CN1586555A - Cinnamon twig and poria oral disnitegration tablet and its preparing method - Google Patents
Cinnamon twig and poria oral disnitegration tablet and its preparing method Download PDFInfo
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Abstract
The cinnamon twig-Poria oral disintegrated tablet consists of effective components extracted from cinnamon twig, Poria, tree peony bark, red peony root and peach kernel and medicinal supplementary material. The present invention features its composite disintegrating agent, which consists of erythritol and chitin, substituted hydroxypropyl methyl cellulose, carboxymethyl starch sodium, cross-linked carboxymethyl starch sodium or insoluble cross-linked polyvinyl pyrrolidone in certain proportion. The erythritol has also the effect of corrective, and this can reduce the amount of the medicinal supplementary material. Pharmaceutical experiment shows that the cinnamon twig-Poria oral disintegrated tablet of the present invention has fast disintegration speed, fast acting and high pharmacological effect.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of cinnamon twig and poria oral disnitegration tablet and preparation method thereof.
Background technology
Oral cavity disintegration tablet is a kind of new pharmaceutical preparation, and it can absorb through hypoglossis mucous membrane, directly enters blood, has avoided first pass effect effectively, so taking dose is little, and safety is good, and effect rapidly.Though be oral formulations, 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.
The preparation oral cavity disintegration tablet will be considered the problem of following critical aspects: 1, the advantage of oral cavity disintegration tablet just is rapid disintegrate, and it is fast to discharge medicine, reaches rapid-action effect, seeks suitable disintegrants, to guarantee oral cavity disintegration tablet disintegrate rapidly in the oral cavity; 2, seek relatively inexpensive pharmaceutic adjuvant, to reduce production cost; 3, only need the just disintegrate fully of water of minute quantity owing to disintegrating tablet, therefore must consider stability, prolongation shelf life and the shelf-life of humidity environment oral cavity disintegration tablet higher relatively in the process of storage, significant to medical manufacturing enterprise.
Disintegrating agent is commonly used in the oral cavity disintegration tablet adjuvant have low-substituted hydroxypropyl cellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa), crospolyvinylpyrrolidone (PVPP), crosslinked carboxymethylstach sodium (CCMS-Na) etc. [He Jianchang, etc.New oral solid quick releasing formulation-oral cavity quick disintegrating slice.The pharmacy practice magazine, 2000,18 (3): 151].These adjuvants are all water insoluble, but a common characteristic is all arranged, and have hygroscopicity [pharmaceutical preparation portion of Shanghai Institute of Pharmaceutical Industry, Pharmaceutical National Engineering Research Center exactly.Pharmaceutic adjuvant application technology (second edition), Chinese Medicine science and technology publishing house, 2002,73～75].In the higher environment of humidity, oral cavity disintegration tablet is the moisture absorption especially easily, and cracked trend is arranged.So relatively harsher to environment requirement in production, storage and transportation with the oral cavity disintegration tablet that these adjuvants are made, must adopt special packing, seal cover, desiccant bag etc., all can produce considerable influence to production cost.And above-mentioned disintegrating agent all is synthetic through chemical process, and price is higher, for the more relatively oral cavity disintegration tablet of adjuvant content, can cause production cost to increase, and and then can increase patient's financial burden.Therefore, seek disintegrating agent functional, that price is suitable, make that the disintegration time of oral cavity disintegration tablet is shorter, price is more cheap, stability better becomes one of key problem in technology of exploitation oral cavity disintegration tablet.
Application number is 99802175 patent application bibliographical information, and during as disintegrating agent, the hardness of making oral cavity disintegration tablet is identical with disintegration time at the erythritol that uses separately equivalent or low-substituted hydroxypropyl cellulose (L-HPC).The erythritol sweet taste is pure, after eating nice and cool mouthfeel characteristic is arranged, and also can make correctives and use, and reduces the weight of oral cavity disintegration tablet.Erythritol can not influence normal carbohydrate metabolism, is fit to diabetes patient; And be sweet taste material low in calories, be suitable for obese patients, simultaneously caries prevention is also had positive role.
Chitin is the relatively low natural pharmaceutic adjuvant of a kind of price, and it has another name called chitin, chitin, is a kind of biological polysaccharide polymer material, extensively is present in the carapace in the unicellular lower eukaryote.This material can be degraded by lyase, has excellent biological compatibility, avirulence, chemical property quite stable.
Ramulus Cinnamomi Poria pill has played extraordinary effect in clinical practice, but Ramulus Cinnamomi Poria pill in clinical practice because the cause of dosage form caused certain trouble for taking of patient, so the compliance that the patient takes medicine is relatively poor relatively; Do not retrieve the cinnamon twig and poria oral disnitegration tablet data.
Summary of the invention
For these reasons, in the selection course that disintegrating agent uses in oral cavity disintegration tablet, we discover that erythritol and disintegrating agent commonly used at present mix by a certain percentage, form a kind of compound disintegrating agent and have more performance, the oral cavity disintegration tablet made from it compares with the simple oral cavity disintegration tablet that uses erythritol or disintegrating agent commonly used at present to make, the disintegration time of oral cavity disintegration tablet was shortened, and because erythritol does not have hygroscopicity, the stability of the feasible oral cavity disintegration tablet of making significantly improves.In the compound disintegrating agent, erythritol is in the amount ranges of 30%-70%, and along with the increase of content, the disintegration time of oral cavity disintegration tablet shortens, and stability strengthens.
We find that in experiment chitin disintegrating agent effect with commonly used at present aspect the disintegrate effect is suitable, even are better than disintegrating agent commonly used.
We have studied compound disintegrating agent in experiment, select the mixture of use erythritol and chitin, disintegrating agent commonly used, are based on many-sided consideration.When making disintegrating agent with single erythritol, though erythritol does not have hygroscopicity, the tablet stability of making is good, and the swelling degree after the single erythritol suction is less, influences the disintegrating property of oral cavity disintegration tablet, and disintegration time is prolonged.Add a certain amount of disintegrating agent commonly used, utilize rapid expansible character after their moisture absorptions, neither influence the stability of oral cavity disintegration tablet, also kept the characteristic of its rapid disintegrate, reached reasonable effect.
The present invention extracts purification to the Ramulus Cinnamomi in the Ramulus Cinnamomi Poria pill, Poria, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae and obtains effective site, mix with the compound disintegrating agent of the present invention, add filler, lubricant, be prepared into oral cavity disintegration tablet, pharmacological evaluation shows, cinnamon twig and poria oral disnitegration tablet of the present invention has that disintegrate is fast, onset is rapid, the better characteristics of pharmacological action.
One. process recipes
(1) crude drug of the present invention is:
Ramulus Cinnamomi: Poria: Cortex Moutan: Radix Paeoniae Rubra: Semen Persicae=1: 1: 1: 1: 1;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, ratio with 20ml/g-30ml/g adds water, heating for dissolving is chilled to room temperature, and in volatile oil: the ratio of 2-HP-=1: 4-10 (v/w) drips above-mentioned volatile oil, stir while dripping, drip and finish the back, take out, 0-4 ℃ of cooling 20-24 hour 40-50 ℃ of continuation stirring 40-80 minute, centrifugal, filter, under the filtering residue room temperature dry 36-48 hour, obtain the Ramulus Cinnamomi Volatile oil clathrate;
(3) get Poria, add 8-12 times of water, decoct 3 times, each 2-4 hour, merge extractive liquid, filtered, and concentrates, and drying obtains Poria effective site;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.05-1.10 when being concentrated to 20 ℃, last macroporous adsorptive resins, with 5-8 times of column volume water elution, eluent discards earlier, the ethanol elution of reuse 50%-85%, 4-8 times column volume, eluent reclaims ethanol, concentrates, drying obtains the effective site of Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae;
(5) the effective site 112-124 weight portion of getting Ramulus Cinnamomi Volatile oil clathrate 14-29 weight portion, Poria effective site 20-40 weight portion, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae mixes with compound recipe disintegrating agent 62-76 weight portion, add filler 139-170 weight portion, granulate, add lubricant 6-8 weight portion, tabletting obtains cinnamon twig and poria oral disnitegration tablet.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
A kind of for in the microcrystalline Cellulose, nano micro crystal cellulose of filler.
Lubricant is a kind of in magnesium stearate, Pulvis Talci, the Stepanol MG.
Macroporous adsorbent resin is nonpolar or the low pole macroporous absorption
Two. the disintegrating agent performance is investigated experiment
Experimental raw: erythritol, chitin, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, insoluble crospolyvinylpyrrolidone, buy by market.
Experimental technique:
(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 1.
(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 1.
(3) measurement of wettability: precision takes by weighing above-mentioned disintegrating agent, dry weighs fully, is put into 1 week under 25 ℃ and 75% the damp condition, takes by weighing weight, and calculating wettability (%) sees Table 1.
(4) volume increases percent: the volume of moisture absorption fore-and-aft survey disintegrating agent, calculate the percent (%) of the volume increase of disintegrating agent, and see Table 1.
Table 1 disintegrating agent performance is investigated relatively
Viscosity (37 ℃) wettability
Disintegrating agent dissolubility (37 ℃) W/V volume increases percent %
mpa.s ％
Erythritol 45 3.5 0.03 0.02
Chitin----11.29 16.57
Low-substituted hydroxypropyl methylcellulose----14.09 20.36
Carboxymethyl starch sodium----21.07 22.89
Crosslinked carboxymethyl fecula sodium----22.18 28.14
Insoluble crospolyvinylpyrrolidone----22.64 27.62
Conclusion: the characteristics of investigating experiment and oral cavity disintegration tablet by above-mentioned performance, we can analyze, erythritol has very big advantage as disintegrating agent in wettability, but because its moisture pick-up properties is very little, volume increase degree is also very little, therefore, in disintegrating procedue volumetric expansion slow, can not reach the requirement of the rapid disintegrate of oral cavity disintegration tablet; Erythritol is again good correctives simultaneously, not only can be used as disintegrating agent but also can be used as correctives if choose suitable weight, can significantly reduce consumption, the operation in the formulation preparation process and the cost of preparation of pharmaceutic adjuvant; Other disintegrating agent hygroscopicity are too big, cause oral cavity disintegration tablet very poor aspect stable; By analyzing, erythritol is carried out mixing of proper proportion with other disintegrating agent, the compound disintegrating agent as oral cavity disintegration tablet has good advantages.
Three. the selection of compound disintegrating agent
Experimental raw: choose crosslinked carboxymethyl fecula sodium and carry out different proportion with erythritol and mix, mixed proportion is respectively erythritol: crosslinked carboxymethyl fecula sodium=1: 9 or 2: 8 or 3: 7 or 4: 6 or 5: 5 or 6: 4 or 7: 3 or 8: 2 or 9: 1, totally 9 groups, be respectively experimental group 1-9, with experimental group 1-9 and same filler (in microcrystalline Cellulose, the nano micro crystal cellulose a kind of) and lubricant (in magnesium stearate, Pulvis Talci, the Stepanol MG a kind of), carry out tabletting; Change above-mentioned disintegrating agent into chitin,, be experimental group 10, carry out tabletting with same filler, mix lubricant with weight; Change above-mentioned disintegrating agent into weight crosslinked carboxymethyl fecula sodium, with same filler, mix lubricant, experimental group 11 carries out tabletting.
Experimental technique:
(1) hardness of mensuration tablet: utilize the tablet hardness tester to measure the hardness of tablet, the results are shown in Table 2.
(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 2.
(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 2.
(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 2.
The selection of table 2 experimental group disintegrating agent
The hardness spoilage
Experimental group disintegration time (s) Orally disintegrating time (s) grittiness taste
(kg) (％)
1 4.1 22.1 42.1 51.2 have bad
2 3.9 21.6 43.6 52.9 have generally
3 2.1 9.3. 26.3 32.9 are seldom good
4 2.2 8.6 25.2 28.3 is seldom good
5 2.2 8.1 26.1 26.7 is seldom good
6 2.1 8.6 26.9 27.4 is seldom good
7 2.0 9.3 26.8 27.3 is seldom good
8 1.9 9.6 35.9 38.6 is seldom good
9 1.8 10.2 35.6 39.1 is seldom good
10 4.6 33.9 54.1 62.9 have much very poor
11 4.8 36.5 55.6 62.8 have much very poor
Change above-mentioned chitin, crosslinked carboxymethyl fecula sodium into chitosan, low-substituted hydroxypropyl methylcellulose, crosslinked carboxymethyl fecula sodium, insoluble crospolyvinylpyrrolidone, experimentize, the result of experiment conclusion and table 2 is close.
Conclusion: experimental result shows, erythritol is mixed with into the mixing disintegrating agent with other disintegrating agent, has good effect, simultaneously because erythritol has sweet taste, so can reduce or replace correctives to use, by experiment erythritol: the suitable ratio of other disintegrating agent be 3-7: 7-3.
Four. check and analysis
Be that [content detection] in the standard of Ramulus Cinnamomi Poria pill of WS-11424 (ZD-1424)-2002 carried out check and analysis according to standard No., obtain the results are shown in Table 3:
Table 3 is respectively organized the preparation component content relatively
Group cinnamic acid (C
9H
8O
2)
Ramulus Cinnamomi Poria pill 0.72mg/ ball
Cinnamon twig and poria oral disnitegration tablet 0.93mg/ sheet
Conclusion: the active constituent content by check and analysis experiment oral cavity disintegration tablet of the present invention obviously improves, and proves absolutely that technology of the present invention has practical significance.
Five. the preparation disintegration time mensuration
In order to prove absolutely that the employed compound disintegrating agent of cinnamon twig and poria oral disnitegration tablet of the present invention has disintegrate characteristics rapidly than single disintegrating agent, we have carried out following experiment: disintegrating agent is selected in the design by table 4 for use, make into oral cavity disintegration tablet with effective ingredient at identical pressure lower sheeting, place the beaker of the 10ml that fills 37 ℃ of water of 5ml, stir with 30 rev/mins speed, measure the disintegration of the oral cavity disintegration tablet that contains different disintegrating agents.
The disintegration time mensuration of the different disintegrating agents of table 4
Disintegrating agent
Real disintegration
Test consumption (s)
Number form (g: g)
1 chitin-30.1
2 erythritols: chitin (3: 7) 18.3
3 low-substituted hydroxypropyl methylcellulose-27.6
4 erythritols: low-substituted hydroxypropyl methylcellulose (4: 6) 16.8
5 carboxymethyl starch sodium-38.3
6 erythritols: carboxymethyl starch sodium (5: 5) 15.2
7 crosslinked carboxymethyl fecula sodium-40.8
8 erythritols: crosslinked carboxymethyl fecula sodium (6: 4) 14.6
9 insoluble crospolyvinylpyrrolidone-33.4
10 erythritols: insoluble crospolyvinylpyrrolidone (7: 3) 13.6
The result: the oral cavity disintegration tablet that uses compound disintegrating agent is in 13.6-18.3 all disintegrates and by No. 2 sieves in second; The oral cavity disintegration tablet that uses single disintegrating agent is in 27.6-40.8 all disintegrates and by No. 2 sieves in second.Illustrate that compound disintegrating agent of the present invention has disintegrate characteristics rapidly really.
Six. the disintegration experiment
Get cinnamon twig and poria oral disnitegration tablet of the present invention, place the beaker of the 10ml that fills 37 ℃ of water of 5ml, stir with 30 rev/mins speed.Oral cavity disintegration tablet of the present invention whole disintegrates in 20 seconds are also sieved by No. 2.
Seven. the dissolution experiment
1. instrument and reagent: the full-automatic digestion instrument of SR-6 type (U.S. Hanson company); Distilled water (self-control); Ramulus Cinnamomi Poria pill (production of Linfen, Shanxi Province pharmaceutical factory of traditional Chinese medicine); Cinnamon twig and poria oral disnitegration tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides).
2. experimental technique: second method of pressing in the dissolution method (" 2000 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 cinnamon twig and poria oral disnitegration 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 cinnamic acid assay method.The results are shown in Table 5.
The dissolution of two kinds of medicines of table 5 relatively
(min) cinnamic acid content sample time (mg)
Medicine group 0.5 1248 12 16 20
Ramulus Cinnamomi Poria pill 0.09 0.12 0.19 0.31 0.46 0.61 0.68 0.71
Cinnamon twig and poria oral disintegrate 0.58 0.62 0.74 0.88 0.92 0.93 0.93 0.93
Sheet
Conclusion: strippings in 30 seconds of cinnamon twig and poria oral disnitegration tablet of the present invention were dissolved almost completely in the time of 50%, 8 minute, proved absolutely that oral cavity disintegration tablet dissolution rate of the present invention is very fast.
Eight. pharmacology embodiment
Influence to the mice granuloma induced by implantation of cotton pellets
Experiment medicine: distilled water (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides);
Ramulus Cinnamomi Poria pill (production of Linfen, Shanxi Province pharmaceutical factory of traditional Chinese medicine);
Cinnamon twig and poria oral disnitegration tablet (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides).
Laboratory animal: the ICR mice is used in experiment, male and female half and half, and body weight 20 ± 2g, 60, be divided into 3 groups, be respectively
Distilled water group, Ramulus Cinnamomi Poria pill group, cinnamon twig and poria oral disnitegration tablet group.
Experimental technique: be made into the roughly the same cotton balls of shape with absorbent cotton, the sterilization back is oxter, heeling-in mice both sides respectively,
In operation back gastric infusion next day, continuous 7 days, put to death, take out granulation tissue, drying,
Sub-balance is weighed, and cotton balls weight difference after the calculating heeling-in the results are shown in Table 6
Table 6 cassia twig and poria cocos preparation is to the influence of mice granuloma induced by implantation of cotton pellets
Group dosage Mus is counted granuloma weight
(g/kg) (only) mg
Distilled water-20 0.3319 ± 0.0091
Ramulus Cinnamomi Poria pill group 25 20 0.3089 ± 0.0046
*
Cinnamon twig and poria oral disnitegration tablet group 25 20 0.2784 ± 0.0039
*[
*]
Annotate: compare with the distilled water group
*P＜0.01, compare with the Ramulus Cinnamomi Poria pill group [
*] P＜0.05
Conclusion: show that by The pharmacological results oral cavity disintegration tablet of the present invention has better pharmacological action.
Nine. preparation embodiment
Embodiment 1
(1) crude drug of the present invention is:
Ramulus Cinnamomi 398.7 grams, Poria 398.7 grams, Cortex Moutan 398.7 grams, Radix Paeoniae Rubra 398.7 grams, Semen Persicae 398.7 grams;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 20ml/g, be chilled to room temperature, in volatile oil: the ratio (v/w) of 2-HP-=1: 4 drips above-mentioned volatile oil, stirs while dripping, drip and finish the back, take out, 0 ℃ of cooling 20 hours 40 ℃ of continuation stirrings 40 minutes, centrifugal, filter, filtering residue room temperature dry 36 hours down obtains Ramulus Cinnamomi Volatile oil clathrate 14 grams;
(3) get Poria, add 8 times of water, decoct 3 times, each 2 hours, merge extractive liquid, filtered, and concentrated, and drying obtains Poria effective site 20 grams;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.05 when being concentrated to 20 ℃, last D101 type macroporous adsorptive resins, with 5 times of column volume water elutions, eluent discards earlier, the ethanol elution of reuse 50%, 4 times of column volumes, eluent reclaims ethanol, concentrates, drying, the effective site 112 that obtains Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae restrains;
(5) effective site 112 grams of getting Ramulus Cinnamomi Volatile oil clathrate 14 grams, Poria effective site 20 grams, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae mix with compound recipe disintegrating agent 76 grams, add filler microcrystalline Cellulose 170 grams, granulate, add magnesium stearate lubricant 8 grams, tabletting obtains 1000 of cinnamon twig and poria oral disnitegration tablets.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 2
(1) crude drug of the present invention is:
Ramulus Cinnamomi 398.7 grams, Poria 398.7 grams, Cortex Moutan 398.7 grams, Radix Paeoniae Rubra 398.7 grams, Semen Persicae 398.7 grams;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 30ml/g, be chilled to room temperature, in volatile oil: the ratio (v/w) of 2-HP-=1: 10 drips above-mentioned volatile oil, stirs while dripping, drip and finish the back, take out, 4 ℃ of coolings 24 hours 50 ℃ of continuation stirrings 80 minutes, centrifugal, filter, filtering residue room temperature dry 48 hours down obtains Ramulus Cinnamomi Volatile oil clathrate 29 grams;
(3) get Poria, add 12 times of water, decoct 3 times, each 4 hours, merge extractive liquid, filtered, and concentrated, and drying obtains Poria effective site 40 grams;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.10 when being concentrated to 20 ℃, last AB-8 type macroporous adsorptive resins, with 8 times of column volume water elutions, eluent discards earlier, the ethanol elution of reuse 85%, 8 times of column volumes, eluent reclaims ethanol, concentrates, drying, the effective site 124 that obtains Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae restrains;
(6) effective site 124 grams of getting Ramulus Cinnamomi Volatile oil clathrate 29 grams, Poria effective site 40 grams, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae mix with compound recipe disintegrating agent 62 grams, add filler nano micro crystal cellulose 139 grams, granulate, add lubricant Pulvis Talci 6 grams, tabletting obtains 1000 of cinnamon twig and poria oral disnitegration tablets.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 3
(1) crude drug of the present invention is:
Ramulus Cinnamomi 398.7 grams, Poria 398.7 grams, Cortex Moutan 398.7 grams, Radix Paeoniae Rubra 398.7 grams, Semen Persicae 398.7 grams;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 25ml/g, be chilled to room temperature, in volatile oil: the ratio (v/w) of 2-HP-=1: 6 drips above-mentioned volatile oil, stirs while dripping, drip and finish the back, take out, 2 ℃ of coolings 22 hours 45 ℃ of continuous stirrings 45 minutes, centrifugal, filter, filtering residue room temperature dry 40 hours down obtains Ramulus Cinnamomi Volatile oil clathrate 24 grams;
(3) get Poria, add 10 times of water, decoct 3 times, each 3 hours, merge extractive liquid, filtered, and concentrated, and drying obtains Poria effective site 32 grams;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.08 when being concentrated to 20 ℃, last NKA type macroporous adsorptive resins, with 6 times of column volume water elutions, eluent discards earlier, the ethanol elution of reuse 60%, 6 times of column volumes, eluent reclaims ethanol, concentrates, drying, the effective site 120 that obtains Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae restrains;
(5) effective site 120 grams of getting Ramulus Cinnamomi Volatile oil clathrate 24 grams, Poria effective site 32 grams, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae mix with compound recipe disintegrating agent 67 grams, add filler microcrystalline Cellulose 150 grams, granulate, add lubricant Stepanol MG 7 grams, tabletting obtains 1000 of cinnamon twig and poria oral disnitegration tablets.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 4
(1) crude drug of the present invention is:
Ramulus Cinnamomi 398.7 grams, Poria 398.7 grams, Cortex Moutan 398.7 grams, Radix Paeoniae Rubra 398.7 grams, Semen Persicae 398.7 grams;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 22ml/g, be chilled to room temperature, in volatile oil: the ratio (v/w) of 2-HP-=1: 5 drips above-mentioned volatile oil, stirs while dripping, drip and finish the back, take out, 3 ℃ of coolings 23 hours 42 ℃ of continuation stirrings 65 minutes, centrifugal, filter, filtering residue room temperature dry 44 hours down obtains Ramulus Cinnamomi Volatile oil clathrate 26 grams;
(3) get Poria, add 10 times of water, decoct 3 times, each 3 hours, merge extractive liquid, filtered, and concentrates, and drying obtains Poria effective site;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.07 when being concentrated to 20 ℃, last D101 type macroporous adsorptive resins, with 7 times of column volume water elutions, eluent discards earlier, the ethanol elution of reuse 70%, 6 times of column volumes, eluent reclaims ethanol, concentrates, drying, the effective site 117 that obtains Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae restrains;
(5) effective site 117 grams of getting Ramulus Cinnamomi Volatile oil clathrate 19 grams, Poria effective site 26 grams, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae mix with compound recipe disintegrating agent 71 grams, add filler nano micro crystal cellulose 160 grams, granulate, add lubricant Pulvis Talci 7 grams, tabletting obtains 1000 of cinnamon twig and poria oral disnitegration tablets.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 5
(1) crude drug of the present invention is:
Ramulus Cinnamomi 398.7 grams, Poria 398.7 grams, Cortex Moutan 398.7 grams, Radix Paeoniae Rubra 398.7 grams, Semen Persicae 398.7 grams;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 26ml/g, be chilled to room temperature, in volatile oil: the ratio (v/w) of 2-HP-=1: 9 drips above-mentioned volatile oil, stirs while dripping, drip and finish the back, take out, 2 ℃ of coolings 23 hours 44 ℃ of continuation stirrings 75 minutes, centrifugal, filter, filtering residue room temperature dry 46 hours down obtains Ramulus Cinnamomi Volatile oil clathrate 27 grams;
(3) get Poria, add 11 times of water, decoct 3 times, each 4 hours, merge extractive liquid, filtered, and concentrated, and drying obtains Poria effective site 36 grams;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.09 when being concentrated to 20 ℃, last AB-8 type macroporous adsorptive resins, with 7 times of column volume water elutions, eluent discards earlier, the ethanol elution of reuse 80%, 7 times of column volumes, eluent reclaims ethanol, concentrates, drying, the effective site 121 that obtains Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae restrains;
(5) effective site 121 grams of getting Ramulus Cinnamomi Volatile oil clathrate 27 grams, Poria effective site 36 grams, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae mix with compound recipe disintegrating agent 65 grams, add filler nano micro crystal cellulose 145 grams, granulate, add lubricant Stepanol MG 6 grams, tabletting obtains cinnamon twig and poria oral disnitegration tablet.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 6
(1) crude drug of the present invention is:
Ramulus Cinnamomi 3987 grams, Poria 3987 grams, Cortex Moutan 3987 grams, Radix Paeoniae Rubra 3987 grams, Semen Persicae 3987 grams;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 25ml/g, be chilled to room temperature, in volatile oil: the ratio (v/w) of 2-HP-=1: 8 drips above-mentioned volatile oil, stirs while dripping, drip and finish the back, take out, 1 ℃ of cooling 22 hours 46 ℃ of continuation stirrings 75 minutes, centrifugal, filter, filtering residue room temperature dry 40 hours down obtains Ramulus Cinnamomi Volatile oil clathrate 279 grams;
(3) get Poria, add 10 times of water, decoct 3 times, each 3 hours, merge extractive liquid, filtered, and concentrated, and drying obtains Poria effective site 376 grams;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.09 when being concentrated to 20 ℃, last NKA type macroporous adsorptive resins, with 6 times of column volume water elutions, eluent discards earlier, the ethanol elution of reuse 75%, 6 times of column volumes, eluent reclaims ethanol, concentrates, drying, the effective site 1209 that obtains Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae restrains;
(5) effective site 1209 grams of getting Ramulus Cinnamomi Volatile oil clathrate 279 grams, Poria effective site 376 grams, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae mix with compound recipe disintegrating agent 641 grams, add filler microcrystalline Cellulose 1417 grams, granulate, add lubricant Stepanol MG 78 grams, tabletting obtains 10000 of cinnamon twig and poria oral disnitegration tablets.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 7
(1) crude drug of the present invention is:
Ramulus Cinnamomi 797.4 grams, Poria 797.4 grams, Cortex Moutan 797.4 grams, Radix Paeoniae Rubra 797.4 grams, Semen Persicae 797.4 grams;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 25ml/g, be chilled to room temperature, in volatile oil: the ratio (v/w) of 2-HP-=1: 6 drips above-mentioned volatile oil, stirs while dripping, drip and finish the back, take out, 2 ℃ of coolings 24 hours 48 ℃ of continuation stirrings 60 minutes, centrifugal, filter, filtering residue room temperature dry 40 hours down obtains Ramulus Cinnamomi Volatile oil clathrate 55 grams;
(3) get Poria, add 10 times of water, decoct 3 times, each 4 hours, merge extractive liquid, filtered, and concentrated, and drying obtains Poria effective site 72 grams;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.08 when being concentrated to 20 ℃, last D101 type macroporous adsorptive resins, with 6 times of column volume water elutions, eluent discards earlier, the ethanol elution of reuse 70%, 6 times of column volumes, eluent reclaims ethanol, concentrates, drying, the effective site 239 that obtains Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae restrains;
(5) effective site 239 grams of getting Ramulus Cinnamomi Volatile oil clathrate 55 grams, Poria effective site 72 grams, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae mix with compound recipe disintegrating agent 130 grams, add filler microcrystalline Cellulose 289 grams, granulate, add lubricant Pulvis Talci 15 grams, tabletting obtains 2000 of cinnamon twig and poria oral disnitegration tablets.
Compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl methylcellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
Claims (6)
1. cinnamon twig and poria oral disnitegration tablet, it is characterized in that it is made up of effective site of extracting in Chinese medicine Ramulus Cinnamomi, Poria, Cortex Moutan, Radix Paeoniae Rubra, the Semen Persicae and pharmaceutic adjuvant, its preparation consists of the effective site 112-124 weight portion of Ramulus Cinnamomi Volatile oil clathrate 14-29 weight portion, Poria effective site 20-40 weight portion, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, disintegrating agent weight portion 62-76 weight portion, filler weight portion 139-170 weight portion, lubricant weight portion 6-8 weight portion; Its feature is that also used disintegrating agent is the compound disintegrating agent that contains erythritol.
2. the compound disintegrating agent that contains erythritol according to claim 1 is characterized in that it by erythritol and a kind of composition that is selected from chitin, low-substituted hydroxypropyl methylcellulose, carboxymethyl starch sodium, crosslinked carboxymethyl fecula sodium, the insoluble crospolyvinylpyrrolidone, and the weight percentage of wherein compound disintegrating agent mesoerythrit is 30%-70%.
3. the preparation method of a kind of cinnamon twig and poria oral disnitegration tablet according to claim 1, its feature may further comprise the steps:
(1) crude drug of the present invention is:
Ramulus Cinnamomi: Poria: Cortex Moutan: Radix Paeoniae Rubra: Semen Persicae=1: 1: 1: 1: 1;
(2) get Ramulus Cinnamomi, pulverize, steam distillation extracts volatile oil, take by weighing the 2-HP-, ratio with 20ml/g-30ml/g adds water, heating for dissolving is chilled to room temperature, and in volatile oil: the ratio of 2-HP-=1: 4-10 (v/w) drips above-mentioned volatile oil, stir while dripping, drip and finish the back, take out, 0-4 ℃ of cooling 20-24 hour 40-50 ℃ of continuation stirring 40-80 minute, centrifugal, filter, under the filtering residue room temperature dry 36-48 hour, obtain the Ramulus Cinnamomi Volatile oil clathrate;
(3) get Poria, add 8-12 times of water, decoct 3 times, each 2-4 hour, merge extractive liquid, filtered, and concentrates, and drying obtains Poria effective site;
(4) get Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae, pulverize, add 100 ℃ of water logging bubbles 1 hour, decoct twice, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and relative density is 1.05-1.10 when being concentrated to 20 ℃, last macroporous adsorptive resins, with 5-8 times of column volume water elution, eluent discards earlier, the ethanol elution of reuse 50%-85%, 4-8 times column volume, eluent reclaims ethanol, concentrates, drying obtains the effective site of Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae;
(5) effective site of getting Ramulus Cinnamomi Volatile oil clathrate, Poria effective site, Cortex Moutan, Radix Paeoniae Rubra, Semen Persicae is mixed with the compound recipe disintegrating agent, adds filler, granulates, and adds lubricant, and tabletting obtains cinnamon twig and poria oral disnitegration tablet.
4. according to claim 1 and 3 described disintegrating tablets, a kind of for in microcrystalline Cellulose, the nano micro crystal cellulose of filler wherein.
5. according to claim 1 and 3 described disintegrating tablets, wherein lubricant is a kind of in magnesium stearate, Pulvis Talci, the Stepanol MG.
6. be nonpolar or the low pole macroporous adsorbent resin according to the described macroporous adsorbent resin of claim 3.
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| CN 200410069115 CN1296070C (en) | 2004-07-06 | 2004-07-06 | Cinnamon twig and poria oral disnitegration tablet and its preparing method |
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| CN 200410069115 CN1296070C (en) | 2004-07-06 | 2004-07-06 | Cinnamon twig and poria oral disnitegration tablet and its preparing method |
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| CN1296070C CN1296070C (en) | 2007-01-24 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104800324A (en) * | 2015-05-11 | 2015-07-29 | 李汶峰 | Traditional Chinese medicine for treating prostatic hyperplasia |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104800324A (en) * | 2015-05-11 | 2015-07-29 | 李汶峰 | Traditional Chinese medicine for treating prostatic hyperplasia |
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