CN1814007A - Yankening medicine preparation and its preparing method - Google Patents
Yankening medicine preparation and its preparing method Download PDFInfo
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Abstract
The present invention relates to an Yankening medicine preparation and its preparation method. It is mainly made up by using 5 Chinese medicinal materials of phellodendron bark, rhubarb, scutellaria root, isatis root and coptis root and proper auxiliary material through a certain preparation process. Said medicine preparation can be made into capsule preparation, and can be effectively used for curing the diseases of acute tonsillitis, bacterial pneumonia, bacillary dysentery, acute conjunctivitis, otitis media, acute mastitis, enteritis, urethral infection and furuncles, etc.
Description
Technical field: the present invention is a kind of 'Yankening ' pharmaceutical preparation and preparation method thereof, belongs to technical field of Chinese medicine.
Technical background: along with the medical science technical merit improves constantly, clinical common various infectious disease have all obtained better treatment and control.But also necessary acutely aware, the phenomenon that China abuses antibiotics at present is very serious, because new, a large amount of antibiotics extensive uses are clinical, thus caused bacterial dissociation and Resistant strain to increase.It has been a global difficult problem that antibiotic abuse causes the drug resistance increase, if find from the less relatively natural resources of Chinese medicinal materials of untoward reaction and side effect the replacement of anti-inflammation curative effect product is arranged equally, and this problem has just solved.Abroad, Many researchers is used some tcm products such as Herba Andrographis already as antibiotic, and the heat-clearing and toxic substances removing effect is remarkable.The inflammation of listing is coated tablet rather, is made up of the pure Chinese medicine of 5 flavors such as Cortex Phellodendri, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Isatidis and Rhizoma Coptidis, has clearing away heat-fire, the effect of anti-inflammtory anti-dysentery is used for the acute tonsillitis, bacterial pneumonia clinically, acute conjunctivitis, otitis media, furuncle carbuncle scrofula, acute mastitis, enteritis, treatment of diseases such as bacillary dysentery and acute urinary tract infection, all has good antibacterial effect, untoward reaction and toxic and side effects are less relatively, do not have drug resistance substantially, and price is also more cheap.In the more and more faster epoch of rhythm of life, the patient has also proposed requirement to medicine: instant effect, and taking convenience, but tablet needs in the process of preparation through the molding of overcompression ability, and disintegrate is slower, and is lower at the intravital dissolution of people; The humidity-proof ability of sugar-coat is poor, weightening finish is big, the coating time is long, and Icing Sugar also is unfavorable for taking of old people and diabetics; These problems have influenced the quality of product to a great extent; In view of such circumstances, need a kind of therapeutic effect ideal of searching, steady quality, the reasonably effective medicine preparation of dosage form to enrich the dosage form kind, satisfy market demand.
Summary of the invention: the objective of the invention is to: a kind of 'Yankening ' pharmaceutical preparation and preparation method thereof is provided, and the capsule of the present invention preparation has easy to carryly, and taking convenience is convenient to store, and molten loose fast, the characteristics of instant effect; The micropill of the present invention's preparation is subjected to food to carry the influence of the rhythm and pace of moving things very little, drug absorption is even and regular, surface area increases can improve medicine and gastrointestinal contact area, make drug absorption complete, improve bioavailability, good looking appearance, good fluidity, release simultaneously stablized, local irritation is little, is difficult for moisture absorption; Can solve the problem that prior art exists.
The present invention constitutes like this: calculate according to components by weight percent, it mainly is made by 380～420 parts of Cortex Phellodendris, 70～90 parts of Radix Et Rhizoma Rhei, 300～320 parts of Radix Scutellariaes, 300～320 parts of Radix Isatidis and 15～25 parts of Rhizoma Coptidis or with their extract of corresponding weight portion.
Described preparation can be capsule, pill, pellet, granule.
The preparation method of described 'Yankening ' pharmaceutical preparation: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water 1～4 time, and each 1～4 hour, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water 1～4 time, and each 1～4 hour, collecting decoction filtered, and filtrate concentrates, add ethanol and make that to contain the alcohol amount be 50～80%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste,, make different preparations then respectively Rhizoma Coptidis, Rhubarb and thick paste mixing.
Say accurately: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is concentrated into 1.5 times of primary dose, adds ethanol and makes that to contain the alcohol amount be 70%, stirs, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, make different preparations then respectively.
Capsule in the described preparation prepares like this: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, for the first time add 8 times of decoctings to boil 3 hours, add 6 times of decoctings for the second time and boil 2 hours, add 6 times of decoctings for the third time and boil 1 hour, and collecting decoction filters, and it is 1.30 thick paste that filtrate is condensed into 60 ℃ of relative densities; Cortex Phellodendri decocts with water three times, adds 6 times of decoctings for the first time and boils 3 hours, adds 6 times of decoctings for the second time and boils 2 hours, adds 6 times of decoctings for the third time and boils 1 hour, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, add ethanol and make that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, being concentrated into 60 ℃ of relative densities is 1.30 thick pastes, add above-mentioned powder and starch and reach the thick paste mixing in right amount, granulate drying, granulate incapsulates, promptly.The granulation of the capsule in the described preparation and drying mode are such: in thick paste, add crude drug powder and appropriate amount of starch, and mixing, the system soft material is granulated with oscillating granulator 40 orders, adopts the heated-air circulation oven drying, 50～60 ℃ of baking temperatures.Should control relative humidity below 65.0% during capsule packing in the described preparation.
Pellet in the described preparation prepares like this: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, add ethanol and make that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, vacuum drying, add then with drug ratios be that 1: 1 microcrystalline Cellulose is as excipient, with 90% ethanol is wetting agent, and 3% hydroxypropyl emthylcellulose is bonding, granulates with centrifugal granulation, engine speed is 200r/min, and binding agent adding speed is 15.2mL/min.Dry then, sterilization, promptly.
Granule in the described preparation prepares like this: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, add ethanol and make that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, add mannitol and aspartame, mixing, make granule, drying, promptly.
In we, Cortex Phellodendri, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Isatidis heat-clearing and toxic substances removing are ministerial drug altogether; Assistant is with Rhizoma Coptidis, and all medicines are harmonious, clearing away heat-fire, anti-inflammtory anti-dysentery.
Compared with prior art, the capsule of the present invention preparation has easy to carry, taking convenience, is convenient to store, be convenient to taste masking, and disintegrate is fast, the characteristics of instant effect, good stability; The micropill of the present invention's preparation is subjected to food to carry the influence of the rhythm and pace of moving things very little, drug absorption is even and regular, surface area increases can improve medicine and gastrointestinal contact area, make drug absorption complete, improve bioavailability, good looking appearance, good fluidity, release simultaneously stablized, local irritation is little, is difficult for moisture absorption; Can solve the problem that prior art exists.
The applicant has carried out a series of experiments, with the supplementary product kind of the preparation technology that selects pharmaceutical preparation provided by the invention, use and consumption, ratio etc.; Guarantee its science, reasonable, feasible; The preparation that obtains has effective therapeutic effect.
Experimental example 1 Study on extraction
(1) factor is selected: the decocting for Chinese herbal medicine extraction effect is subjected to the influence of factors such as amount of water, extraction time, extraction time.Because of the primary standard extraction process is investigated extraction time, extraction time, so when Radix Scutellariae, Radix Isatidis and two groups of medical materials of Cortex Phellodendri decoct investigation, choose amount of water as factor, the varying level of high spot reviews factor is to decocting the influence of extraction effect.Take all factors into consideration the selection factor level in conjunction with aspects such as production cost, the energy.
(2) index is determined: Radix Scutellariae, Radix Isatidis select extractum recovery rate and content of baicalin as evaluation index, and Cortex Phellodendri selects extractum recovery rate and content of berberine as evaluation index, and its reason and assay method are as follows:
1. extractum recovery rate: extractum is the material base of solid preparation performance curative effect, and its yield height directly influence preparation process, is reasonable, effective control device so be chosen as the extraction index.Radix Scutellariae, Radix Isatidis decoct assay method: take by weighing Radix Scutellariae 100g, Radix Isatidis 100g decoctions that feed intake, merge extractive liquid,, filtration, adjustment is settled to 1000ml, precision is measured 50ml, puts in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath, in 105 ℃ of dryings 3 hours, move in the exsiccator, cooled off 30 minutes, weight decided in accurate rapidly title, calculate, promptly.
Cortex Phellodendri decocts assay method: take by weighing Cortex Phellodendri 100g decoctions that feed intake, merge extractive liquid,, filtration, concentrated, precipitate with ethanol are adjusted and are settled to 1000ml, and precision is measured 50ml, put in the evaporating dish that is dried to constant weight, behind evaporate to dryness in the water-bath,, move in the exsiccator in 105 ℃ of dryings 3 hours, cooled off 30 minutes, weight decided in accurate rapidly title, calculates, promptly.
2. assay: extractum recovery rate height can not reflect fully that active ingredient extracts situation, decocts screening index so measure the contained content of baicalin of Radix Scutellariae simultaneously as Radix Scutellariae, Radix Isatidis, adopts high-efficient liquid phase technique mensuration content of baicalin; Measure the contained content of berberine hydrochloride of Cortex Phellodendri and decoct screening index as Cortex Phellodendri.Adopt high-efficient liquid phase technique to measure the content of berberine hydrochloride.
(3) test: test arrangement and the results are shown in following table.
Radix Scutellariae, Radix Isatidis amount of water are investigated table as a result
| Tested number | Amount of water (doubly) | Extractum recovery rate (%) | Content of baicalin (mg/ml) | ||
| For the first time | For the second time | For the third time | |||
| 1 | 6 | 6 | 4 | 25.67 | 3.636 |
| 2 | 6 | 6 | 6 | 28.71 | 3.688 |
| 3 | 8 | 6 | 4 | 30.65 | 3.708 |
| 4 | 8 | 6 | 6 | 31.58 | 3.756 |
| 5 | 8 | 8 | 6 | 31.61 | 3.758 |
As seen from the above table, it is that 8,8,6 times extractum recovery rate and content of baicalin difference is little with amount of water that amount of water is 8,6,6 times, from energy savings with become original and consider that the optimised process of amount of water is for decocting with water three times, amount of water is 8,6,6 times.And carry out confirmatory experiment according to this condition.
The Cortex Phellodendri amount of water is investigated table as a result
| Tested number | Amount of water (doubly) | Extractum recovery rate (%) | Content of berberine hydrochloride (mg/ml) | ||
| For the first time | For the second time | For the third time | |||
| 1 | 6 | 6 | 6 | 10.47 | 2.156 |
| 2 | 8 | 6 | 6 | 10.58 | 2.161 |
| 3 | 8 | 8 | 6 | 10.57 | 2.158 |
| 4 | 8 | 8 | 8 | 10.61 | 2.164 |
As seen from the above table, the extractum recovery rate and the content of berberine hydrochloride difference of each group are little, consider with becoming originally that the optimised process of amount of water added 6 times of amounts for decocting with water three times at every turn from energy savings.And carry out confirmatory experiment according to this condition.
(4) confirmatory experiment: carry out confirmatory experiment by above extraction process condition, experimental result is listed as follows:
Radix Scutellariae, Radix Isatidis confirmatory experiment result
| Scheme | Tested number | Extractum recovery rate (%) | Content of baicalin (mg/ml) |
| Decoct with water three times, for the first time adding 8 times of decoctings boiled 3 hours, for the second time add 6 times of decoctings and boiled 2 hours, add 6 times of decoctings for the third time and boiled 1 hour | 1 | 31.61 | 3.743 |
| 2 | 31.57 | 3.762 | |
| 3 | 31.59 | 3.757 |
Remarks: investigation amount 100g
Extract by visible this optimum organization condition of the result of confirmatory experiment that extractum recovery rate and content of baicalin fluctuation are little as a result, this extraction process condition be rationally, stablize feasible.
Cortex Phellodendri confirmatory experiment result
| Scheme | Tested number | Extractum recovery rate (%) | Content of berberine hydrochloride (mg/ml) |
| Decoct with water three times, add 6 times of water gagings at every turn.Decocted 3 hours for the first time, decocted 2 hours for the second time, decocted for the third time 1 hour. | 1 | 10.49 | 2.157 |
| 2 | 10.53 | 2.162 | |
| 3 | 10.52 | 2.156 |
Remarks: investigation amount 100g
Extract by visible this optimum organization condition of the result of confirmatory experiment that extractum recovery rate and content of berberine hydrochloride fluctuation are little as a result, this extraction process condition be rationally, stablize feasible.
In sum, Radix Scutellariae, Radix Isatidis optimum extraction process add 8 times of decoctings for the first time and boiled 3 hours for decocting with water three times, add 6 times of decoctings for the second time and boil 2 hours, add 6 times of decoctings for the third time and boil 1 hour; The optimum extraction process of Cortex Phellodendri adds 6 times of decoctings for the first time and boiled 3 hours for decocting with water three times, adds 6 times of decoctings for the second time and boils 2 hours, adds 6 times of decoctings for the third time and boils 1 hour.
Experimental example 2: Study on Forming
2.1 capsule
2.1.1 hygroscopic agent
Investigate by wettability test, think that the extractum that adds the crude drug powder has anti-preferably hygroscopic effect.Because paste-forming rate slightly fluctuates, and can add starch and adjust total amount in right amount.Wettability test the results are shown in following table.
The wettability test result
| Sample | Pure extract powder | Extract powder+crude drug powder | |
| The weighing bottle numbering | 1 | 2 | |
| Weight of material (g) | 0.9959 | 1.0125 | |
| Moisture absorption blanking time percentage (%) | 1h | 1.49 | 0.71 |
| 2h | 4.09 | 1.82 | |
| 3h | 5.75 | 3.54 | |
| 4h | 8.0g | 5.03 | |
| 6h | 9.68 | 6.24 | |
| 8h | 11.57 | 8.15 | |
| 10h | 13.02 | 10.01 | |
| 12h | 16.25 | 12.11 | |
| 24h | 18.42 | 14.31 | |
| 36h | 21.94 | 16.24 | |
| 48h | 26.15 | 18.95 | |
| 72h | 29.42 | 21.62 | |
| 84h | 31.58 | 22.21 | |
The result shows, adopts crude drug powder double as adjuvant rationally feasible, need not to use other adjuvants to adjust hygroscopicity.
2.1.2 granulate and drying mode
In thick paste, add crude drug powder and appropriate amount of starch, mixing, the system soft material is granulated with oscillating granulator (40 order), adopts the heated-air circulation oven drying, 50～60 ℃ of baking temperatures, granulate, promptly.
2.1.3 fill material fluidity determining
For guaranteeing that divided dose is accurate, require the good flowability of fill material tool, so to measure the flowability of method examination angle of repose fill material.
Fixed funnel method: get 3 funnel series connection, lowermost end is apart from horizontal positioned graph paper 1.5cm place, carefully fill material is poured into along hopper walls in the funnel of going up most till the granule cone tip that bottom funnel forms touches the funnel end opening, measure the diameter of conical base by graph paper, (tg α=H/R/2), result of calculation sees the following form to calculate angle of repose.
α angle of repose of fill material
| Working sample | Angle of repose |
| 1 2 3 | 33.5° |
| 32.3° | |
| 34.8° |
As seen from the above table, filler particles angle of repose＜40 ° promptly show the filler particles good fluidity, can satisfy and divide a reload request.
2.1.4 the fill material bulk density is measured and capsulae vacuus is selected
Generally according to the difference of crystal formation, fineness, density and the dosage of medicine, particularly bulk density is determined in the selection of capsulae vacuus specification.Adopt the graduated cylinder method to measure granulation mass density, the granule that is about to precision weighing is packed in the exsiccant 10ml graduated cylinder, about jolting gently, 20 times back and forth, recording capacity calculates, and the results are shown in following table.
The bulk density measurement result
| Batch | Weight (g) | Capacity (ml) | Bulk density (g/ml) | Meansigma methods |
| 1 | 2.251 | 3.22 | 0.70 | 0.70 |
| 2 | 2.255 | 3.27 | 0.69 | |
| 3 | 2.249 | 3.17 | 0.71 |
The result records the about 0.70 (g/cm of filler particles bulk density
3), according to the relation of capsulae vacuus number and approx. volume, select the packing of No. 1 hungry area softgel shell.Know that by aforementioned extraction can get dry extract and the about 340g of crude drug powder, add appropriate amount of starch, make 1000 capsules, so the heavy 0.40g of every capsules.Filling in No. 1 capsulae vacuus, polishing, promptly.
2.1.5 critical relative humidity (CRH) is measured
Whether be subjected to the influence of environment when investigating packing, granule is carried out equilibrium hygroscopicity test, i.e. moisture equilibrium at dry side curve determination.Get totally six parts of each about 1g of granule, put in the weighing botle, the accurate title, decide, the weighing bottle cap is opened, put into relative humidity respectively and be 20%, 33%, 43%, 60%, 75%, 92% environment, in 25 ℃ of constant incubators, placed 84 hours, take out weighing botle, it is fixed to add a cover the accurate title in back, calculates the moisture absorption percentage rate, is abscissa with the relative humidity, the moisture absorption percentage rate is a vertical coordinate, draw the moisture equilibrium at dry side curve and see accompanying drawing 1 (abscissa is relative humidity %, and vertical coordinate is moisture absorption percentage rate %), result of the test sees the following form.
The moisture absorption percentage rate (%) of filler particles
| The saturated salt solution kind | Relative humidity (%) | Moisture absorption percentage rate (%) |
| CH 3COOK·1.5H 2O | 20 | 3.15 |
| MgCl 2·6H 2O | 33 | 4.63 |
| K 2CO 3·2H 2O | 43 | 7.23 |
| NaBr·2H 2O | 60 | 13.21 |
| NaCl | 75 | 22.21 |
| KNO 3 | 92 | 42.98 |
As can be known from the above table, capsule is under different relative humidity environment, and its water absorption does not wait, and is about 65.0% when following at relative humidity, and capsule moisture is less than 9.0%, so should control relative humidity below 65.0% during packing, and storage should be airtight, protection against the tide.
2.2 pellet
2.2.1 the screening of excipient kind and consumption
The percentile mensuration of moisture absorption: the bottom is filled saturated KBr solution place 2d, make its inner RH constant, in the weighing botle of dry constant weight, put the about 2g micropill of people 84% at 20 ℃, be tiled in the bottom, thick about 2mm opens weighing botle, timing is weighed and is calculated the moisture absorption percentage rate, the results are shown in following table.
The moisture absorption percentage rate (%) of different excipient
| Excipient is without excipient starch microcrystalline Cellulose (MCC) equal proportion starch and microcrystalline | Wetting agent | 90 | Binding agent 3%HPMC 3%HPMC 3%HPMC 3%HPMC | 24h 10.7 10.3 9.3 9.8 | 48h 14.1 13.5 13.2 13.8 |
By the result of last table as can be known, the starch hygroscopicity is greater than microcrystalline Cellulose for this product, and therefore, it is excipient that the present invention little nine selects microcrystalline Cellulose, but the adding of various dose excipient also can produce certain influence to the quality of micropill.For this reason, the applicant compares and screens the use amount of microcrystalline Cellulose, measures the angle of repose and the bulk density of the different use amount micropills of MCC, and concrete data see the following form.
The different use amounts of MCC are to the influence of micropill angle of repose and bulk density
| Product and MCC ratio in the middle of the micropill | Angle of repose (°) | Bulk density (g/ml) |
| 1∶2 1∶1 2∶1 | 35 36 38 | 0.70 0.68 0.64 |
According to the data of last table as can be known, along with the increase of MCC content, reduce the angle of repose of gained micropill, and bulk density increases, but considers from the cost aspect, and selecting soft material and MCC ratio is 1: 1.
2.2.2 the influence of main frame rotary speed
Product in the middle of the micropill and MCC are even by 1: 1 mixed, get 500g and put in the centrifugal granulator, be binding agent with the 3%HPMC aqueous solution, addition is 90mL, and engine speed is respectively 100,200, and 300r/min the results are shown in following table.
Engine speed is to the influence of micropill particle size distribution and yield
| Yield (%) under the different engine speeds (r/min) | |||
| Micropill particle diameter (μ m) 200～400 400～600 600～900 900～1500 | 100 17.7 44.5 25.4 13.6 | 200 11.5 76.8 9.6 3.7 | 300 13.6 78.3 10.5 1.4 |
By experimental result as can be known, when the main frame rotary speed was 100r/min, most of powder depended on the chassis and does not reach even moistening, and the result of granulation is bigger aggregation block, micropill and middle product and deposits that the yield of particle diameter 600～400 μ m micropills is lower; When engine speed increased to 200r/min, because the powder moistening is comparatively even, the bump impulse force of granule and plate washer became big, bigger further fragmentation of granule, thereby particle diameter is reduced greater than the granule of 900 μ m with less than the powder of 400 μ m thereupon; When engine speed when 200r/min increases to 300r/min, change of size is no longer obvious, illustrates that this moment, particle fragmentation reached balance substantially with gathering, so for this product, engine speed should be 200r/min.
2.2.3 binding agent adds the influence of speed (spray pump rotating speed)
Product in the middle of the micropill and MCC are even by 1: 1 mixed, get 500g and put in the centrifugal granulator, be binding agent with 3% hydroxypropyl emthylcellulose (HPMC) aqueous solution; addition is 90mL; regulate the spray pump rotating speed and be respectively 10,20,30; 50r/min (is equivalent to 7.6; 15.2,22.8,38mL/min); the whitewashing time the results are shown in following table to having sprayed till the binding agent.
Binding agent adds the influence of speed to micropill particle size distribution and yield
| Different binding agents add the yield (%) under the speed (r/min) | ||||
| Micropill particle diameter (μ m) 200～400 | 10 35.4 | 20 12.5 | 30 8.2 | 50 1.9 |
| 400～600 600～900 900～1500 | 60.3 4.2 0.9 | 74.2 8.7 4.2 | 66.3 18.6 8.5 | 13.1 36.5 47.8 |
By experimental result as can be known, binding agent adding speed is bigger to the property effect of micropill of the present invention, and along with the increase of spray pump rotating speed, grain diameter increases sharply.When spouting velocity comparatively during 10r/min, the binding agent deficiency so that product of the present invention in the middle of product moistening assemble promptly drying gradually, so particle diameter is more less than the powder of 400 μ m; When it continue to increase, binding agent before dry owing to have that the refining middle product of chien shih are gathered into micropill when enough, so little nine showed increased of particle diameter 600～400 μ m; But when spouting velocity is 50r/min because that binding agent sprays the people at short notice is too much, refining in the middle of product mix fully inadequately with binding agent, powder sticks to very soon and has formed little nine surface, causes bulky grain significantly to increase, the coarse inequality of particle surface; Still to select binding agent adding speed be 15.2mL/min.
2.2.4 the influence of round as a ball time
Product in the middle of the micropill and MCC are even by 1: 1 mixed, get 500g and put in the centrifugal granulator, be binding agent with the 3%HPMC aqueous solution, addition is 90mL, and binding agent adds the back rotating disk and is rotated further 2,4, and 6min (round as a ball time) the results are shown in following table.
The round as a ball time is to the influence of molding micropill particle size distribution and yield
| Micropill particle diameter (μ m) | Yield (%) under the different round as a ball times (min) | ||
| 2 | 4 | 6 | |
| 200～400 400～600 600～900 900～1500 | 13.6 74.1 9.9 2.9 | 11.3 75.7 9.2 3.8 | 11.6 75.0 9.8 3.6 |
By experimental result as can be known, round as a ball is after binding agent adds, and rotating disk continues the process of rolling, the no longer phenomenal growth of micropill this moment, and particle size distribution does not have much variations yet.
Experimental example 3: dissolution experiment
Simulated gastric fluid-95% ethanol (3: 2) is solvent, 37 ± 0.5 ℃ 100 rev/mins.Get YANKENING PIAN, capsule of the present invention, put and get the 6ml solvent when changeing in the basket respectively at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 90min, put immediately in the centrifuge tube with 4,000 rev/mins of centrifugal 5min, get supernatant 5ml, thin up is to 10ml, with the content of high-efficient liquid phase technique mensuration berberine hydrochloride, calculate the cumulative percentage rate that discharges.
| Cumulative percentage rate % | ||
| YANKENING PIAN | Capsule of the present invention | |
| 5min 10min 20min 30min 40min 50min 60min 90min | 0.52 39.40 58.36 62.45 76.31 84.27 88.32 92.18 | 2.04 45.12 65.35 77.06 88.29 98.03 100.10 101.03 |
By experimental result as can be known, tablet needs in the process of preparation through the molding of overcompression ability, and disintegrate is slower, and is lower at the intravital dissolution of people, and by contrast, capsule of the present invention more helps the absorption by human body utilization.
Experimental example 4: pharmacodynamic experiment
4.1 the diarrheal therapeutical effect is studied
Get NIH mice 40, body weight 180～220g.Select the normal mice of stool to include experiment in, mice male and female half and half, random packet, be divided into model group, the YANKENING PIAN group, Capsules group of the present invention and micropill group of the present invention, except that model group, each organizes rat gastric infusion YANKENING PIAN respectively, capsule of the present invention and micropill of the present invention, behind the administration 1h, every mice is irritated stomach Folium Sennae leachate (Folium Sennae being made into 10% leachate with 90 ℃ of hot water) by 30 μ L/g body weight, every single cage of mice is observed then, and the muck counting is made in shop absorbent paper under the cage, how much represents the diarrhoea degree with the muck number, in time change absorbent paper, write down each Mus and irritate 4h muck number of times behind Folium Sennae; " muck " is meant soft excrement of the pasty state of sub-circular or loose stool, around it brown endless belt arranged in absorbent paper, and normal argol then is bat shape or fusiformis, do not show color around it in absorbent paper.Concrete outcome sees the following form.
Folium Sennae is caused the influence of diarrhea of mouse
| Group | Dosage (g/kg) | The mice number of elements | The muck number of times |
| Model group YANKENING PIAN group Capsules group of the present invention micropill group of the | 5 5 5 5 | 10 10 10 10 | 3.5±1.5 2.0±1.0 1.9±1.3 1.6±0.8 |
By the result of last table as can be known, capsule of the present invention and micropill of the present invention can reduce Folium Sennae induced mice diarrheal muck number of times effectively, and capsule of the present invention and micropill of the present invention have certain therapeutical effect to diarrhoea, and effect is not less than YANKENING PIAN.
4.2 therapeutical effect research to bacterial pneumonia
Get 50 of the male old rats of SD, 20～22 monthly ages.Make with reference to the Zhang Shi endotracheal intubation.Draw in the 0.02ml bacterial suspension sprue bushing with microsyringe.Keep the about 10min of rat original position, make bacterium liquid in the sleeve pipe because action of gravity flows in bronchus and the alveolar, to reach pulmonary infection.The modeling Mus is divided into model group, YANKENING PIAN group, Capsules group of the present invention and micropill group of the present invention at random, and 10 every group, other gets 10 similar not modeling Mus is the normal control group.Two groups of normal control groups, model group begin to irritate stomach with normal saline in the modeling proxima luce (prox. luc); All the other two groups begin respectively to irritate stomach (5g/kg/d) with YANKENING PIAN, capsule of the present invention and micropill of the present invention in the modeling proxima luce (prox. luc), and 6d puts to death whole rats then continuously.Arterial blood extracting prepares blood plasma, serum .-20 ℃ preservation, and is to be measured; Open breast and get full lung, left side lung formalin fixed. right lung is got bronchoalveolar lavage fluid (BALF), injects trachea with 2mlHanks liquid, massages right lung 30s gently and draws back perfusion fluid. pour into this liquid again, pour into repeatedly 3 times, at last the liquid that pours into being extracted out is that 1 lavation finishes.With method operation totally 3 times.Whole irrigating solutions are collected together, surveyed total capacity, reclaim BALF (response rate＞50%), filter the back in the centrifugal 15min of 3000r/min with double-deck dry gauze, it is standby to get supernatant; Go the precipitation behind the supernatant partly to do cell neutrophilic granulocyte counting, unit is with * 10
6/ L represents.Adopt xanthine oxidase to measure the SOD activity, adopt chemical colorimetry measuring N O content, the employing colorimetric method for determining MDA content of nitrate reductase.Concrete data see the following form.
Each organizes the variation of rat blood serum NO, MDA, SOD content
| Group | NO(μmol/L) | MDA(NU/ml) | SOD(mmol/ml) |
| Normal control group model group YANKENING PIAN group Capsules group of the present invention micropill group of the present invention | 112.61±34.27 245.73±48.06 174.52±38.47 170.04±43.85 162.36±40.17 | 108.39±30.14 174.58±19.35 134.29±13.52 130.60±15.73 127.47±12.65 | 389.56±57.39 269.36±67.62 354.25±34.87 359.28±30.54 363.74±35.26 |
By the result of last table as can be known: rat NO raises after the modeling, SOD is active to be reduced, MDA content raises, and the normal trend of recovering arranged after Capsules group of the present invention and the micropill group of the present invention medication, illustrate that capsule of the present invention and micropill of the present invention improve significantly to the bacillary lungs pathological change of old rats, and effect is not less than YANKENING PIAN.
Description of drawings: Fig. 1 is a moisture equilibrium at dry side curve chart of the present invention, and wherein: abscissa is relative humidity %, and vertical coordinate is moisture absorption percentage rate %.
Concrete embodiment:
Embodiments of the invention 1: Cortex Phellodendri 413.8g, Radix Et Rhizoma Rhei 82.8g, Radix Scutellariae 310.3g, Radix Isatidis 310.3g, Rhizoma Coptidis 20.7g
Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, add 8 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2 hours, add 6 times of decoctings for the third time and boil 1 hour, and collecting decoction filters, and filtrate is condensed into the thick paste that relative density is 1.30 (60 ℃); Cortex Phellodendri decocts with water three times, adds 6 times of decoctings for the first time and boils 3 hours, adds 6 times of decoctings for the second time and boils 2 hours; add 6 times of decoctings for the third time and boiled 1 hour, collecting decoction filters; filtrate is concentrated into 1.5 times of primary dose, adds ethanol and makes that to contain the alcohol amount be 70%, stirs; leave standstill, filter, reclaim ethanol; being concentrated into relative density is 1.30 (60 ℃) thick paste; add above-mentioned powder and starch and reach the thick paste mixing in right amount, in thick paste, add crude drug powder and appropriate amount of starch, mixing; the system soft material; granulate with oscillating granulator 40 orders, adopt the heated-air circulation oven drying, 50～60 ℃ of baking temperatures; make granule; drying, granulate incapsulates; make 1000; promptly get capsule, should control relative humidity during packing below 65.0%, this product oral; three times on the one; each 3-4 grain.
Embodiments of the invention 2: 25 parts of 420 parts of Cortex Phellodendris, 90 parts of Radix Et Rhizoma Rhei, 320 parts of Radix Scutellariaes, 320 parts of Radix Isatidis, Rhizoma Coptidis (among the embodiment part be weight portion, as: kilogram, restrain or the like)
Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, add ethanol and make that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, vacuum drying, add then with drug ratios be that 1: 1 MCC is as excipient, with 90% ethanol is wetting agent, and 3%HPMC is bonding, granulates with centrifugal granulation, engine speed is 200r/min, and binding agent adding speed is 15.2mL/min.Dry then, sterilization promptly get pellet.
Embodiments of the invention 3: 413.8 parts of Cortex Phellodendris, 82.8 parts of Radix Et Rhizoma Rhei, 310.3 parts of Radix Scutellariaes, 310.3 parts of Radix Isatidis, 20.7 parts of Rhizoma Coptidis
Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water 1 time, and each 1 hour, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water 1 time, and each 1 hour, collecting decoction filtered, and filtrate concentrates, add ethanol and make that to contain the alcohol amount be 50%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, drying, extrude-spheronization prepares micropill, promptly gets pellet.
Embodiments of the invention 4: 413.8 parts of Cortex Phellodendris, 82.8 parts of Radix Et Rhizoma Rhei, 310.3 parts of Radix Scutellariaes, 310.3 parts of Radix Isatidis, 20.7 parts of Rhizoma Coptidis
Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water 4 times, and each 4 hours, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water 4 times, and each 4 hours, collecting decoction filtered, filtrate concentrates, and adds ethanol and makes that to contain the alcohol amount be 80%, stirs, leave standstill, filter, reclaim ethanol, be condensed into thick paste,, granulate Rhizoma Coptidis, Rhubarb and thick paste mixing, with Opadry 2 is coating material, coating material with 70% dissolve with ethanol after, at 50 ℃ of following coatings, the spray intervals time is 80s, and is encapsulated behind the coating, promptly gets capsule.
Embodiments of the invention 5: 413.8 parts of Cortex Phellodendris, 82.8 parts of Radix Et Rhizoma Rhei, 310.3 parts of Radix Scutellariaes, 310.3 parts of Radix Isatidis, 20.7 parts of Rhizoma Coptidis
Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, add ethanol and make that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, add mannitol and aspartame, mixing, make granule, drying, promptly.
Embodiments of the invention 6: 413.8 parts of Cortex Phellodendris, 82.8 parts of Radix Et Rhizoma Rhei, 310.3 parts of Radix Scutellariaes, 310.3 parts of Radix Isatidis, 20.7 parts of Rhizoma Coptidis
Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is concentrated into 1.5 times of primary dose, adds ethanol and makes that to contain the alcohol amount be 70%, stirs, leave standstill, filter, reclaim ethanol, be condensed into thick paste,, extract powder put in the coating pan Rhizoma Coptidis, Rhubarb and thick paste mixing, add an amount of wetting agent, be rolled onto female ball, spray the female ball of wetting agent moistening again, add extract powder then and roll coated, repeatable operation, the coating pan rotating speed is 25r/min, and preparation time 10h takes the dish out of the pot, select ball, promptly.
Embodiments of the invention 7: 20.7 parts of 413.8 parts of Cortex Phellodendris, 82.8 parts of Radix Et Rhizoma Rhei, 310.3 parts of Radix Scutellariaes, 310.3 parts of Radix Isatidis, Rhizoma Coptidis are broken into fine powder with Rhizoma Coptidis, Radix Et Rhizoma Rhei powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, adds ethanol and makes that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, oven dry below 80 ℃, be ground into fine powder, add appropriate amount of starch, with ethanol and soybean oil system soft material, extruding-round as a ball pill, drying promptly gets pellet.
Claims (9)
1. 'Yankening ' pharmaceutical preparation, it is characterized in that: calculate according to components by weight percent, it mainly is made by 380～420 parts of Cortex Phellodendris, 70～90 parts of Radix Et Rhizoma Rhei, 300～320 parts of Radix Scutellariaes, 300～320 parts of Radix Isatidis and 15～25 parts of Rhizoma Coptidis or with their extract of corresponding weight portion.
2. according to the described 'Yankening ' pharmaceutical preparation of claim 1, it is characterized in that: described preparation is capsule, pill, pellet or granule.
3. the preparation method of 'Yankening ' pharmaceutical preparation as claimed in claim 1 or 2 is characterized in that: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water 1～4 time, and each 1～4 hour, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water 1～4 time, and each 1～4 hour, collecting decoction filtered, and filtrate concentrates, add ethanol and make that to contain the alcohol amount be 50～80%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste,, make different preparations then respectively Rhizoma Coptidis, Rhubarb and thick paste mixing.
4. according to the preparation method of the described 'Yankening ' pharmaceutical preparation of claim 3, it is characterized in that:
Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is concentrated into 1.5 times of primary dose, adds ethanol and makes that to contain the alcohol amount be 70%, stirs, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, make different preparations then respectively.
5. according to the preparation method of claim 3 or 4 described 'Yankening ' pharmaceutical preparations, it is characterized in that: the capsule in the described preparation prepares like this: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, for the first time add 8 times of decoctings to boil 3 hours, add 6 times of decoctings for the second time and boil 2 hours, add 6 times of decoctings for the third time and boil 1 hour, and collecting decoction filters, and it is 1.30 thick paste that filtrate is condensed into 60 ℃ of relative densities; Cortex Phellodendri decocts with water three times, adds 6 times of decoctings for the first time and boils 3 hours, adds 6 times of decoctings for the second time and boils 2 hours, adds 6 times of decoctings for the third time and boils 1 hour, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, add ethanol and make that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, being concentrated into 60 ℃ of relative densities is 1.30 thick pastes, add above-mentioned powder and starch and reach the thick paste mixing in right amount, granulate drying, granulate incapsulates, promptly.
6. according to the preparation method of the described 'Yankening ' pharmaceutical preparation of claim 5, it is characterized in that:
The granulation of the capsule in the described preparation and drying mode are such: in thick paste, add crude drug powder and appropriate amount of starch, and mixing, the system soft material is granulated with oscillating granulator 40 orders, adopts the heated-air circulation oven drying, 50～60 ℃ of baking temperatures.
7. according to the preparation method of the described 'Yankening ' pharmaceutical preparation of claim 5, it is characterized in that:
Should control relative humidity below 65.0% during capsule packing in the described preparation.
8. according to the preparation method of claim 3 or 4 described 'Yankening ' pharmaceutical preparations, it is characterized in that: the pellet in the described preparation prepares like this: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, add ethanol and make that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, vacuum drying, add then with drug ratios be that 1: 1 microcrystalline Cellulose is as excipient, with 90% ethanol is wetting agent, and 3% hydroxypropyl emthylcellulose is bonding, granulates with centrifugal granulation, engine speed is 200r/min, and binding agent adding speed is 15.2mL/min.Dry then, sterilization, promptly.
9. according to the preparation method of claim 3 or 4 described 'Yankening ' pharmaceutical preparations, it is characterized in that: the granule in the described preparation prepares like this: Rhizoma Coptidis, Radix Et Rhizoma Rhei powder are broken into fine powder; Radix Scutellariae, Radix Isatidis decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into thick paste; Cortex Phellodendri decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filters, and filtrate is concentrated into 1.5 times of primary dose, add ethanol and make that to contain the alcohol amount be 70%, stir, leave standstill, filter, reclaim ethanol, be condensed into thick paste, with Rhizoma Coptidis, Rhubarb and thick paste mixing, add mannitol and aspartame, mixing, make granule, drying, promptly.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101322747B (en) * | 2008-08-13 | 2010-11-03 | 中国农业大学 | Medicament for treating mammitis |
| CN101396465B (en) * | 2008-10-09 | 2010-12-29 | 刘运波 | Traditional Chinese medicine for treating chronic suppurative tonsillitis |
| CN110368430A (en) * | 2019-07-25 | 2019-10-25 | 天地恒一制药股份有限公司 | A kind of inflammation can peaceful ball preparation method |
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2005
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101322747B (en) * | 2008-08-13 | 2010-11-03 | 中国农业大学 | Medicament for treating mammitis |
| CN101396465B (en) * | 2008-10-09 | 2010-12-29 | 刘运波 | Traditional Chinese medicine for treating chronic suppurative tonsillitis |
| CN110368430A (en) * | 2019-07-25 | 2019-10-25 | 天地恒一制药股份有限公司 | A kind of inflammation can peaceful ball preparation method |
| CN110368430B (en) * | 2019-07-25 | 2023-06-13 | 天地恒一制药股份有限公司 | Preparation method of yankening pills, ultrasonic extraction tank and extraction device |
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