CN104490837A - Oral preparation of monosialotetrahexosyl ganglioside sodium - Google Patents
Oral preparation of monosialotetrahexosyl ganglioside sodium Download PDFInfo
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- CN104490837A CN104490837A CN201410849184.9A CN201410849184A CN104490837A CN 104490837 A CN104490837 A CN 104490837A CN 201410849184 A CN201410849184 A CN 201410849184A CN 104490837 A CN104490837 A CN 104490837A
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Abstract
The invention discloses an oral preparation of monosialotetrahexosyl ganglioside sodium, belongs to the field of medicines, and aims at solving the problems that a monosialotetrahexosyl ganglioside sodium injection hurts a human body and is high in cost. A monosialotetrahexosyl ganglioside sodium tablet is prepared from monosialotetrahexosyl ganglioside sodium, a filler, a drying adhesive, a disintegrating agent and a lubricant; and a hard capsule of monosialotetrahexosyl ganglioside sodium is prepared from monosialotetrahexosyl ganglioside sodium, a diluent, a lubricant, a glidant, a disintegrating agent and a wetting agent. The oral preparation has the advantages of relatively low cost, small medication pain and high medicine effect.
Description
Technical field
The invention belongs to medicine field; Being specifically related to a kind of take GM1 as the oral formulations of main component, comprises tablet and hard capsule.
Background technology
The structural formula of GM1:
The molecular formula of GM1 is C
73h
130n
3naO
31or C
75h
134n
3naO
31molecular weight is 1568.84 or 1597.18.
GM1; system extracts obtained to the effective material of neurocyte function damage tool in Medulla sus domestica, can promote the functional rehabilitation mechanism of action of the central nervous system injury caused due to a variety of causes be promote " neural remodeling neuroplasticity " (the existence axon growth and the synapse that comprise neurocyte generate) Monostalotetrahexosylgangliside to after after damage, secondary neurodegenerative has protective effect application Monostalotetrahexosylgangliside to the improvement of cerebral hemodynamic parameter with damage alleviating of associated with hydrocephalus and have desirable influence Monostalotetrahexosylgangliside to alleviate neurocyte edema animal by the activity improving cell membrane enzyme to test and show Monostalotetrahexosylgangliside and can improve behavior disorder caused by parkinson disease.LD
50be 872mg/kg (i.v.) to >8g/kg (s.c.), depend on that the subacute and chronic toxicity test tertogenicity test reproductive toxicity test perinatal toxicity test that animal species and the various animal of route of administration carry out and Study On Mutagenicity all do not show any toxic action of this product.
GM1 has multiple important biological function, and introducing domestic product is the earliest its sodium-salt parenteral solution produced by Argentinian TRB PHARMA, import is called "
" be used for the treatment of central nervous system pathological change and comprise brain trauma, spinal cord injuries receptor, cerebrovas-cularaccident (apoplexy), parkinson etc.1996 Nian Qi China start application
do clinical treatment, domestic market there is the injection GM1 kind of the injection of GM1 and freeze-dried powder form reach 18 kinds, be widely used in treatment vascular or traumatic central nervous system damage; Spinal cord injury; Brain atrophy cerebral infarction, cerebral hemorrhage, brain injury cerebral palsy of children, hypoxic ischemic encephalopathy of newborn, children's's peripheral neuritis parkinson diabetic cranial neuropathy; Diabetic peripheral neuropathy; Peripheral neuropathy, evident in efficacy, safety is high, has retrieved numerous patient from the edge of disease.Obtain the accreditation of numerous doctors and patient.
GM1 preparation commercially available is up to now injection, by subcutaneous, intramuscular injection or intravenous drip administration, can damage like this, bring the misery on health to patient to the skin of patient and blood vessel wall; Medicine directly enters blood, likely can introduce impurity, also can cause burden to liver, kidney, cause damage to the health of patient; injection is for production in addition, the environment of transport, conditional request is higher, in addition certain restriction is had to administration form, therefore drug cost is higher, certain financial burden GM1 can be caused to patient, system extracts obtained to the effective material of neurocyte function damage tool in Medulla sus domestica, can promote that the functional rehabilitation mechanism of action of the central nervous system injury caused due to a variety of causes promotes that " neural remodeling neuroplasticity " (the existence axon growth and the synapse that comprise neurocyte generate) Monostalotetrahexosylgangliside has desirable influence Monostalotetrahexosylgangliside to alleviate the experiment of neurocyte edema animal by the activity improving cell membrane enzyme to show Monostalotetrahexosylgangliside and can improve behavior disorder caused by parkinson disease to alleviating of the improvement of cerebral hemodynamic parameter and damage associated with hydrocephalus to after secondary neurodegenerative has protective effect application Monostalotetrahexosylgangliside after damage.LD
50be 872mg/kg (i.v.) to >8g/kg (s.c.), depend on that the subacute and chronic toxicity test tertogenicity test reproductive toxicity test perinatal toxicity test that animal species and the various animal of route of administration carry out and Study On Mutagenicity all do not show any toxic action of this product.
GM1 has multiple important biological function, and introducing domestic product is the earliest its sodium-salt parenteral solution produced by Argentinian TRB PHARMA, import is called "
" be used for the treatment of central nervous system pathological change and comprise brain trauma, spinal cord injuries receptor, cerebrovas-cularaccident (apoplexy), parkinson etc.1996 Nian Qi China start application
do clinical treatment, domestic market there is the injection GM1 kind of the injection of GM1 and freeze-dried powder form reach 18 kinds, be widely used in treatment vascular or traumatic central nervous system damage; Spinal cord injury; Brain atrophy cerebral infarction, cerebral hemorrhage, brain injury cerebral palsy of children, hypoxic ischemic encephalopathy of newborn, children's's peripheral neuritis parkinson diabetic cranial neuropathy; Diabetic peripheral neuropathy; Peripheral neuropathy, evident in efficacy, safety is high, has retrieved numerous patient from the edge of disease.Obtain the accreditation of numerous doctors and patient.
GM1 preparation commercially available is up to now injection, by subcutaneous, intramuscular injection or intravenous drip administration, can damage like this, bring the misery on health to patient to the skin of patient and blood vessel wall; Medicine directly enters blood, likely can introduce impurity, also can cause burden to liver, kidney, cause damage to the health of patient; Injection is higher for the environment produced, transport, conditional request in addition, and have certain restriction to administration form, therefore drug cost is higher in addition, can cause certain financial burden to patient.
Summary of the invention
The present invention will solve GM1 injection to human body, technical problem that cost is high; And provide the oral formulations of GM1.
The oral formulations of GM1, is characterized in that the oral formulations of GM1 is the tablet be made up of the raw material of following weight proportioning:
GM1 medicine advantage of lower cost, medication painful little by 20% ~ 30%, filler 10% ~ 80%, dry adhesive 10% ~ 80%, disintegrating agent 0.1% ~ 8% and lubricant 0.1% ~ 5%.
Described filler is pregelatinized Starch, microcrystalline Cellulose, spray-dried lactose, fructose, sucrose mannitol, calcium phosphate or calcium hydrogen phosphate.
Described dry adhesive is pregelatinized Starch, microcrystalline Cellulose, spray-dried lactose, hydroxypropyl cellulose, cellulose ether or pectin
Described disintegrating agent is dried starch, carboxymethyl starch sodium, calcium hydrogen phosphate, micropowder silica gel, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose or crospolyvinylpyrrolidone.
Described lubricant is micropowder silica gel, stearic acid, stearate or Pulvis Talci.
The manufacture method of the oral formulations of GM1, it is characterized in that the preparation method of the oral formulations of GM1 is carried out in the steps below: GM1, filler, dry adhesive and disintegrating agent fully mix, after evenly, adding after lubricant continues mix homogeneously adopts direct powder compression to be pressed into label, peplos; Obtain the oral tablet of GM1.
The advantage of tablet: advantage of lower cost, medication misery are little, the effective ingredient that impurity is hydrolyzed by liver enzyme.Add the utilizability of medicine, reduce the requirement to material content.Objectionable impurities is become effective ingredient, improves bioavailability.
The oral formulations of GM1 is the hard capsule be made up of the raw material of following weight proportioning:
GM1 10% ~ 20%, diluent 50% ~ 80%, lubricant 0.1% ~ 5%, fluidizer 1% ~ 10%, disintegrating agent 0.5% ~ 10% and wetting agent 0.1% ~ 5%.
Described diluent is mannitol, microcrystalline Cellulose, magnesium oxide, magnesium carbonate, calcium hydrogen phosphate, lactose, pregelatinized Starch or corn starch.
Described lubricant is magnesium stearate, glyceryl monostearate, stearic acid or Pulvis Talci.
Described fluidizer is micropowder silica gel or Pulvis Talci,
Described disintegrating agent is corn starch, polyvinylpolypyrrolidone, cross-linked cellulose, pregelatinized Starch, carboxymethyl starch sodium, glycyl Starch Sodium or alginic acid; Described wetting agent is polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, water, ethanol, starch slurry, syrup, liquid paraffin, PVP or PEG4000.
The manufacture method of GM1 hard capsule is: GM1, diluent, mix homogeneously are added wetting agent in proportion, drops in suitable wet mixing pelletizer, mixing, granulation; The suitable condition of gained material carries out drying, granulate; Add lubricant, fluidizer, disintegrating agent carry out capsule fill, polishing after always mixing.
The advantage of hard capsule: advantage of lower cost, medication misery are little.The effective ingredient that impurity is hydrolyzed by liver enzyme.Add the utilizability of medicine, reduce the requirement to material content.Objectionable impurities is become effective ingredient, improves bioavailability.
Ganglioside is a kind of compound glycosyl sphingolipid, is a series of general names containing sialic glycosyl sphingolipid.The name of ganglioside adopts Svennerholm method usually: represent ganglioside with capitalization " G "; With A, M, D, T, Q, P, H, S, represent containing 0-7 sialic acid respectively; Represent containing identical sialic acid but the ganglioside of different glycosyl by the difference of 5-glycosyl number; The position that sialic acid connects is represented with a, b or c.The composition of ganglioside mainly contains GM1, GD3, GD1a, GD1b, GT1b etc., GM1 raw material in the process extracted from the cerebral tissue of animal because the composition of similar is many and complicated difficult produces some impurity components, as GD3, GD1a etc. with the meeting avoided.Because GM1 has fat-soluble feature, blood brain barrier can be passed through, embed neuron membrane and effectively play its biologic activity, and GM1 is uniquely can through a kind of ganglioside of blood brain barrier, therefore GM1 as the impurity components such as GD3, GD1a during injection can not absorb by human body, and be likely free in blood vessel risk is produced to medication patient, as the impurity restriction index of injection.When making oral solid formulation, due to medicine digesting and assimilating through gastrointestinal and liver, under the effect of enzyme, bifunctional sialyltransferase, three sialic acides are taken off sialic acid and are resolved into single sialic acid, become GM1 can absorb by human body, improve drug effect, reduce drug risk.The present invention is by adopting Tablet and Capsula, the effective ingredient that impurity is hydrolyzed by liver enzyme.Add the utilizability of medicine, objectionable impurities is become effective ingredient, reduce the requirement to material content.In addition, GM1 injection to thermally labile, in slant acidity solution, easily there is hydrolysis, therefore as injection, it also has inconvenience in transport, storage, use procedure, the present invention develops its solid orally ingestible, overcomes these unfavorable factors, has the value of producing and using.
Accompanying drawing explanation
Fig. 1 is animal behavioral study appraisal result figure.
Detailed description of the invention
Detailed description of the invention one: in present embodiment, the manufacture method of GM1 tablet is as follows: by 500g GM1 and 1000g pregelatinized Starch, spraying dry mannitol 350g, 100g microcrystalline Cellulose, 40g carboxymethyl starch sodium, drop into after mixing 10-30 minute in three-dimensional motion mixer and add 10g magnesium stearate continuation mixing 5-20 minute, gained material tablet machine is pressed into the tablet of such as following technical specification:
Nominal-mass 200mg
Diameter 5mm
Thickness 3mm
Then can in a suitable seed-coating machine with conventional containing the coating substance of polymer or the dragee coatings material of routine, spray tablet continuously, make it to superscribe homogeneous coating.
Detailed description of the invention two: in present embodiment, 250g GM1 is dropped in three-dimensional motion mixer with 2000g mannitol, 1000g pregelatinized Starch, 450g microcrystalline Cellulose and mix 5-10 minute, add 10%PVP aqueous solution appropriate, continue mixing to granulate for 5-10 minute, gained material under 70 DEG C of conditions dry 3 hours, granulate, add 50g micropowder silica gel, 100g carboxymethylstach sodium always mixes, to be mixed evenly after select 2# Capsules to carry out capsule fill, every loading amount is made to be 0.4g, polishing.
Adopt following experimental verification invention effect
1, laboratory animal and preparation
Get SD female (Sprague-Dawley) rat 50, require: be healthy without pregnant, body weight 210-250g.Receptacle keeps temperature 18-26 DEG C, relative humidity 40-70%, avoids high light direct projection, noise excessive, timing ventilation ventilation every day.
2, divide into groups
Be divided into 5 groups at random: blank group, sham operated rats, spinal cord injury group (GM1 tablet), spinal cord injury group (GM1 capsule), spinal cord injury group (placebo), often organize 10.Specific experiment distribution refers to following table:
Table 1
3, model preparation
Treating excess syndrome is tested and is used SD rat, intraperitoneal anesthesia (30mg/kg) is done with 2% pentobarbital sodium, after anesthesia, ventricumbent position is fixed on fixing head, carry out preserved skin in a usual manner, disinfect in alcohol, successively skin is cut centered by T9, be separated paraspinal muscle meat, expose T8-T10 spinous process, vertebral plate, transverse process.Careful separation surrounding soft tissue, remove T9 vertebral plate, finishing bone window edge, makes bone window ara be large enough to hold beating device striker, prepares animal model with spinal cord damnification with Allen ' s ram, hitting dynamics is 10g ╳ 2.5cm, clash into the spinal cord that T9 bone window is corresponding, cause acute spinal cord injury, hit rat successfully and occur spastic reflection of wagging the tail, two hind leg bounces back and is flaccid paralysis, and hematoma appears in myeloid tissue.Muscle, fascia, skin is successively closed after modeling success.
Rats in sham-operated group only cuts vertebral plate, does not hit, and postoperative beginning SD every day every rats by intraperitoneal injection penicillin 50,000 U, with prevention of postoperative infection, continues 1 week altogether.Massage bladder every day 2 times, manually urinate, until animal self micturition reflex functional rehabilitation.
4, dosage and administering mode
Calculate according to dosage conversion table human-animal:
Table 2: the per kilogram of body weight dosage conversions coefficient table of animals and human beings body
The dosage of this oral formulations people is: 50mg/ people/day.Then the consumption of rat is 6.25 ╳ 50mg/60kg=5.2mg/kg.
By purified water, GM1 tablet, capsule are diluted to the suspension of 1mg/ml, calculate dosage by rat body weight, take ball-type syringe needle stomach tube drug administration by injection, once-a-day.Food starch is then diluted to the suspension of 2mg/ml as placebo by purified water by placebo group, is equivalent to the placebo of medicinal liquid same volume by rat body weight.
5, animal behavioral study
Double-blind method carries out scoring to each treated animal to be observed, within postoperative 3 days, start to observe, propose and the BBB improved (basso beattie bresnahan locomotor rating scale with reference to Basso etc., BBB) rats with spinal cord injury functional rehabilitation judgment criteria is marked, this law totally 21 grades, 0 is divided into function of nervous system completely without visible hind limb motor, and 21 are divided into completely normally.
6, result and data analysis
Continuous data is with mean ± standard deviation
represent, every observing time is 3min.(Sham: sham operated rats, n=10, SCI: spinal cord injury group n=10)
Table 3: clinical follow BBB marks summary sheet
| 3d | 6d | 9d | 12d | 15d | 18d | |
| Blank group | 21 | 21 | 21 | 21 | 21 | 21 |
| Sham | 12.2±2.15 | 17.9±0.88 | 18.9±0.99 | 19.4±0.84 | 20.2±0.79 | 20.8±0.42 |
| SCI (GM1 tablet) | 0.2±0.42 | 3.7±1.70 | 9.3±2.11 | 12±1.94 | 13.2±1.87 | 14.3±1.89 |
| SCI (GM1 capsule) | 0.3±0.67 | 4.1±2.64 | 8.9±1.91 | 11.8±1.81 | 13.9±1.73 | 14.8±1.87 |
| SCI (placebo) | 0.1±0.32 | 1.1±0.99 | 5.9±1.85 | 6.7±1.34 | 7.5±1.65 | 7.8±1.48 |
| 21d | 4w | 5w | 6w | 7w | 8w | |
| Blank group | 21 | 21 | 21 | 21 | 21 | 21 |
| Sham | 20.8±0.42 | 20.9±0.32 | 21±0 | 21±0 | 21±0 | 21±0 |
| SCI (GM1 tablet) | 15±1.89 | 15.6±1.96 | 16±1.94 | 16±1.94 | 16.4±1.90 | 16.7±1.95 |
| SCI (GM1 capsule) | 15.4±2.01 | 15.9±1.97 | 16.1±1.79 | 16.2±1.81 | 16.8±1.69 | 17.1±1.37 |
| SCI (placebo) | 8±1.25 | 8.4±1.17 | 8.5±1.35 | 9±1.25 | 9.4±1.43 |
The result of composition graphs 1 and table 3 is visible, there were significant differences that its difference has statistical significance (P < 0.05) for blank group and SCI group, Post operation SCI placebo group and SCI tablet, SCI capsule group all produce serious hind limb motor dysfunction, compare that there were significant differences (P < 0.05) with sham operated rats.1-2 week after spinal cord injury, medication group compares BBB and marks and significantly improve (P < 0.05) with placebo group, after medication is described, the spinal function resume speed of rat obviously increases, and oral GM1 preparation can promote the recovery of rats with spinal cord injury function of nervous system.
Claims (10)
1. the oral formulations of GM1, is characterized in that the oral formulations of GM1 is the tablet be made up of the raw material of following weight proportioning:
GM1 20% ~ 30%, filler 10% ~ 80%, dry adhesive 10% ~ 80%, disintegrating agent 0.1% ~ 8% and lubricant 0.1% ~ 5%.
2. the oral formulations of GM1 according to claim 1, is characterized in that described filler is pregelatinized Starch, microcrystalline Cellulose, spray-dried lactose, fructose, sucrose mannitol, calcium phosphate or calcium hydrogen phosphate.
3. the oral formulations of GM1 according to claim 1, is characterized in that described dry adhesive is pregelatinized Starch, microcrystalline Cellulose, spray-dried lactose, hydroxypropyl cellulose, cellulose ether or pectin.
4. the oral formulations of GM1 according to claim 1, is characterized in that described disintegrating agent is dried starch, carboxymethyl starch sodium, calcium hydrogen phosphate, micropowder silica gel, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose or crospolyvinylpyrrolidone.
5. the oral formulations of GM1 according to claim 1, is characterized in that described lubricant is micropowder silica gel, stearic acid, stearate or Pulvis Talci.
6. the oral formulations of GM1, is characterized in that the oral formulations of GM1 is the hard capsule be made up of the raw material of following weight proportioning:
GM1 10% ~ 20%, diluent 50% ~ 80%, lubricant 0.1% ~ 5%, fluidizer 1% ~ 10%, disintegrating agent 0.5% ~ 10% and wetting agent 0.1% ~ 5%.
7. the oral formulations of GM1 according to claim 6, is characterized in that described diluent is mannitol, microcrystalline Cellulose, magnesium oxide, magnesium carbonate, calcium hydrogen phosphate, lactose, pregelatinized Starch or corn starch.
8. the oral formulations of GM1 according to claim 6, is characterized in that described lubricant is magnesium stearate, glyceryl monostearate, stearic acid or Pulvis Talci.
9. the oral formulations of GM1 according to claim 6, is characterized in that described fluidizer is micropowder silica gel or Pulvis Talci.
10. the oral formulations of GM1 according to claim 6, is characterized in that described disintegrating agent is corn starch, polyvinylpolypyrrolidone, cross-linked cellulose, pregelatinized Starch, carboxymethyl starch sodium, glycyl Starch Sodium or alginic acid; Described wetting agent is polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, water, ethanol, starch slurry, syrup, liquid paraffin, PVP or PEG4000.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309410A (en) * | 2016-10-14 | 2017-01-11 | 珠海赛隆药业股份有限公司 | Monosialotetrahexosylganglioside sodium slow-release capsule and preparation method thereof |
| CN106361718A (en) * | 2016-10-14 | 2017-02-01 | 珠海赛隆药业股份有限公司 | Colon-specific bioadhesive tablet containing monosialotetrahexosyl ganglioside sodium |
| CN106619545A (en) * | 2016-10-14 | 2017-05-10 | 珠海赛隆药业股份有限公司 | Monosialotetrahexosyl ganglioside sodium oral preparation stabilized in gastrointestinal tract and preparation method |
| CN108815131A (en) * | 2018-09-11 | 2018-11-16 | 四川奇格曼药业有限公司 | A kind of gangliosides sustained release tablets and preparation method thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309410A (en) * | 2016-10-14 | 2017-01-11 | 珠海赛隆药业股份有限公司 | Monosialotetrahexosylganglioside sodium slow-release capsule and preparation method thereof |
| CN106361718A (en) * | 2016-10-14 | 2017-02-01 | 珠海赛隆药业股份有限公司 | Colon-specific bioadhesive tablet containing monosialotetrahexosyl ganglioside sodium |
| CN106619545A (en) * | 2016-10-14 | 2017-05-10 | 珠海赛隆药业股份有限公司 | Monosialotetrahexosyl ganglioside sodium oral preparation stabilized in gastrointestinal tract and preparation method |
| CN106309410B (en) * | 2016-10-14 | 2019-01-08 | 珠海赛隆药业股份有限公司 | A kind of monosialotetrahexose ganglioside sodium spansule and preparation method thereof |
| CN106361718B (en) * | 2016-10-14 | 2019-01-25 | 珠海赛隆药业股份有限公司 | The colon target biology adhesion tablet of monosialotetrahexose ganglioside sodium |
| CN108815131A (en) * | 2018-09-11 | 2018-11-16 | 四川奇格曼药业有限公司 | A kind of gangliosides sustained release tablets and preparation method thereof |
| CN108815131B (en) * | 2018-09-11 | 2021-01-01 | 四川奇格曼药业有限公司 | Ganglioside sustained release tablet and preparation method thereof |
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Application publication date: 20150408 |