CN106176673A - A kind of Aiweimopan stomach dissolution type pellet tablet and preparation method thereof - Google Patents
A kind of Aiweimopan stomach dissolution type pellet tablet and preparation method thereof Download PDFInfo
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- CN106176673A CN106176673A CN201610827724.2A CN201610827724A CN106176673A CN 106176673 A CN106176673 A CN 106176673A CN 201610827724 A CN201610827724 A CN 201610827724A CN 106176673 A CN106176673 A CN 106176673A
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- aiweimopan
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- stomach dissolution
- micropill
- tablet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of Aiweimopan pellet tablet and preparation method thereof, this medicine is intestinal obstruction after iatrotechnics, first with fluidized bed coating technique, principal agent Aiweimopan is prepared as stomach dissolution type coated micropill, after then being mixed with filler, disintegrating agent, binding agent, plasticizer, lubricant etc. by coated micropill, prepares stomach dissolution type tablet with compressing dry granulation technology.This tablet can directly be swallowed, it is also possible in water, rapid disintegrate becomes micropill, conveniently swallows inconvenient patient particularly children taking.It is that one both can guarantee that dosage was accurate, the dosage form of safety, taking convenience again.
Description
Technical field
The invention belongs to pharmaceutical field, relate to a kind of pellet tablet, be specifically related to a kind of Aiweimopan stomach dissolution type pellet tablet and
Its preparation method.
Background technology
1, medicine overview
Ai Weiyingpan (Alvimopan) is to be combined with A Daoluo (Adolor) company by GlaxoSmithKline PLC company (GSK) by this medicine
Exploitation, Aiweimopan (alvimopan), was used by FDA (Food and Drug Adminstration) (FDA) approval listing on May 20th, 2008
In the gastrointestinal function early recovery of intestinal excision postoperative patient, trade name Entereg.Aiweimopan be a kind of novel outside
All μ type opiate receptor antagonists, clinically for the gastrointestinal dysfunction performed the operation and use opioid drug to cause, idiopathic
Constipation and irritable bowel syndrome etc..
2, market prospect
Postoperative intestinal obstruction (Post-operative ileus) is called for short POI.It is common among all abdominal operations, its genesis mechanism
Complex, the most not completely remove, mainly show themselves in that stomachache, Nausea and vomiting, can not take food, abdominal distension/flatulence, row
Just delay etc..Postoperative intestinal obstruction makes troubles to patient's post-operative recovery, and puts off long length of patient stay, causes the biggest economy
Burden, how to overcome POI and as early as possible recovery patient's gastrointestinal tract function be always a postoperative difficult problem.It is special to there is no clinically at present
Medicine treat, main method is some simple Supporting Therapys, and effect is the most undesirable.Therefore a kind of curative effect of exploitation is bright
Really, to the treatment of POI and to improve the prognosis of patients with abdominal surgery significant for the medicine that safety is good.Aiweimopan is
A unique medicine with good clinic, market prospect in this field at present, the peripheral action mechanism of its uniqueness makes it
There is the highest targeting feature.Aiweimopan enters gastrointestinal μ type opiate receptor to be played antagonism, owing to can not pass through blood
Brain barrier, does not therefore affect the opium effect mediated by nervus centralis, does not affect making of opioid analgesic medicine in operation
With.Aiweimopan has determined curative effect, and it has good prospect in the application of operation.
For the patient of dysphagia, particularly child and old man, exploitation one both safe and effective, taking conveniences, again can
Ensure that dosage product accurately is very important.
Summary of the invention
The invention provides a kind of steady quality, evident in efficacy, the Aiweimopan gastric solubleness used particular for child patient
Type pellet tablet.
The pellet tablet of the present invention can rapid disintegrate be micropill in water, facilitates the child patient of dysphagia to take, and improves
Safety, it is ensured that medication dose is accurate.
The pellet tablet of the present invention, is first prepared as stomach dissolution type coating with fluidized bed coating technique by principal agent Aiweimopan micro-
Ball, with compressing dry granulation technology system after then mixing coated micropill with filler, disintegrating agent, binding agent, plasticizer, lubricant etc.
Standby one-tenth stomach dissolution type pellet tablet.
Aiweimopan stomach dissolution type pellet tablet of the present invention, composed of the following components:
| Aiweimopan | 1-20 part |
| Filler | 100-500 part |
| Disintegrating agent | 15-50 part |
| Binding agent | 15-50 part |
| Lubricant | 1-10 part |
| Macromolecule coating material | 2-6 part |
| Plasticizer | 1-4 part |
| Antitackiness agent | 1-4 part |
| Pigment | 2-5 part |
Wherein, Aiweimopan micropill, composed of the following components:
| Aiweimopan | 1-20 part |
| Fine pellet core | 100-200 part |
| Binding agent | 15-30 part |
| Antitackiness agent | 1-3 part |
| Stomach dissolution type coating powder | 10-20 part |
Wherein, the one or several during described fine pellet core is starch ball, sugar pill, microcrystalline Cellulose ball, lactose, dicalcium phosphate
Kind；
Wherein, described filler is starch, sucrose, dextrin, lactose, pregelatinized Starch, microcrystalline Cellulose, mannitol, inorganic calcium
One or more in salt, xylitol, sorbitol, glucose, erithritol；
Wherein, described disintegrating agent is dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crosslinked polyethylene pyrrolidine
One or more in ketone, cross-linking sodium carboxymethyl cellulose；
Wherein, described binding agent be water, ethanol, starch slurry, sodium carboxymethyl cellulose, hypromellose, methylcellulose and
One or more in ethyl cellulose, cross-linking sodium carboxymethyl cellulose；
Wherein, one or more during described lubricant is magnesium stearate, Pulvis Talci, polyethylene glycols, differential silica gel；
Wherein, described plain edition macromolecule coating material is hypromellose, hydroxypropylcellulose, methylcellulose, ethoxy
One or more in cellulose；
Wherein, the one or several during described plasticizer is glycerol, Polyethylene Glycol, propylene glycol, Semen Maydis oil, Oleum Ricini, liquid Paraffin
Kind；
Wherein, one or more during described antitackiness agent is Pulvis Talci, magnesium stearate, differential silica gel；
Wherein, one or more during described pigment is yellow ferric oxide, red ferric oxide.
In composition described above, part is weight portion, if in grams, composition described above can be made into 1000 compositions lists of compositions
Position, described compositions unit refers to, the final product composition having made, and is 1000 as made tablet, is 1000 as made capsule,
Make granule 1000.
Preferably, Aiweimopan stomach dissolution type pellet tablet of the present invention, (percentage by weight) composed of the following components:
| Aiweimopan | 1-20 part |
| Microcrystalline Cellulose | 100-300 part |
| Low-substituted hydroxypropyl cellulose | 15-50 part |
| Magnesium stearate | 1-5 part |
| Hypromellose | 2-10 part |
| Ferrum oxide | 2-6 part |
| Pulvis Talci | 1-4 part |
| Polyethylene glycol 6000 | 1-4 part |
Wherein, Aiweimopan micropill, (percentage by weight) composed of the following components:
| Aiweimopan | 1-20 part |
| Fine pellet core | 100-200 part |
| Hypromellose | 6-20 part |
| Pulvis Talci | 1-3 part |
| Stomach dissolution type coating powder | 10-20 part |
Further object is that the preparation method that Aiweimopan stomach dissolution type pellet tablet is provided, comprise the following steps:
1) being added to the water by binding agent, heating makes it be completely dissolved, and cooling adds Aiweimopan, after it is completely dissolved, and will be anti-
Glutinous agent is dispersed in this solution；
2) fine pellet core is placed in fluid bed, then by step 1) in solution fluidized bed plant be uniformly sprayed at fine pellet core table
Face, makes Aiweimopan micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Aiweimopan micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is coated；
5) uniform to Aiweimopan coated micropill, filler, disintegrating agent, mix lubricant；
6) being pressed into the sheet of 0.1～0.5g weight, slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) plain edition macromolecule coating material, plasticizer, antitackiness agent, pigment are added in ethanol so that it is dispersed；
8) sheet weighed up is put in coating pan, by step 7) in solution be uniformly sprayed on Aiweimopan pellet tablet,.
The Aiweimopan relatively conventional tablet of stomach dissolution type pellet tablet of the present invention has the following characteristics that
This stomach dissolution type pellet tablet is possible not only to directly swallow, and for the patient of dysphagia, can be dissolved in water first
Row disintegrate is that micropill takes down again, is difficult to adhere on chamber wall, it is ensured that dosage is accurate, improves patient and takes medicine and comply with
Property.
Aiweimopan stomach dissolution type pellet tablet of the present invention, also has the advantages that
(1) dosage is mainly for children, taking convenience, it is simple to carry；
(2) Aiweimopan has bitterness, and coating can cover bitterness, and drug compliance is good；
(3) tablet disintegrate can become micropill, convenient for children to swallow rapidly in water, is discharged by principal agent rapidly in gastric juice, biological profit
Expenditure is high；
(4) principal agent micropill improves medicine stability after stomach dissolution type film coating liquid coating, it is simple to storage.
Detailed description of the invention
By specific examples below, the present invention is further illustrated, but not as the restriction of the present invention.
Prepared by embodiment 1 Aiweimopan stomach dissolution type pellet tablet
1.1 prescription
A, Aiweimopan stomach dissolution type micropill
| Aiweimopan | 12g |
| Starch capsule core | 150g |
| Hypromellose | 10g |
| Pulvis Talci | 3g |
| Stomach dissolution type coating powder | 10g |
| Purified water | 300g |
| Ethanol | 100g |
B, Aiweimopan stomach dissolution type pellet tablet
1.2 methods preparing above-mentioned prescription Aiweimopan stomach dissolution type pellet tablet, follow the steps below:
1) being added to the water by hypromellose, heating makes it be completely dissolved, and cooling adds Aiweimopan, treats that it is completely dissolved
After, Pulvis Talci is dispersed in this solution；
2) starch capsule core is placed in fluid bed, then " 1) " will uniformly be sprayed at starch capsule core table by solution fluidized bed plant
Face, makes Aiweimopan micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Aiweimopan micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is coated；
5) Aiweimopan coated micropill, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously；
6) sheet of 0.1～0.8g weight it is pressed into.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) hypromellose, polyethylene glycol 6000, Pulvis Talci, yellow ferric oxide are added in ethanol so that it is be uniformly dispersed；
8) sheet weighed up is put in coating pan, will " 7) " in solution be uniformly sprayed on Aiweimopan pellet tablet so that it is surface
Smooth, color even.
Prepared by embodiment 2 Aiweimopan stomach dissolution type pellet tablet
2.1 prescription
A, Aiweimopan stomach dissolution type micropill
| Aiweimopan | 24g |
| Starch capsule core | 100g |
| Hypromellose | 8g |
| Pulvis Talci | 3g |
| Stomach dissolution type coating powder | 10g |
| Purified water | 250g |
| Ethanol | 100g |
B, Aiweimopan stomach dissolution type pellet tablet
2.2 methods preparing above-mentioned prescription Aiweimopan stomach dissolution type pellet tablet, follow the steps below:
1) being added to the water by hypromellose, heating makes it be completely dissolved, and cooling adds Aiweimopan, treats that it is completely dissolved
After, Pulvis Talci is dispersed in this solution；
2) starch capsule core is placed in fluid bed, then " 1) " will uniformly be sprayed at starch capsule core table by solution fluidized bed plant
Face, makes Aiweimopan micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Aiweimopan micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is coated；
5) Aiweimopan coated micropill, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously；
6) sheet of 0.1～0.8g weight it is pressed into.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) hypromellose, polyethylene glycol 6000, Pulvis Talci, yellow ferric oxide are added in ethanol so that it is be uniformly dispersed；
8) sheet weighed up is put in coating pan, will " 7) " in solution be uniformly sprayed on Aiweimopan pellet tablet so that it is surface
Smooth, color even.
Prepared by embodiment 3 Aiweimopan stomach dissolution type pellet tablet
3.1 prescription
A, Aiweimopan stomach dissolution type micropill
| Aiweimopan | 6g |
| Starch capsule core | 80g |
| Hypromellose | 6g |
| Pulvis Talci | 3g |
| Stomach dissolution type coating powder | 10g |
| Purified water | 160g |
| Ethanol | 100g |
B, Aiweimopan stomach dissolution type pellet tablet
3.2 methods preparing above-mentioned prescription Aiweimopan stomach dissolution type pellet tablet, follow the steps below:
1) being added to the water by hypromellose, heating makes it be completely dissolved, and cooling adds Aiweimopan, treats that it is completely dissolved
After, Pulvis Talci is dispersed in this solution；
2) starch capsule core is placed in fluid bed, then " 1) " will uniformly be sprayed at starch capsule core table by solution fluidized bed plant
Face, makes Aiweimopan micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Aiweimopan micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is coated；
5) Aiweimopan coated micropill, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate mix homogeneously；
6) sheet of 0.1～0.8g weight it is pressed into.Slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) hypromellose, polyethylene glycol 6000, Pulvis Talci, yellow ferric oxide are added in ethanol so that it is be uniformly dispersed；
8) sheet weighed up is put in coating pan, will " 7) " in solution be uniformly sprayed on Aiweimopan pellet tablet so that it is surface
Smooth, color even.
Claims (3)
1. an Aiweimopan stomach dissolution type pellet tablet, composed of the following components:
Pellet tablet described in accordance with the above, it is characterised in that Aiweimopan micropill, composed of the following components:
Pellet tablet in accordance with the above, it is characterised in that
Wherein, the one or several during described fine pellet core is starch ball, sugar pill, microcrystalline Cellulose ball, lactose, dicalcium phosphate
Kind；
Wherein, described filler is starch, sucrose, dextrin, lactose, pregelatinized Starch, microcrystalline Cellulose, mannitol, inorganic calcium
One or more in salt, xylitol, sorbitol, glucose, erithritol；
Wherein, described disintegrating agent is dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crosslinked polyethylene pyrrolidine
One or more in ketone, cross-linking sodium carboxymethyl cellulose；
Wherein, described binding agent be water, ethanol, starch slurry, sodium carboxymethyl cellulose, hypromellose, methylcellulose and
One or more in ethyl cellulose, cross-linking sodium carboxymethyl cellulose；
Wherein, one or more during described lubricant is magnesium stearate, Pulvis Talci, polyethylene glycols, differential silica gel；
Wherein, described plain edition macromolecule coating material is hypromellose, hydroxypropylcellulose, methylcellulose, ethoxy
One or more in cellulose；
Wherein, the one or several during described plasticizer is glycerol, Polyethylene Glycol, propylene glycol, Semen Maydis oil, Oleum Ricini, liquid Paraffin
Kind；
Wherein, one or more during described antitackiness agent is Pulvis Talci, magnesium stearate, differential silica gel；
Wherein, one or more during described pigment is yellow ferric oxide, red ferric oxide.
Pellet tablet the most according to claim 1, it is characterised in that composed of the following components:
Pellet tablet according to claim 1, it is characterised in that Aiweimopan micropill, composed of the following components:
Pellet tablet according to claim 1, it is characterised in that every weight is 0.1～0.8g.
Pellet tablet the most according to claim 1, it is characterised in that composed of the following components:
Wherein, Aiweimopan micropill consists of the following composition:
The preparation method of the pellet tablet described in claim 1, it is characterised in that comprise the following steps:
1) being added to the water by binding agent, heating makes it be completely dissolved, and cooling adds Aiweimopan, after it is completely dissolved, and will be anti-
Glutinous agent is dispersed in this solution；
2) fine pellet core is placed in fluid bed, then by step 1) in solution fluidized bed plant be uniformly sprayed at fine pellet core table
Face, makes Aiweimopan micropill；
3) stomach dissolution type film coating powder is dissolved in ethanol so that it is dispersed；
4) Aiweimopan micropill is placed in fluid bed, then stomach dissolution type film coating solution fluidized bed plant is coated；
5) uniform to Aiweimopan coated micropill, filler, disintegrating agent, mix lubricant；
6) being pressed into the sheet of 0.1～0.8g weight, slice, thin piece shape can be polygon, capsule shape, circle, annular and all rational shapes
Shape；
7) plain edition macromolecule coating material, plasticizer, antitackiness agent, pigment are added in ethanol so that it is dispersed；
8) sheet weighed up is put in coating pan, by step 7) in solution be uniformly sprayed on Aiweimopan pellet tablet,.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610827724.2A CN106176673A (en) | 2016-09-18 | 2016-09-18 | A kind of Aiweimopan stomach dissolution type pellet tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610827724.2A CN106176673A (en) | 2016-09-18 | 2016-09-18 | A kind of Aiweimopan stomach dissolution type pellet tablet and preparation method thereof |
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| CN106176673A true CN106176673A (en) | 2016-12-07 |
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Citations (9)
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| CN101355942A (en) * | 2005-10-07 | 2009-01-28 | 阿得罗公司 | Solid dispersions of opioid antagonists |
| CN101429154A (en) * | 2008-11-14 | 2009-05-13 | 天津泰普药品科技发展有限公司 | Anhydrous alvimopan and medicament composition thereof |
| CN102499908A (en) * | 2011-12-22 | 2012-06-20 | 天津泰普药品科技发展有限公司 | Alvimopan solid preparation and preparation method thereof |
| CN103948593A (en) * | 2014-05-21 | 2014-07-30 | 福建省微生物研究所 | Alvimopan medicine composition and preparation method thereof |
| CN104546791A (en) * | 2013-10-16 | 2015-04-29 | 辽宁亿灵科创生物医药科技有限公司 | Solid preparation for opioid receptor antagonist and preparation method of solid preparation |
| CN105399659A (en) * | 2015-10-26 | 2016-03-16 | 扬子江药业集团北京海燕药业有限公司 | Amorphous alvimopan and preparation method thereof |
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| CN105820106A (en) * | 2015-01-07 | 2016-08-03 | 上海医药工业研究院 | Method for preparing Alvimopan intermediate |
-
2016
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| WO2007044713A1 (en) * | 2005-10-07 | 2007-04-19 | Adolor Corporation | Solid dispersions of opioid antagonists |
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| CN103948593A (en) * | 2014-05-21 | 2014-07-30 | 福建省微生物研究所 | Alvimopan medicine composition and preparation method thereof |
| CN105820106A (en) * | 2015-01-07 | 2016-08-03 | 上海医药工业研究院 | Method for preparing Alvimopan intermediate |
| CN105399659A (en) * | 2015-10-26 | 2016-03-16 | 扬子江药业集团北京海燕药业有限公司 | Amorphous alvimopan and preparation method thereof |
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Application publication date: 20161207 |