 7.11g/kg Mus, be equivalent to 70 times, 35 times, 15 times of the clinical consumption per day of 70kg people, successive administration 90 days, observe the general situation of animal, body weight change, appetite, the water yield, after the off-test, detect hematology, blood biochemical indexes respectively; And live and kill 2/3 animal, detect the organ coefficient and the histopathologic change of important organ.Remain 1/3 animal, carry out 45 day convalescent period and observe, the repetition measurement These parameters is not all found the toxic reaction that lose tangible toxicity, side effect and secondary, back, illustrate medicine of the present invention intend employing clinical medicine dose and the course of treatment safety, low toxicity.
Advantage of the present invention is:
1, scientific formula: promptly according to TCM Document ancient books and distinguished veteran doctors of TCM experience prescription, utilization modern medicine technology screening Chinese medicine preparation has breakthrough on traditional Chinese medical science Shi Zhi is dialectical.
2, medicine source abundance is simple for process, very easily promotes the use of.
3, evident in efficacy, toxic and side effects is little, safety and low toxicity.
The specific embodiment:
For a better understanding of the present invention, further set forth the present invention, but be not understood to that the present invention is had any restriction below by specific embodiment.
Embodiment 1
Pericarpium Citri Reticulatae Viride 400g, Radix Curcumae 400g, Rhizoma Cyperi 480g, Semen Sinapis Albae 240g, Radix Salviae Miltiorrhizae 600g, Radix Astragali 600g, Herba Sedi 60.Pericarpium Citri Reticulatae Viride is ground into coarse powder, adds 8 times of water gagings and soaked 4 hours, extracted volatile oil 6 hours with the way of distillation, the aqueous solution after the distillation concentrates, and is standby; Volatile oil is standby; Medicinal residues contain the 50% alcohol reflux secondary of NaOH0.1% with 10 times of amounts, each 1.5 hours; Merge extractive liquid, filters, decompression filtrate recycling ethanol, and 80 mesh sieves were pulverized in oven dry, and were standby.Radix Curcumae, Rhizoma Cyperi two flavors add 10 times of water gagings and soaked 2 hours, extract volatile oil 5 hours with the way of distillation, and 8 times of water gagings of medicinal residues reuse extracted 1 hour, collected extracting solution, concentrated, and are standby.Volatile oil mixes with Pericarpium Citri Reticulatae Viride volatile oil with 6 times of amount beta-schardinger dextrin-s, 50 ℃ of following enclose 2 hours.Radix Salviae Miltiorrhizae, the Radix Astragali add 8 times of amount 70% alcohol reflux secondaries, and each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and 80 mesh sieves were pulverized in oven dry.Herba Sedi, Semen Sinapis Albae and Radix Salviae Miltiorrhizae, Radix Astragali alcohol extraction medicinal residues add 10 times of water gagings and extract secondary, and each 1 hour, merge extractive liquid, filtered, and concentrates.Merge concentrated solution, add ethanol and make and contain the alcohol amount and reach 70%, 80 mesh sieves are filtered, concentrated, dry, pulverized to alcohol deposit fluid.Merge with the dry powder of Pericarpium Citri Reticulatae Viride alcohol extraction, promptly.
Embodiment 2
The preparation of granule:
Prescription: Pericarpium Citri Reticulatae Viride 400g, Radix Curcumae 400g, Rhizoma Cyperi 480g, Semen Sinapis Albae 240g, Radix Salviae Miltiorrhizae 600g, Radix Astragali 600g, Herba Sedi 600g.
Extraction process is by the above.Put forced air drying in the baking oven with extracting the extractum that concentrates gained, pulverized 80 mesh sieves and get dry powder.Add 2 times of heavy dextrin of amount of dry powder, 2% steviosin, dextrin and steviosin are all crossed 80 mesh sieves.With 70% ethanol moistening system soft material, cross 14 mesh sieves and granulate, 60 ℃ of oven dry of wet granular, behind the dried granule granulate, packing, promptly.
Embodiment 3
The preparation of tablet:
Prescription: Pericarpium Citri Reticulatae Viride 400g, Radix Curcumae 400g, Rhizoma Cyperi 480g, Semen Sinapis Albae 240g, Radix Salviae Miltiorrhizae 600g, Radix Astragali 600g, Herba Sedi 600g.
Extraction process is by the above.Extracting solution is concentrated, dries, pulverized 80 mesh sieves, the dry powder that makes is added 5% starch, add 70% suitable ethanol and make granule, drying, dried granule is crossed 20 mesh sieve granulate.Add 0.5% magnesium stearate again, mix homogeneously, tabletting is made plain sheet or Film coated tablets promptly.
Embodiment 4
The preparation of capsule:
Prescription: Pericarpium Citri Reticulatae Viride 400g, Radix Curcumae 400g, Rhizoma Cyperi 480g, Semen Sinapis Albae 240g, Radix Salviae Miltiorrhizae 600g, Radix Astragali 600g, Herba Sedi 600g.
Extraction process is by the above.Extracting solution concentrates, dry, pulverized 80 mesh sieves and made dry powder.Add 2% carboxymethyl starch sodium, make granule with 75% suitable ethanol, drying, dried granule is crossed 20 mesh sieve granulate.Add 0.5% magnesium stearate again, mixing, the capsule of packing into No. 0, promptly.
Embodiment 5
The preparation of dispersible tablet:
Prescription: Pericarpium Citri Reticulatae Viride 400g, Radix Curcumae 400g, Rhizoma Cyperi 480g, Semen Sinapis Albae 240g, Radix Salviae Miltiorrhizae 600g, Radix Astragali 600g, Herba Sedi 600g.
The extracting solution that extracts gained with above-mentioned extraction process makes dry powder through concentrated, dry, pulverizing, the microcrystalline Cellulose of adding 5%, add 2% guar gum again, with 70% ethanol is that wetting agent is made granule, drying, and dried granule is crossed 20 mesh sieve granulate, the magnesium stearate of adding 0.5%, mixing, tabletting, promptly.
Embodiment 6
Preparation of soft capsule:
Prescription: Pericarpium Citri Reticulatae Viride 400g, Radix Curcumae 400g, Rhizoma Cyperi 480g, Semen Sinapis Albae 240g, Radix Salviae Miltiorrhizae 600g, Radix Astragali 600g, Herba Sedi 600g.
An amount of soybean oil
Extract the extracting solution of gained by said extracted technology and make dry powder, be dissolved in the soybean oil, this solution is made soft capsule, promptly through concentrated, dry, pulverizing.
Embodiment 7
The preparation of drop pill:
Prescription: Pericarpium Citri Reticulatae Viride 400g, Radix Curcumae 400g, Rhizoma Cyperi 480g, Semen Sinapis Albae 240g, Radix Salviae Miltiorrhizae 600g, Radix Astragali 600g, Herba Sedi 600g.
Macrogol 4000 is an amount of
Press said extracted technology and extract, extracting solution is made dry powder through concentrated, dry, pulverizing, treats to add the fine drug powder mix homogeneously after the substrate fusion, adds Pericarpium Citri Reticulatae Viride, Radix Curcumae, Rhizoma Cyperi volatile oil mixing immediately, insulation about 80 ℃.With internal diameter is 3.3mm, and external diameter is the 5.1mm dropper, with 60-70 drip/minute drip speed to splash in the methyl-silicone oil, collect drop pill, absorb liquid coolant with filter paper, promptly.
Claims (6)
1, a kind of compound Chinese medicinal preparation for the treatment of chronic cholecystitis is characterized in that the Chinese medicine preparation (1000 preparation units) that it is made by the following weight proportion raw material.
Pericarpium Citri Reticulatae Viride 200～1000 weight portion Radix Curcumaes 150～1000 weight portions
Rhizoma Cyperi 150～1200 weight portion Semen Sinapis Albaes 150～600 weight portions
Radix Salviae Miltiorrhizae 300～1500 weight portion Radixs Astragali 300～1500 weight portions
Herba Sedi 120～1500 weight portions
2, a kind of compound Chinese medicinal preparation (1000 preparation units) for the treatment of chronic cholecystitis according to claim 1, wherein the optimum weight proportioning of each Chinese crude drug is:
Pericarpium Citri Reticulatae Viride 400 weight portion Radix Curcumaes 400 weight portions
Rhizoma Cyperi 480 weight portion Semen Sinapis Albaes 240 weight portions
The Radix Salviae Miltiorrhizae 600 weight portion Radixs Astragali 600 weight portions
Herba Sedi 600 weight portions
3, the compound Chinese medicinal preparation of treatment chronic cholecystitis according to claim 1 and 2 is characterized in that described dosage form is the above a dosage form of any pharmaceutics.
4,, the compound Chinese medicinal preparation of treatment chronic cholecystitis according to claim 3, it is characterized in that described medicament is tablet, capsule, pill, powder, syrup, mixture, drop pill, granule, oral liquid, drop or the like.
5, the preparation method of the compound Chinese medicinal preparation of a kind of claim 1,2,3,4 described treatment chronic cholecystitiss is characterized in that:
Pericarpium Citri Reticulatae Viride is ground into coarse powder, adds 8 times of water gagings and soaks 4 hours, extracts volatile oil 6 hours with the way of distillation, and the aqueous solution after the distillation concentrates, and is standby; Volatile oil is standby;
Above-mentioned medicinal residues contain the 50% alcohol reflux secondary of NaOH0.1% with 10 times of amounts, each 1.5 hours; Merge extractive liquid, filters, decompression filtrate recycling ethanol, and 80 mesh sieves were pulverized in oven dry, and were standby.
Radix Curcumae, Rhizoma Cyperi two flavors add 10 times of water gagings and soaked 2 hours, extract volatile oil 5 hours with the way of distillation, and 8 times of water gagings of medicinal residues reuse extracted 1 hour, collected extracting solution, concentrated, and are standby.Volatile oil mixes with Pericarpium Citri Reticulatae Viride volatile oil with 6 times of amount beta-schardinger dextrin-s, 50 ℃ of following enclose 2 hours.
Radix Salviae Miltiorrhizae, the Radix Astragali add 8 times of amount 70% alcohol reflux secondaries, and each 1 hour, merge extractive liquid, filtered, decompression filtrate recycling ethanol, and 80 mesh sieves were pulverized in oven dry.
Herba Sedi, Semen Sinapis Albae and Radix Salviae Miltiorrhizae, Radix Astragali alcohol extraction medicinal residues add 10 times of water gagings and extract secondary, and each 1 hour, merge extractive liquid, filtered, and concentrates.Merge concentrated solution, add ethanol and make and contain the alcohol amount and reach 70%, 80 mesh sieves are filtered, concentrated, dry, pulverized to alcohol deposit fluid.Merge with the dry powder of Pericarpium Citri Reticulatae Viride alcohol extraction, promptly.Add suitable adjuvant and make various dosage forms such as tablet, capsule, pill, powder, syrup, soft extract, mixture, drop pill, granule, oral liquid, drop.
6, the function according to the compound Chinese medicinal preparation of claim 1,2,3,4,5 described treatment chronic cholecystitiss cures mainly and indication, and it is characterized in that: have soothing liver and strengthening spleen, the effect of function of gallbladder promoting collateral dredging cures mainly chronic cholecystitis, stagnation of liver-QI with deficiency of the spleen, syndrome of accumulated dampness-heat.Card is seen: right side of body distending pain and gastral cavity abdomen are the spleen-distension not to relax, and often accompanies belch sigh, dry mouth with bitter taste, anorexia, tired, loose stool, whenever increases the weight of etc. because of feelings will or eating and drinking without temperance.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102078568A (en) * | 2010-12-24 | 2011-06-01 | 夏玲 | Traditional Chinese medicine tablet for treating chronic cholecystitis |
| CN103040876A (en) * | 2012-12-17 | 2013-04-17 | 浙江佐力药业股份有限公司 | Preparation method for composition of solid traditional Chinese medicine particles |
| CN104491754A (en) * | 2015-01-12 | 2015-04-08 | 白忠可 | Traditional Chinese medicine preparation for treating cholecystitis and preparation method of traditional Chinese medicine preparation |
| CN104800472A (en) * | 2015-04-02 | 2015-07-29 | 中国人民解放军***总医院 | Traditional Chinese medicine composition for treating liver depression and spleen deficiency type chronic cholecystitis |
| CN104958706A (en) * | 2015-07-21 | 2015-10-07 | 青岛蓝盛洋医药生物科技有限责任公司 | Traditional Chinese medicine composition for treating chronic cholecystitis |
| CN105168760A (en) * | 2015-08-14 | 2015-12-23 | 高伟 | Traditional Chinese medicine treating liver qi stagnation chronic cholecystitis and preparation method therefor |
-
2006
- 2006-01-23 CN CN 200610042099 patent/CN101007157A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102078568A (en) * | 2010-12-24 | 2011-06-01 | 夏玲 | Traditional Chinese medicine tablet for treating chronic cholecystitis |
| CN103040876A (en) * | 2012-12-17 | 2013-04-17 | 浙江佐力药业股份有限公司 | Preparation method for composition of solid traditional Chinese medicine particles |
| CN103040876B (en) * | 2012-12-17 | 2015-03-25 | 浙江佐力药业股份有限公司 | Preparation method for composition of solid traditional Chinese medicine particles |
| CN104491754A (en) * | 2015-01-12 | 2015-04-08 | 白忠可 | Traditional Chinese medicine preparation for treating cholecystitis and preparation method of traditional Chinese medicine preparation |
| CN104800472A (en) * | 2015-04-02 | 2015-07-29 | 中国人民解放军***总医院 | Traditional Chinese medicine composition for treating liver depression and spleen deficiency type chronic cholecystitis |
| CN104958706A (en) * | 2015-07-21 | 2015-10-07 | 青岛蓝盛洋医药生物科技有限责任公司 | Traditional Chinese medicine composition for treating chronic cholecystitis |
| CN105168760A (en) * | 2015-08-14 | 2015-12-23 | 高伟 | Traditional Chinese medicine treating liver qi stagnation chronic cholecystitis and preparation method therefor |
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