CN105168279A - Application of eight-jewel elixir to preparing medicine for treating primary sclerosing cholangitis - Google Patents
Application of eight-jewel elixir to preparing medicine for treating primary sclerosing cholangitis Download PDFInfo
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Abstract
The invention discloses eight-jewel elixir and novel application of preparations of the eight-jewel elixir, and particularly relates to application of eight-jewel elixir to preparing medicine for treating primary sclerosing cholangitis. The application has the advantages that the eight-jewel elixir and preparations of the eight-jewel elixir can be applied to wide fields, and a novel traditional Chinese medicine treatment method is developed for treating the primary sclerosing cholangitis.
Description
Technical field
The present invention relates to the novelty teabag of pill of Eight Treasures, especially pill of Eight Treasures and the application of preparation in preparation treatment primary sclerosing cholangitis medicine thereof.
Background technology
The main component of pill of Eight Treasures is Calculus Bovis, Fel Serpentis, Cornu Saigae Tataricae, Margarita, Radix Notoginseng, Moschus etc.; existing being applied to caused by damp-heat accumulation is generated heat; jaundice; yellowish or reddish urine, nausea and vomiting, indigestion and loss of appetite; hypochondriac pain abdominal distention; yellowish fur or thick greasy extra dry white wine, or urethra scorching hot twinge, lower abdominal distention pain caused by damp invasion of lower energizer, and spreading venereal diseases toxicity hepatitis, acute cholecystitis, the infection of acute urinary system etc. are shown in there is above-mentioned patient.
Primary sclerosing cholangitis (PSC) is a kind of chronic cholestatic hepatopathy, with the Progressive symmetric erythrokeratodermia inflammation of bile duct, fibrosis and multiple narrow in major pathologic features.The pathogenesis of PSC is not yet illustrated, may be relevant with autoimmune function disorder, Gene Susceptibility and bile duct epithelial cell dysfunction.Current medication effect is undesirable, and existing several frequently seen medicine for treatment thing is as follows:
(1) UDCA(ursodesoxycholic acid): UDCA is the medicine of a kind of effective treatment PBC, is therefore recommended as the drug candidate of PSC treatment.The initial stage nineties one little pilot study display, in PSC patient use 10 ~ 15mg/(kgd) dosage UDCA treatment, histology that is biochemical and some cases improves.Another prior research is the doubleblind-placebo Comparative study that 105 patients reported by Lindor for 1997 participate in, and the dosage using UDCA is 13 ~ 15mg/kg, continue for 2 years altogether.Result display liver serum test project improves, but symptom is without obvious change, the more important thing is, according to disease classified estimation, liver histological aspect is not improved.
Study for one of Scandinavia and reach 219 people into group patient number, treatment cycle reaches 5 years, and the drug dose of use is 17 ~ 23mg/(kgd), the survival rate comparatively placebo raising of result display UDCA treatment group, but comparatively matched group compares, statistically there was no significant difference.Compared with other are studied, biochemical responses relative mistake, prompting may with the comparatively difference correlation of the compliance of part study population.
Recently, heavy dose of UDCA28 ~ the 30mg/(kgd of the use carried out in a multicenter 150 patients) the research failure that lasts 5 years, because although biochemical character is improved in whole treatment group, but add the danger that UDCA treatment group arrives Primary endpoint in some progressive disease, this comprises liver transplantation and cirsoid progress simultaneously.Like this, the effect that UDCA reduces the hepatic disease progress that PSC is correlated with is still unclear, and the UDCA of high dose may be harmful to terminal illness.
(2) immunosuppressant and other preparations: glucocorticoid and other immunosuppressant do not demonstrate and play a role in improving to the activeness of disease or the final result of PSC.Little random, placebo or pilot study have been used as research once to immunosuppressant, and these medicines comprise prednisone, cloth ground a kind of apple moral, azathioprine, ciclosporin A, methotrexate, tacrolimus, pentoxifylline, colchicine and penicillamine etc.Not evidence suggests that these medicines are effective, so do not recommend for the classical PSC for the treatment of.
To sum up, acquired data display UDCA(15 ~ 20mg/d) improve serologic test index and prognosis Substitute Indexes, but not proving survival rate is benefited, limited data does not make the license of special recommendation UDCA as PSC basic medicine.Glucocorticoid and other immunosuppressant do not advise application in adult PSC treatment.
Summary of the invention
The object of the present invention is to provide the novelty teabag of pill of Eight Treasures, i.e. the application of pill of Eight Treasures in preparation treatment primary sclerosing cholangitis medicine, for primary sclerosing cholangitis provides new medicine.
The invention discloses the application of pill of Eight Treasures in preparation treatment primary sclerosing cholangitis medicine.
Wherein, described pill of Eight Treasures selectivity adds customary adjuvant, and technique makes acceptable preparation clinically routinely, and described preparation comprises lozenge, capsule, tablet, granule, pill, powder.
Wherein, dose is 1.0 ~ 3.0g described pill of Eight Treasures day.
Primary sclerosing cholangitis (PSC) is a kind of chronic cholestasis autoimmune liver disease, it is characterized by extrahepatic duct inflammation and fibrosis, and then causes multifocal stenosis of bile duct.PSC clinical manifestation variability is large, and morbidity is slowly hidden.Early stage non-evident sympton, early diagnosis has difficulties.During PSC patient assessment main manifestations be repeated relapsing jaundice, weak, poor appetite, skin pruritus, hepatalgia, become thin, fatigue, hepatomegaly, abdominal distention or with fear of cold, heating etc.
In Chinese medicine, primary sclerosing cholangitis is belonged to the category such as " hypochondriac pain ", " jaundice ", " gathering ", " tympanites ", " asthenia ".Main manifestations is Mental fatigue, weak, the symptom such as pruritus, jaundice clinically, has the features such as chronic delay, obstinate refractory and recurrent exerbation.The basic pathogenesis of PSC is " deficiency in origin and excess in superficiality ", " weakened body resistance hold the stasis of blood under the arm ".Liver controlling conveyance and dispersion, bar reach, store blood, and depression of liver-QI, the mechanism of qi stasis of blood are stagnant, hematogenous blockage and the hyperamization stasis of blood.Damp is accumulate in resistance burnt, and taste mistake is strong, irritability stasis, and catharsis is unfavorable, causes the catharsis of gallbladder antiperspirant not normal, bile Bu Xunchang road, excessive skin, bet bladder, and sends out the disease for icteric sclera, skin Huang, yellow urine.Primary treatments is the cholestatic symptom of relieve chronic, and regulating qi to disperse stagnation, invigorating the spleen and benefiting QI, improve microcirculation in liver, promotes alluvial Bile metabolism, expands narrow bile duct tube chamber.
Calculus Bovis is mainly the cholelithiasis of cattle or Babalus bubalis L., calculus in minority system bile duct or common hepatic duct, modern pharmacology research Calculus Bovis is mainly containing gallbladder acid, deoxycholic acid, cholesterol and bilirubin, taurine etc., taurine is a kind of beta amino acids of the sulfur-bearing be transformed by cystine, for human body condition essential amino acids, its major part is distributed in cell, there is biological effect very widely, liver is the important target organ of taurine, research confirms that taurine has antioxidation and suppresses Kupffer Cell activation, preventive effect is had to LSP liver toxicity, to hepatic injury, chronic hepatopathy has certain curative effect.
Containing abundant trace element, bile acid, glycine and taurocholic acid etc. in Fel Serpentis; trace elements zn in Fel Serpentis, Cu, Fe and macroelement Ca; Mg; they are to the active function of enzyme multiple in body, all have direct or indirect effect, also can promote epithelial reparation to the synthesis of nucleic acid and protein, immunologic process; cell division is increased; T cell increases, increased activity, thus plays regulatory role organism immune function.Fel Serpentis can reduce hepatocyte inner cell pigment P
450content, reduces the free radical that carbon tetrachloride metabolism generates, thus produces protective effect to liver.
Cornu Saigae Tataricae nature and flavor are salty-cold, return liver, heart channel, and tool suppressing the hyperactive liver to relieve the wind syndrome, heat clearing away is relieving convulsion, the merit of removing toxic substances.
Natural peral is containing calcium carbonate 91.72%, and Organic substance 5.94%, water 2.23%, indicates in " Chinese medicine voluminous dictionary ": Margarita has the effects such as arresting convulsion of calming the nerves, improving eyesight removing nebula, removing toxic substances and promoting granulation.
Radix Notoginseng is the dry root of araliaceae ginseng plant Radix Notoginseng, its sweet in the mouth, micro-hardship, warm in nature, has function of gallbladder promoting, jaundice eliminating, falls the effects such as enzyme, can improve the plasma albumin of patients with chronic liver.Radix Notoginseng extract has and significantly reduces serum bilirubin, promotes bile secretion effect.
Moschus nature and flavor are pungent, warm, GUIXIN spleen channel, and main chemical compositions has macrocyclic ketone compounds, pyridine compounds and their, steroid compound, polypeptide protein compound, aliphatic acid and ester compounds and some inorganic elementss etc.Water soluble polypeptide in Moschus is protein-based can have an impact by centering granulocyte function, thus plays antiinflammatory action.
The present invention is on the application foundation of existing pill of Eight Treasures and preparation thereof, develop the new application different from script curative effect, several main component plays its respective effect and synergism above, pass through clinical trial, its treated effect is high, for control primary sclerosing cholangitis opens a kind of new treatment by Chinese herbs method.
Detailed description of the invention
In order to make object of the present invention, technical scheme and advantage clearly understand, below in conjunction with embodiment, the present invention is further elaborated.
Embodiment 1
Get commercially available pill of Eight Treasures capsule (the accurate word Z10940006 of traditional Chinese medicines, Xiamen Chinese Medicine Co., Ltd produces), every contains pill of Eight Treasures 0.25 ~ 0.3g, for the preparation of in treatment primary sclerosing cholangitis medicine, when patient takes, and every day 2 ~ 3 times, each 2.
Embodiment 2
Get commercially available pill of Eight Treasures lozenge (the accurate word Z10940005 of traditional Chinese medicines, Xiamen Chinese Medicine Co., Ltd produces) to pulverize, add customary adjuvant and make tablet, containing pill of Eight Treasures 0.5g in every tablet preparation, for the preparation of in treatment primary sclerosing cholangitis medicine, when patient takes, every day 3 times, each 1 ~ 2.
Embodiment 3
Get commercially available pill of Eight Treasures lozenge (the accurate word Z10940005 of traditional Chinese medicines, Xiamen Chinese Medicine Co., Ltd produces) to pulverize, add customary adjuvant and make granule, containing pill of Eight Treasures 0.6g in every bag of granule, for the preparation of in treatment primary sclerosing cholangitis medicine, when patient takes, every day 3 times, each 1 bag.
Embodiment 4
Get commercially available pill of Eight Treasures lozenge (the accurate word Z10940005 of traditional Chinese medicines, Xiamen Chinese Medicine Co., Ltd produces) to pulverize, add customary adjuvant and make pill, containing pill of Eight Treasures 0.5g in every pill, for the preparation of in treatment primary sclerosing cholangitis medicine, when patient takes, every day 3 times, each 1 ~ 2.
Embodiment 5
Get commercially available pill of Eight Treasures lozenge (the accurate word Z10940005 of traditional Chinese medicines, Xiamen Chinese Medicine Co., Ltd produces) pulverize, add customary adjuvant and make powder, containing pill of Eight Treasures 0.5 ~ 0.8g in every bag of powder, for the preparation of in treatment primary sclerosing cholangitis medicine, when patient takes, every day 3 times, each 1 bag.
Below in conjunction with clinical experiment the present invention done and further verify explanation.
1, diagnostic criteria
(1) chronic cholestatic, serum levels of ALP is greater than 2 times of the reference value upper limit, and the time was more than 6 months;
(2) inflammatory bowel medical history is had;
(3) MRC or ERCP checks that prompting liver is outer, stones in intrahepatic bile duct has the beading of multiple stricture dilation to show;
(4) liver impedance rheograph shows occlusion of bile duct, bile duct surrounding annulus, bile duct rareness or biliary cirrhosis;
(5) pANCA and low titre ANA, smooth muscle antibody (ASMA) is had.
2, index of assessment of curative effect:
(1) clinical symptoms before and after treatment improves situation;
(2) improvement of serum levels of ALP level decline, liver function;
(3) improvement of liver histological.
3, clinical experiment process
2011.04-2014-07 period, follow the tracks of case 14 example of primary sclerosing cholangitis.14 routine sufferers are divided into two groups, two groups of ages, sex, the cause of disease, course of disease uniform distribution.
Matched group: case 7 example, adopts conventional therapy.
Treatment group: 7 examples, pill of Eight Treasures is taken on the basis of conventional therapy, and during medication, non-drug combination, pill of Eight Treasures occupation mode is 0.6 gram/times, 3 times on the one, the June course for the treatment of.
4, experimental result
(1) clinical symptoms before and after treatment improves situation: comparatively matched group is good for the clinical symptoms improvement situation of 7 routine treatment groups, and the cardinal symptom integration before and after treatment is in table 1.
(2) liver function main manifestations is that ALP, GGT raise.Before 14 routine patient treatments, ALP on average raises 4 times, and GGT on average raises 6 times, treatment group (basis of conventional therapy being taken pill of Eight Treasures 6 months), has 3 routine ALP, GGT to return to normal level in 7 routine patients, and all the other 4 routine ALP, GGT on average raise 1 ~ 2 times.In the routine patient of matched group 7, ALP on average raises 2 ~ 3 times, and GGT on average raises 2 ~ 4 times.The successful of visible treatment group is better than matched group.
5, model case:
The old * * of patient, man, 63 years old, because intermittence is weak, right epigastric discomfort, yellowish urine 1 month, pruritus first quarter moon, become thin half a year, patient goes to a doctor in JIUYUE, 2012 to hospital outpatient, without cholelithiasis, operation on biliary tract history except cholecystectomy, ultrasound diagnosis prompting liver spleen pancreas no abnormality seen, gallbladder wall thickens a little, liver function: alanine aminotransferase (ALT) 121U/L, aspartate amino transferase (AST) 68U/L, gamma glutamyl transpeptidase (GGT) 778U/L, total bilirubin (TBiL) 33 μm of ol/L, bilirubin direct (DBiL) 21 μm of ol/L, alkali phosphatase (ALP) 211U/L.First, second, third, Hepatitis virus blood serum designated object is all negative.Carry out cholangiography inspection, prompting liver is outer, stones in intrahepatic bile duct has the beading of multiple stricture dilation to show, Patient height 167cm, body weight 67kg, be diagnosed as primary sclerosing cholangitis.Give pill of Eight Treasures 0.6 gram/times, 3 times on the one, the June course for the treatment of, after medication June, weak, the right epigastric discomfort of patient, yellowish urine, pruritis disappear, sign increases by 5.2 kilograms, check liver function: ALT25.0U/L, AST19U/L, GGT141U/L, TBiL11.1 μm of ol/L, DBiL7.6 μm of ol/L, ALP110U/L.Ultrasound diagnosis prompting gallbladder wall thickens a little and alleviates, and cholangiography display biliary tract diffusivity " beading " changes and alleviates to some extent, and patient continues intermittence voluntarily and takes pill of Eight Treasures, follows up a case by regular visits to 27 months, and private prosecution symptom does not recur again.
The above, be only the present invention's preferably detailed description of the invention, is anyly familiar with those skilled in the art in the technical scope that the present invention discloses, the change that can expect easily or replacement, all should be encompassed within protection scope of the present invention.
Claims (3)
1. the application of pill of Eight Treasures in preparation treatment primary sclerosing cholangitis medicine.
2. application according to claim 1, is characterized in that: described pill of Eight Treasures selectivity adds customary adjuvant, and technique makes acceptable preparation clinically routinely, and described preparation comprises lozenge, capsule, tablet, granule, pill, powder.
3. apply as claimed in claim 1 or 2, it is characterized in that, described pill of Eight Treasures day dose be 1.0g ~ 3.0g.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2094289B1 (en) * | 2006-12-04 | 2013-03-13 | Promedior, Inc. | Combination of sap and enalapril for use in the treatment of fibrotic or fibroproliferative disorders |
| CN103961387A (en) * | 2014-05-20 | 2014-08-06 | 厦门中药厂有限公司 | Application of traditional Chinese medicine composition in preparing drugs for treating hepatolith |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2094289B1 (en) * | 2006-12-04 | 2013-03-13 | Promedior, Inc. | Combination of sap and enalapril for use in the treatment of fibrotic or fibroproliferative disorders |
| CN103961387A (en) * | 2014-05-20 | 2014-08-06 | 厦门中药厂有限公司 | Application of traditional Chinese medicine composition in preparing drugs for treating hepatolith |
Non-Patent Citations (2)
| Title |
|---|
| 国家药典委员会: "《国家药品标准(新药转正标准)》", 31 December 1999 * |
| 王育群: "《常见肝胆疾病的中医预防和护养》", 31 October 2013 * |
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