CN1267128C - Orally disintegrating tablet of 'Huoxiang Zhengqi' and its preparation process - Google Patents
Orally disintegrating tablet of 'Huoxiang Zhengqi' and its preparation process Download PDFInfo
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Abstract
The present invention discloses an ageratum Qi purifying orally disintegrating tablet and a preparation method thereof. The present invention is characterized in that the orally disintegrating tablet is prepared from effective components extracted from traditional Chinese medicine atractylodes rhizome, dried tangerine peel, officinal magnolia bark processed with ginger, dahurian angelica, tuckahoe, areca peel and raw pinellia, liquorice extract, patchouli oil, perilla oil and pharmaceutical adjuvant; a composite disintegrating agent containing erythritol is also used; erythritol and chitin or low-substituted hydroxypropyl cellulose or sodium carboxymethyl starch or crosslinked sodium carboxymethyl starch or non-soluble crosslinked polyvinyl pyrrolidone are combined with raw materials according to a certain proportion to prepare a composite disintegrating agent. Since erythritol has the effect of corrigents simultaneously, the dosage of pharmaceutical adjuvant of the preparation is reduced; pharmacological experiments show that the ageratum Qi purifying orally disintegrating tablet of the present invention has the characteristics of quick disintegration, rapid effect-taking and excellent pharmacological action.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of oral disintegration tablet of ' Huo Xiang Zheng Qi ' 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.
HUOXIANG ZHENGQI ZHIJI has oral liquid, water preparation, soft capsule, capsule, tablet, pill, drop pill in the dosage form of clinical practice, in process of clinical application, to alleviating the heatstroke symptom good effect is arranged, therefore, developmental research goes out that a kind of onset is rapid, the better HUOXIANG ZHENGQI ZHIJI of pharmacological action, and having very widely, social meaning does not retrieve about the oral disintegration tablet of ' Huo Xiang Zheng Qi ' Patent 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 with disintegrating agent of the present invention each flavour of a drug in the ageratum and mixes, add filler, lubricant, be prepared into oral cavity disintegration tablet, pharmacological evaluation shows, oral disintegration tablet of ' Huo Xiang Zheng Qi ' of the present invention has that disintegrate is fast, onset is rapid, the better characteristics of pharmacological action.
The present invention is achieved through the following technical solutions.
One. process recipes
(1) crude drug of the present invention is:
Rhizoma Atractylodis 150-250 weight portion, Pericarpium Citri Reticulatae 150-250 weight portion, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 150-250 weight portion, Radix Angelicae Dahuricae 250-350 weight portion, Poria 250-350 weight portion, Pericarpium Arecae 250-350 weight portion; Rhizoma Pinelliae 150-250 weight portion, Radix Glycyrrhizae extractum 20-30 weight portion, patchouli oil 1.5-2.5ml, Folium perillae acutae oil 0.8-1.5ml;
(2) crude drug of the present invention is:
Rhizoma Atractylodis 200 weight portions, Pericarpium Citri Reticulatae 200 weight portions, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 200 weight portions, the Radix Angelicae Dahuricae 300 weight portions, Poria 300 weight portions, Pericarpium Arecae 300 weight portions; Rhizoma Pinelliae 200 weight portions, Radix Glycyrrhizae extractum 25 weight portions, patchouli oil 2ml, Folium perillae acutae oil 1ml;
(3) get the Radix Angelicae Dahuricae, pulverize, put into the supersound extraction jar, with 3-5 doubly, 95% ethanol extraction 2-4 time, each 8-12 minute, filter, merge extractive liquid, reclaims ethanol to most, vacuum concentration, cold drying obtains Radix Angelicae Dahuricae effective site;
(4) get Cortex Magnoliae Officinalis, with 6-8 doubly, 60%-80% ethanol extraction 2 times, each 2 hours, filter, it is standby to extract residue, merge extractive liquid, reclaims ethanol to the greatest extent, concentrates, drying obtains Cortex Magnoliae Officinalis alcohol extraction effective site;
(5) get Pericarpium Citri Reticulatae, extract volatile oil, standby, medicinal residues are standby;
(6) get Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis medicinal residues and Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae and add 10-20 times of water, decoct 2 times, each 2-5 hour, collecting decoction filters, and filtrate and Radix Glycyrrhizae extractum merge, vacuum concentration, drying obtains Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site;
(7) get Pericarpium Citri Reticulatae volatile oil, Herba Pogostemonis Volatile oil, Folium Perillae volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 20ml/g-30ml/g, be chilled to room temperature, in volatile oil: the ratio of 2-HP-=1: 4-10 (v/g) adds above-mentioned volatile oil, mixing time 40-80 minute, takes out cooling 20-24 hour, centrifugal, filter, under the filtering residue room temperature dry 36-48 hour, obtain volatile oil clathrate compound;
(8) getting Radix Angelicae Dahuricae effective site is the 1.6-4.5 weight portion, Cortex Magnoliae Officinalis alcohol extraction effective site 1.5-5 weight portion, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 66-151 weight portion, multiple and the disintegrating agent 58-96 weight portion of volatile oil clathrate compound 12-44 weight portion and the present invention mixes, and adds filler 132.5-212.9 weight portion, granulate, add lubricant 5-10 weight portion, tabletting obtains oral disintegration tablet of ' Huo Xiang Zheng Qi '.
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 wherein compound disintegrating agent mesoerythrit is 30%-70%.
Filler is a kind of in microcrystalline Cellulose, the nano micro crystal cellulose.
Lubricant is a kind of in magnesium stearate, Pulvis Talci, the Stepanol MG.
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
| Disintegrating agent | Dissolubility (37 ℃) W/V | Viscosity (37 ℃) mpa.s | Wettability % | Volume increases percent % |
| Erythritol chitin low-substituted hydroxypropyl methylcellulose | 45 - - | 3.5 - - | 0.03 11.29 14.09 | 0.02 16.57 20.36 |
| The insoluble crospolyvinylpyrrolidone of carboxymethyl starch sodium crosslinked carboxymethyl fecula sodium | - - - | - - - | 21.07 22.18 22.64 | 22.89 28.14 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
| Experimental group | Hardness (kg) | Spoilage (%) | Disintegration time (s) | The Orally disintegrating time (s) | Grittiness | Taste |
| 1 2 3 4 5 6 7 8 9 10 11 | 4.1 3.9 2.1 2.2 2.2 2.1 2.0 1.9 1.8 4.6 4.8 | 22.1 21.6 9.3. 8.6 8.1 8.6 9.3 9.6 10.2 33.9 36.5 | 42.1 43.6 26.3 25.2 26.1 26.9 26.8 35.9 35.6 54.1 55.6 | 51.2 52.9 32.9 28.3 26.7 27.4 27.3 38.6 39.1 62.9 62.8 | Having seldom to have much has a lot | Bad generally carefully good carefully 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
The check and analysis of Hesperidin
In the standard according to WS-10057 (ZD-0057)-2002 [assay], carry out check and analysis, see Table 3:
Table 3 Determination of Hesperidin Content
| The medicine group | Content of hesperidin |
| The HUOXIANG ZHENGQI PIAN oral disintegration tablet of ' Huo Xiang Zheng Qi ' | 0.3678mg/ sheet 0.3712mg/ sheet |
Five. the preparation disintegration time mensuration
In order to prove absolutely that the employed compound disintegrating agent of oral disintegration tablet of ' Huo Xiang Zheng Qi ' 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
| The experiment number | Disintegrating agent | Disintegration (s) | |
| Form | Consumption (g: g) | ||
| 1 2 3 4 5 6 7 8 9 10 | Chitin antierythrite: chitin low-substituted hydroxypropyl methylcellulose antierythrite: low-substituted hydroxypropyl methylcellulose sodium carboxymethyl starch antierythrite: sodium carboxymethyl starch crosslinked carboxymethyl fecula sodium antierythrite: the insoluble PVPP antierythrite of crosslinked carboxymethyl fecula sodium: insoluble PVPP | - (3∶7) - (4∶6) - (5∶5) - (6∶4) - (7∶3) | 30.4 17.9 27.5 16.8 38.4 15.1 40.6 14.7 33.9 13.5 |
The result: the oral cavity disintegration tablet that uses compound disintegrating agent is in 13.5-17.9 all disintegrates and by No. 2 sieves in second; Use the oral cavity friend of single disintegrating agent to separate sheet in 27.5-40.6 all disintegrates and in second by No. 2 sieves.Illustrate that compound disintegrating agent of the present invention has disintegrate characteristics rapidly really.
Six. the disintegration experiment
Get oral disintegration tablet of ' Huo Xiang Zheng Qi ' 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); HUOXIANG ZHENGQI PIAN (pharmaceutical Co. Ltd is covered in the Ulan Hot in the Inner Mongol); Oral disintegration tablet of ' Huo Xiang Zheng Qi ' (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 oral disintegration tablet of ' Huo Xiang Zheng Qi ' 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 Hesperidin assay method.The results are shown in Table 5.
The dissolution of two kinds of medicines of table 5 relatively
| The medicine group | (min) content of hesperidin sample time (mg) | |||||||
| 0.5 | 1 | 2 | 4 | 8 | 12 | 16 | 20 | |
| The HUOXIANG ZHENGQI PIAN oral disintegration tablet of ' Huo Xiang Zheng Qi ' | 0.0423 0.1892 | 0.0689 0.2456 | 0.0865 0.3012 | 0.1198 0.3478 | 0.1984 0.3710 | 0.2412 0.3710 | 0.3056 0.3710 | 0.3512 0.3710 |
Conclusion: strippings in 30 seconds of oral disintegration tablet of ' Huo Xiang Zheng Qi ' of the present invention were dissolved almost completely in the time of 50%, 8 minute.
Seven. pharmacology embodiment
Heat is exposed the protective effect research of rat
Experiment medicine: HUOXIANG ZHENGQI PIAN (pharmaceutical Co. Ltd is covered in the Ulan Hot in the Inner Mongol);
HUOXIANG ZHENGQI RUANJIAONANG (new Pharmaceutical reaches core hall pharmaceutical factory in the Tianjin)
Oral disintegration tablet of ' Huo Xiang Zheng Qi ' (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides).
Laboratory animal: healthy Wistar rat, male and female are not limit (through identical high heat condition preliminary experiment contrast, the physiology of female tom, pathological reaction, take place are not had significant difference at the time-to-live heat shock time), and body weight 200～250g, is divided into 4 groups by totally 80.
Experimental technique: with 4 treated animal animals, irritate stomach respectively and give the heat exposure down of distilled water, HUOXIANG ZHENGQI PIAN, soft capsule, oral cavity disintegration tablet the same terms, reach shock state (it is the heat shock standard that animal is subjected in the thermal process blood pressure to reduce to 9.3kPa), writing time, continuing heat exposes, observe the death time, the results are shown in Table 6.
The comparison (min) of heat shock time and shock back time-to-live takes place in the identical hot exposure condition rat of table 6
| Group | Number of animals | Reach the heat shock time | Time-to-live after the heat shock |
| Distilled water group HUOXIANG ZHENGQI PIAN HUOXIANG ZHENGQI RUANJIAONANG oral disintegration tablet of ' Huo Xiang Zheng Qi ' | 20 20 20 20 | 79.2±3.8 84.3±3.7 * 83.2±3.6 * 88.1±2.5 ** | 18.3±5.2 24.6±4.6 * 25.9±3.8 * 28.7±3.6 ** |
Annotate:
*P＜0.01,
*P＜0.05
Conclusion: show that by pharmacological evaluation oral cavity disintegration tablet of the present invention has better pharmacological action.
Eight. preparation embodiment
Embodiment 1
(1) crude drug of the present invention is:
Rhizoma Atractylodis 150 grams, Pericarpium Citri Reticulatae 150 grams, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 150 grams, the Radix Angelicae Dahuricae 250 grams, Poria 250 grams, Pericarpium Arecae 250 grams, Rhizoma Pinelliae 150 grams, Radix Glycyrrhizae extractum 20 grams, patchouli oil 1.5ml, Folium perillae acutae oil 0.8ml;
(2) get the Radix Angelicae Dahuricae, pulverize, put into the supersound extraction jar, with 3 times, 95% ethanol extraction 2 times, each 8 minutes, filter, merge extractive liquid, reclaims ethanol to the greatest extent, vacuum concentration, cold drying obtains Radix Angelicae Dahuricae effective site 1.6 and restrains;
(3) get Cortex Magnoliae Officinalis, with 6,60% ethanol extraction 2 times, each 2 hours, filter, it is standby to extract residue, and merge extractive liquid, reclaims ethanol to the greatest extent, concentrates, and drying obtains Cortex Magnoliae Officinalis alcohol extraction effective site 1.5 grams;
(4) get Pericarpium Citri Reticulatae, extract volatile oil, standby, medicinal residues are standby;
(5) get Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis medicinal residues and Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae and add 10 times of water, decoct each 2 hours 2 times, collecting decoction filters, and filtrate and Radix Glycyrrhizae extractum merge, vacuum concentration, drying obtains Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 66 grams;
(6) get Pericarpium Citri Reticulatae volatile oil, Herba Pogostemonis Volatile oil, Folium Perillae 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/g) of 2-HP-=1: 4 adds above-mentioned volatile oil, and mixing time 40 minutes is taken out cooling 20 hours, centrifugal, filter, filtering residue room temperature dry 36 hours down obtains volatile oil clathrate compound 12 grams;
(7) getting Radix Angelicae Dahuricae effective site is 1.6 grams, Cortex Magnoliae Officinalis alcohol extraction effective site 1.5 grams, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 66 grams, volatile oil clathrate compound 12 grams are multiple and disintegrating agent 96 grams with the present invention, mix, and add filler microcrystalline Cellulose 212.9 grams, granulate, add magnesium stearate lubricant 10 grams, tabletting obtains 1000 of oral disintegration tablet of ' Huo Xiang Zheng Qi '.
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 wherein compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 2
(1) crude drug of the present invention is:
Rhizoma Atractylodis 250 grams, Pericarpium Citri Reticulatae 250 grams, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 250 grams, the Radix Angelicae Dahuricae 350 grams, Poria 350 grams, Pericarpium Arecae 350 grams, Rhizoma Pinelliae 250 grams, Radix Glycyrrhizae extractum 30 grams, patchouli oil 2.5ml, Folium perillae acutae oil 1.5ml;
(2) get the Radix Angelicae Dahuricae, pulverize, put into the supersound extraction jar, with 5 times, 95% ethanol extraction 4 times, each 12 minutes, filter, merge extractive liquid, reclaims ethanol to the greatest extent, vacuum concentration, cold drying obtains Radix Angelicae Dahuricae effective site 4.5 and restrains;
(3) get Cortex Magnoliae Officinalis, with 8 times, 80% ethanol extraction 2 times, each 2 hours, filter, it is standby to extract residue, and merge extractive liquid, reclaims ethanol to the greatest extent, concentrates, and drying obtains Cortex Magnoliae Officinalis alcohol extraction effective site 5 grams;
(4) get Pericarpium Citri Reticulatae, extract volatile oil, standby, medicinal residues are standby;
(5) get Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis medicinal residues and Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae and add 20 times of water, decoct each 5 hours 2 times, collecting decoction filters, and filtrate and Radix Glycyrrhizae extractum merge, vacuum concentration, drying obtains Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 151 grams;
(6) get Pericarpium Citri Reticulatae volatile oil, Herba Pogostemonis Volatile oil, Folium Perillae 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/g) of 2-HP-=1: 10 adds above-mentioned volatile oil, and mixing time 80 minutes is taken out cooling 24 hours, centrifugal, filter, filtering residue room temperature dry 48 hours down obtains volatile oil clathrate compound 44 grams;
(7) getting Radix Angelicae Dahuricae effective site is 4.5 grams, Cortex Magnoliae Officinalis alcohol extraction effective site 5 grams, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 151 grams, volatile oil clathrate compound 44 grams are multiple and disintegrating agent 58 grams with the present invention, mix, and add filler nano micro crystal cellulose 132.5 grams, granulate, add lubricant Pulvis Talci 5 grams, tabletting obtains 1000 of oral disintegration tablet of ' Huo Xiang Zheng Qi '.
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 wherein compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 3
(1) crude drug of the present invention is:
Rhizoma Atractylodis 200 grams, Pericarpium Citri Reticulatae 200 grams, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 200 grams, the Radix Angelicae Dahuricae 300 grams, Poria 300 grams, Pericarpium Arecae 300 grams; Rhizoma Pinelliae 200 grams, Radix Glycyrrhizae extractum 25 grams, patchouli oil 2ml, Folium perillae acutae oil 1ml;
(2) get the Radix Angelicae Dahuricae, pulverize, put into the supersound extraction jar, with 4 times, 95% ethanol extraction 3 times, each 9 minutes, filter, merge extractive liquid, reclaims ethanol to the greatest extent, vacuum concentration, cold drying obtains Radix Angelicae Dahuricae effective site 3.6 and restrains;
(3) get Cortex Magnoliae Officinalis, with 7 times, 65% ethanol extraction 2 times, each 2 hours, filter, it is standby to extract residue, and merge extractive liquid, reclaims ethanol to the greatest extent, concentrates, and drying obtains Cortex Magnoliae Officinalis alcohol extraction effective site 4.2 grams;
(4) get Pericarpium Citri Reticulatae, extract volatile oil, standby, medicinal residues are standby;
(5) get Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis medicinal residues and Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae and add 12 times of water, decoct each 3 hours 2 times, collecting decoction filters, and filtrate and Radix Glycyrrhizae extractum merge, vacuum concentration, drying obtains Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 121 grams;
(6) get Pericarpium Citri Reticulatae volatile oil, Herba Pogostemonis Volatile oil, Folium Perillae 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/g) of 2-HP-=1: 8 adds above-mentioned volatile oil, mixing time 40-80 minute, takes out cooling 22 hours, centrifugal, filter, under the filtering residue room temperature dry 36-48 hour, obtain volatile oil clathrate compound 35 grams;
(7) get Radix Angelicae Dahuricae effective site, Cortex Magnoliae Officinalis alcohol extraction effective site, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site, multiple and disintegrating agent 77 grams of volatile oil clathrate compound and the present invention mix, and add filler microcrystalline Cellulose 152.5 grams, granulate, add lubricant Stepanol MG 7 grams, tabletting obtains 1000 of oral disintegration tablet of ' Huo Xiang Zheng Qi '.
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 wherein compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 4
(1) crude drug of the present invention is:
Rhizoma Atractylodis 180 grams, Pericarpium Citri Reticulatae 180 grams, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 180 grams, the Radix Angelicae Dahuricae 280 grams, Poria 280 grams, Pericarpium Arecae 280 grams, Rhizoma Pinelliae 180 grams, Radix Glycyrrhizae extractum 24 grams, patchouli oil 1.8ml, Folium perillae acutae oil 1.2ml;
(2) get the Radix Angelicae Dahuricae, pulverize, put into the supersound extraction jar, with 4 times, 95% ethanol extraction 3 times, each 10 minutes, filter, merge extractive liquid, reclaims ethanol to the greatest extent, vacuum concentration, cold drying obtains Radix Angelicae Dahuricae effective site 2.6 and restrains;
(3) get Cortex Magnoliae Officinalis, with 7 times, 70% ethanol extraction 2 times, each 2 hours, filter, it is standby to extract residue, and merge extractive liquid, reclaims ethanol to the greatest extent, concentrates, and drying obtains Cortex Magnoliae Officinalis alcohol extraction effective site 2.8 grams;
(4) get Pericarpium Citri Reticulatae, extract volatile oil, standby, medicinal residues are standby;
(5) get Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis medicinal residues and Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae and add 16 times of water, decoct 2 times,, each 4 hours, collecting decoction filters, and filtrate and Radix Glycyrrhizae extractum merge, vacuum concentration, drying obtains Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 88 grams;
(6) get Pericarpium Citri Reticulatae volatile oil, Herba Pogostemonis Volatile oil, Folium Perillae 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/g) of 2-HP-=1: 5 adds above-mentioned volatile oil, and mixing time 50 minutes is taken out cooling 22 hours, centrifugal, filter, filtering residue room temperature dry 38 hours down obtains volatile oil clathrate compound 24 grams;
(7) get Radix Angelicae Dahuricae effective site, Cortex Magnoliae Officinalis alcohol extraction effective site, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site, multiple and disintegrating agent 69 grams of volatile oil clathrate compound and the present invention mix, and add filler microcrystalline Cellulose 205.6 grams, granulate, add lubricant Stepanol MG 8 grams, tabletting obtains 1000 of oral disintegration tablet of ' Huo Xiang Zheng Qi '.
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 wherein compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 5
(1) crude drug of the present invention is:
Rhizoma Atractylodis 220 grams, Pericarpium Citri Reticulatae 220 grams, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 220 grams, the Radix Angelicae Dahuricae 320 grams, Poria 320 grams, Pericarpium Arecae 320 grams, Rhizoma Pinelliae 220 grams, Radix Glycyrrhizae extractum 28 grams, patchouli oil 2.2ml, Folium perillae acutae oil 1.4ml;
(2) get the Radix Angelicae Dahuricae, pulverize, put into the supersound extraction jar, with 4 times, 95% ethanol extraction 2 times, each 11 minutes, filter, merge extractive liquid, reclaims ethanol to the greatest extent, vacuum concentration, cold drying obtains Radix Angelicae Dahuricae effective site 3.2 and restrains;
(3) get Cortex Magnoliae Officinalis, with 6 times, 75% ethanol extraction 2 times, each 2 hours, filter, it is standby to extract residue, and merge extractive liquid, reclaims ethanol to the greatest extent, concentrates, and drying obtains Cortex Magnoliae Officinalis alcohol extraction effective site 3.8 grams;
(4) get Pericarpium Citri Reticulatae, extract volatile oil, standby, medicinal residues are standby;
(5) get Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis medicinal residues and Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae and add 18 times of water, decoct each 4 hours 2 times, collecting decoction filters, and filtrate and Radix Glycyrrhizae extractum merge, vacuum concentration, drying obtains Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 118 grams;
(6) get Pericarpium Citri Reticulatae volatile oil, Herba Pogostemonis Volatile oil, Folium Perillae volatile oil, take by weighing the 2-HP-, add water, heating for dissolving with the ratio of 28ml/g, be chilled to room temperature, in volatile oil: the ratio (v/g) of 2-HP-=1: 9 adds above-mentioned volatile oil, and mixing time 65 minutes is taken out cooling 22 hours, centrifugal, filter, filtering residue room temperature dry 44 hours down obtains volatile oil clathrate compound 38 grams;
(7) get Radix Angelicae Dahuricae effective site, Cortex Magnoliae Officinalis alcohol extraction effective site, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site, multiple and disintegrating agent 79 grams of volatile oil clathrate compound and the present invention mix, and add filler nano micro crystal cellulose 149 grams, granulate, add lubricant 9 magnesium stearate gram, tabletting obtains 1000 of oral disintegration tablet of ' Huo Xiang Zheng Qi '.
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 wherein compound disintegrating agent mesoerythrit is 30%-70%.
Embodiment 6
(1) crude drug of the present invention is:
Rhizoma Atractylodis 200 grams, Pericarpium Citri Reticulatae 200 grams, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 200 grams, the Radix Angelicae Dahuricae 300 grams, Poria 300 grams, Pericarpium Arecae 300 grams; Rhizoma Pinelliae 200 grams, Radix Glycyrrhizae extractum 25 grams, patchouli oil 2ml, Folium perillae acutae oil 1ml;
(2) get the Radix Angelicae Dahuricae, pulverize, put into the supersound extraction jar, with 4 times, 95% ethanol extraction 3 times, each 10 minutes, filter, merge extractive liquid, reclaims ethanol to the greatest extent, vacuum concentration, cold drying obtains Radix Angelicae Dahuricae effective site 4.1 and restrains;
(3) get Cortex Magnoliae Officinalis, with 8 times, 65% ethanol extraction 2 times, each 2 hours, filter, it is standby to extract residue, and merge extractive liquid, reclaims ethanol to the greatest extent, concentrates, and drying obtains Cortex Magnoliae Officinalis alcohol extraction effective site 4.4 grams;
(4) get Pericarpium Citri Reticulatae, extract volatile oil, standby, medicinal residues are standby;
(5) get Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis medicinal residues and Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae and add 15 times of water, decoct each 3 hours 2 times, collecting decoction filters, and filtrate and Radix Glycyrrhizae extractum merge, vacuum concentration, drying obtains Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 117 grams;
(6) get Pericarpium Citri Reticulatae volatile oil, Herba Pogostemonis Volatile oil, Folium Perillae 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/g) of 2-HP-=1: 8 adds above-mentioned volatile oil, and mixing time 50 minutes is taken out cooling 22 hours, centrifugal, filter, filtering residue room temperature dry 40 hours down obtains volatile oil clathrate compound 38 grams;
(7) get Radix Angelicae Dahuricae effective site, Cortex Magnoliae Officinalis alcohol extraction effective site, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site, multiple and disintegrating agent 84 grams of volatile oil clathrate compound and the present invention mix, and add filler microcrystalline Cellulose 144.5 grams, granulate, add lubricant Pulvis Talci 8 grams, tabletting obtains 1000 of oral disintegration tablet of ' Huo Xiang Zheng Qi '.
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 wherein compound disintegrating agent mesoerythrit is 30%-70%.
Claims (1)
1. oral disintegration tablet of ' Huo Xiang Zheng Qi ' is characterized in that preparation method is:
(1) crude drug consists of:
Rhizoma Atractylodis 200 grams, Pericarpium Citri Reticulatae 200 grams, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 200 grams, the Radix Angelicae Dahuricae 300 grams, Poria 300 grams, Pericarpium Arecae 300 grams, Rhizoma Pinelliae 200 grams, Radix Glycyrrhizae extractum 25 grams, 2 milliliters of patchouli oils, 1 milliliter of Folium perillae acutae oil;
(2) get the Radix Angelicae Dahuricae, pulverize, put into the supersound extraction jar, with 4 times 95% ethanol extraction 3 times, each 9 minutes, filter, merge extractive liquid, reclaims ethanol to the greatest extent, vacuum concentration, cold drying obtains Radix Angelicae Dahuricae effective site 3.6 and restrains;
(3) get Cortex Magnoliae Officinalis, with 7 times of 65% ethanol extraction 2 times, each 2 hours, filter, it is standby to extract residue, and merge extractive liquid, reclaims ethanol to the greatest extent, concentrates, and drying obtains Cortex Magnoliae Officinalis alcohol extraction effective site 4.2 grams;
(4) get Pericarpium Citri Reticulatae, extract volatile oil, standby, medicinal residues are standby;
(5) get Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis medicinal residues and Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae and add 12 times of water, decoct each 3 hours 2 times, collecting decoction filters, and filtrate and Radix Glycyrrhizae extractum merge, vacuum concentration, drying obtains Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site 121 grams;
(6) get Pericarpium Citri Reticulatae volatile oil, Herba Pogostemonis Volatile oil, Folium Perillae 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 envelope-bulk to weight ratio of 2-HP-is that 1: 8 ratio adds above-mentioned volatile oil, mixing time 40-80 minute, takes out cooling 22 hours, centrifugal, filter, under the filtering residue room temperature dry 36-48 hour, obtain volatile oil clathrate compound 35 grams;
(7) get Radix Angelicae Dahuricae effective site, Cortex Magnoliae Officinalis alcohol extraction effective site, Pericarpium Citri Reticulatae, Cortex Magnoliae Officinalis, Rhizoma Atractylodis, Poria, Pericarpium Arecae, Rhizoma Pinelliae effective site, volatile oil clathrate compound and compound disintegrating agent 77g mix, and add filler microcrystalline Cellulose 152.5 grams, granulate, add lubricant Stepanol MG 7 grams, tabletting obtains 1000 of oral disintegration tablet of ' Huo Xiang Zheng Qi ';
Wherein compound disintegrating agent is made up of erythritol and chitin or low-substituted hydroxypropyl cellulose or carboxymethyl starch sodium or crosslinked carboxymethyl fecula sodium or insoluble crospolyvinylpyrrolidone, and the weight percentage of compound disintegrating agent mesoerythrit is 30%-70%.
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