CN1263457C - Orally disintegrating tablet of gypenosides and its preparation process - Google Patents
Orally disintegrating tablet of gypenosides and its preparation process Download PDFInfo
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- CN1263457C CN1263457C CN 200410058041 CN200410058041A CN1263457C CN 1263457 C CN1263457 C CN 1263457C CN 200410058041 CN200410058041 CN 200410058041 CN 200410058041 A CN200410058041 A CN 200410058041A CN 1263457 C CN1263457 C CN 1263457C
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- herb gynostemmae
- gynostemmae pentaphylli
- disintegrating tablet
- pentaphylli total
- orally disintegrating
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Abstract
The present invention relates to a gynostemma pentaphylla total glycoside orally disintegrating tablet and a preparation process thereof. The gynostemma pentaphylla total glycoside orally disintegrating tablet has the effects of reducing blood lipid, improving myocardial ischemia and anoxia, protecting cerebral ischemia, resisting oxidation, nourishing the heart, tonifying the spleen, benefiting qi, promoting blood circulation, eliminating phlegm, removing blood stasis, etc., and the tablet is suitable for treating hyperlipoidemia, palpitation and shortness of breath, oppression in chest, numbness of limbs, vertigo, headache, amnesia, tinnitus, spontaneous sweating, weakness, abdominal fullness and distention, deficiency of heart qi and spleen qi, stagnation of phlegm and blood stasis, etc. The present invention aims at making up for the preparation insufficiency of existing gynostemma pentaphylla total glycoside preparation and providing a gynostemma pentaphylla total glycoside orally disintegrating tablet and a preparation process thereof for all patients and medical workers; the gynostemma pentaphylla total glycoside orally disintegrating tablet has the advantages of convenient use and rapid absorption and effect-taking. Gynostemma pentaphylla total glycoside is used as raw materials; filling agents, disintegrating agents, corrigents, flow aid, lubricating agents, etc. are used as auxiliary materials; adhesives or coating materials can also be used according to different situations; appropriate quantity of effervescent agents can be added on specific situation; the orally disintegrating tablet is prepared by a specific preparation method and obtained after tabletting by tabletting machines. The orally disintegrating tablet of the present invention has the characteristics of good friability, rapid disintegration, good taste, no gravel feel, no need of specific production condition, low production cost, convenient carry, storage, transportation and use, etc.
Description
[technical field]
The present invention relates to a kind of hyperlipemia that is applicable to, see that had palpitation is breathed hard, heart deficiency of spleen-QI such as limb fiber crops uncomfortable in chest, dizziness and headache, forgetful tinnitus, unconsciously sweat and tire or distension and fullness in the abdomen, the Herb Gynostemmae Pentaphylli total glycosides orally disintegrating tablet preparation of diseases such as stagnation of phlegm blood stasis.
[background technology]
Herb Gynostemmae Pentaphylli [gynostemma pentaphyllum (thunb) mak] is dicotyledonous guiding principle cucurbitaceae genus gynostemma.Chinese medicine is called Herba Gynostemmatis.In Japan, be described as " Gospel grass ".Include multiple Saponin, vitamin and aminoacid to the human body beneficial.Studies show that the Herb Gynostemmae Pentaphylli active ingredient has effects such as blood fat reducing, blood sugar lowering, antitumor, defying age, the liver protecting and enhancing body immune function.Diseases such as Cardiovascular system disorders such as hyperlipemia, hypertension, coronary heart disease, diabetes, tumor had good prevention effect.The making health promoting beverage is drunk, good taste and have health care and be worth, and long-term drink has no side effect, and is described as China's " southern Radix Ginseng " " anticancer rising star ".
Motherland's medical science is thought, Herb Gynostemmae Pentaphylli bitter in the mouth, cold in nature, nontoxic.Eliminating inflammation and expelling toxin, the eliminating phlegm and stopping cough of being used among the people, the producing region masses adopt its stem and leaf in summer and fry in shallow oil water and make refreshment drink more.1972, Qujing Prefecture, Yunnan Province combination of Chinese and Western medicine group was applied to Herb Gynostemmae Pentaphylli clinical first, and every day, dosage 2.5-3 gram was decocted in water for oral dose for 3 times every day, and 10 is a course of treatment, treats senile chronic tracheitis 537 examples altogether.Clinical cure 25 examples wherein, produce effects 133 examples, 266 examples that take a turn for the better, total effective rate 79% generally has no side effect.
According to assay, Herb Gynostemmae Pentaphylli also has more than 50 kind of Saponin except that containing sterol, sugar part, pigment, comprise tetracyclic triterpenoids compound, and wherein Herba Gynostemmatis Saponin III, IV, VII, XII are four kinds, are same substances with ginsenoside Rb1, Rb3, Rd, F2 respectively; Its acid hydrolysis products and ginsenoside acid hydrolysis products---the panoxadiol has identical physicochemical property.This is very rare in the plant of non-Araliaceae, thereby is described as " second Radix Ginseng ".
Nineteen eighty-two, the little field of the Japanese scholar respectful husband's in island etc. experiment shows that the Herba Gynostemmatis Saponin has the obvious suppression effect to the propagation of cancerous cell such as hepatocarcinoma, pulmonary carcinoma, uterus carcinoma, skin carcinoma.Japan's pharmacological testing and clinical practice confirm, Herb Gynostemmae Pentaphylli not only has effects such as nourishing, calmness, hypnosis, antitonic, short appetite, blood fat reducing, cholesterol reducing, transaminase lowering, slow down aging to human body, can also prevent the normal cell cancerization and make cancerous cell transformation is normal cell.Can be used for more than 20 kind of cancers such as pulmonary carcinoma, gastric cancer, hepatocarcinoma, esophageal carcinoma, carcinoma of gallbladder, rectal cancer, cancer of pancreas, breast carcinoma and uterus carcinoma clinically, can also prevent and treat cardiovascular disease, change general obesity, control hepatitis B, liver cirrhosis, gastric duodenal ulcer, treatment migraine, poliosis, insomnia, the indefinite anxious disease etc. of telling.Thereby represented wide prospect in medicine.
The dosage form of existing gynostemma pentaphyllum total glycosides formulation has: drop pill, hard capsule, soft capsule and ordinary tablet.
Because dosage form needs a large amount of water to send down when most of oral formulations are taken, this makes the patient of many old peoples, infant or dysphagia, water intaking inconvenience be difficult to take.Injection often is easy to generate anaphylaxis or untoward reaction etc. again, and it is big that the while injection also exists operation easier, and the patient suffering is also big, makes and medical treatment cost high the shortcoming that patient economy burden is heavy.Therefore, be necessary to prepare and take convenient dosage form to satisfy the multiple needs that clinical treatment and family use.
[summary of the invention]
The objective of the invention is to improve the deficiency of existing Herb Gynostemmae Pentaphylli total glycosides aspect peroral dosage form, provide a kind of taking convenience, absorption is rapid-action, bioavailability is high Herb Gynostemmae Pentaphylli total glycosides orally disintegrating tablet preparation to extensive patients and medical personnel.Needn't drink water when the present invention relates to take, in the oral cavity, only need get final product rapid disintegrate or dissolving in tens seconds, can finish gynostemma pentaphyllum total glucoside oral disintegration tablets of taking medicine and preparation method thereof with saliva hypopharynx.
One, prescription
The gynostemma pentaphyllum total glucoside oral disintegration tablets that reaches of the present invention comprises the material medicine Herb Gynostemmae Pentaphylli total glycosides, needs following former, the auxiliary material of 9 classes altogether, and wherein: when not making Cotton seeds, then do not use coating material, effervescent also can for selecting adjuvant for use as one sees fit.
Herb Gynostemmae Pentaphylli total glycosides (5-50) %, binding agent (0-5) %, filler (10-80) %, disintegrating agent (2-35) %, correctives (1-40) %, coating material (0-40) %, effervescent (0-30) %, fluidizer (0.01-5) %, lubricant (0.3-3) %.
Wherein:
Binding agent includes but are not limited to starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, gelatin, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum, hydroxypropyl cellulose and hydroxypropyl emthylcellulose (HPMC), can use use also capable of being combined separately.
Filler includes but are not limited to mannitol (granular or powdery), xylitol, sorbitol, maltose, erithritol, microcrystalline Cellulose, PROSOLV SMCC, polymerization sugar (EMDEX), coupling sugar, glucose, lactose, sucrose, dextrin and starch etc., can use separately, also can applied in any combination, consumption is generally (10-80) %.
Disintegrating agent includes but are not limited to crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) and soybean polysaccharide (EMCOSOY) etc., can use use also capable of being combined separately.
Correctives includes but are not limited to mannitol, xylitol, stevioside, lactose, fructose, sucrose, protein sugar, maltose alcohol, glycyrrhizin, Sodium Cyclamate, gelatin, aspartame, flavoring banana essence, flavoring pineapple essence, vanillin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid etc., can use use also capable of being combined separately.
Coating material includes but are not limited to gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit series), polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol etc., can use use also capable of being combined separately.
Fluidizer includes but are not limited to micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate etc., can use use also capable of being combined separately.
Lubricant includes but are not limited to magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, magnesium laurylsulfate, Stepanol MG and Pulvis Talci etc., can use use also capable of being combined separately.
Effervescent includes but are not limited to the mixture of malic acid, citric acid or citric acid and sodium bicarbonate or sodium carbonate.
Two, preparation method
The gynostemma pentaphyllum total glucoside oral disintegration tablets that reaches of the present invention, its preparation method is a direct compression process, the manufacturer with preparation conventional tablet all can adopt.
The Herb Gynostemmae Pentaphylli total glycosides bitter in the mouth, the present invention can adopt two kinds of distinct methods to carry out flavoring or taste masking: 1. adopt the direct flavoring of correctives; 2. in advance Herb Gynostemmae Pentaphylli total glycosides is carried out powder coating with taste masking.
Concrete preparation method is as follows:
The preprocess method of first step Herb Gynostemmae Pentaphylli total glycosides:
1. directly the flavoring method---this law is granulated to the Herb Gynostemmae Pentaphylli total glycosides raw material or is not dealt with, and directly enters
Second step;
2. powder coating taste masking---get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, getting Herb Gynostemmae Pentaphylli total glycosides again places ebullated bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get Herb Gynostemmae Pentaphylli total glycosides powder coating granule, dry back sieving for standby;
Second step took by weighing correctives and Herb Gynostemmae Pentaphylli total glycosides or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, effervescent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, and adding lubricant mixing is standby;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
[beneficial effect]
Tablet is a kind of conventional dosage forms, because of its steady quality, dosage accurately, take, easy to carry, mechanization degree is high, low one of the at present the most frequently used dosage form that becomes of production cost, but because of the tablet extrusion forming, disintegrate is slow, bioavailability is lower, and part patient swallows comparatively difficult, thereby promoting the use of to a certain extent of tablet is restricted.The oral administration solid quick releasing formulation becomes a focus, particularly oral cavity disintegration tablet of new drug development in recent years for this reason, because of its taking convenience, rapid-action, bioavailability is high, the good emphasis that becomes tablet exploitation of mouthfeel.
Oral cavity disintegration tablet is meant not to be needed water or only needs low amounts of water, need not to chew, and tablet places lingual surface, disintegrate rapidly after the chance saliva, or borrow and swallow power, medicine can be gone into the tablet of stomach onset.The characteristics of oral cavity disintegration tablet are that absorption is fast, bioavailability is high, and intestinal is residual few, and side effect is low, avoids liver first-pass effect etc.
According to the requirement of " formulation characteristic of oral cavity disintegration tablet and quality control meeting summary ", oral cavity disintegration tablet has essential leap than the disintegration rate of drop pill and ordinary tablet, and the disintegrate of oral cavity disintegration tablet generally in 30 seconds, is no more than 1 minute at most.
[specific embodiment]
For the preparation method of gynostemma pentaphyllum total glucoside oral disintegration tablets of the present invention better is described, in conjunction with directly flavoring method and powder coating taste masking method are as follows for an embodiment respectively:
Embodiment one direct flavoring method
One. prescription
1. raw material---Herb Gynostemmae Pentaphylli total glycosides 20.0g;
2. binding agent---polyvinylpyrrolidone K-30 0.5g;
3. filler---mannitol 58.5g;
PROSOLV?SMCC?5.0g；
4. correctives---aspartame 1.0g;
Ginseng essence 1.0g;
5. disintegrating agent-crospolyvinylpyrrolidone 8.0g;
L-HPC?4.0g；
6. fluidizer---micropowder silica gel 1.0g;
7. lubricant---sodium stearyl fumarate 1.0g.
Gross weight 100g makes 1000 altogether.
Two. preparation method
1) get the Herb Gynostemmae Pentaphylli total glycosides raw material pulverizing, granulate, cross 26 mesh sieves with polyvinylpyrrolidone K-30, standby;
2) with micropowder silica gel, ginseng essence, PROSOLV SMCC and aspartame, cross 40 mesh sieves respectively, mix homogeneously adds the Herb Gynostemmae Pentaphylli total glycosides granule of having granulated again, and mix homogeneously is standby;
3) get mannitol, L-HPC and crospolyvinylpyrrolidone and cross 40 mesh sieves respectively, mix homogeneously will add and mix homogeneously through the raw material of flavoring again, adds sodium stearyl fumarate and mix homogeneously at last;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Embodiment two powder coating taste masking methods
One. prescription
1. raw material-Herb Gynostemmae Pentaphylli total glycosides 20.0g;
2. coating material---Eudragit E100 3.5g;
Eudragit NE30D (doing) 1.5g;
3. filler---mannitol 55.5g;
Microcrystalline Cellulose 5.0g;
4. correctives---aspartame 1.0g;
Ginseng essence 1.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 6.0g;
L-HPC?4.0g；
6. fluidizer---micropowder silica gel 1.5g;
7. lubricant---sodium stearyl fumarate 1.0g.
Gross weight 100g makes 1000 altogether.
Two. preparation method
1) gets Eudragit E100 and Eudragit NE30D Eudragit NE30D with the dissolving of the medicinal industrial alcohol more than 95% and to be diluted to finite concentration standby;
2) get Herb Gynostemmae Pentaphylli total glycosides and place ebullated bed to seethe with excitement, spray into above-mentioned solution by certain speed and carry out powder coating, make Herb Gynostemmae Pentaphylli total glycosides powder coating granule, dry back is standby;
3) with mannitol, microcrystalline Cellulose, micropowder silica gel, PVPP, L-HPC, aspartame, sodium stearyl fumarate and ginseng essence mix homogeneously, again and sieve after the coated granule mixing standby;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Embodiment three effervescent flavoring methods
One. prescription
1. raw material---Herb Gynostemmae Pentaphylli total glycosides 20.0g;
2. binding agent---polyvinylpyrrolidone K-30 0.5g;
3. effervescent---citric acid 12.5g;
Sodium bicarbonate 10.0g;
4. filler---mannitol 33.0g;
PROSOLV?SMCC?5.0g；
5. correctives---aspartame 1.0g;
Fragrant citrus essence 1.0g;
6. disintegrating agent---crospolyvinylpyrrolidone 10.0g;
L-HPC?5.0g；
7. fluidizer---micropowder silica gel 1.0g;
8. lubricant---sodium stearyl fumarate 1.0g.
Gross weight 100g makes 1000 altogether.
Two. preparation method
1) get Herb Gynostemmae Pentaphylli total glycosides and citric acid raw material and mix the back pulverizing, granulate, cross 26 mesh sieves with polyvinylpyrrolidone K-30, standby;
2) get sodium bicarbonate and pulverize, granulate, cross 26 mesh sieves with polyvinylpyrrolidone K-30, standby;
3) adjuvant that all the other are all is crossed mix homogeneously behind 40 mesh sieves respectively, adds the granule of having granulated again, and mix homogeneously is standby;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Claims (7)
1. Herb Gynostemmae Pentaphylli total saponin oral disintegrating tablet, it is characterized in that its weight consists of Herb Gynostemmae Pentaphylli total saponins 5～50%, clothing sheet material polyacrylic resin 5～40%, disintegrating agent crospolyvinylpyrrolidone and low-substituted hydroxypropyl methylcellulose amount to 2～35%, filler 10-80%, correctives 1～40%, fluidizer 0.01～5%, lubricant 0.3～3% is formed, wherein filler is selected from mannitol, microcrystalline Cellulose, dextrin, lactose, starch, in maltodextrin and the pregelatinized Starch one or more, correctives is selected from mannitol, lactose, stevioside, gelatin, aspartame, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, in the citric acid one or more, fluidizer is selected from micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, in the hydrated sodium aluminosilicate one or more, lubricant is selected from magnesium stearate, glyceryl monostearate, Stepanol MG, in the Pulvis Talci, in the sodium stearyl fumarate one or more; After wherein the Herb Gynostemmae Pentaphylli total saponins being carried out powder coating with coating material, the gained granule is pressed into disintegrating tablet with other adjuvant.
2. Herb Gynostemmae Pentaphylli total saponin oral disintegrating tablet as claimed in claim 1, wherein filler is mannitol and/or microcrystalline Cellulose.
3. Herb Gynostemmae Pentaphylli total saponin oral disintegrating tablet as claimed in claim 1, wherein correctives is aspartame and/or ginseng essence.
4. Herb Gynostemmae Pentaphylli total saponin oral disintegrating tablet as claimed in claim 1, wherein lubricant is a sodium stearyl fumarate.
5. Herb Gynostemmae Pentaphylli total saponin oral disintegrating tablet as claimed in claim 1, wherein fluidizer is micropowder silica gel.
6. Herb Gynostemmae Pentaphylli total saponin oral disintegrating tablet as claimed in claim 1, it is characterized in that its weight consists of: 20 parts of Herb Gynostemmae Pentaphylli total saponins, 5 parts of polyacrylic resins, 55.5 parts in mannitol, 5 parts of microcrystalline Cellulose, 1 part of aspartame, 1 part of ginseng essence, 6 parts of crospolyvinylpyrrolidone, 4 parts of low-substituted hydroxypropyl methylcellulose, 1.5 parts of micropowder silica gels, 1 part of sodium stearyl fumarate.
7.. the preparation method as any described Herb Gynostemmae Pentaphylli total saponin oral disintegrating tablet of claim 1-6 is characterized in that being made up of following steps:
The pretreatment of first step Herb Gynostemmae Pentaphylli total saponins; Get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, get the Herb Gynostemmae Pentaphylli total saponins again and place fluid bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get Herb Gynostemmae Pentaphylli total saponins powder coating granule, dry back sieving for standby;
Second step took by weighing correctives and Herb Gynostemmae Pentaphylli total saponins granule or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, added the lubricant mixing, and is standby;
The 4th step gained material detects through intermediate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410058041 CN1263457C (en) | 2004-08-10 | 2004-08-10 | Orally disintegrating tablet of gypenosides and its preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410058041 CN1263457C (en) | 2004-08-10 | 2004-08-10 | Orally disintegrating tablet of gypenosides and its preparation process |
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| Publication Number | Publication Date |
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| CN1602882A CN1602882A (en) | 2005-04-06 |
| CN1263457C true CN1263457C (en) | 2006-07-12 |
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| CN 200410058041 Expired - Fee Related CN1263457C (en) | 2004-08-10 | 2004-08-10 | Orally disintegrating tablet of gypenosides and its preparation process |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100441181C (en) * | 2006-03-03 | 2008-12-10 | 陕西新药技术开发中心 | Method for preparing micropill capsule of salvia miltiorrhiza bge, and gynostemma pentaphyllum, and its use |
| CN102861035B (en) * | 2012-10-26 | 2014-04-16 | 吴俊华 | Application of Gypensapogenin B in medicine for treating myocardial ischemia |
| CN105147631A (en) * | 2015-09-28 | 2015-12-16 | 宁夏康亚药业有限公司 | Fenofibric acid tablet and preparing method thereof |
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Address after: 100083 A building, block 15, Tiangong building, No. 30, Haidian District, Beijing, Xueyuan Road Patentee after: COSCI MED-TECH Co.,Ltd. Address before: 100080, Haidian District satellite building, No. 63, Zhichun Road, Beijing, room 1410, Beijing Patentee before: COSCI MED-TECH Co.,Ltd. |
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