CN1899506A - Shenmai oral disintegration tablet and its preparing method - Google Patents
Shenmai oral disintegration tablet and its preparing method Download PDFInfo
- Publication number
- CN1899506A CN1899506A CN 200510087020 CN200510087020A CN1899506A CN 1899506 A CN1899506 A CN 1899506A CN 200510087020 CN200510087020 CN 200510087020 CN 200510087020 A CN200510087020 A CN 200510087020A CN 1899506 A CN1899506 A CN 1899506A
- Authority
- CN
- China
- Prior art keywords
- extract
- shenmai
- filler
- disintegrating agent
- lubricant
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The Shenmai orally disintegrating tablet consists of the extract of Chinese medicine material ginseng and ophiopogon root and optimized medicinal supplementary material. Pharmaceutical experiment shows that the Shenmai orally disintegrating tablet has the features of fast disintegrating, fast acting and high pharmaceutical effect.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of Shenmai oral disintegration tablet and preparation method thereof.
Background technology
Radix Ginseng, Radix Ophiopogonis, prescription was prepared into SHENMAI ZHUSHEYE, very extensive in clinical practice, obtained extraordinary curative effect, obtain doctor and patient's approval, has supplementing QI to prevent collapse, YIN nourishing and the production of body fluid promoting is given birth to the effect of arteries and veins, is used for the treatment of shock, coronary heart disease, viral myocarditis, chronic cardiopulmonary disease, the granulocytopenia of type of deficiency of both QI and YIN; SHENMAI ZHUSHEYE is one of indispensable Chinese patent medicine of national institute of traditional Chinese medicine emergency treatment.Along with clinical extensive use, its untoward reaction performance more and more widely, main adverse reaction comprises: anaphylaxis, anaphylactic shock, erythra chest pain, backache, tachycardia, respiratory tract obstruction, severe dyspnea, low grade fever, mucositis mucosal symptoms, upper gastrointestinal hemorrhage etc. [2005 the 19th the 4th phases of volume of Chinese Pharmaceutical Affairs, " SHENMAI ZHUSHEYE analysis of adverse reactions "]; In addition, injection system is mainly taked in the SHENMAI ZHUSHEYE first aid, need certain device and professional, send the patient to go to hospital also will stall for time, therefore the injection containing ginseng extract formulation preparation should be become a kind of novel form, have onset rapidly, steady quality, advantage such as easy to use, this is a lot of Chinese medicine research personnel problems to be solved.
Oral cavity disintegration tablet is a kind of new pharmaceutical preparation, it can absorb through hypoglossis mucous membrane, directly enter blood, avoided first pass effect effectively, therefore taking dose is little, safety is good, and effect is rapid, though be oral formulations, but can reach the effect of ejection preparation, therefore just progressively become the focus that pharmaceutical manufacturer and research and development field are paid close attention to, this dosage form mainly is to select suitable fast disintegrant, by the existing certain rigidity of its tablet of making, certain sedimentation is arranged again, can not need the water assisting deglutition when taking, can rapid disintegrate become fine grained in the oral cavity, only several swallowing acts can be finished drug administration process.Its more common solid orally ingestible absorbs fast, bioavailability height, and taking convenience.
Preparation traditional Chinese medicine mouth cavity disintegrating tablet subject matter is sensory issues, the traditional Chinese medicine mouth cavity disintegrating tablet is owing to becoming fine particle at intraoral disintegration or existing with molecularity, thereby bitterness sense is arranged, medicine that zest is heavier and water-insoluble adjuvant also can cause certain sensory issues; Sensory issues mainly is grittiness and bitterness, can not be dissolved into the molecule attitude fully because of insoluble adjuvant, and a kind of grittiness is often arranged in pill taker's mouth; Therefore, when the preparation oral cavity disintegration tablet, different extracts mixes the ratio that a kind of the best is all arranged with pharmaceutic adjuvant, the oral cavity disintegration tablet disintegration rate for preparing under this optimal proportion is fast, and pharmacological action is good, therefore, must be when the preparation oral cavity disintegration tablet according to the chemical property and the physical property of Chinese medicine extract, determine the ratio of suitable pharmaceutic adjuvant and pharmaceutic adjuvant, make oral cavity disintegration tablet meet the characteristics of this dosage form, do not strengthen patient's dose again
Consult patent and document, do not retrieve the data of Shenmai oral disintegration tablet.
Summary of the invention
For these reasons, we carry out deep analysis at the physical property and the chemical property of Radix Ginseng extract, Radix Ophiopogonis extract, by a large amount of experimentatioies, add disintegrating agent, filler, lubricant, according to the mouthfeel of Radix Ginseng, Radix Ophiopogonis extract character preferably, do not add correctives, be prepared into oral cavity disintegration tablet, have the characteristics fast, that onset is rapid, pharmacological action is good of separating.
We are when research Shenmai oral disintegration tablet preparation process, determine a kind of ratio of the best, be the ratio of extract and pharmaceutic adjuvant: Radix Ginseng extract is the 4.5-7.5 weight portion, Radix Ophiopogonis extract 1-3 weight portion, pharmaceutic adjuvant is the 89.5-94.5 weight portion, wherein disintegrating agent is the 29-31 weight portion, filler is the 56-60 weight portion, lubricant 3.5-4.5 weight portion, the Shenmai oral disintegration tablet for preparing under this ratio meets the requirement of oral cavity disintegration tablet fully, disintegration rate is fast, and the effective ingredient dissolution rate of extract is fast, has better pharmacological action.
The present invention is achieved through the following technical solutions.
One. process recipes
Preparation prescription is: Radix Ginseng extract is the 4.5-7.5 weight portion, and Radix Ophiopogonis extract 1-3 weight portion, pharmaceutic adjuvant are the 89.5-94.5 weight portion, and wherein disintegrating agent is the 29-31 weight portion, and filler is the 56-60 weight portion, lubricant 3.5-4.5 weight portion;
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains Shenmai oral disintegration tablet.
Wherein disintegrating agent is low-substituted hydroxypropyl cellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa), crospolyvinylpyrrolidone (PVPP), crosslinked carboxymethylstach sodium (CCMS-Na); Erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone are formed;
Wherein filler is a kind of in microcrystalline Cellulose, the nano micro crystal cellulose;
Wherein lubricant is a kind of in magnesium stearate, Pulvis Talci, the Stepanol MG;
In the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 50%-85%;
Radix Ophiopogonis extract is counted 50%-85% with ophiopogonin;
The invention reside in provides the Shenmai oral disintegration tablet that a kind of mouthfeel is good, rapid-action, toxic and side effects is little;
The present invention also is to provide a kind of preparation method of Shenmai oral disintegration tablet.
Two. the check and analysis experiment
1. panaxoside Rg, Rb in the Radix Ginseng extract
1, Re check and analysis
According to high effective liquid chromatography for measuring.
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile 0.05% phosphoric acid solution (19: 81) is a mobile phase; The detection wavelength is 203nm.
The preparation of reference substance solution: precision takes by weighing panaxoside Rg, the Rb that is dried to constant weight in phosphorus pentoxide desiccator
1, each 5mg of Re, put in the 25ml measuring bottle, add acetonitrile: water (19: 81) shakes up to scale, and precision is measured 5ml, puts in the 10ml measuring bottle, adds acetonitrile: water (19: 81) is diluted to scale, shakes up, promptly.
The preparation of need testing solution: get end user's conopsea extraction raw material 10mg of the present invention and put in the 25ml measuring bottle, add acetonitrile: water (19: 81) shakes up to scale, precision is measured 5ml, puts in the 10ml measuring bottle, adds acetonitrile: water (19: 81) is diluted to scale, shake up, promptly get as need testing solution.
Algoscopy: accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing, inject chromatograph of liquid respectively, measure, promptly.The results are shown in Table 1:
Table 1 Radix Ginseng extract assay
| Group | Ginsenoside Rg, Rb 1, Re content % |
| Radix Ginseng extract | 50-85 |
2. extract assay Radix Ophiopogonis
Tlc scanning determination Saponin Radix Ophiopogonis constituents
Experimental drug: ophiopogonin B (ophioponinB), D (ophio-pogoninD) (Shenyang Pharmaceutical University's Chinese patent medicine is analyzed teaching and research room); The Radix Ophiopogonis extract raw material (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides) that the present invention uses
Experimental apparatus: Tianjin, island CS-930 type thin-layer chromatogram scanner; Silica gel plate (German Merck company).
Chromatographic condition: developing solvent is ethyl acetate-methanol-water (15: 5: 1), and developer is 10% sulphuric acid, and scan mode is saw-tooth sweep, SX=6, slit: 1.2mm * 1.2mm.Through in the interscan of 370～700nm scope, determine that 570nm is the mensuration wavelength of ophiopogonin B, D.
The standard curve preparation: precision takes by weighing ophiopogonin B, D, with methanol constant volume, make that its concentration is respectively 0.9,1.0g/L, draw 2.0,4.0,6.0,8.0,10.0 μ L point samples respectively, launch, after the colour developing, measure the area integral value, concentration range is at 2～10 μ g, and the regression equation of ophiopogonin B, D (n=5) is respectively:
Y＝-1.675×104+1.426×104C r＝0.992
Y＝-3.904×104+1.714×104C r＝0.997
Sample determination: get Radix Ophiopogonis extract sample and ophiopogonin B, D contrast liquid point sample 5.0 μ L respectively, measure by the chromatographic condition of Saponin analysis.Assay the results are shown in Table 2.
Table 2 Radix Ophiopogonis extract assay
| Group | In ophiopogonin % |
| Radix Ophiopogonis extract | 50-85 |
Conclusion: show that by above-mentioned experiment technology of the present invention has practical significance.
Determining by following optimization experiment of extract of the present invention and pharmaceutic adjuvant optimal proportion preparation technology is definite.
Three. extract and pharmaceutic adjuvant determination of ratio
Character according to Radix Ginseng extract, Radix Ophiopogonis extract, we determine that pharmaceutic adjuvant is less than 80 weight portions, can not prepare tablet, pharmaceutic adjuvant surpasses 98 weight portions, the pressure that the tablet that is pressed into needs is very big, do not meet the requirement of oral cavity disintegration tablet, therefore, we determine that tentatively pharmaceutic adjuvant 80-98 weight portion experimentizes, to obtain optimal proportion, we are by the pharmaceutic adjuvant of different proportion, and different proportion such as disintegrating agent experimentizes in the pharmaceutic adjuvant, mainly investigates experiment by the disintegrating agent performance to oral cavity disintegration tablet.
Determining of experimental program:
Scheme 1: extract 20 weight portions, pharmaceutic adjuvant accounts for 80 weight portions, and wherein filler is 51 weight portions, and disintegrating agent is 25 weight portions, and lubricant is 4 weight portions.
Scheme 2: extract accounts for 15 weight portions, pharmaceutic adjuvant 85 weight portions, and wherein filler is 54 weight portions, and disintegrating agent is 27 weight portions, and lubricant is 4 weight portions.
Scheme 3: extract accounts for 10.5 weight portions, pharmaceutic adjuvant 89.5 weight portions, and wherein filler is 56 weight portions, and disintegrating agent is 29 weight portions, and lubricant is 4.5 weight portions.
Scheme 4: extract accounts for 9 weight portions, and pharmaceutic adjuvant accounts for 91 weight portions, and wherein filler is 57 weight portions, and disintegrating agent is 30 weight portions, and lubricant is 4 weight portions.
Scheme 5: extract 7 weight portions, pharmaceutic adjuvant accounts for 93 weight portions, and wherein filler is 58 weight portions, and disintegrating agent is 31 weight portions, and lubricant is 4 weight portions.
Scheme 6: extract 5.5 weight portions, pharmaceutic adjuvant accounts for 94.5 weight portions, and wherein filler is 60 weight portions, and disintegrating agent is 31 weight portions, and lubricant is 3.5 weight portions.
Scheme 7: extract accounts for 5 weight portions, and pharmaceutic adjuvant accounts for 95 weight portions, and wherein filler is 62 weight portions, and disintegrating agent is 31 weight portions, and lubricant is 2 weight portions.
Scheme 8: extract accounts for 2 weight portions, and pharmaceutic adjuvant accounts for 98 weight portions, and wherein filler is 65 weight portions, and disintegrating agent is 30 weight portions, and lubricant is 3 weight portions.
Experimental technique one:
(1) solubility experiment: the saturated aqueous solution at 37 ℃ of preparation samples, utilize membrane filter to filter, obtain filtrate, the filtrate of predetermined of accurately weighing is utilized the freeze-drying drying, thereby is obtained the content of water, calculate water-soluble on the water content basis that obtains thus again, the results are shown in Table 3.
(2) viscosity experiment: the saturated aqueous solutions at 37 ℃ of different disintegrating agents of preparation, utilize membrane filter to filter, obtain filtrate, utilize viscometer to obtain filtrate 37 ℃ viscosity, the results are shown in Table 3.
(3) measurement of wettability: precision takes by weighing above-mentioned oral cavity disintegration tablet, dry weighs fully, is put into 1 week under 25 ℃ and 75% the damp condition, takes by weighing weight, and calculating wettability (%) sees Table 3.
(5) volume increases percent: the volume of moisture absorption fore-and-aft survey disintegrating agent, calculate the percent (%) of the volume increase of oral cavity disintegration tablet, and see Table 3.
Table 3 disintegrating agent performance is investigated relatively
| Group | Dissolubility (37 ℃) W/V | Viscosity (37 ℃) mpa.s | Wettability % | Volume increases percent % |
| Scheme 1 scheme 2 schemes 3 schemes 4 schemes 5 | 6.5 6.1 5.5 4.8 4.4 | 2.9 3.2 3.3 3.5 3.6 | 0.12 0.17 0.24 0.28 0.34 | 0.08 0.31 0.23 0.25 0.26 |
| Scheme 6 schemes 7 schemes 8 | 4.3 4.0 3.7 | 3.8 4.3 4.4 | 0.40 0.59 0.62 | 0.41 0.52 0.79 |
Experimental technique two:
(1) hardness of mensuration tablet: utilize the tablet hardness tester to measure the hardness of tablet, the results are shown in Table 4.
(2) stability experiment: tablet is put into 12 weeks under 25 ℃ and 75% the damp condition, observes the tablet spoilage, the results are shown in Table 4.
(3) disintegrate experiment: according to the disintegration of tablet method of testing of stipulating in the Pharmacopoeia of People's Republic of China, utilize the disintegrate tester to measure, the results are shown in Table 4.
(4) disintegrate test in the oral cavity, disintegration time, grittiness, taste to three health adults have tested experimental group the results are shown in Table 4.
Table 4 disintegrating property is investigated
| Experimental group | Hardness (kg) | Spoilage (%) | Disintegration time (s) | The Orally disintegrating time (s) | Grittiness | Taste |
| Scheme 1 scheme 2 schemes 3 schemes 4 schemes 5 schemes 6 schemes 7 schemes 8 | 4.3 4.6 4.6 4.7 4.8 5.6 7.4 7.8 | 18.7 17.3 6.5. 6.0 5.3 4.1 3.9 3.4 | 39.1 36.4 19.7 19.2 18.1 19.6 68.4 74.3 | 46.3 42.9 27.1 26.3 24.6 25.7 - - | Seldom have | General carefully good OK bad |
Annotate: we carry out a series of variations with disintegrating agent, filler, lubricant ratio in experimental program 1, scheme 2 pharmaceutic adjuvants, and experimental result changes little.
Experimental technique three
1. disintegration: get above-mentioned Shenmai oral disintegration tablet, place the beaker of the 10ml that fills 37 ℃ of water of 5ml, stir, calculate whole disintegrates and the required time by No. 2 sieves with 30 rev/mins speed.The results are shown in Table 5;
2. dissolution experiment
(1) instrument and reagent: the full-automatic digestion instrument of SR-6 type (U.S. Hanson company); Distilled water (self-control); Shenmai oral disintegration tablet (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides);
(2) experimental technique: second method of pressing in the dissolution method (" 2005 editions two appendix XC of Chinese pharmacopoeia) is measured.Each container fills the distilled water through degassing processing of 100ml, and heating makes water temperature remain on 37 ℃ ± 0.5 ℃, and rotating speed of agitator is 50 rev/mins.Put into 1 of Shenmai oral disintegration tablet of the present invention, in the time of 20 minutes, get 2ml solution, centrifugal 10 minutes (12000rpm), supernatant is as need testing solution.Measure with above-mentioned check and analysis ophiopogonin assay method.The record effective ingredient no longer the time of stripping be the time of whole strippings, and dissolution the results are shown in Table 5.
Table 5 disintegration, dissolution are relatively
| Group | The time (second) of whole disintegrates | The time (branch) of whole strippings | The content of dissolution ophiopogonin (mg/ml) |
| Scheme 1 scheme 2 schemes 3 schemes 4 schemes 5 schemes 6 schemes 7 schemes 8 | 40.2 39.8 19.1 18.7 18.7 19.8 66.4 74.8 | 6.2 6.3 4.3 3.8 3.6 4.1 10.9 11.3 | 2.25 2.04 1.91 1.72 1.58 1.47 1.02 0.87 |
Conclusion: the preferred proportion of determining extract and pharmaceutic adjuvant by above-mentioned experiment is: Radix Ginseng extract is the 4.5-7.5 weight portion, Radix Ophiopogonis extract 1-3 weight portion, pharmaceutic adjuvant is the 89.5-94.5 weight portion, wherein disintegrating agent is the 29-31 weight portion, filler is the 56-60 weight portion, lubricant 3.5-4.5 weight portion
Four. toxicological experiment
Acute toxicological experiment
Experiment medicine: SHENMAI ZHUSHEYE (Shijiazhuang Shineway Pharmaceutical Co., Ltd); Shenmai oral disintegration tablet of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides);
Laboratory animal: healthy mice 18-22g,, male and female half and half;
Experimental technique: get mice, be divided into commercially available SHENMAI ZHUSHEYE group, this patent Shenmai oral disintegration tablet group, commercially available injection SHENMAI ZHUSHEYE intraperitoneal administration, this patent Shenmai oral disintegration tablet group gastric infusion is converted into the mice dosage according to body surface area, administration every day 3 times, continuous 7 days, observe the dead mouse situation, record data calculate LD by the improvement karber's method
50The value experimental result sees Table 6:
Table 6 mice medication LD
50Value relatively
| Group | Number of animals only | LD 50 g/kg |
| Commercially available SHENMAI ZHUSHEYE group this patent Shenmai oral disintegration tablet group | 20 20 | 23.6 28.9 |
Conclusion: show that by above-mentioned experiment Shenmai oral disintegration tablet of the present invention is better than commercially available safety of Shenmai injection.
Five. pharmacological evaluation
Experiment 1
To the Acute Myocardial Ischemia in Rats protective effect
Experiment medicine: SHENMAI ZHUSHEYE (Shijiazhuang Shineway Pharmaceutical Co., Ltd); Shenmai oral disintegration tablet of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides); (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides normal saline
Laboratory animal: 50 of animal wister rat, male, body weight (300 ± 20) g.
Experimental technique: the ramus descendens anterior arteriae coronariae sinistrae of ligation rat causes the acute myocardial ischemia model.Society's nano injection liquid group is carried out tail intravenously administrable (1.5g/kg administration), the Shenmai oral disintegration tablet gastric infusion, and dosage is 1.5g/kg, administration is 20% urethane (1g/kg, p) anesthesia, separation common carotid artery after 45 minutes, parallel trachea is inserted art, connects animal respirator.Left side the 4th intercostal is opened breast, cuts off pericardium, separates ramus descendens anterior arteriae coronariae sinistrae, and the ligation position is done in flat right auricle.The taking-up heart is weighed,-10 ℃ of freezing 30～50min, under the heart ligature, parallel coronary sulcus becomes 5 with the ventricle crosscut, behind the normal saline flushing, the concentration that places the preparation of pH value 8.0 phosphate buffers is 1% triphenyltetrazolium chloride (TTC) solution, 10min dyes in 38 ℃ of waters bath with thermostatic control, normal myocardium is coloured to kermesinus, infarcted myocardium is dyed lark, cuts off the part that myocardium sheet is colored, and the ischemic infarction district cardiac muscle that is not colored is weighed, (the ischemic infarction area accounts for heavy whole-heartedly percentage ratio, the results are shown in Table 7 to calculate the ischemia scope.
Table 7 group preparation is to the Acute Myocardial Ischemia in Rats protective effect
| Group | Heart heavy (g) | Heart infarction heavy (g) | Heart infarction percentage rate (%) |
| Normal saline SHENMAI ZHUSHEYE oral cavity disintegration tablet group of the present invention | 0.926 0.880 0.901 | 0.192 0.103 0.111 | 20.73 11.70 ** 12.31 ** |
Compare with the normal saline group
*P＜0.01,
Embodiment 2
The short effect of waking up to mice
Laboratory animal: mice: 50 of Kunming kind white mice in vigorous health, body weight 18-22g, male and female half and half.
Experiment medicine: SHENMAI ZHUSHEYE (Shijiazhuang Shineway Pharmaceutical Co., Ltd); Shenmai oral disintegration tablet of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides); (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides normal saline
Experimental technique: get 50 of mices, random packet, every group 10, tail vein injection is given normal saline solution respectively, SHENMAI ZHUSHEYE (dosage is the 2.0g/kg administration), oral cavity disintegration tablet gastric infusion of the present invention (dosage is the 2.0g/kg administration), once a day, successive administration 2d, 15min after the last administration, the every 20g body weight of mice lumbar injection pentobarbital sodium normal saline solution (3mg/ml) 0.3ml, meter record mice righting reflex loss is to the time of recovering, calculate each class mean and standard deviation, carry out the t check,, the results are shown in Table 8 with blank group comparing difference significance.
Table 8 is respectively organized preparation to the short effect of waking up of mice
| Group | Number of animals (only) | Mice recovery time (min) |
| Normal saline SHENMAI ZHUSHEYE oral cavity disintegration tablet group of the present invention | 10 10 10 | 29.1±4.0 21.0±3.6 ** 22.9±4.1 ** |
Compare with the normal saline group
*P＜0.01,
Conclusion: show that by pharmacological evaluation Shenmai oral disintegration tablet of the present invention and SHENMAI ZHUSHEYE have great pharmacological effects.
The present invention respectively organizes preparation and also can be used for treatment for cancer.
Six. preparation embodiment
Embodiment 1
Preparation prescription is: Radix Ginseng extract is 4.5 grams, and Radix Ophiopogonis extract 1 gram, pharmaceutic adjuvant are 94.5 grams, and wherein disintegrating agent low-substituted hydroxypropyl cellulose (L-HPC) is 31 grams, and filler is microcrystalline Cellulose 60 grams, magnesium stearate lubricant 3.5 grams; [in the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 85%; Radix Ophiopogonis extract counts 85% with ophiopogonin; ]
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains 1000 of Shenmai oral disintegration tablets.
Embodiment 2
Preparation prescription is: Radix Ginseng extract is 7.5 grams, and Radix Ophiopogonis extract 3 grams, pharmaceutic adjuvant are 89.5 grams, and wherein disintegrating agent cross-linking sodium carboxymethyl cellulose (CCNa) is 29 grams, and the filler nano micro crystal cellulose is 56 grams, lubricant Pulvis Talci 4.5 grams; [in the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 50%; Radix Ophiopogonis extract counts 50% with ophiopogonin; ]
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains 1000 of Shenmai oral disintegration tablets.
Embodiment 3
Preparation prescription is: Radix Ginseng extract is 6.0 grams, and Radix Ophiopogonis extract 2 grams, pharmaceutic adjuvant are 92 grams, and wherein disintegrating agent crospolyvinylpyrrolidone (PVPP) is 30 grams, and the filler microcrystalline Cellulose is 58 grams, lubricant Stepanol MG 4 grams; [in the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 70%; Radix Ophiopogonis extract counts 65% with ophiopogonin; ]
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains 1000 of Shenmai oral disintegration tablets.
Embodiment 4
Preparation prescription is: Radix Ginseng extract is 5.0 grams, and Radix Ophiopogonis extract 1.5 grams, pharmaceutic adjuvant are 93.5 grams, and wherein the crosslinked carboxymethylstach sodium of disintegrating agent (CCMS-Na) is 31 grams, and the filler nano micro crystal cellulose is 59 grams, magnesium stearate lubricant 3.5 grams; [in the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 82%; Radix Ophiopogonis extract counts 79% with ophiopogonin; ]
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains 1000 of Shenmai oral disintegration tablets.
Embodiment 5
Preparation prescription is: Radix Ginseng extract is 5.5 grams, and Radix Ophiopogonis extract 1.8 grams, pharmaceutic adjuvant are 92.7 grams, and wherein disintegrating agent erythritol and chitin are 31 grams, and the filler nano micro crystal cellulose is 58 grams, lubricant Pulvis Talci 3.7 grams; [in the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 76%; Radix Ophiopogonis extract counts 77% with ophiopogonin; ]
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains 1000 of Shenmai oral disintegration tablets.
Embodiment 6
Preparation prescription is: Radix Ginseng extract is 6.5 grams, Radix Ophiopogonis extract 2.2 grams, pharmaceutic adjuvant are 91.3 grams, and wherein disintegrating agent erythritol, low-substituted hydroxypropyl methylcellulose are 29 grams, the filler microcrystalline Cellulose is 58 grams, lubricant Stepanol MG 4.3 grams; [in the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 60%; Radix Ophiopogonis extract counts 57% with ophiopogonin; ]
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains 1000 of Shenmai oral disintegration tablets.
Embodiment 7
Preparation prescription is: Radix Ginseng extract is 7.0 grams, and Radix Ophiopogonis extract 2.8 grams, pharmaceutic adjuvant are 90.2 grams, and wherein disintegrating agent erythritol, crosslinked carboxymethyl fecula sodium are 30 grams, and the filler microcrystalline Cellulose is 56 grams, magnesium stearate lubricant 4.2 grams; [in the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 54%; Radix Ophiopogonis extract counts 57% with ophiopogonin; ]
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains 1000 of Shenmai oral disintegration tablets.
Claims (3)
1. Shenmai oral disintegration tablet, it is characterized in that it is is the 4.5-7.5 weight portion by Radix Ginseng extract, Radix Ophiopogonis extract 1-3 weight portion, pharmaceutic adjuvant is prepared from for the 89.5-94.5 weight portion, wherein disintegrating agent is the 29-31 weight portion in the pharmaceutic adjuvant, filler is the 56-60 weight portion, lubricant 3.5-4.5 weight portion; Its feature also is in the Radix Ginseng extract with ginsenoside Rg, Rb
1, Re counts 50%-85%; Radix Ophiopogonis extract is counted 50%-85% with ophiopogonin.
2. according to a kind of Shenmai oral disintegration tablet of claim 1, wherein preparation method may further comprise the steps:
(1) get Radix Ginseng extract, Radix Ophiopogonis extract respectively, pulverize, sieve, standby;
(2) get disintegrating agent, filler, lubricant respectively, pulverize, sieve, standby;
(3) get Radix Ginseng extract, the Radix Ophiopogonis extract pulverized and mix, add filler, add lubricant with the disintegrating agent of pulverizing, mix homogeneously, tabletting obtains Shenmai oral disintegration tablet.
3. Shenmai oral disintegration tablet according to claim 1 and 2, wherein filler is a kind of in microcrystalline Cellulose, the nano micro crystal cellulose.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510087020 CN1899506A (en) | 2005-07-22 | 2005-07-22 | Shenmai oral disintegration tablet and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510087020 CN1899506A (en) | 2005-07-22 | 2005-07-22 | Shenmai oral disintegration tablet and its preparing method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1899506A true CN1899506A (en) | 2007-01-24 |
Family
ID=37655617
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510087020 Pending CN1899506A (en) | 2005-07-22 | 2005-07-22 | Shenmai oral disintegration tablet and its preparing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1899506A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104839722A (en) * | 2015-06-03 | 2015-08-19 | 通化百泉保健食品有限公司 | Ginseng and Chinese yam compound healthcare buccal tablet and preparation method thereof |
| CN104839723A (en) * | 2015-06-03 | 2015-08-19 | 通化百泉保健食品有限公司 | Ginseng and radix ophiopogonis composite health buccal tablet and preparation method thereof |
-
2005
- 2005-07-22 CN CN 200510087020 patent/CN1899506A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104839722A (en) * | 2015-06-03 | 2015-08-19 | 通化百泉保健食品有限公司 | Ginseng and Chinese yam compound healthcare buccal tablet and preparation method thereof |
| CN104839723A (en) * | 2015-06-03 | 2015-08-19 | 通化百泉保健食品有限公司 | Ginseng and radix ophiopogonis composite health buccal tablet and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1939298A (en) | Schuqindin sulfate solid and target preparation and their making method | |
| CN1853631A (en) | Fast disintegrant containing paroxetine | |
| CN1799543A (en) | Telmisartan dispersible tablet and its preparation method | |
| CN1899506A (en) | Shenmai oral disintegration tablet and its preparing method | |
| CN108785268B (en) | Sotalol hydrochloride preparation and preparation method thereof | |
| CN1582952A (en) | Use of asiaticoside in preparation of medicines for diseases of cardio-cerebral blood vessels | |
| CN1899397A (en) | Heart activating oral disintergration tablet and its preparing method | |
| CN1887277A (en) | Dispersant tablet containing hypolipidemic component and its prepn process | |
| CN1548121A (en) | Soft antiviral capsule and its prepn | |
| CN1277569C (en) | Orally disintegrating tablet of 'Shengmai' and its preparation | |
| CN1273116C (en) | Orally disintegrating tablet of gingko leaf and its preparation process | |
| CN1682926A (en) | Ginseng-ophiopogon root freeze-dried powder injection and its preparing method | |
| CN1891256A (en) | Red sage root dispersible tablet for treating cornary heart diseae and its preparing method | |
| CN1285332C (en) | Ginkgo keto-ester soft capsules with long stable effect and preparation thereof | |
| CN1593633A (en) | Orally disintegrating tablet for dredging vascular thrombus and its preparation process | |
| CN1293895C (en) | Oral disintegration tablet for laryngopathy and its preparing method | |
| CN1278705C (en) | Orally disintegrating tablet of 'Tongxinluo' and its preparation | |
| CN1271995C (en) | Orally disintegrating tablet of 'Xintongning' and its preparation | |
| CN1259037C (en) | Orally disintegrating tablet of antiviral medicine and its preparation process | |
| CN1283231C (en) | Orally disintegrating tablet and its preparation | |
| CN1253156C (en) | Orally disintegrating tablet of | |
| CN1267128C (en) | Orally disintegrating tablet of 'Huoxiang Zhengqi' and its preparation process | |
| CN1634014A (en) | Sodium ferulate oral disintegrating tablet and its preparation process | |
| CN1296070C (en) | Cinnamon twig and poria oral disnitegration tablet and its preparing method | |
| CN1309379C (en) | Asari dripping pills and its preparation process |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |