CN1739501A - Coated thioctic acid tablet for treating and controlling diabetic neural lesion - Google Patents
Coated thioctic acid tablet for treating and controlling diabetic neural lesion Download PDFInfo
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- CN1739501A CN1739501A CN 200510029900 CN200510029900A CN1739501A CN 1739501 A CN1739501 A CN 1739501A CN 200510029900 CN200510029900 CN 200510029900 CN 200510029900 A CN200510029900 A CN 200510029900A CN 1739501 A CN1739501 A CN 1739501A
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- thioctic acid
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Abstract
The present invention is coated thioctic acid tablet for treating and controlling diabetic neural lesion and belongs to the field of medicine technology. The tablet core consists of thioctic acid 600 mg, stuffing/diluent 150-180 mg, adhesive 20-25 mg, disintegrant 20-25 mg and lubricant 80-90 mg, and has total weight of 889.6-938.2 mg. The coating consists of skeleton/filming agent 10-12 mg, opacifier 5-6 mg, coloring agent 0.1-0.2 mg, surfactant 0.5-1 mg and plasticizer 5-6 mg, and has total weight of 20.10-24.20 mg. The present invention has less excipient for easy orally taking, film to screen light for long preservation period and high medicine content.
Description
Technical field
What the present invention relates to is a kind of tablet of medical technical field, specifically, is a kind of coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy.
Background technology
Thioctic acid is water-fast white or light yellow crystal, is distributed widely in the biological tissues such as animals and plants, is separated obtaining first from Hepar Sus domestica by the people such as Reed of the U.S. in nineteen fifty.Be widely used in clinical medicine the America and Europe, as diseases such as hepatic insufficiency, subacute necrosis encephalopathy, nervous system disease, radioactivity injury diseases.Nineteen seventies, its medicine of Germany's approval for treatment hepatitis, the nineties is ratified its treatment that is used for type ii diabetes again.U.S. FDA goes on the market as health product in approval thioctic acid in 1997.The research of Germany scientist recently further confirms: thioctic acid class medicine and other medicines share for treatment degenerative brain disorder effect remarkable.The main dosage form of now external thioctic acid (comprising health product) has capsule, injection and tablet.From the convenient consideration of using, tablet and capsule obviously are better than injection, and now on the market particularly the thioctic acid on the health-product market mainly be capsule.
Find through literature search prior art, U.S. Patent Publication No. is US5334612, open day is 19940802, patent name is: PHARMACEUTICAL COMPOSITONS CONTAINING AS ACTIVESUBSTANCE SULPHUR-CONTAINING CARBOXYLIC ACID AND THEIR USE IN COMBATINGRETROVIRUSES (containing pharmaceutical composition and the application during reversing go into viral therapy of thionothiolic acid as active ingredient), this patent disclosure contain dimercapto carboxylic acid or dimercapto derivant and comprise that thioctic acid and the sad medicine as active component of sulfurous form, contain and described it and be used to prepare the medicament contg of various preparations, and mentioned in preparation and need add the adjuvant that can add on some preparations during various types of preparation, but do not relate to concrete composition prescription and prescription, more not mentioned concrete preparation method.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy is provided, it is taken than the injection thing that is easy to carry,, be more convenient for storage better than the capsule medicine stability, and this product is the tablet of big specification, more is applicable to disposable oral medication.
The present invention is achieved by the following technical solutions, label prescription of the present invention and proportioning following (each thousand): thioctic acid 600mg, filler/diluent 150mg～180mg, binding agent 20mg～25mg, disintegrating agent 20mg～25mg, lubricant 80mg～90mg, label total amount 889.6mg～938.2mg; Coating prescription and proportioning following (each thousand): skeleton agent/film former 10mg～12mg, opacifier 5mg～6mg, coloring agent 0.1mg～0.2mg, surfactant 0.5mg～1mg, plasticizer 5mg～6mg, coating total amount 20.10g～24.20g.
Described filler/diluent is a kind of or any multiple mixture in starch, lactose, pregelatinized Starch, the microcrystalline Cellulose.
Described binding agent is a kind of or any multiple mixture in hydroxypropyl cellulose, hypromellose, the polyvidone.
Described disintegrating agent is a kind of or any multiple mixture in carboxymethyl starch sodium, polyvinylpolypyrrolidone, the cross-linking sodium carboxymethyl cellulose.
Described lubricant is a kind of or any multiple mixture in magnesium stearate, micropowder silica gel, the Pulvis Talci.
Described skeleton agent/film former is selected hydroxypropyl emthylcellulose for use.
Described opacifier is selected titanium dioxide for use.
Described surfactant is selected anion surfactant for use.
Described coloring agent is selected lemon yellow, sunset yellow, indigo, carmine, the pigment of amaranth or a kind of or multiple combination arbitrarily in the color lake for use.
Described plasticizer is selected a kind of or multiple combination arbitrarily in liquid paraffin, Polyethylene Glycol-4000, the Polyethylene Glycol-6000 for use.
By wet granulation behind prescription weighing thioctic acid, filler, binding agent and the disintegrating agent mix homogeneously, sieve drying.By compressed cores behind prescription weighing residue label adjuvant and the dried granule mix homogeneously; add an amount of water by prescription weighing film former, opacifier, coloring agent, surfactant and plasticizer in addition and prepare coating solution; the label that presses with after screening out fine powder, is put into the coating pan coating.The coating after drying is more than 12 hours.
There was extraordinary therapeutic effect external a large amount of clinical showing to diabetic neuropathy in oral thioctic acid 200～800mg/ days, and clinical data shows simultaneously: become general therapeutic dose for the diabetes nerve sexually transmitted disease (STD) and be oral 600mg * 3/ day.The tablet characteristics of considering big specification are to add too much excipient, and tablet is taken easily; And thioctic acid is oxidation very easily, and heliosensitivity is strong.
Less being easy to of the tablet excipient that the present invention obtains taken; Adopt the film coating lucifuge.The big specification thioctic acid coated tablet that makes less uses excipient, adopts the film coating lucifuge, has prolonged the holding time of medicine, is convenient to storage.Because the drug content height, be suitable for disposable orally, can remove the inconvenience of medicine injection from.
The specific embodiment
Embodiment 1: the label prescription and the proportioning following (each thousand) of this example: thioctic acid 600g, lactose 78g, polyvidone 21g, microcrystalline Cellulose 96g, cross-linking sodium carboxymethyl cellulose 24g, colloidization silica gel 45g, magnesium stearate 36g, label total amount 900g; Coating prescription (each thousand): hydroxypropyl emthylcellulose 9.24g, sodium lauryl sulphate 1g, titanium dioxide 5.48g, lemon yellow 0.11g, sunset yellow 0.04g, liquid paraffin 5.15g, coating total amount 21.02g.
Less being easy to of excipient that this example uses taken; Adopt the film coating lucifuge.The big specification thioctic acid coated tablet that makes less uses excipient, adopts the film coating lucifuge, has prolonged the holding time of medicine, is convenient to storage.Because the drug content height, be suitable for disposable orally, can remove the inconvenience of medicine injection from.
Embodiment 2: the label prescription and the proportioning following (each thousand) of this example: thioctic acid 600g, lactose 60g, Carboxymethyl cellulose sodium 25g, microcrystalline Cellulose 90g, polyvinylpolypyrrolidone 25g, Pulvis Talci 50g, magnesium stearate 35g, label total amount 885g; Coating prescription (each thousand): hydroxypropyl emthylcellulose 9g, sodium lauryl sulphate 1g, titanium dioxide 5g, lemon yellow 0.08g, carmine 0.02g, liquid paraffin 5g, coating total amount 20.10g.
Less being easy to of excipient that this example uses taken; Adopt the film coating lucifuge.The big specification thioctic acid coated tablet that makes less uses excipient, adopts the film coating lucifuge, has prolonged the holding time of medicine, is convenient to storage.Because the drug content height, be suitable for disposable orally, can remove the inconvenience of medicine injection from.
Embodiment 3: the label prescription and the proportioning following (each thousand) of this example: thioctic acid 600g, lactose 70g, hypromellose 20g, microcrystalline Cellulose 100g, cross-linking sodium carboxymethyl cellulose 20g, colloidization silica gel 45g, magnesium stearate 40g, label total amount 895g; Coating prescription (each thousand): hydroxypropyl emthylcellulose 10g, sodium lauryl sulphate 2g, titanium dioxide 6g, sunset yellow 0.05g, carmine 0.15g, liquid paraffin 6g, coating total amount 24.20g.
Less being easy to of excipient that this example uses taken; Adopt the film coating lucifuge.The big specification thioctic acid coated tablet that makes less uses excipient, adopts the film coating lucifuge, has prolonged the holding time of medicine, is convenient to storage.Because the drug content height, be suitable for disposable orally, can remove the inconvenience of medicine injection from.
Embodiment 4: the label prescription and the proportioning following (each thousand) of this example: thioctic acid 600g, lactose 70g, hypromellose 22g, microcrystalline Cellulose 105g, cross-linking sodium carboxymethyl cellulose 19g, colloidization silica gel 43g, magnesium stearate 40g, label total amount 899g; Coating prescription (each thousand): hydroxypropyl emthylcellulose 9g, sodium lauryl sulphate 2g, titanium dioxide 5g, sunset yellow 0.05g, carmine 0.15g, liquid paraffin 6g, coating total amount 22.20g.
Less being easy to of excipient that this example uses taken; Adopt the film coating lucifuge.The big specification thioctic acid coated tablet that makes less uses excipient, adopts the film coating lucifuge, has prolonged the holding time of medicine, is convenient to storage.Because the drug content height, be suitable for disposable orally, can remove the inconvenience of medicine injection from.
Embodiment 5: the label prescription and the proportioning following (each thousand) of this example: thioctic acid 600g, lactose 70g, hypromellose 23g, microcrystalline Cellulose 102g, cross-linking sodium carboxymethyl cellulose 19g, colloidization silica gel 44g, magnesium stearate 40g, label total amount 898g; Coating prescription (each thousand): hydroxypropyl emthylcellulose 9g, sodium lauryl sulphate 2g, titanium dioxide 5g, sunset yellow 0.05g, carmine 0.15g, liquid paraffin 5g, coating total amount 21.20g.
Less being easy to of excipient that this example uses taken; Adopt the film coating lucifuge.The big specification thioctic acid coated tablet that makes less uses excipient, adopts the film coating lucifuge, has prolonged the holding time of medicine, is convenient to storage.Because the drug content height, be suitable for disposable orally, can remove the inconvenience of medicine injection from.
Embodiment 6: the label prescription and the proportioning following (each thousand) of this example: thioctic acid 600g, lactose 70g, hypromellose 22g, microcrystalline Cellulose 100g, cross-linking sodium carboxymethyl cellulose 20g, colloidization silica gel 43g, magnesium stearate 40g, label total amount 895g; Coating prescription (each thousand): hydroxypropyl emthylcellulose 9g, sodium lauryl sulphate 2g, titanium dioxide 5.5g, sunset yellow 0.05g, carmine 0.15g, liquid paraffin 5g, coating total amount 21.70g.
Less being easy to of excipient that this example uses taken; Adopt the film coating lucifuge.The big specification thioctic acid coated tablet that makes less uses excipient, adopts the film coating lucifuge, has prolonged the holding time of medicine, is convenient to storage.Because the drug content height, be suitable for disposable orally, can remove the inconvenience of medicine injection from.
Claims (10)
1. coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy, it is characterized in that, label prescription and proportioning are as follows: thioctic acid 600mg, filler/diluent 150mg～180mg, binding agent 20mg～25mg, disintegrating agent 20mg～25mg, lubricant 80mg～90mg, label total amount 889.6mg～938.2mg; Coating prescription and proportioning are as follows: skeleton agent/film former 10mg～12mg, opacifier 5mg～6mg, coloring agent 0.1mg～0.2mg, surfactant 0.5mg～1mg, plasticizer 5mg～6mg, coating total amount 20.10g～24.20g.
2. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1 is characterized in that, described filler/diluent is a kind of or any multiple mixture in starch, lactose, pregelatinized Starch, the microcrystalline Cellulose.
3. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1 is characterized in that, described binding agent is a kind of or any multiple mixture in hydroxypropyl cellulose, hypromellose, the polyvidone.
4. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1, it is characterized in that described disintegrating agent is a kind of or any multiple mixture in carboxymethyl starch sodium, polyvinylpolypyrrolidone, the cross-linking sodium carboxymethyl cellulose.
5. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1 is characterized in that, described lubricant is a kind of or any multiple mixture in magnesium stearate, micropowder silica gel, the Pulvis Talci.
6. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1 is characterized in that, described skeleton agent/film former is selected hydroxypropyl emthylcellulose for use.
7. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1 is characterized in that described opacifier is selected titanium dioxide for use.
8. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1 is characterized in that described surfactant is selected anion surfactant for use.
9. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1, it is characterized in that described coloring agent is selected lemon yellow, sunset yellow, indigo, carmine, the pigment of amaranth or a kind of or multiple combination arbitrarily in the color lake for use.
10. the coated thioctic acid tablet that is used for the treatment of the control of diabetes neuropathy according to claim 1 is characterized in that, described plasticizer is selected a kind of or multiple combination arbitrarily in liquid paraffin, Polyethylene Glycol-4000, the Polyethylene Glycol-6000 for use.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510029900 CN1739501A (en) | 2005-09-22 | 2005-09-22 | Coated thioctic acid tablet for treating and controlling diabetic neural lesion |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510029900 CN1739501A (en) | 2005-09-22 | 2005-09-22 | Coated thioctic acid tablet for treating and controlling diabetic neural lesion |
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| Publication Number | Publication Date |
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| CN1739501A true CN1739501A (en) | 2006-03-01 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200510029900 Pending CN1739501A (en) | 2005-09-22 | 2005-09-22 | Coated thioctic acid tablet for treating and controlling diabetic neural lesion |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103099793A (en) * | 2013-02-06 | 2013-05-15 | 中国人民解放军第二军医大学 | Tablet and preparation method |
| CN103251566A (en) * | 2013-05-22 | 2013-08-21 | 中国人民解放军第二军医大学 | Tablet and preparation method thereof |
| CN103622927A (en) * | 2013-12-09 | 2014-03-12 | 山东齐都药业有限公司 | Thioctic acid tablets and preparation method thereof |
| CN103655495A (en) * | 2013-11-08 | 2014-03-26 | 南京海融医药科技有限公司 | Lipoic acid tablets with few types and small dose of accessories and preparation method thereof |
| CN109401336A (en) * | 2018-10-25 | 2019-03-01 | 华东理工大学 | The preparation method of supermolecule polymer film with humidity response and recoverable |
| WO2021145625A1 (en) * | 2020-01-13 | 2021-07-22 | 한국유나이티드제약 주식회사 | Pharmaceutical composition comprising r-thioctic acid or pharmaceutically acceptable salt thereof and enteric coating base material |
-
2005
- 2005-09-22 CN CN 200510029900 patent/CN1739501A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103099793A (en) * | 2013-02-06 | 2013-05-15 | 中国人民解放军第二军医大学 | Tablet and preparation method |
| CN103251566A (en) * | 2013-05-22 | 2013-08-21 | 中国人民解放军第二军医大学 | Tablet and preparation method thereof |
| CN103655495A (en) * | 2013-11-08 | 2014-03-26 | 南京海融医药科技有限公司 | Lipoic acid tablets with few types and small dose of accessories and preparation method thereof |
| CN103655495B (en) * | 2013-11-08 | 2015-06-10 | 南京瑞尔医药有限公司 | Lipoic acid tablets with few types and small dose of accessories and preparation method thereof |
| CN103622927A (en) * | 2013-12-09 | 2014-03-12 | 山东齐都药业有限公司 | Thioctic acid tablets and preparation method thereof |
| CN109401336A (en) * | 2018-10-25 | 2019-03-01 | 华东理工大学 | The preparation method of supermolecule polymer film with humidity response and recoverable |
| CN109401336B (en) * | 2018-10-25 | 2021-02-12 | 华东理工大学 | Preparation method of recyclable supramolecular polymer film with humidity response |
| WO2021145625A1 (en) * | 2020-01-13 | 2021-07-22 | 한국유나이티드제약 주식회사 | Pharmaceutical composition comprising r-thioctic acid or pharmaceutically acceptable salt thereof and enteric coating base material |
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