CN101411747B - Salvia root polyphenol acid orally disintegrating tablets and preparation method thereof - Google Patents
Salvia root polyphenol acid orally disintegrating tablets and preparation method thereof Download PDFInfo
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- CN101411747B CN101411747B CN2008102193982A CN200810219398A CN101411747B CN 101411747 B CN101411747 B CN 101411747B CN 2008102193982 A CN2008102193982 A CN 2008102193982A CN 200810219398 A CN200810219398 A CN 200810219398A CN 101411747 B CN101411747 B CN 101411747B
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- disintegrating agent
- radix salviae
- salviae miltiorrhizae
- orally disintegrating
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Abstract
The invention discloses a radix salviae miltiorrhizae polyphenolic acid orally disintegrating tablet, which is prepared from 5 to 40 weight percent of a main medicine and residual auxiliary materials, wherein the main medicine is radix salviae miltiorrhizae polyphenolic acid; the auxiliary materials comprise the following compositions in percentage by weight: 2 to 40 percent of disintegrating agent, 0.1 to 6 percent of flavoring, 30 to 70 percent of filler and 0.5 to 8 percent of adhesive, wherein the disintegrating agent consists of an internal disintegrating agent and an external disintegrating agent; and the internal disintegrating agent accounts for 20 to 50 percent of the total weight of the disintegrating tablet. The invention also discloses a method for preparing the radix salviae miltiorrhizae polyphenolic acid orally disintegrating tablet, which comprises the following steps: the radix salviae miltiorrhizae polyphenolic acid is uniformly mixed with the internal disintegrating agent and the filler; the adhesive is added into the mixture for preparing soft materials and granulating; and finally the external disintegrating agent and the flavoring are added after drying and granulation, uniformly mixed and subjected to tabletting to obtain the radix salviae miltiorrhizae polyphenolic acid orally disintegrating tablet. The radix salviae miltiorrhizae polyphenolic acid orally disintegrating tablet can be disintegrated when contacting saliva for 30 to 60 seconds, thereby improving the compliance of oral application of the radix salviae miltiorrhizae polyphenolic acid.
Description
Technical field
The present invention relates to a kind of oral cavity disintegration tablet and preparation method thereof, specifically a kind of salvia root polyphenol acid orally disintegrating tablets and preparation method thereof.
Background technology
Poly phenolic acid of Radix Salviae Miltiorrhizae is the water solublity effective site of from the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bage., extracting; Comprise salvianolic acid A (danshensu), multiple phenolic acid compounds such as salvianolic acid B, salvianolic acid C, rosmarinic acid, rosmarinic acid methyl ester, protocatechualdehyde, Hesperetic acid, caffeic acid.The total content of multiple phenolic acid reaches more than 60% in the poly phenolic acid of Radix Salviae Miltiorrhizae, and wherein, salvianolic acid B accounts for more than 80% of total phenolic acid.Poly phenolic acid of Radix Salviae Miltiorrhizae can make degree of myocardial ischemia significantly descend, and the myocardial ischemia scope is dwindled, and the primary cellular defect when alleviating myocardial ischemia has significant function of resisting myocardial ischemia.Also can reduce the heart oxygen consumption, and can resist the inductive platelet aggregation of ADP and suppress thrombosis, have the characteristics and the advantage that in the therapeutic dose scope, do not influence the cardiac hemodynamics function.Clinical experimental study shows that salvianolate is for coronary heart disease, angina pectoris, evident in efficacy, safe in utilization.
Poly phenolic acid of Radix Salviae Miltiorrhizae is the important drugs of treatment cardiovascular and cerebrovascular disease, and poly phenolic acid of Radix Salviae Miltiorrhizae has only a kind of dosage form listing of injection at present.Injection must be granted the patient by the medical personnel of specialty usually, also is prone to take place untoward reaction.Oral solid formulation commonly used is effective for the cardiovascular and cerebrovascular disease patient, but for some particular patients ', and especially gerontal patient, the patient that is unable to leave the bed, is difficult to independently take medicine with function of deglutition obstacle person or when the water intaking inconvenience can increase the medication difficulty.Oral cavity disintegration tablet be a kind of in the oral cavity tablet of disintegrate in 60 seconds, the patient does not need water or only can swallow with a spot of mixing in water for oral taking.Poly phenolic acid of Radix Salviae Miltiorrhizae is made as oral cavity disintegration tablet will overcomes all inconvenience that above-mentioned patient takes medicine, improve the medication compliance of its treatment cerebrovascular disease aspect.
The preparation technology of oral cavity disintegration tablet commonly used has direct compression of full-powder technology, molding process, freeze drying process, drying process with atomizing etc. at present.Some is difficult to adapt to the domestic industry working condition.
Summary of the invention
The objective of the invention is for a kind of medication convenience, good mouthfeel and good stability salvia root polyphenol acid orally disintegrating tablets are provided.
Another purpose of the present invention provide a kind of above-mentioned salvia root polyphenol acid orally disintegrating tablets that is fit to present domestic tablet commercial production conditions wet granule compression tablet method for preparing.
The following technical scheme of the object of the invention realizes:
A kind of salvia root polyphenol acid orally disintegrating tablets is processed by percentage by weight 5%～40% principal agent and surplus adjuvant, and said principal agent is a poly phenolic acid of Radix Salviae Miltiorrhizae, and said adjuvant comprises the component of following percetage by weight:
Disintegrating agent 2%～40%,
Correctives 0.1%～6%,
Filler 30%～70%,
Adhesive 0.5%～8%.
Said disintegrating agent by interior with disintegrating agent with add disintegrating agent and form; Be a kind of in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose or the carboxymethyl starch sodium or mixture that both are above with disintegrating agent in said; In be preferably polyvinylpolypyrrolidone with disintegrating agent, in account for 20%～50% of disintegrating agent total amount with disintegrating agent; Saidly add the mixture that disintegrating agent is low-substituted hydroxypropyl cellulose and microcrystalline Cellulose, the two weight ratio is 1:4～1:9, and preferred proportion is 1:4.
Said correctives is a kind of or both the above mixture in Aspartane, stevioside, essence, saccharin sodium, maltose alcohol or the Mentholum.
Said filler is a kind of or both the above mixture in lactose, mannitol, the glucose.
Said adhesive is the alcoholic solution of polyvidone, and the content of polyvidone in alcoholic solution is 2%～10%, is preferably 4%～6%; The said alcoholic acid alcohol amount of containing is 75%～95%, and preferably containing the alcohol amount is 85%～95%.
Salvia root polyphenol acid orally disintegrating tablets of the present invention also can add the conventional adjuvant in other pharmacy in raw material, like lubricant or wetting agent etc.
The method for preparing of the above-mentioned salvia root polyphenol acid orally disintegrating tablets of the present invention be earlier with poly phenolic acid of Radix Salviae Miltiorrhizae with in disintegrating agent, filler mixing; Add adhesive system soft material again, granulate; Adding adds disintegrating agent, correctives behind the final drying granulate, mixing, and tabletting promptly gets.
The present invention compared with prior art has following beneficial effect:
(1) oral cavity disintegration tablet of the present invention, main by the poly phenolic acid of Radix Salviae Miltiorrhizae of effective dose with do not influence the active inert excipients of poly phenolic acid of Radix Salviae Miltiorrhizae and form, professional medical personnel needn't be arranged during the salvia root polyphenol acid orally disintegrating tablets medication; When taking, do not need water or only need low amounts of water; Tablet is placed lingual surface, and chance saliva was disintegratable or dissolving in 30～60 seconds, can obey down by means of swallowing power then; Taking convenience; In the oral cavity, run into saliva and just can dissolve rapidly, to gerontal patient and cardiovascular and cerebrovascular disease patient, or independently taking medicine when other complication, paralysis bed, function of deglutition impaired patients and water inconvenience are arranged brings great convenience; Improved the compliance of poly phenolic acid of Radix Salviae Miltiorrhizae oral administration greatly, especially made things convenient for the gerontal patient and be unable to leave the bed the relatively poor patient of function of deglutition and take medicine;
(2) further increase absorption through independently or not independently swallowing the entering gastrointestinal behind the Orally disintegrating, made drug absorption complete, further improved bioavailability;
(3) preparation technology is simple, and the orally disintegrating tablet preparation technology that the present invention relates to need not special installation, and every have the pharmacy corporation of tablet manufacturing line all can produce, and cost is low, and efficient is high, is easy to suitability for industrialized production, has good economic benefit and social benefit;
(4) the sheet type that makes has ideal hardness and dissolution, and is convenient to packing, transportation and storage; The method for preparing that provides is simple, and the product hardness that makes is big, and disintegration time is short, and mouthfeel is good, and when preparing this product, every sheet is heavy variable;
(5) disintegrating tablet appearance looks elegant provided by the invention, mouthfeel is good, has increased patient's medication compliance, and market prospect is wide.
The specific embodiment
Embodiment 1
Prepare salvia root polyphenol acid orally disintegrating tablets according to the said prescription of table 1:
Table 1 salvia root polyphenol acid orally disintegrating tablets prescription
| Component | Throw appearance amount (g/1000 sheet) | The proportion of composing of tablet (%) |
| Poly phenolic acid of Radix Salviae Miltiorrhizae | 40.5 | 16.2 |
| Low-substituted hydroxypropyl cellulose | 15.0 | 6.0 |
| Microcrystalline Cellulose | 60.0 | 24.0 |
| Polyvinylpolypyrrolidone | 17.5 | 7.0 |
| 5% polyvidone alcoholic solution | 1.25 | 0.5 |
| Aspartane | 11.5 | 4.6 |
| Flavoring pineapple essence | 1.25 | 0.5 |
| Mannitol | 103.0 | 41.2 |
Preparation salvia root polyphenol acid orally disintegrating tablets: poly phenolic acid of Radix Salviae Miltiorrhizae is dry; Sieve; With polyvinylpolypyrrolidone, mannitol mixing, add 5% polyvidone alcoholic solution system soft material, granulate; With low-substituted hydroxypropyl cellulose and microcrystalline Cellulose (1:4) mixture, Aspartane, flavoring pineapple essence mixing, compacting in flakes behind dry, the granulate.
The salvia root polyphenol acid orally disintegrating tablets Orally disintegrating time that makes: 30 seconds.
Embodiment 2
Prepare salvia root polyphenol acid orally disintegrating tablets according to the said prescription of table 2:
Table 2 salvia root polyphenol acid orally disintegrating tablets prescription
| Component | Throw appearance amount (g/1000 sheet) | The proportion of composing of tablet (%) |
| Poly phenolic acid of Radix Salviae Miltiorrhizae | 44.6 | 17.84 |
| Low-substituted hydroxypropyl cellulose | 12.5 | 5.0 |
| Microcrystalline Cellulose | 51.5 | 20.6 |
| Polyvinylpolypyrrolidone | 22.0 | 8.8 |
| 6% polyvidone alcoholic solution | 1.25 | 0.5 |
| Stevioside | 9.4 | 3.76 |
| Strawberry essence | 2.5 | 1.0 |
| Lactose | 106.25 | 42.5 |
Preparation salvia root polyphenol acid orally disintegrating tablets: poly phenolic acid of Radix Salviae Miltiorrhizae is dry; Sieve; With polyvinylpolypyrrolidone, lactose mixing, add 6% polyvidone alcoholic solution system soft material, granulate; With low-substituted hydroxypropyl cellulose and microcrystalline Cellulose (1:4) mixture, stevioside, strawberry essence mixing, compacting in flakes behind dry, the granulate.
The salvia root polyphenol acid orally disintegrating tablets Orally disintegrating time that makes: 33 seconds.
Embodiment 3
Prepare salvia root polyphenol acid orally disintegrating tablets according to the said prescription of table 3:
Table 3 salvia root polyphenol acid orally disintegrating tablets prescription
| Component | Throw appearance amount (g/1000 sheet) | The proportion of composing of tablet (%) |
| Poly phenolic acid of Radix Salviae Miltiorrhizae | 60.75 | 24.3 |
| Low-substituted hydroxypropyl cellulose | 12.5 | 5.0 |
| Microcrystalline Cellulose | 50.75 | 20.3 |
| Polyvinylpolypyrrolidone | 17.5 | 7.0 |
| 6% polyvidone alcoholic solution | 1.25 | 0.5 |
| Aspartane | 8.5 | 3.4 |
| Flavoring orange essence | 0.75 | 0.3 |
| Mannitol | 98.0 | 39.2 |
Preparation salvia root polyphenol acid orally disintegrating tablets: poly phenolic acid of Radix Salviae Miltiorrhizae is dry; Sieve; With polyvinylpolypyrrolidone, mannitol mixing, add 6% polyvidone alcoholic solution system soft material, granulate; With low-substituted hydroxypropyl cellulose and microcrystalline Cellulose (1:4) mixture, Aspartane, flavoring orange essence mixing, compacting in flakes behind dry, the granulate.
The salvia root polyphenol acid orally disintegrating tablets Orally disintegrating time that makes: 33 seconds.
Embodiment 4
Prepare salvia root polyphenol acid orally disintegrating tablets according to the said prescription of table 4:
Table 4 salvia root polyphenol acid orally disintegrating tablets embodiment 4 prescriptions
| Component | Throw appearance amount (g/1000 sheet) | The proportion of composing of tablet (%) |
| Poly phenolic acid of Radix Salviae Miltiorrhizae | 68.75 | 27.5 |
| Low-substituted hydroxypropyl cellulose | 15.0 | 6.0 |
| Microcrystalline Cellulose | 58.5 | 23.4 |
| Polyvinylpolypyrrolidone | 14.0 | 5.6 |
| 4% polyvidone alcoholic solution | 1.25 | 0.5 |
| Aspartane | 8.75 | 3.5 |
| Flavoring pineapple essence | 0.5 | 0.2 |
| Glucose | 83.25 | 33.3. |
Preparation salvia root polyphenol acid orally disintegrating tablets: poly phenolic acid of Radix Salviae Miltiorrhizae is dry; Sieve; With polyvinylpolypyrrolidone, glucose mixing, add 4% polyvidone alcoholic solution system soft material, granulate; With low-substituted hydroxypropyl cellulose and microcrystalline Cellulose (1:4) mixture, Aspartane, flavoring pineapple essence mixing, compacting in flakes behind dry, the granulate.
The salvia root polyphenol acid orally disintegrating tablets Orally disintegrating time that makes: 38 seconds.
Claims (5)
1. a salvia root polyphenol acid orally disintegrating tablets is processed by percentage by weight 5%～40% principal agent and surplus adjuvant, and said principal agent is a poly phenolic acid of Radix Salviae Miltiorrhizae, and said adjuvant comprises the component of following percetage by weight:
Disintegrating agent 2%～40%,
Correctives 0.1%～6%,
Filler 30%～70%,
Adhesive 0.5%～8%;
Said disintegrating agent by interior with disintegrating agent with add disintegrating agent and form; Be polyvinylpolypyrrolidone with disintegrating agent in said, account for 20%～50% of disintegrating agent gross weight; The said disintegrating agent that adds is the mixture that low-substituted hydroxypropyl cellulose and microcrystalline Cellulose were formed by weight 1: 4.
2. the method for preparing of the said salvia root polyphenol acid orally disintegrating tablets of claim 1, it is characterized in that earlier with poly phenolic acid of Radix Salviae Miltiorrhizae with in disintegrating agent, filler mixing; Add adhesive system soft material again, granulate; Adding adds disintegrating agent, correctives behind the final drying granulate, mixing, and tabletting promptly gets.
3. method for preparing as claimed in claim 2 is characterized in that said correctives is a kind of or both the above mixture in Aspartane, stevioside, essence, saccharin sodium, maltose alcohol or the Mentholum.
4. method for preparing as claimed in claim 2 is characterized in that said filler is a kind of or both the above mixture in lactose, mannitol, the glucose.
5. method for preparing as claimed in claim 2 is characterized in that said adhesive is the alcoholic solution of polyvidone, and the content of polyvidone in alcoholic solution is 2%～10%; The said alcoholic acid alcohol amount of containing is 75%～95%.
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| CN2008102193982A CN101411747B (en) | 2008-11-25 | 2008-11-25 | Salvia root polyphenol acid orally disintegrating tablets and preparation method thereof |
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| CN2008102193982A CN101411747B (en) | 2008-11-25 | 2008-11-25 | Salvia root polyphenol acid orally disintegrating tablets and preparation method thereof |
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| CN101411747B true CN101411747B (en) | 2012-10-31 |
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| CN106093223B (en) * | 2016-05-31 | 2018-06-15 | 天津中医药大学 | A kind of research method of Danshen injection polyphenol absolute acid stability and its analysis method of degradation pathway |
| CN109512790A (en) * | 2018-12-28 | 2019-03-26 | 金日制药（中国）有限公司 | A kind of prescription and preparation process of oral disnitegration tablet |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101028338A (en) * | 2006-02-28 | 2007-09-05 | 中国科学院上海药物研究所 | Oral-cavity disintegrant tablet for treating cardiovascular disease |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101028338A (en) * | 2006-02-28 | 2007-09-05 | 中国科学院上海药物研究所 | Oral-cavity disintegrant tablet for treating cardiovascular disease |
Non-Patent Citations (2)
| Title |
|---|
| 王文喜等.阿司匹林口腔崩解片的研制.《中国新药杂志》.2005,第14卷(第8期),1014-1016. * |
| 许宣林等.均匀设计法优化丹参提取物口腔崩解片的制备研究.《陕西中医学院学报》.2008,第31卷(第3期),63-64. * |
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Address after: 510006 Guangdong City, Guangzhou province outside the University of East Ring Road, No. 280 Patentee after: GUANGDONG PHARMACEUTICAL University Address before: 510006 Guangdong City, Guangzhou province outside the University of East Ring Road, No. 280 Patentee before: Guangdong Pharmaceutical University |
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