CN1323667C - Notoginseng dispersible tablet and its preparing process - Google Patents
Notoginseng dispersible tablet and its preparing process Download PDFInfo
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- CN1323667C CN1323667C CNB2004100551053A CN200410055105A CN1323667C CN 1323667 C CN1323667 C CN 1323667C CN B2004100551053 A CNB2004100551053 A CN B2004100551053A CN 200410055105 A CN200410055105 A CN 200410055105A CN 1323667 C CN1323667 C CN 1323667C
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- radix notoginseng
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- polyvinylpolypyrrolidone
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Abstract
The present invention relates to a dispersive tablet of notoginseng, which is prepared from 20 to 100 parts of notoginseng total saponin, 80 to 300 parts of lactose, 80 to 300 parts of cellulose microcrystalline, 20 to 100 parts of low-substituted hydroxypropyl cellulose, 20 to 100 parts of cross-linked polyvinylpolypyrrolidone, 20 to 20 parts of micro-powder of silica gel and 1 to 10 parts of magnesium stearate. The present invention also provides a preparation method of the dispersive tablet which uses a secondary granulation method. The obtained dispersive tablet of the present invention can achieve the effect that the dispersive tablet can be disintegrated in 3 minutes.
Description
Technical field
The invention belongs to a kind of preparation of field of medicaments, be specifically related to a kind of Radix Notoginseng dispersible tablet and preparation method thereof, this dispersible tablet selects for use a certain proportion of Radix Notoginseng total arasaponins and disintegrating agent and other to fill adjuvant mixing granulation tabletting, can so that to dispersible tablet reach the effect of disintegrate within three minutes.
Background technology
Radix Notoginseng is more a kind of Chinese crude drug of Recent study, and its biological activity and effective ingredient are mainly Radix Notoginseng total arasaponins, and modern pharmacological research shows, Radix Notoginseng total arasaponins can increase blood flow volume, anticoagulant, effects such as blood viscosity lowering, the clinical cardio-cerebrovascular disease that is mainly used in.
In the clinical use, notoginseng preparations has conventional tablet, capsule, drop pill, injection and freeze-dried powder etc., and injection and freeze-dried powder carry, administration is all inconvenient; Tablet and the stripping of capsule effective ingredient are slow, onset in time; Drop pill is to be a kind of solid dispersion system of carrier with the PEG material, and catabiosis such as drug crystallization, dissolution reduction appear in long time stored meeting, influence drug absorption; Want to overcome purity that above-mentioned many disadvantages can only be by improving effective ingredient and quality or realize by two kinds of approach of dosage form improvement.The technology of extracting total saponins from Radix Notoginseng has been routine techniques, studies confirm that in a large number, even Radix Notoginseng total arasaponins is implemented further refining and purification, its pharmacological effect also can not get obvious raising, therefore, attempt to reach and improve people the compliance of notoginseng preparations is difficult to realize for various clinical needs, to have only the different-effect of considering that different dosage form can bring by improving Radix Notoginseng total arasaponins purity and quality.
The special dosage form of one class---dispersible tablet is arranged in tablet, and its characteristics (being advantage) are to meet behind the water in the very short time (generally in 3 minutes) disintegrate to become very granule and form uniform suspension; Therefore, compare with general tablet, dispersible tablet has and is uniformly dispersed, and disintegration time is short, the medicine stripping is rapid, absorbs soon the bioavailability height, characteristics such as taking convenience can swallow, chew, contain and suck or be dissolved in drink-service in the water, especially are fit to the old children and the patient of difficulty that swallows.In addition, the dispersible tablet production technology is identical with common non-coated tablet, and production cost is low, and its advantage is conspicuous.
The insider also is the research of fast-release tablet in the dosage form improvement of actively being devoted to containing Radix Notoginseng total arasaponins, Chinese patent (application number: 02133464.1) disclose a kind of Radix Notoginseng dispersible tablet for example, it is by Radix Notoginseng total arasaponins and the required conventional adjuvant (as: lactose of preparation dispersible tablet, mannitol, crospolyvinylpyrrolidone and magnesium stearate) obtain with a certain proportion of simple combination, wherein lactose is a filler, mannitol is cosolvent, crospolyvinylpyrrolidone is a disintegrating agent, magnesium stearate is a lubricant, content according to the disclosure of the disclosure text, be to adopt the disintegrating agent of single variety to prepare dispersible tablet, though can reach the requirement of dispersible tablet in theory, but in actual applications, its disintegrate effect often is not so good as the effect that two or more disintegrating agent coupling can reach; In addition, the ethanol of employing 90% is as binding agent and wetting agent in this application, by a traditional granulation preparing product, experiment showed, because the character of Radix Notoginseng total arasaponins has determined its viscosity very big, do binding agent mixing spice and be difficult to make soft material and wet granular to be lower than 95% ethanol, even if made wet granular, though also may produce the qualified but unfavorable situation of medicine stripping of disintegrate character behind the tabletting, when the situation is critical, it is sorry that the delay of onset time might cause treating; In addition, granulation dispersible tablet of preparing viscous medicaments also may influence the disintegrate effect of this tablet.
So a kind of curative effect that had both kept former Radix Notoginseng oral formulations is badly in need of developing in this area, the new oral formulations that contains Radix Notoginseng total arasaponins of onset rapidly again.
Summary of the invention
The present invention gropes through a large amount of tests, is developed into a kind of Radix Notoginseng dispersible tablet, and it contains Radix Notoginseng total arasaponins and a certain proportion of suitable disintegrants, has solved the shortcoming that the conventional dosage forms onset is slow, bioavailability is low, has improved its using value clinically.
The object of the present invention is to provide a kind of Radix Notoginseng dispersible tablet, it contains Radix Notoginseng total arasaponins and suitable pharmaceutic adjuvant, utilizes standard compliant Radix Notoginseng total arasaponins to cooperate the good and adjuvant that possess short disintegrate effect of molten aqueous to prepare, and obtains onset Radix Notoginseng dispersible tablet rapidly.
The present invention also aims to provide a kind of method for preparing the Radix Notoginseng dispersible tablet, adopt secondary granulation (in add+outer addition) preparation, this dispersible tablet disintegrate and medicine stripping all meet the requirements.
Radix Notoginseng dispersible tablet provided by the invention contains: 20～100 parts of Radix Notoginseng total arasaponinss, 80～300 parts of lactose, 80～300 parts of microcrystalline Cellulose, 20～100 parts of low-substituted hydroxypropyl celluloses, 20～100 parts of polyvinylpolypyrrolidone, 2～20 parts of micropowder silica gels, 1～10 part of magnesium stearate.
Proportioning raw materials involved in the present invention is weight portion.
The present invention also provides a kind of method for preparing the Radix Notoginseng dispersible tablet, comprises adopting the secondary granulation, binding agent and Radix Notoginseng total arasaponins and adjuvant is mixed and made into the process of dispersible tablet.
As the improvement of dosage form, product of the present invention by selected adjuvant and proportioning thereof, adopts the secondary method of granulating when keeping former effective composition, and the dispersible tablet that makes has reached the effect of disintegrate within three minutes really.
Preferred following composition of Radix Notoginseng dispersible tablet of the present invention and proportioning: 50 parts of Radix Notoginseng total arasaponinss, 160～180 parts of lactose, 160～180 parts of microcrystalline Cellulose, 40～60 parts of low-substituted hydroxypropyl celluloses, 40～50 parts of polyvinylpolypyrrolidone, 2～10 parts of micropowder silica gels, 1～10 part of magnesium stearate; Wherein also can comprise sweeting agent such as steviosin.
In the above-mentioned selected adjuvant, micropowder silica gel and magnesium stearate are lubricants, and low-substituted hydroxypropyl cellulose and polyvinylpolypyrrolidone are disintegrating agents, and microcrystalline Cellulose and lactose are diluent.
The present invention finds through overtesting, selects suitable adjuvant, carries out appropriate combination then, can obtain the dispersible tablet that the disintegrate effect significantly changes.Because the Radix Notoginseng total arasaponins oneself viscosity is very big, it is especially obvious to meet water, after having added the adjuvant of conventional disintegrate, disintegration time is still more than 30 minutes, only in the dispersible tablet prescription design of this kind, grope comprehensively, look for out the dispersible tablet adjuvant and the usage ratio thereof that are fit to Radix Notoginseng total arasaponins, the disintegrative of this tablet could take place significantly to change, referring to embodiment 1.
The inventor also finds, select a kind of filler that relatively is fit to Radix Notoginseng total arasaponins can solve this this Radix Notoginseng total arasaponins and meet the big difficult problem of water viscosity, through a large amount of screenings, the present invention selects a certain amount of magnesium stearate and micropowder silica gel as lubricant, the experiment proved that, micropowder silica gel with the effect of short disintegrating agent, has therefore successfully solved the problems referred to above in dispersible tablet of the present invention.
Find that in development process because the Radix Notoginseng total arasaponins oneself viscosity is very big, general wetting agent (for example ethanol 95% below) is difficult to be made into suitable soft material, have only and select 95% or during above ethanol, the effect of making soft material is best.
On the other hand, the present invention also provides the preparation method of Radix Notoginseng dispersible tablet.The starting point of dispersible tablet prescription of the present invention design is to make the granule that disintegrate one-tenth is very little in the short as far as possible time (less than 3min) behind the tablet chance water and form uniform suspension.Advantageously, in conjunction with the characteristics of Radix Notoginseng total arasaponins, technology of the present invention is taked two step granulations (also claiming the secondary granulation), and promptly principal agent is granulated with the part disintegrating agent earlier, again with the disintegrating agent of surplus and the method for other adjuvant mixing film-makings.The advantage of this method is that the tablet disintegrate is rapider, and granule disperses more even in solution, and the rapid release effect is obvious.
The result of integrated survey shows, dispersible tablet adjuvant of the present invention, wherein the outer dosage of polyvinylpolypyrrolidone is 1/3 and 1/2 o'clock, the disintegrate effect is all very desirable, but when adding 1/2 amount, disintegration of this dispersible tablet and disperse the homogeneity time shorter, and the dissolution that adds 1/2 product that makes obviously is better than adding 1/3 o'clock product, referring to embodiment 2.
In sum, this method preferably includes: adjuvant was pulverized 100 mesh sieves, take by weighing the polyvinylpolypyrrolidone of Radix Notoginseng total arasaponins, lactose, microcrystalline Cellulose, hyprolose (the low replacement), 1/3～1/2 amount according to the composition proportioning of above-mentioned dispersible tablet, mixing, adding concentration is not less than 95% ethanol system soft material, crosses the wet grain of sieve series, dry, granulate, the polyvinylpolypyrrolidone, micropowder silica gel and the magnesium stearate that add surplus again, mixing, tabletting gets final product; This dispersible tablet can be conventional sheet or is special-shaped tablets, and specification is divided into 100mg, 50mg, 25mg, and clinical recommendation consumption is 50～100mg/ time, three times on the one.
Said method can add an amount of sweeting agent (as steviosin) to increase the mouthfeel of taking behind the tabletting in the process of system soft material.
General pelletization is especially once granulated, and is applied in the dispersible tablet of the present invention, and the disintegrate effect is bad.And secondary granulate (addition promptly+outer addition) at home and abroad addition to make the tablet disintegrate be coarse grain with adding disintegrating agent, play disintegrate first, in to make the disintegrate of coarse granule secondary with disintegrating agent be fine grained, uniform particles is dispersed in the solution, reach the rapid release effect.
Active component among the present invention---Radix Notoginseng total arasaponins is for meeting WS
3The Radix Notoginseng total arasaponins of-B-3590-2001 (Z) standard, promptly should calculate according to standard volume, contain that the ginsenoside Rb1 must not be less than 30%, the ginsenoside Rg1 must not be less than 20%, arasaponin R1 must not be less than 5.0%, and the total amount of ginsenoside Rb1, ginsenoside Rg1, arasaponin R1 must not be less than 60.0%.Described Radix Notoginseng total arasaponins can prepare voluntarily, also can sell by the merchant and buy.
Select as another kind, Radix Notoginseng total arasaponins dry powder also can keep smaller particle size to satisfy the requirement of dissolution as far as possible in the dispersible tablet of the present invention, for example relies on superfine powder to reach the purpose of rapid release.
Radix Notoginseng total arasaponins belongs to water soluble ingredient, the inventor finds Radix Notoginseng total arasaponins and specific pharmaceutic adjuvant are made up through a large amount of tests, make new Radix Notoginseng dispersible tablet, can shorten the onset time of Radix Notoginseng total arasaponins to greatest extent, reach the instant effect of rapid release, the bioavailability height, can buccal, swallow or in water disintegrate or disperse after take, various ways make take convenient, and stable quality after long time storage.Should, the present invention is to the once breakthrough of Radix Notoginseng total arasaponins in dosage form is improved.
The specific embodiment
Further set forth the present invention below in conjunction with specific embodiments, but not as limitation of the present invention.
Embodiment 1:
Six kinds of schemes (six prescriptions) according to the different amounts of different usages of two kinds of disintegrating agents of the physicochemical property of Radix Notoginseng total arasaponins screening (coupling or single with) and adjuvant, the consumption of Radix Notoginseng total arasaponins is all identical with preparation method (secondary granulation) and product specification, specifically see Table 1, the results are shown in Table 2:
The composition and the consumption of table 1 prescription
| Prescription is formed | Prescription one | Prescription two | Prescription three | Prescription four | Prescription five | Prescription six |
| Radix Notoginseng total arasaponins | 50 | 50 | 50 | 50 | 50 | 50 |
| Lactose | 240 | 240 | 200 | 190 | 180 | 170 |
| Microcrystalline Cellulose | 150 | 150 | 150 | 160 | 160 | 160 |
| Hyprolose | 40 | 40 | 50 | 50 | 50 | |
| Polyvinylpolypyrrolidone | 40 | 40 | 30 | 40 | 50 | |
| Steviosin | 10 | 10 | 10 | 10 | 10 | 10 |
| Ethanol (95%) | 80 | 80 | 80 | 80 | 80 | 80 |
| Micropowder silica gel | 5 | 5 | 5 | 5 | 5 | 5 |
| Magnesium stearate | 2 | 2 | 2 | 2 | 2 | 2 |
The investigation index and the result of the dispersible tablet that six kinds of adjuvants of table 2 are different
| Investigate index | Prescription one | Prescription two | Prescription three | Prescription four | Prescription five | Prescription six |
| Outward appearance | Bright and clean attractive in appearance | Bright and clean attractive in appearance | Bright and clean attractive in appearance | Bright and clean attractive in appearance | Bright and clean attractive in appearance | Bright and clean attractive in appearance |
| Compressibility | Good | Good | Good | Good | Good | Good |
| Angle of repose ° | 32.5° | 33.6° | 30.2° | 31.7° | 30.8° | 29.4° |
| Hardness kg/cm 2 | 7.8 | 7.6 | 7.4 | 7.0 | 7.2 | 7.4 |
| Weight differential | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification |
| Disintegration | 3.2 | 3.7 | 2.4 | 1.5 | 1.2 | 1.0 |
| Dispersing uniformity | 3.8 | 4.3 | 2.8 | 2.1 | 1.7 | 1.4 |
The result of above-mentioned investigation shows that every index of prescription six is the best, illustrates that the two coupling effect of disintegrating agent of the present invention is best.
Embodiment 2:
Disintegrating agent of the present invention is low-substituted hydroxypropyl cellulose and polyvinylpolypyrrolidone, wherein polyvinylpolypyrrolidone is efficient disintegrating agent, play main disintegrate, adopt the difference of the polyvinylpolypyrrolidone ratio that adds that the influence of dispersible tablet is experimentized, to investigate best outer dosage, the composition of two groups of dispersible tablets, consumption and preparation method all identical (referring to the scheme of embodiment 3) in the experiment the results are shown in Table 3:
The comparative result of the different outer dosages of table 3 disintegrating agent polyvinylpolypyrrolidone
| Investigate index | Add 1/3 | Add 1/2 |
| Outward appearance | Bright and clean attractive in appearance | Bright and clean attractive in appearance |
| Compressibility | Good | Good |
| Angle of repose ° | 29.3° | 29.2° |
| Hardness kg/cm 2 | 7.3 | 7.4 |
| Weight differential | Up to specification | Up to specification |
| Disintegration | 0.9 | 0.8 |
| Dispersing uniformity | 1.1 | 0.9 |
| Dissolution % | 91.3 | 97.0 |
The result shows, it is 1/3 and 1/2 all more satisfactory that the disintegrating agent polyvinylpolypyrrolidone adds, and reaches the requirement of dispersible tablet, singly adds for 1/2 disintegration and disperse homogeneity better.
Embodiment 3:
Proportioning raw materials:
Radix Notoginseng total arasaponins 50g
Lactose 170g
Microcrystalline Cellulose 160g
Hyprolose (the low replacement) 50g
Polyvinylpolypyrrolidone 50g
95% ethanol 80ml
Micropowder silica gel 5g
Magnesium stearate 2g
Make 1000
Preparation technology:
Adjuvant was pulverized 100 mesh sieves, polyvinylpolypyrrolidone according to above-mentioned recipe quantity weighting raw materials Radix Notoginseng total arasaponins, lactose, microcrystalline Cellulose, hyprolose (the low replacement), about 1/2 amount, mix homogeneously, add 95% ethanol system soft material, cross the wet grain of sieve series, dry, granulate, the polyvinylpolypyrrolidone, micropowder silica gel and the magnesium stearate that add surplus again, mix homogeneously, tabletting gets final product.
Can in prescription, add steviosin 10 grams, preferably in system soft material process, add with adjuvant.
Embodiment 4:
Proportioning raw materials:
Radix Notoginseng total arasaponins 100g
Lactose 300g
Microcrystalline Cellulose 300g
Hyprolose (the low replacement) 100g
Polyvinylpolypyrrolidone 100g
95% ethanol is an amount of
Micropowder silica gel 20g
Magnesium stearate 10g
Make 1000
Preparation technology:
Preparation method with embodiment 1.Also can in prescription, add steviosin 40g.
Embodiment 5:
Proportioning raw materials:
Radix Notoginseng total arasaponins 20g
Lactose 80g
Microcrystalline Cellulose 80g
Hyprolose (the low replacement) 20g
Polyvinylpolypyrrolidone 20g
95% ethanol is an amount of
Micropowder silica gel 2g
Magnesium stearate 1g
Make 400
Preparation technology:
Preparation method with embodiment 1.Also can in prescription, add steviosin 5g.
More than having described the preferred embodiment for the present invention, is not in order to limit the present invention.Those skilled in the art can not depart from the improvement and the variation of category of the present invention and spirit to embodiment disclosed herein.
Claims (5)
1, a kind of Radix Notoginseng dispersible tablet is characterized in that the raw material composition comprises: 50 parts of Radix Notoginseng total arasaponinss, 170 parts of lactose, 160 parts of microcrystalline Cellulose, 50 parts of low-substituted hydroxypropyl celluloses, 50 parts of polyvinylpolypyrrolidone, 5 parts of micropowder silica gels, 2 parts of magnesium stearate, it makes with following method:
The polyvinylpolypyrrolidone of proportionally getting Radix Notoginseng total arasaponins, lactose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, 1/3～1/2 amount adds 95% ethanol and carries out mixed soft material, granulate, add the mixed pressuring plate process of polyvinylpolypyrrolidone, micropowder silica gel and the magnesium stearate of surplus again.
2, the described Radix Notoginseng dispersible tablet of claim 1, wherein the amount of the polyvinylpolypyrrolidone that adds in the step of mixed soft material is 1/2 of its total amount.
3, the described Radix Notoginseng dispersible tablet of claim 1 wherein also comprises sweeting agent.
4, a kind of method for preparing the described Radix Notoginseng dispersible tablet of claim 1, it is characterized in that comprising, adopt the secondary granulation, the polyvinylpolypyrrolidone of proportionally getting Radix Notoginseng total arasaponins, lactose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, 1/3～1/2 amount adds 95% ethanol and carries out mixed soft material, granulate, add the mixed pressuring plate process of polyvinylpolypyrrolidone, micropowder silica gel and the magnesium stearate of surplus again.
5, the described method of claim 4, the amount of the polyvinylpolypyrrolidone that adds in the step of wherein said mixed soft material is 1/2 of its total amount.
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| CN1323667C true CN1323667C (en) | 2007-07-04 |
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Cited By (1)
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| CN112618590A (en) * | 2021-01-22 | 2021-04-09 | 海南海力制药有限公司 | Xuesaitong dispersible tablet and preparation method thereof |
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| US20100016322A1 (en) * | 2007-02-28 | 2010-01-21 | Nagesh Nagaraju | Water Dispersible Pharmaceutical Formulation and Process for Preparing The Same |
| CN104473765B (en) * | 2014-12-17 | 2018-12-11 | 文山学院文山三七研究院 | A kind of moulding process of Radix Notoginseng granule |
| CN105055476B (en) * | 2015-08-24 | 2019-01-15 | 江苏红瑞制药有限公司 | A kind of Xuesaitong dispersible tablet and preparation method thereof |
| CN109512792A (en) * | 2019-01-11 | 2019-03-26 | 安徽东盛友邦制药有限公司 | A kind of process of the Genpril of granulation production twice |
| CN113069426A (en) * | 2021-04-09 | 2021-07-06 | 海南海力制药有限公司 | Preparation method of Xuesaitong dispersion tablet and Xuesaitong dispersion tablet |
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