CN100506228C - Lansoprazole enteric coated tablet and preparing method thereof - Google Patents
Lansoprazole enteric coated tablet and preparing method thereof Download PDFInfo
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- CN100506228C CN100506228C CNB2008100011922A CN200810001192A CN100506228C CN 100506228 C CN100506228 C CN 100506228C CN B2008100011922 A CNB2008100011922 A CN B2008100011922A CN 200810001192 A CN200810001192 A CN 200810001192A CN 100506228 C CN100506228 C CN 100506228C
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Abstract
The invention belongs to the technical field of pharmaceutical preparation, in particular to a lansoprazole enteric-coated tablet; wherein, the enteric-coated tablet consists of the following components: a) tablet core consisting of lansoprazole and pharmaceutical excipient; b) a enteric coating layer consisting of castor oil, polyacrylic resin II and pharmaceutical excipient. The enteric coating layer of the invention contains castor oil which is water insoluble plasticizer and has good compatibility with the polyacrylic resin II, thereby effectively preventing the lansoprazole of the raw material from being damaged by the polyacrylic resin II which is the acidic and intestinal-lysis coating material; therefore, an isolated layer is not needed to be packed between an enteric-coated layer and a tablet core, and fatherly allowing the invention has the advantages of simplifying the preparation process, reducing production cost, high dissolution rate of the prepared enteric-coated tablet, high bioavailability and good stability.
Description
Technical field
The present invention relates to the pharmacy dosage form, relate in particular to a kind of Lansoprazole enteric-coated tablet and preparation method thereof.
Background technology
The chemical structural formula of lansoprazole:
Lansoprazole (Lansoprazole) is in the world second proton pump inhibitor class antiulcerative after omeprazole, potent inhibitor for the most advanced and sophisticated secretion of parietal cell film inner proton pump, its mechanism of action is the same with omeprazole, also is by the excretory final tache H of gastric acid inhibitory
+-K
+-ATP enzyme (proton pump) and playing a role.Because this product is a weakly basic drugs, former medicine activity is minimum, be transported to gastric mucosal cell after being absorbed into blood, final secretory duct and the acid chamber of arriving, the pH at this place＜1, former medicine is by protonated back positively charged and constantly enrichment, and is converted to the sulfenic acids of biologically active and the medicine of sulfenic acids amine form under the catalysis of acid, this active medicine and H
+-K
+-ATP enzyme transporting mechanism and bring into play and suppress sour secretory action.Therefore lansoprazole fully chemical mediators such as blockage of acetylcholine, gastrin and histamine stimulate the gastric acid secretion that causes, have and press down acid and act on strongly and persistently.Can effectively treat various types of peptic ulcers and reach the disease that causes owing to sour hypersecretion, its effect is better than bisfentidine commonly used, especially the intractable ulcer and the collagen ulcer of failing to respond to any medical treatment the latter is had better effects.Because this medicine is at bringing out that two causes of disease of ulcer---sour hypersecretion and H.P infect, so treatment ulcer relatively rapidly, effectively, and relapse rate is low.Be applicable to gastric ulcer, duodenal ulcer, erosive stomach-esophageal reflux disease, helicobacter pylori, Zollimger-ellison syndrome.
Lansoprazole is insoluble in water, and is unstable under acidic condition, destroyed easily in gastric acid, make sheet or capsule after oral absorption slower, and bioavailability is lower, stability is also relatively poor.Usually it is prepared into enteric coatel tablets or enteric solubility capsule in the prior art.CN1907281 discloses a kind of lansoprazole intestine dissolving capsule, consider that lansoprazole capsule is unstable in acid medium, more stable in alkaline medium, therefore at the outermost layer bag of micropill with enteric coating, between ball core and enteric coating, add bag one deck contagion gown, to improve stability of formulation.Chinese Pharmaceutical Journal volume the 3rd phase " research of Lansoprazole enteric-coated tablet " literary composition March the 34th in 1999 discloses a kind of Lansoprazole enteric-coated tablet, the enteric coatings material adopts acrylic resin II number, and the II resin is acidic materials, therefore in the sheet heart and enteric coating layer, wrap sealing coat, the sheet heart and enteric coating layer are kept apart.
As seen, in the prior art,,, all need to wrap one deck sealing coat in order to improve stability of drug no matter be preparation enteric solubility capsule or preparation enteric solubility tablet, thus complex manufacturing technology, volume of production is little, and the production cost height is unsuitable for mass mechanized production.In view of this, special proposition the present invention.
Summary of the invention
The object of the present invention is to provide a kind of Lansoprazole enteric-coated tablet, do not need to wrap sealing coat in the sheet heart of these enteric coatel tablets and the enteric coating layer, dissolution rate and bioavailability are good, steady quality, and dosage is accurate, carries, transportation, taking convenience.
For achieving the above object, the technical solution adopted in the present invention is:
A kind of Lansoprazole enteric-coated tablet is characterized in that described enteric coatel tablets are made up of following ingredients: a) label of being made up of lansoprazole and pharmaceutically acceptable auxiliaries; B) enteric layer of forming by Oleum Ricini, polyacrylic resin II number and pharmaceutically acceptable auxiliaries.
Lansoprazole is a benzimidazole compounds, it is unstable to acid, for preventing lost efficacy by stomach acids destroy behind the drug oral, therefore be prepared as enteric coated tablet or capsule usually in the prior art, and in label and enteric layer bag one deck sealing coat, label and enteric coating layer are kept apart, to improve stability of drug.And Lansoprazole enteric-coated tablet provided by the present invention, between label and enteric layer, do not need to wrap sealing coat, thereby simplified production technology, preparation method is simpler, has overcome preparation Lansoprazole enteric-coated tablet in the prior art or capsule need wrap sealing coat in the sheet heart and enteric layer prejudice.
Lansoprazole enteric-coated tablet provided by the present invention, its enteric layer is made up of Oleum Ricini, enteric coating material and pharmaceutically acceptable auxiliaries.Adopt prescription provided by the invention to prepare Lansoprazole enteric-coated tablet, between label and enteric layer, do not need to wrap sealing coat.The inventor also once had query to stability of the prepared Lansoprazole enteric-coated tablet of prescription provided by the present invention etc., test of many times attempts to find the reasonable dismissal that does not need to wrap sealing coat, but do not find proper explanations so far as yet, may be because the enteric layer among the present invention contains Oleum Ricini, Oleum Ricini is as the solvent of insoluble drug, oxidative rancidity takes place in air hardly, and storage stability is good, can be used as surfactant or plasticizer.Oleum Ricini is a kind of water-insoluble plasticizer in the present invention, with diethyl phthalate as plasticizer, film property is better, prevented that effectively the active constituents of medicine lansoprazole from being destroyed for II number by acid enteric coatings material polyacrylic resin, thereby make enteric coatel tablets of the present invention between enteric layer and label, not need to wrap sealing coat, and stability of drug is better equally.
Lansoprazole enteric-coated tablet of the present invention, wherein used pharmaceutic adjuvant is starch, microcrystalline Cellulose, ethanol and magnesium stearate in the label.
Above-mentioned pharmaceutic adjuvant also comprises hyprolose and carboxymethylstach sodium.
Make diluent with starch among the present invention,, also need to be aided with suitable solubilizing agent in order to improve the dissolution of tablet.Select for use hyprolose to do solubilizing agent among the present invention, can promote the dissolution of tablet effectively.
Lansoprazole enteric-coated tablet of the present invention, wherein used pharmaceutic adjuvant is diethyl phthalate, tween 80 and ethanol in the enteric layer.
After among the present invention polyacrylic resin II number, dimethyl phthalate, Oleum Ricini, tween 80 and ethanol being prepared by a certain percentage, make enteric coating solution, not only solve the easy variable color of lansoprazole, unsettled quality problems, but also overcome the technology prejudice that between label and enteric layer, to wrap one deck sealing coat when preparing Lansoprazole enteric-coated tablet or enteric coated capsule in the prior art.
Specifically, Lansoprazole enteric-coated tablet of the present invention is made up of following ingredients:
A) label of forming by lansoprazole and following excipient
Lansoprazole 15g
Starch 90g
Microcrystalline Cellulose 20g
Hyprolose 10g
Ethanol is an amount of
Carboxymethylstach sodium 8g
Magnesium stearate is an amount of
B) contain the enteric coat layer of enteric material:
Polyacrylic resin II 5g
Diethyl phthalate 2ml
Oleum Ricini 1ml
Tween-80 2ml
Ethanol 90ml
Label is the dehydrated alcohol of mannitol-lactose, poloxamer and 5%PVP in the disclosed Lansoprazole enteric-coated tablet of Chinese Pharmaceutical Journal the 34th volume the 3rd phase " research of a Lansoprazole enteric-coated tablet " literary composition (hereinafter to be referred as documents) March in 1999, wherein mannitol-lactose is a diluent, poloxamer is solubilizing agent, the dehydrated alcohol of 5%PVP is a binding agent, enteric coat layer is polyacrylic resin II number, diethyl phthalate, tween 80 and alcoholic acid solution, also has sealing coat between enteric coat layer and the label.And adopt Oleum Ricini, polyacrylic resin II number, diethyl phthalate, tween 80 and alcoholic acid solution to make enteric coat layer among the present invention, Oleum Ricini and diethyl phthalate are jointly as plasticizer, film property is better, prevented that effectively lansoprazole from being destroyed for II number by acid enteric coatings material polyacrylic resin, thereby do not needed to wrap sealing coat between label and the enteric coating layer.
In addition, when the inventor adopts mannitol-lactose to make diluent and poloxamer in overtesting is found documents to do solubilizing agent, the solubilising power of poloxamer a little less than, the result of extraction of tablet is relatively poor, and adopt the sheet cored structure and the enteric coating layer of the present invention of documents to prepare Lansoprazole enteric-coated tablet, can not get the effect of product Lansoprazole enteric-coated tablet of the present invention.
Another object of the present invention is to provide a kind of preparation method of Lansoprazole enteric-coated tablet, this method technology is simple, and volume of production is big, and production cost is low, and " sanitary standard " reaches easily, is suitable for mass mechanized production.
The preparation method of Lansoprazole enteric-coated tablet provided by the present invention is characterized in that, this method comprises the steps:
1) preparation of label
Get lansoprazole, microcrystalline Cellulose, the hyprolose crushing screening of recipe quantity, mix, add binding agent ethanol, mixing granulation, drying, 16 mesh sieve granulate add an amount of carboxymethylstach sodium, magnesium stearate, and tabletting promptly gets the lansoprazole label;
2) preparation of enteric layer
Be dissolved in the ethanol for polyacrylic resin II number with recipe quantity, add diethyl phthalate, tween 80 and the Oleum Ricini of recipe quantity again, stirring obtains enteric coating liquid;
3) preparation of enteric coatel tablets
Get the lansoprazole label, the bag enteric layers promptly gets Lansoprazole enteric-coated tablet.
Above-mentioned steps 1) pharmaceutically acceptable auxiliaries in is starch and microcrystalline Cellulose.Wherein starch is done diluent, and microcrystalline Cellulose is done binding agent and disintegrating agent.
Pharmaceutically acceptable auxiliaries in the step 1) also comprises hyprolose and carboxymethylstach sodium.
Wherein carboxymethylstach sodium adopts outer addition to add.Adopt starch to do diluent, microcrystalline Cellulose is done binding agent and disintegrating agent, ethanol is made wetting agent, the lubricant magnesium stearate, the slice, thin piece outward appearance of making is passable, but stripping is undesirable, and medicinal adjuvant increases hyprolose and promotes stripping among the present invention, and adopts outer addition to add carboxymethylstach sodium promotion disintegrate and stripping.
Step 2) pharmaceutically acceptable auxiliaries in is diethyl phthalate and tween 80.
Lansoprazole is a benzimidazole compounds, it is unstable to acid, for preventing lost efficacy by stomach acids destroy behind the drug oral, so often be prepared as enteric coated tablet in the prior art, because enteric coatings material II resin commonly used is acidic materials, usually adopt bag one deck sealing coat in label and enteric coating layer in the prior art, label and enteric coating layer are kept apart.And after among the present invention polyacrylic resin II number, diethyl phthalate, Oleum Ricini, tween 80 and ethanol being prepared by a certain percentage, make enteric coating solution, not only solve the unsettled quality problems of the easy variable color of lansoprazole, but also overcome the technology prejudice that between label and enteric layer, to wrap one deck sealing coat when preparing Lansoprazole enteric-coated tablet or enteric coated capsule in the prior art.
Lansoprazole enteric-coated tablet provided by the present invention and preparation method thereof has following advantage:
(1) Lansoprazole enteric-coated tablet dissolution rate provided by the present invention and bioavailability are better;
(2) Lansoprazole enteric-coated tablet dosage provided by the present invention is accurate, and the medicine content difference is less in the tablet;
(3) Lansoprazole enteric-coated tablet steady quality provided by the present invention, tablet is a drying solid, so light, air, moisture etc. are less to its influence;
(4) Lansoprazole enteric-coated tablet provided by the present invention carries, transports, takes more convenient;
(5) preparation method of Lansoprazole enteric-coated tablet provided by the present invention is simple, need not wrap sealing coat between label and enteric layer, is suitable for mechanization production, and output is big, and cost is low, and " sanitary standard " also reaches easily.
(6) medicine of the present invention has made things convenient for clinical medical and nursing personnel, patient's medication, and stronger clinical practice arranged.
Description of drawings
Fig. 1 is the Lansoprazole enteric-coated tablet of method that documents the provided preparation stripping situation at phosphate buffer (pH6.8).
The specific embodiment
Below be the specific embodiment of the present invention, described embodiment is in order to further describe the present invention rather than restriction the present invention.
Embodiment 1
Prescription (making 1000):
(1) label of forming by lansoprazole and pharmaceutically acceptable auxiliaries
Lansoprazole 15g
Starch 90g
Microcrystalline Cellulose 20g
Hyprolose 10g
Ethanol is an amount of
Carboxymethylstach sodium 8g
Magnesium stearate is an amount of
(2) enteric layer
Polyacrylic resin II 5g
Diethyl phthalate 2ml
Oleum Ricini 1ml
Tween-80 2ml
Ethanol 90ml
Preparation method:
1) preparation of label
Get lansoprazole, microcrystalline Cellulose, the hyprolose crushing screening of recipe quantity, mix, add binding agent ethanol, mixing granulation, drying, 16 mesh sieve granulate add an amount of, carboxymethylstach sodium, magnesium stearate, and tabletting promptly gets the lansoprazole label;
2) preparation of enteric layers coating
Polyacrylic resin II number is dissolved in the ethanol, diethyl phthalate, tween 80 and the Oleum Ricini that adds recipe quantity mix enteric coating liquid;
3) preparation of enteric coatel tablets
Get the lansoprazole label, the bag enteric layers promptly gets Lansoprazole enteric-coated tablet.
Prescription (making 1000):
(1) label of forming by lansoprazole and pharmaceutically acceptable auxiliaries
Lansoprazole 15g
Starch 110g
Microcrystalline Cellulose 10g
Ethanol is an amount of
Magnesium stearate is an amount of
(2) enteric layer
Polyacrylic resin III 5g
Diethyl phthalate 2ml
Oleum Ricini 1ml
Tween-80 2ml
Ethanol 90ml
Preparation method:
1) preparation of label
Get lansoprazole, starch, the microcrystalline Cellulose of recipe quantity and pulverize and sieve, mix, add binding agent ethanol, mixing granulation, drying, 16 mesh sieve granulate add an amount of magnesium stearate, and tabletting promptly gets the lansoprazole label;
2) preparation of enteric layers coating
Polyacrylic resin II number is dissolved in the ethanol, diethyl phthalate, tween 80 and the Oleum Ricini that adds recipe quantity mix enteric coating liquid;
3) preparation of enteric coatel tablets
Get the lansoprazole label, the bag enteric layers promptly gets Lansoprazole enteric-coated tablet.
Embodiment 3
Prescription (making 1000):
(1) label of forming by lansoprazole and pharmaceutically acceptable auxiliaries
Lansoprazole 15g
Starch 90g
Microcrystalline Cellulose 20g
Hyprolose 10g
Ethanol is an amount of
Carboxymethylstach sodium 3g
Magnesium stearate is an amount of
(2) enteric layer
Polyacrylic resin II 5g
Diethyl phthalate 2ml
Oleum Ricini 1ml
Tween-80 2ml
Ethanol 90ml
Preparation method:
1) preparation of label
Get lansoprazole, starch, microcrystalline Cellulose, the hyprolose crushing screening of recipe quantity, mix, add binding agent ethanol, mixing granulation, drying, 16 mesh sieve granulate add an amount of carboxymethylstach sodium, magnesium stearate, and tabletting promptly gets the lansoprazole label;
2) preparation of enteric layers coating
Polyacrylic resin II number is dissolved in the ethanol, diethyl phthalate, tween 80 and the Oleum Ricini that adds recipe quantity mix enteric coating liquid;
3) preparation of enteric coatel tablets
Get the lansoprazole label, the bag enteric layers promptly gets Lansoprazole enteric-coated tablet.
Experimental example 1
This experimental example relates to the research of the prepared Lansoprazole enteric-coated tablet stability test of the embodiment of the invention 1.
The embodiment of the invention 1 prepared Lansoprazole enteric-coated tablet was placed 6 months through 40 ℃ of temperature, relative humidity 75%, and accelerated test shows that its appearance character, content and identification check and other inspection items all do not take place obviously to change; Lansoprazole enteric-coated tablet is placed test in 6 months through room temperature and is investigated, and the result shows that its appearance character, content and identification check and other inspection items all do not take place obviously to change, and illustrates that Lansoprazole enteric-coated tablet stability is fine.
The prepared Lansoprazole enteric-coated tablet of other embodiment of the present invention has similar substantially result.
Experimental example 2
This experimental example investigated the prepared Lansoprazole enteric-coated tablet of the embodiment of the invention 1, according to the dissolution of the Lansoprazole enteric-coated tablet (hereinafter to be referred as reference substance) of Chinese Pharmaceutical Journal the 34th the 3rd phase of volume the 169th page of method that is provided preparation March in 1999.
Method: the commentaries on classics basket method of pressing Chinese Pharmacopoeia version regulation in 2005 dissolution method is measured, and dissolution medium is 0.1molL
-1HCl 1000ml, rotating speed are 100rmin
-1, operate 2h in accordance with the law, will change basket emersion liquid level, for test piece crack or disintegration phenomenon must not be arranged; Being about to changes among the phosphate buffer 1 000ml of basket immersion pH6.8, and rotating speed is constant, when being operated to 45min in accordance with the law, getting liquid and filters, and according to the spectrophotography of stipulating in two appendix of Chinese Pharmacopoeia version in 2005, measures absorbance at the 284nm place.Other takes by weighing lansoprazole reference substance 15mg, places the 1000ml measuring bottle, adds methanol 2ml dissolving, and (pH6.8) is diluted to scale with phosphate buffer, shakes up, and the same method is surveyed absorbance, presses the stripping quantity of every of the ratio calculation of both absorbances.
The result: Lansoprazole enteric-coated tablet of the present invention is at 0.1molL
-12.3h is stable in the hydrochloric acid solution of HCl, and is all right in the stripping of phosphate buffer (pH6.8), and stripping result and reference substance are approximate during 45min, as shown in drawings.
The prepared Lansoprazole enteric-coated tablet of other embodiment of the present invention has similar substantially result.
Experimental example 3
This experimental example is that Lansoprazole enteric-coated tablet of the present invention and reference substance are carried out Study on relative bioavailability.
Enteric coatel tablets and reference substance through the inventive method preparation carry out Study on relative bioavailability, and the result is as follows: peak time t
MaxBe respectively (3.52 ± 1.13) and (3.60 ± 1.22) h, peak concentration c
MaxBe respectively (496 ± 271) and (467 ± 242) ngml
-1Absorb phase half-life t
1/2(Ka) be respectively (1.31 ± 0.42) and (1.08 ± 0.43) h; The average leg time is respectively (10.3 ± 0.39) and (12.5 ± 0.4) h; Area under curve AUC is respectively (3614 ± 2839) and (3554 ± 3039) nghml
-1, there was no significant difference (P＜0.05) shows two preparation degree of absorption basically identicals.Relative bioavailability F value average out to (94.9 ± 11.2) % of two preparations.
Above-mentioned experiment studies show that the Lansoprazole enteric-coated tablet that the embodiment of the invention 1 is prepared and the degree of absorption basically identical of reference substance.
The prepared Lansoprazole enteric-coated tablet of other embodiment of the present invention has similar substantially result.
Claims (8)
1, a kind of Lansoprazole enteric-coated tablet is characterized in that described enteric coatel tablets are made up of following ingredients: a) label of being made up of lansoprazole and pharmaceutically acceptable auxiliaries; B) enteric coating layer of forming by Oleum Ricini, polyacrylic resin II number and pharmaceutically acceptable auxiliaries; Pharmaceutically acceptable auxiliaries in the wherein said enteric coating layer is diethyl phthalate, tween 80 and ethanol.
2, Lansoprazole enteric-coated tablet according to claim 1 is characterized in that the pharmaceutically acceptable auxiliaries in the described label is starch, microcrystalline Cellulose, ethanol and magnesium stearate.
3, Lansoprazole enteric-coated tablet according to claim 2 is characterized in that the pharmaceutically acceptable auxiliaries in the described label also comprises hyprolose and carboxymethylstach sodium.
4, Lansoprazole enteric-coated tablet according to claim 3 is characterized in that described enteric coatel tablets are made up of following ingredients:
A) label of forming by lansoprazole and following pharmaceutically acceptable auxiliaries
Lansoprazole 15g
Starch 90g
Microcrystalline Cellulose 20g
Hyprolose 10g
Ethanol is an amount of
Carboxymethylstach sodium 8g
Magnesium stearate is an amount of
B) enteric coating layer of forming by Oleum Ricini, polyacrylic resin II number and pharmaceutically acceptable auxiliaries
Polyacrylic resin II 5g
Diethyl phthalate 2ml
Oleum Ricini 1ml
Tween-80 2ml
Ethanol 90ml.
5, the preparation method of the described Lansoprazole enteric-coated tablet of a kind of claim 1 is characterized in that this method comprises the steps:
1) preparation of label
With lansoprazole and pharmaceutically acceptable auxiliaries crushing screening, mix, add ethanol, mixing granulation, drying, the granulate that sieves adds an amount of magnesium stearate, and tabletting promptly gets the lansoprazole label;
2) preparation of enteric layer
Be dissolved in the ethanol for polyacrylic resin II number with recipe quantity, add diethyl phthalate, tween 80 and the Oleum Ricini of recipe quantity again, stirring obtains enteric coating liquid;
3) preparation of enteric coatel tablets
Get the lansoprazole label,, promptly get Lansoprazole enteric-coated tablet according to this area method enteric-coating layer commonly used.
6, the preparation method of Lansoprazole enteric-coated tablet according to claim 5 is characterized in that the pharmaceutically acceptable auxiliaries in the step 1) is starch and microcrystalline Cellulose.
7, the preparation method of Lansoprazole enteric-coated tablet according to claim 6 is characterized in that the pharmaceutically acceptable auxiliaries in the step 1) also comprises hyprolose and carboxymethylstach sodium.
8, the preparation method of blue rope enteric coatel tablets according to claim 7 is characterized in that described carboxymethylstach sodium adopts outer addition to add.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101716159B (en) * | 2009-11-20 | 2012-01-04 | 上海新亚药业闵行有限公司 | Stable lansoprazole tablet and preparation method thereof |
| CN102579389B (en) * | 2012-03-20 | 2014-05-07 | 北京易明康元医药科技有限公司 | Medicine composition |
| CN102973534B (en) * | 2012-12-14 | 2016-03-02 | 贵州信邦制药股份有限公司 | A kind of enteric coating liquid being suitable for tablet |
| CN104606168A (en) * | 2015-03-08 | 2015-05-13 | 崔银方 | Drug composition for treating digestive system diseases |
| CN104606169A (en) * | 2015-03-08 | 2015-05-13 | 崔银方 | Preparation method of drug composition for treating digestive system diseases |
| CN104739801A (en) * | 2015-03-08 | 2015-07-01 | 崔银方 | Pharmaceutical composition for treating digestive system disease |
| CN104739802A (en) * | 2015-03-08 | 2015-07-01 | 崔银方 | Preparation method of pharmaceutical composition for treating digestive system disease |
| CN106138000A (en) * | 2016-07-19 | 2016-11-23 | 南京正宽医药科技有限公司 | A kind of Omeprazole Enteric-coated Tablets and preparation method thereof |
| CN109692161A (en) * | 2017-10-24 | 2019-04-30 | 汉寿康运医药科技有限公司 | A kind of Lansoprazole sustained-release preparation |
| CN113768896B (en) * | 2021-10-28 | 2023-04-25 | 中国中医科学院中药研究所 | Gardenia duodenum positioning preparation for treating cholestatic liver diseases |
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