CN1861147A - 'Weitongning' dispersing tablets prepn. for treating stomach trouble and its prepn. method - Google Patents
'Weitongning' dispersing tablets prepn. for treating stomach trouble and its prepn. method Download PDFInfo
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Abstract
A Chinese medicine 'Weitongning' in the form of dispersing tablet for treating stomach-ache is prepared from aluminum hydroxide, fennel oil and 4 Chinese-medicinal materials including dandelion herb, liquorice, Chinese gentian, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to peaceful dispersible tablet formulation of a kind of stomachache and preparation method thereof, belong to technical field of medicaments.
Technical background
Peptic ulcer mainly refers to occur in the bulboduodenal chronic ulcer of harmonization of the stomach, is clinical a kind of commonly encountered diseases, frequently-occurring disease.Chinese medicine does not have this name of disease and belongs to the category of the traditional Chinese medical science " gastric abscess ", " acid regurgitation ", " noisy " according to clinical manifestation, character, position, and owing to ulcer reason complexity, the recurrence factor is more, becomes the focus of current medical research.The peaceful sheet of having a stomachache is exactly at treatment stomach, duodenal ulcer, the reasonable Chinese patent medicine of effects such as gastritis.But in actual use, be not difficult to find that owing to be subjected to the restriction of its dosage form, the tablet dissolution is slower, even can influence its bioavailability; Tablet is not easy to child and comatose patient shortcoming such as swallow.Influence the curative effect of medicine, delay treatment.
Summary of the invention
The object of the invention is, peaceful dispersible tablet formulation of a kind of stomachache and preparation method thereof is provided.The present invention's peaceful sheet of will having a stomachache changes agent and makes the peaceful dispersible tablet of stomachache, when improving bioavailability of medicament, also has taking convenience, absorbs fast and advantage such as untoward reaction is little, can solve the problem that prior art exists and increase a kind of peaceful novel form of having a stomachache.
Technical scheme of the present invention.The peaceful dispersible tablet of having a stomachache, to produce 1000, it is to add adjuvant again by following materials of weight proportions to be prepared from, raw material is:
Herba Taraxaci extract 300g aluminium hydroxide 300g
Radix Glycyrrhizae dry extractum 210g Semen Hyoscyami extractum 25g
Radix Gentianae powder 155g fennel oil 4ml
Adjuvant is: low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, micropowder silica gel, calcium sulfate two water things, ethanol.
The peaceful dispersible tablet of above-mentioned stomachache, supplementary product consumption is: low-substituted hydroxypropyl cellulose 55～65g, microcrystalline Cellulose 190～210g, micropowder silica gel 8～11g, calcium sulfate two water things 85～105g.
The preparation method of the peaceful dispersible tablet of above-mentioned stomachache is that concrete steps comprise:
A, preparation Herba Taraxaci extract are got Herba Taraxaci, water merceration twice, and each 24 hours, filter, merging filtrate adds saturated limewater, transfers pH value to 11-12, left standstill 12-24 hour, the collecting precipitation thing, 60 ℃ of dryings, promptly;
B, preparation Radix Glycyrrhizae dry extractum, the extracting liquorice medical material runs through, and section decocts with water three times, and each 2 hours, collecting decoction, placing spends the night makes precipitation.Get supernatant concentration to the thick paste shape, 80 ℃ dry down, pulverizes, and sieves, promptly;
C, preparation Semen Hyoscyami extractum are got the Semen Hyoscyami coarse powder, according to the percolation under fluid extract and the extractum item, make solvent with 70% ethanol, after the diafiltration, measure its content, are concentrated into every 100g extractum and contain that to show alkali be 0.27-0.33g;
D, preparation fennel oil are got Fructus Foeniculi, extract volatile oil with steam distillation, promptly;
E, get Herba Taraxaci extract 300g, aluminium hydroxide 300g, Radix Glycyrrhizae dry extractum 210g, Semen Hyoscyami extractum 25g and Radix Gentianae powder 155g mixing, add low-substituted hydroxypropyl cellulose, microcrystalline Cellulose and calcium sulfate, abundant mixing, the low-substituted hydroxypropyl cellulose that adds 3/4 amount, the calcium sulfate of the microcrystalline Cellulose of 3/4 amount and 3/4 amount, alcoholic solution with 90% is granulated, cut into 24～30 order granules with cutter, airpillow-dry under 60～70 ℃ of temperature, with 24～28 mesh sieve granulate, spray into fennel oil again, mixing with an amount of ethanol dilution, the low-substituted hydroxypropyl cellulose that adds surplus again, microcrystalline Cellulose and calcium sulfate, and micropowder silica gel and an amount of magnesium stearate, abundant mixing, granulate, scrobicula stamping with φ 9.5-10, or the bag film-coat, packing promptly gets the peaceful dispersible tablet of having a stomachache.
Compared with prior art: the present invention is on the basis of the peaceful sheet of former stomachache, through novel form and the preparation method of testing, contrast, conclude, screen, sum up acquisition repeatedly.The present invention's peaceful sheet of will having a stomachache is made dispersible tablet, has improved bioavailability, absorbs soon, reaches disintegrate rapidly behind the affected part, and effective reduction of patient pain is a kind of safe, stable, novel form efficiently.In the present invention: the key of dispersible tablet formulation technology is the selection of disintegrating agent and consumption thereof, the selection of swellability adjuvant and consumption thereof, and the selection of other pharmaceutic adjuvant and consumption thereof.For this reason, the applicant is filtering out best proportioning on a large amount of experiment basis, makes dispersible tablet that the present invention makes when having oral tablet and oral liquid advantage concurrently, also possesses good stability, is easy to carry, advantage such as taking convenience.These characteristics such as fast as the dispersible tablet disintegration rate, that dispersion is high, dissolution rate is fast are rather brought into play its curative effect as a medicine that solves stomach pain for stomachache and are reached faster a, effect more efficiently.Can swallow, chew as this medicine of dispersible tablet, take separately after also can placing water to disperse, the patient who especially is fit to old man, child and the solid difficulty of swallowing uses, and has enlarged the use face of medicine.
The applicant has done a series of experiments, can prove that method provided by the invention is effectively controlled, and preparation stabilization is efficient, the production method simple possible.
The screening of experimental example 1 disintegrating agent
According to the screening of preliminary experiment, under the situation of this prescription and adjuvant proportions constant, drug extract and extract powder are directly added different disintegrating agents, granulate, tabletting, as investigating index, experimental result sees Table 1 with the important indicator disintegration time of dispersible tablet:
Table 1: the selection of disintegrating agent
| Sample number into spectrum | The disintegrating agent title | Disintegration time |
| 1 2 3 4 5 6 | Sodium carboxymethyl starch (CMS-Na) Ac-Di-Sol (c CMC-Na) crosslinked Suo good basic Starch Sodium (c CMS-Na) low-substituted hydroxypropyl cellulose (L-HPS) PVPP (PPVP) microcrystalline cellulose (MCC) | 9min 6min 7.5min 4min 3min 18min |
This experiment shows, and is in above-mentioned several disintegrating agents, the shortest with low-substituted hydroxypropyl cellulose (L-HPS), crospolyvinylpyrrolidone (PPVP) disintegration time.But do not reach fully " in two ones of the Chinese pharmacopoeia versions in 2005 to the requirement of dispersible tablet disintegration time.We have selected suitable high-quality disintegrating agent according to nature of drugs as mentioned above, consider the advantage of various disintegrating agents, we select the mode of disintegrating agent coupling for use, and look for the suitable proportion of different disintegrating agent couplings, and adopt suitable adding method, improve the disintegration of dispersible tablet to greatest extent.According to the preliminary experiment result, we find that microcrystalline Cellulose (MCC) is as using the widest pharmaceutic adjuvant at present, it is spongiform porous tubular structured, its structure changes into linear array when pressurized, plastic deformation in addition, after MCC meets water, hydrone just destroys its inner hydrogen bond structure, impel tablet speed to collapse, but as shown in table 1, it is under situation about using separately, its disintegrate effect is relatively poor, according to the data of literatures finishing analysis, we find that microcrystalline Cellulose (MCC) as the stripping that auxiliary disintegrating agent can improve medicine greatly, shortens disintegration time.For this reason, we all with the mutual compatibility of equivalent, survey its disintegration time to three kinds of disintegrating agent low-substituted hydroxypropyl celluloses (L-HPC), polyvinylpyrrolidone (PPVP), microcrystalline Cellulose (MCC), and experimental result sees Table 2:
Table 2: the coupling screening of disintegrating agent
| Sample number into spectrum | The disintegrating agent coupling | Disintegration time |
| 1 2 3 4 | L-HPC+MCC L-HPC+PPVP PPVP+MCC L-HPC+PPVP+MCC | 145s 192s 171s 194s |
The result shows that when low-substituted hydroxypropyl cellulose (L-HPC) and microcrystalline Cellulose (MCC) coupling, its disintegration time is the shortest, and meets " two regulations of Chinese pharmacopoeia version in 2005.
The screening of experimental example 2 filleies
In experimental example 1, though after adopting fine disintegrating agent, its disintegration time is up to specification, owing to mostly be drug extract or dry extract in the former prescription, but the general viscosity of Chinese medicine extract is bigger, moisture absorption is stronger, and low-substituted hydroxypropyl cellulose (L-HPC) has stronger hygroscopicity, after medicament mixed, through long-time placement the extract powder moisture absorption is strengthened, viscosity increases and makes the difficult disintegrate of tablet, influences medicine in the intravital stripping of people, reduces its bioavailability.Therefore should select a kind of filler to reduce the moisture absorption of medicinal substances extract and extract powder, be convenient to granulate and reduce the consumption of disintegrating agent.Experiment with L-HPC and MCC coupling as disintegrating agent, for fully investigating the influence of filler to prescription, in this experiment, reduce the disintegrating agent consumption, the filler that adds the variety classes same amount with prescription composition and adjuvant according to a certain percentage, through granulation, tabletting, be to investigate index with the disintegration time, experimental result sees Table 3:
Table 3: the selection of filler
| Sample number into spectrum | The filler title | Disintegration time |
| 1 2 3 4 5 | Maltodextrin lactose mannitol calcium sulfate two water thing calcium hydrogen phosphate | 15min 21min 12min 7min 10min |
Experimental result shows, calcium sulfate with prescription composition mixing, behind the pelletizing press sheet, its disintegration time is the shortest, to the hardness of tablet, influence such as tablet weight variation is less.
The selection of experimental example 3 other additives
When pelletizing press sheet,, can consider to add fluidizer for improving particulate flowability.Through preliminary experiment, draw and adopt micropowder silica gel as fluidizer, not only can effectively improve particulate flowability, the silanol base on silica gel surface makes it have strong polarity and hydrophilic simultaneously, helps penetrating of moisture, helps the disintegrate of tablet.Under the situation of prescription and adjuvant proportions constant, drug extract and extract powder are directly added the above-mentioned disintegrating agent (low-substituted hydroxypropyl cellulose, microcrystalline Cellulose) of equivalent and the micropowder silica gel of different proportion, granulate tabletting, as investigating index, experimental result sees Table 4 with compressibility:
Table 4: the consumption of micropowder silica gel
| Sample number into spectrum | The addition of micropowder silica gel | Compressibility |
| 1 2 3 | 1.0% of 0.8% total amount of 0.6% total amount of total amount | General better |
As seen experimental result adopts 0.8% and 1.0% micropowder silica gel of total amount, and the granule compressibility that obtains is all better.Because the use micropowder silica gel reaches at 0.8% o'clock of total amount, its compressibility is better, is good with the micropowder silica gel that adds total amount 0.8% therefore.
Owing to after this product is scattered in the water, promptly form thick suspension, so need not add suspending agent again.
The proportioning screening of experimental example 4 supplementary product consumptions
Experimental technique: determine after the kind of adjuvant, in order to guarantee the quality of dispersible tablet, and make its quality more good, the consumption and the proportioning of various adjuvants are screened.Through preliminary experiment repeatedly, adopt in the adjuvant to add the method that combines that adds, its ratio is, in add: add=3: 1, select wet granulation for use, make 24-30 order granule, with 24-28 purpose screen cloth granulate, be fluidizer with the micropowder silica gel of total amount 0.8%, an amount of calcium sulfate (CaSO
42H
2O) being filler, is index with disintegration time (s), selects microcrystalline Cellulose (MCC) and low-substituted hydroxypropyl cellulose (L-HPC) to do the associating disintegrating agent, is the influence factor with the percentage ratio of shared medicated powder, carries out Orthogonal Experiment and Design.The factor level table sees Table 5, the results are shown in Table 6, and variance analysis sees Table 7:
Table 5: the preferred factor level table of disintegrate collection in the dispersible tablet prescription
Table 6: Orthogonal experiment results
| The experiment number | A | B | C | D | Average disintegration (S) |
| 1 2 3 4 5 6 7 8 9 K 1 K 2 K 3 R | 1 1 1 2 2 2 3 3 3 240.3 113.3 152.0 127.0 | 1 2 3 1 2 3 1 2 3 197.7 170.7 137.3 60.3 | 1 2 3 2 3 1 3 1 2 175.7 171.3 158.7 17.0 | 1 2 3 3 1 2 2 3 1 178.0 166.3 161.3 16.7 | 286 243 192 138 115 87 169 154 133 |
Table 7: analysis of variance table
| Source of variation | Quadratic sum | Degree of freedom | Mean square | The F value | Significant level |
| A B C D | 25426.9 5480.2 468.2 438.9 | 2 2 2 2 | 12713.4 2740.1 234.1 219.4 | 56.06 12.08 | 0.00119 ** 0.02017 * |
Analysis result shows that the influence of A, B two factors is A＞B in proper order, and the major influence factors that promptly influences the disintegration time of dispersible tablet is the adding of low-substituted hydroxypropyl cellulose (L-HPC), and optimum extraction process is A
2B
3Even microcrystalline Cellulose (MCC) coupling of low-substituted hydroxypropyl cellulose of medication powder amount 6% (L-HPC) and medicated powder amount 20%, with inside and outside addition 3: 1, wet granulation, make 24-30 order granule, with 24-28 purpose screen cloth granulate, be fluidizer with the micropowder silica gel of total amount 0.8%, an amount of calcium sulfate (CaSO
42H
2O) be prepared for filler.
Method is the same, adds with the disintegrating agent that preferably comes out and granulates, and investigates filler calcium sulfate (CaSO
42H
2O) consumption is to the influence of dispersible tablet compressibility.For getting rid of some artificial subjective influences, outward appearance, tablet weight variation, hardness of considering mobility of particle, particulate granularity, slice, thin piece simultaneously etc. all is to influence the influence of the compressibility of the factor of tablet compressibility or tablet to whole tablet quality, still worked out the index evaluation detailed rules and regulations of a compressibility:
Compressibility is good: angle of repose α＜45 °; Grain graininess 20-60 order percentage by weight＞70%; The slice, thin piece outward appearance is complete, bright and clean; Tablet weight variation meets " regulation of Chinese pharmacopoeia version in 2005; Slice, thin piece hardness＞5Kg.
Compressibility is better: angle of repose 45 °＜α＜50 °; Grain graininess 20-60 order percentage by weight 60%～70%; The slice, thin piece outward appearance is complete, bright and clean; Tablet weight variation meets " regulation of Chinese pharmacopoeia version in 2005; Slice, thin piece hardness 4Kg～5Kg.
Compressibility is general: angle of repose 50 °＜α＜55 °; Grain graininess 20-60 order percentage by weight 50%～60%; The slice, thin piece outward appearance is complete but fineness is poor; Tablet weight variation meets " regulation of Chinese pharmacopoeia version in 2005; Slice, thin piece hardness 3Kg～4Kg.
Compressibility is relatively poor: angle of repose 55 °＜α＜60 °; Grain graininess 20-60 order percentage by weight 40%～50%; The slice, thin piece outward appearance is not sufficiently complete; Tablet weight variation is bigger; Slice, thin piece hardness＜3Kg.
Poor compressibility: angle of repose α＞60 °; Grain graininess 20-60 order percentage by weight＜40%; The slice, thin piece outward appearance is not sufficiently complete; Tablet weight variation is big; Slice, thin piece hardness＜3Kg.
Experimental result sees Table 8:
Table 8: the screening of filler calcium sulfate consumption
| Sample number into spectrum | The calcium sulfate consumption | Compressibility is estimated |
| 1 2 3 4 | 20% of 12% total amount of 8% total amount of 5% total amount of total amount | General better relatively poor |
According to the compressibility evaluation of indexes, can find out 8%, 12% calcium sulfate (CaSO of total amount
42H
2O) all can make the compressibility of dispersible tablet reach standard preferably, meet the regulation of dispersible tablet, consider the Financial cost problem, select the calcium sulfate (CaSO of total amount 8% for use
42H
2O) fill, because calcium sulfate two water things at high temperature can lose its water of crystallization, and cause it after meeting water, to harden, so when carrying out drying, should control its temperature below 70 ℃.
Experimental example 5 Study on Forming
Through result's arrangement of a large amount of preliminary experiments, the applicant finds that this dispersible tablet adopts the wet particle method film-making, and the dispersible tablet quality that obtains is good, disintegrate is fast, and process stabilizing.
1. the screening of binding agent
Get Herba Taraxaci extract 300g, aluminium hydroxide 300g, Radix Glycyrrhizae dry extractum 210g, Semen Hyoscyami extractum 25g, Radix Gentianae powder 155g mixing, add preferred prescription proportioning adjuvant, fully mixing is granulated with Different concentrations of alcohol solution respectively, cuts into 24～30 order granules with cutter, airpillow-dry under 60～70 ℃ of temperature, with 24～28 mesh sieve granulate, spray into fennel oil again, mixing with an amount of ethanol dilution, add above-mentioned preferred prescription proportioning adjuvant (ratio that adds wherein in 3: 1 adds) again, abundant mixing, granulate, tabletting, measure disintegration time, the results are shown in Table 9:
Table 9: the screening of binding agent
| Sample number into spectrum | Alcoholic solution concentration | Disintegration time |
| 1 2 3 4 5 | 75％ 80％ 85％ 90％ 95％ | 175 150 128 93 107 |
The result shows that 90% alcoholic solution is granulated best.
2. the inside and outside addition ratio screening of disintegrating agent
Find when the difference adding method of disintegrating agent is investigated in to wet granulation, the dispersible tablet that adopts the inside and outside addition of adjuvant to obtain, its disintegrate is rapid, stripping is complete.Because the prescription ratio of adjuvant of inside and outside added-time is influential to the disintegrate of dispersible tablet, the applicant by a large amount of The effects the write out a prescription best proportioning of adjuvant of inside and outside added-time, specific embodiments is:
Get Herba Taraxaci extract 300g, aluminium hydroxide 300g, Radix Glycyrrhizae dry extractum 210g, Semen Hyoscyami extractum 25g, Radix Gentianae powder 155g mixing, add preferred prescription proportioning adjuvant, abundant mixing, the alcoholic solution with 90% is granulated, cut into 24～30 order granules with cutter, airpillow-dry under 60～70 ℃ of temperature with 24～28 mesh sieve granulate, sprays into the fennel oil with an amount of ethanol dilution again, mixing, add above-mentioned preferred prescription proportioning adjuvant (add wherein by different proportion and add) again, abundant mixing, the micropowder silica gel of adding total amount 0.8%, granulate, tabletting is with disintegration time, compressibility the results are shown in Table 11 as investigating index:
Table 11: inside and outside addition disintegrating agent ratio screening
| Sample number into spectrum | Dosage in the adjuvant | The outer dosage of adjuvant | Disintegration time | Compressibility |
| 1 2 3 4 5 6 | 4 parts 4 parts 3 parts 3 parts 2 parts 1 part | 1 part 3 parts 1 part 2 parts 1 part 1 part | 178s 99s 103s 146s 127s 87s | Better general better general |
According to experimental result overall merit, add with in 3 parts of the adjuvants, 1 adds prepared dispersible tablet especially no matter in disintegration time, and aspects such as the outward appearance of tablet, quality all have quality preferably.
Promptly get Herba Taraxaci extract 300g, aluminium hydroxide 300g, Radix Glycyrrhizae dry extractum 210g, Semen Hyoscyami extractum 25g, Radix Gentianae powder 155g mixing, add 3 parts of the preferred prescription of part proportioning adjuvants (4.5% low-substituted hydroxypropyl cellulose (L-HPC) of medicated powder amount, the microcrystalline Cellulose of medicated powder amount 15% (MCC), and the calcium sulfate (CaSO of total amount 6%
42H
2O)), abundant mixing, alcoholic solution with 90% is granulated, and cuts into 24～30 order granules with cutter, airpillow-dry under 60～70 ℃ of temperature, with 24～28 mesh sieve granulate, spray into the fennel oil with an amount of ethanol dilution again, mixing adds 1 part of above-mentioned adjuvant (1.5% low-substituted hydroxypropyl cellulose (L-HPC) of medicated powder amount again, the microcrystalline Cellulose of medicated powder amount 5% (MCC), the calcium sulfate (CaSO of total amount 2%
42H
2O)), and the micropowder silica gel of total amount 0.8%, abundant mixing, granulate with the scrobicula stamping of φ 9.5-10, adds magnesium stearate, the bag film-coat, packing, promptly.
Experimental example 6 dissolution in vitro are investigated
The interior quantizating index of body of estimating the biological effectiveness of preparation is a bioavailability, and external quantizating index is a dissolution, " on the basis that require 3 minute disintegration of Chinese pharmacopoeia regulation, tackle its dissolution and investigate and control, guarantee the concordance of medicine vivo and vitro performance satisfied.
According to " first method is measured under two appendix XC of Chinese pharmacopoeia version in 2005 dissolution method item, and dissolve medium is selected the fresh distilled water that removes air for use, and compares with the peaceful sheet of common stomachache, is index with the stripping percentage rate, the results are shown in Table 12:
Table 12: the comparison of have a stomachache peaceful dispersible tablet and the peaceful sheet dissolution of common stomachache
The result shows that the dissolution of dispersible tablet is better than conventional tablet.
Experimental example 7 is prepared according to addition inside and outside the wet method of preferred best supplementary product consumption and proportioning and optimum, prepares three batches of peaceful dispersible tablets of stomachache respectively, investigates the stability of its technology.
Preparation method according to dispersible tablet repeats to prepare three batches of peaceful dispersible tablets of stomachache, according to " the corresponding prescription of dispersible tablet is measured its disintegration under two tablet items of Chinese pharmacopoeia version in 2005, the results are shown in Table 13:
Table 13: three batches of peaceful dispersible tablets of stomachache are every down relatively
| Batch | Outward appearance | Average sheet heavy (g) | Tablet weight variation (RSD%) | Average hardness (Kg) | Disintegration (s) |
| First second batch the 3rd batch | Bright and clean, evenly bright and clean, evenly bright and clean, even | 0.75 0.80 0.79 | 1.02 0.89 1.14 | 4.55 4.78 4.49 | 137 151 141 |
As seen, this process stabilizing is feasible, and the gained dispersible tablet meets " two regulations of Chinese pharmacopoeia version in 2005.
The applicant finds in development process: the selection of disintegrating agent kind and consumption, the selection of sweller kind and consumption, and the selection of other adjuvants and consumption, the size of grain graininess, the selection of adjuvant adding method (in add, add, in add), film-coated techniques etc. all can directly influence the quality of this product, for example: the kind of disintegrating agent and consumption, select suitable high-quality disintegrating agent according to nature of drugs, otherwise be difficult to reach the disintegrate requirement, should also be noted that the advantage of various disintegrating agents simultaneously, look for the suitable proportion of different disintegrating agent couplings, and adopt suitable adding method, improve the disintegration of dispersible tablet to greatest extent.The applicant found through experiments this product: adopt the disintegrating agent coupling to be used alone disintegrating agent, the time of its disintegrate can improve greatly; And during identical 2 kinds of disintegrating agent couplings, its proportioning difference also has comparatively remarkable influence to disintegration time.The applicant finds by the research experiment to disintegrating agent screening: adopt low-substituted hydroxypropyl cellulose (L-HPC) and microcrystalline Cellulose (MCC) coupling, and resize ratio makes its disintegration time the fastest, meet " two requirements of Chinese pharmacopoeia version in 2005.The applicant has selected for use by a large amount of experimentatioies: the wet granule compression tablet packaging technique of the inside and outside addition of adjuvant, the low-substituted hydroxypropyl cellulose (L-HPC) of wherein interior added-time adding medicated powder amount 4.5%, the microcrystalline Cellulose (MCC) of medicated powder amount 15% are as disintegrating agent, and the calcium sulfate (CaSO of total amount 6%
42H
2O) as filler, abundant mixing, the alcoholic solution with 90% is granulated, and through granulate, cuts into 24～30 order granules with cutter, and airpillow-dry under 60～70 ℃ of temperature with 24～28 mesh sieve granulate, sprays into the fennel oil with an amount of ethanol dilution, mixing again; The outer added-time then add 1.5% low-substituted hydroxypropyl cellulose (L-HPC) of medicated powder amount, the microcrystalline Cellulose of medicated powder amount 5% (MCC), the calcium sulfate (CaSO of total amount 2%
42H
2O), and the micropowder silica gel of total amount 0.8%, abundant mixing, granulate, tabletting, the bag film-coat, promptly.
The specific embodiment
Embodiments of the invention.The peaceful dispersible tablet of having a stomachache, according to the preparation of following weight proportion raw material,
Crude drug: Herba Taraxaci extract 300g aluminium hydroxide 300g
Radix Glycyrrhizae dry extractum 210g Semen Hyoscyami extractum 25g
Radix Gentianae powder 155g fennel oil 4ml
Adjuvant and supplementary product consumption are: low-substituted hydroxypropyl cellulose 60g, microcrystalline Cellulose 200g, micropowder silica gel 10g, calcium sulfate two water thing 100g.
Above raw material, adjuvant are prepared into the peaceful dispersible tablet of stomachache by the inside and outside addition in the wet granulation technology.
Preparation process:
A. the preparation of Herba Taraxaci extract, it is a certain amount of to get Herba Taraxaci, water merceration twice, each 24 hours, filter, merging filtrate adds saturated limewater, transfers pH value to 11-12, left standstill 12-24 hour, the collecting precipitation thing, 60 ℃ of dryings, promptly.
B. the preparation of Radix Glycyrrhizae dry extractum, the extracting liquorice medical material runs through, and section decocts with water three times, and each 2 hours, collecting decoction, placing spends the night makes precipitation; Get supernatant concentration to the thick paste shape, 80 ℃ dry down, pulverizes, and sieves, promptly.
C. the Semen Hyoscyami coarse powder is got in the preparation of Semen Hyoscyami extractum, the percolation under photograph fluid extract and the extractum item (" appendix IO of Chinese pharmacopoeia version in 2005), make solvent with 70% ethanol, after the diafiltration, measure its content, being concentrated into every 100g extractum, to contain outstanding alkali be 0.27-0.33g.
D. Fructus Foeniculi is got in the extraction of fennel oil, extracts volatile oil with steam distillation, promptly.
E. get raw material by given composition by weight proportioning, prepare the peaceful dispersible tablet of stomachache by following step:
Get Herba Taraxaci extract 300g, aluminium hydroxide 300g, Radix Glycyrrhizae dry extractum 210g, Semen Hyoscyami extractum 25g, Radix Gentianae powder 155g mixing, the low-substituted hydroxypropyl cellulose that adds 3/4 amount, the calcium sulfate of the microcrystalline Cellulose of 3/4 amount and 3/4 amount, abundant mixing, alcoholic solution with 90% is granulated, and cuts into 24～30 order granules with cutter, airpillow-dry under 60～70 ℃ of temperature, with 24～28 mesh sieve granulate, spray into the fennel oil with an amount of ethanol dilution again, mixing adds the low-substituted hydroxypropyl cellulose (L-HPC) of surplus again, microcrystalline Cellulose (MCC) and calcium sulfate (CaSO
42H
2O), and the micropowder silica gel of 10g and an amount of magnesium stearate, abundant mixing, granulate with the scrobicula stamping of φ 9.5-10, obtains 1000 peaceful dispersible tablets of stomachache, or the bag film-coat, packing, promptly.Oral, one time 3,2～3 times on the one.
Claims (3)
1, the peaceful dispersible tablet of a kind of stomachache is characterized in that, to produce 1000, it is to add adjuvant again by following materials of weight proportions to be prepared from, and raw material is:
Herba Taraxaci extract 300g aluminium hydroxide 300g
Radix Glycyrrhizae dry extractum 210g Semen Hyoscyami extractum 25g
Radix Gentianae powder 155g fennel oil 4ml
Adjuvant is: low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, micropowder silica gel, calcium sulfate two water things, ethanol.
2, the peaceful dispersible tablet of stomachache according to claim 1 is characterized in that, supplementary product consumption is: low-substituted hydroxypropyl cellulose 55～65g, microcrystalline Cellulose 190～210g, micropowder silica gel 8～11g, calcium sulfate two water things 85～105g.
3, the preparation method of the peaceful dispersible tablet of stomachache as claimed in claim 1 or 2 is characterized in that concrete steps comprise:
A, preparation Herba Taraxaci extract are got Herba Taraxaci, water merceration twice, and each 24 hours, filter, merging filtrate adds saturated limewater, transfers pH value to 11-12, left standstill 12-24 hour, the collecting precipitation thing, 60 ℃ of dryings, promptly;
B, preparation Radix Glycyrrhizae dry extractum, the extracting liquorice medical material runs through, and section decocts with water three times, and each 2 hours, collecting decoction, placing spends the night makes precipitation, gets supernatant concentration to the thick paste shape, and 80 ℃ are dry down, pulverize, and sieve, promptly;
C, preparation Semen Hyoscyami extractum are got the Semen Hyoscyami coarse powder, according to the percolation under fluid extract and the extractum item, make solvent with 70% ethanol, after the diafiltration, measure its content, are concentrated into every 100g extractum and contain that to show alkali be 0.27-0.33g;
D, preparation fennel oil are got Fructus Foeniculi, extract volatile oil with steam distillation, promptly;
E, get Herba Taraxaci extract 300g, aluminium hydroxide 300g, Radix Glycyrrhizae dry extractum 210g, Semen Hyoscyami extractum 25g and Radix Gentianae powder 155g mixing, add low-substituted hydroxypropyl cellulose, microcrystalline Cellulose and calcium sulfate, abundant mixing, the low-substituted hydroxypropyl cellulose that adds 3/4 amount, the calcium sulfate of the microcrystalline Cellulose of 3/4 amount and 3/4 amount, alcoholic solution with 90% is granulated, cut into 24～30 order granules with cutter, airpillow-dry under 60～70 ℃ of temperature, with 24～28 mesh sieve granulate, spray into fennel oil again, mixing with an amount of ethanol dilution, the low-substituted hydroxypropyl cellulose that adds surplus again, microcrystalline Cellulose and calcium sulfate, and micropowder silica gel, abundant mixing, granulate, scrobicula stamping with φ 9.5-10, or the bag film-coat, packing promptly gets the peaceful dispersible tablet of having a stomachache.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100509905A CN100441209C (en) | 2006-03-29 | 2006-03-29 | 'Weitongning' dispersing tablets prepn. for treating stomach trouble and its prepn. method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117562954A (en) * | 2024-01-16 | 2024-02-20 | 江西汇仁药业股份有限公司 | Shenbao tablet preparation and evaluation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117562954A (en) * | 2024-01-16 | 2024-02-20 | 江西汇仁药业股份有限公司 | Shenbao tablet preparation and evaluation method thereof |
| CN117562954B (en) * | 2024-01-16 | 2024-04-26 | 江西汇仁药业股份有限公司 | Shenbao tablet preparation and evaluation method thereof |
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Effective date of registration: 20090206 Address after: Guizhou province Anshun City West Economic and Technological Development Zone Avenue Patentee after: Guizhou Bailing Group Pharmacy Co., Ltd. Address before: Guizhou province Anshun City West Economic and Technological Development Zone Avenue Patentee before: Pharmaceutical Co., Ltd., Guizhou Bailing Enterprise Group |
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Owner name: BRAUN GUIZHOU PHARMACEUTICAL ENTERPRISE GROUP CO. Free format text: FORMER OWNER: BAILING ENTERPRISE GROUP PHARMACY CO., LTD., GUIZHOU Effective date: 20090206 |