CN1985882A - Compound motherwort tablet and its preparing method - Google Patents
Compound motherwort tablet and its preparing method Download PDFInfo
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- CN1985882A CN1985882A CN 200610134770 CN200610134770A CN1985882A CN 1985882 A CN1985882 A CN 1985882A CN 200610134770 CN200610134770 CN 200610134770 CN 200610134770 A CN200610134770 A CN 200610134770A CN 1985882 A CN1985882 A CN 1985882A
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Abstract
The present invention is compound motherwort tablet and its preparation process, and belongs to the field of Chinese medicine technology. The compound motherwort tablet is prepared with motherwort 1250-1400 weight portions, angelica 620-720 weight portions, Chuanxiong rhizome 300-380 weight portions, and aucklandia root 100-150 weight portions, and through water extraction and alcohol precipitation of motherwort, alcohol extraction of the other three Chinese medicinal materials, and other separates. The compound motherwort tablet has obvious curative effect on dysmenorrhea, irregular menstruation, postpartum abdominal pain and other common women's diseases.
Description
Technical field: the present invention relates to a kind of compound motherwort tablet for the treatment of dysmenorrhea, menoxenia and preparation method thereof, belong to the field of Chinese medicines.
Background technology: dysmenorrhea, menoxenia are commonly encountered diseases, frequently-occurring disease, Herba Leonuri paste, Herba Leonuri oral liquid or the Western medicine analgesic etc. of adopting in the treatment more, this type of medicine deficiency and excess can not be taken into account, the QI and blood specimen can not be ruled together, thereby curative effect of medication is not good enough, and existing preparation method at tablet adopts water extraction usually, when preparing compound motherwort tablet with the water extraction of traditional preparation process tablet, the extracting solution thickness, paste-forming rate is higher, and it is many to contain inert matter, is unfavorable for bringing into play the drug effect of Herba Leonuri.
Summary of the invention:, the invention provides the tangible compound motherwort tablet of a kind of therapeutic effect in order to solve the problem of above-mentioned existence; Another object of the present invention provides the preparation method of compound motherwort tablet.The objective of the invention is to be achieved through the following technical solutions: a kind of compound motherwort tablet, it is to be made by following raw materials by weight proportions: Herba Leonuri 1250～1400g, Radix Angelicae Sinensis 620～720g, Rhizoma Chuanxiong 300～380g, the Radix Aucklandiae 100～150g.
2, the preparation method of compound motherwort tablet:
(a) get Herba Leonuri and add 8 times of water gagings decoction secondaries, 3 hours for the first time, 2 hours for the second time at every turn, collecting decoction, filter, it is 1.12～1.14 (60 ℃) that filtrate is concentrated into relative density, adds ethanol and makes that to contain the alcohol amount be 60%, stir evenly, cold preservation 24 hours filters filtrate recycling ethanol, get concentrated solution 1, standby;
(b) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Aucklandiae three flavors in addition, measured 70% alcohol reflux 3 hours, filtration with 8 times, filtrate recycling ethanol merges with above-mentioned concentrated solution 1, and being concentrated into relative density is the thick paste of 1.30～1.35 (60 ℃), add starch, the amount of starch accounts for 2%～10% of total medical material amount, vacuum drying, pulverize, 95% alcohol granulation, drying, the magnesium stearate compacting that adds dried particles total amount 1% is in blocks, the bag film-coat, promptly.
Beneficial effect of the present invention: Herba Leonuri has excitation to the uterus, promoting blood flow to regulate menstruation, the blood circulation in promotion uterus; Radix Angelicae Sinensis is kind can foster the spirit of nobility the promoting blood flow to regulate menstruation pain relieving; The Rhizoma Chuanxiong blood circulation promoting competent silt, the wind pain relieving of loosing, tranquillizing to relieve muscle spasm, the Radix Aucklandiae is regulated the flow of vital energy, the pain relieving spasmolytic; This prescription is with Herba Leonuri, and the Radix Angelicae Sinensis blood circulation promoting and enriching is treated menoxenia, and Rhizoma Chuanxiong, the Radix Aucklandiae, regulating the flow of QI to dissipate blood stasis, promoting the circulation of QI to relieve pain, the function of blending liver spleen, has significant curative effect for commonly encountered diseases such as dysmenorrhea, menoxenia, puerperal abdonimal pains, particularly adopt the preparation method of YIMUCAO PIAN of the present invention, because its extracting mode adopts decoction and alcohol sedimentation technique, paste-forming rate is lower, the inert matter that contains in the extracting solution is few like this, so the therapeutic effect of compound motherwort tablet of the present invention is obvious.
The specific embodiment:
Below by testing the influence of routine therapeutic effect of setting forth compound motherwort tablet of the present invention and preparation method thereof to the performance optimum medicine efficacy:
Test example 1: the therapeutic effect contrast of clinical observation compound motherwort tablet of the present invention and compound recipe Herba Leonuri oral liquid:
1, physical data
Accept out-patient's totally 201 examples for medical treatment, 18～23 years old 137 age example wherein, 24～30 years old 42 example, 31～40 years old 22 example.
2, diagnostic criteria: (1) primary dysmenorrhea: refer to that gynecologial examination, genitals do not have significant organic pathological changes person, pilosity is born in behind the menarche 2 to the 3 years adolescent girls or the young woman of fertility not.
(2) secondary dysmenorrhea: the genitals has tangible organic disease person, pelvic inflammatory disease, endometriosis pathological changes etc. is arranged and cause dysmenorrhea through gynecologial examination, ultrasound diagnosis, laparoscopy etc.
The tcm diagnosis standard: the women all menstrual period or through preceding through after (in the week) occur periodically that hypogastralgia is a main symptom, with other discomforts, so that influence work and live the diagnosable dysmenorrhea that is.
3, Therapeutic Method
(1) treatment group: clothes " compound motherwort tablet " secondary every day, each 4, with the simulation oral liquid, every day secondary, each two, each menstrual onset a few days ago begins to take medicine, seven days is a course of treatment, serve on three menstrual cycle.
(2) matched group: clothes " compound recipe Herba Leonuri oral liquid " secondary every day, each two, with the simulation sheet, every day secondary, each 4, each menstrual onset a few days ago begins to take medicine, seven days is a course of treatment, serve on three menstrual cycle.
4, efficacy assessment standard
One, dysmenorrhea curative effect determinate standard
(1) recovery from illness: the back integration of taking medicine returned to 0 fen, stomachache and other transference cures, and 3 menstrual cycle of drug withdrawal are the recidivist not.
(2) produce effects: integration is reduced to preceding below 1/2 of integration of treatment after the treatment, and stomachache obviously alleviates, and all the other symptoms take a turn for the better, and the disobedience analgesic can be adhered to work.
(3) effective: treatment back integration is reduced to 1/2～3/4 of the preceding integration of treatment, and stomachache alleviates, and all the other symptoms take a turn for the better, and the clothes analgesic can be adhered to work.
(4) invalid: stomachache and other symptom do not have obvious improver.
Two, tcm syndrome curative effect determinate standard:
Recovery from illness: n 〉=90%
Produce effects: 90%＞n 〉=60%
Effectively: 60%＞n 〉=30%
Invalid: n＜30%
5, therapeutic outcome sees Table 1,2,3
Table 1: use compound motherwort tablet and compound recipe Herba Leonuri oral liquid Comparison of therapeutic:
| Group | Case load | Recovery from illness and produce effects | Effectively | Invalid | Cure-remarkable-effectiveness rate | Effective percentage |
| Compound motherwort tablet | 100 | 58 | 39 | 3 | 58％ | 97％ |
| Compound recipe Herba Leonuri oral liquid | 101 | 54 | 40 | 7 | 53.47％ | 93.07％ |
Table 2: use compound motherwort tablet and compound recipe Herba Leonuri oral liquid tcm syndrome curative effect relatively
| Group | Case load | Recovery from illness and produce effects | Effectively | Invalid | Cure-remarkable-effectiveness rate | Effective percentage |
| Compound motherwort tablet | 100 | 66 | 31 | 3 | 66％ | 97％ |
| Compound recipe Herba Leonuri oral liquid | 101 | 58 | 36 | 7 | 57.43％ | 93.07％ |
Table 3: stomachache persistent period comparison sheet after compound motherwort tablet and the medication of compound recipe Herba Leonuri oral liquid
| Suffer from abdominal pain the persistent period after the medication (branch) (X ± S) | The group internal ratio | ||||||
| First month and second month | First month and March | ||||||
| First month | Second month | March | |||||
| t | p | t | p | ||||
| Between compound motherwort tablet n=100 compound Stachydrine n=101 group than t p | 18.2700±18.8340 22.6881±28.7572 1.2903 ＞0.05 | 11.9330±15.2424 17.5950±17.1588 2.4738 ＜0.05 | 7.3900±10.9576 11.1139±14.3192 2.0694 ＜0.05 | 2.6154 1.5285 | ＜0.01 ＞0.05 | 5.9053 6.3135 | ＜0.01 ＜0.01 |
Contrast through table 1,2 data: cure-remarkable-effectiveness rate, compound motherwort tablet (treatment group) is 58%, compound recipe Herba Leonuri oral liquid (matched group) is 53.47%, total effective rate, the treatment group is 97%, matched group is 93.07%.The patient of our institute's diagnosis and treatment serves as main to account for 89% with moderate, severe, illustrate this medicine to moderate, severe pain through having than satisfactory therapeutic effects.Distending pain in the chest and hypochondrium, distending pain of the breast, uncomfortable in chest not relaxing there are not significant curative effect, and regulating menoxenia is preferably arranged improving aspect the tcm symptom.
Table 3 data declaration, 3 months analgesic effects of taking medicine are best, and each age group patient constitutional and secondary dysmenorrhea are all had curative effect preferably.Compound motherwort tablet is effective than compound recipe Herba Leonuri oral liquid formulations aspect shortening the stomachache persistent period, P＜0.05.Item indexs such as treatment group treatment back hemorheology whole blood viscosity make moderate progress before the treatment.The blood speed of penetrating after the treatment of treatment group in the pelvic blood flow diagram unit interval before vasoconstriction power slightly is better than treatment, points out this medical instrument that the effect that promotes the pelvic cavity blood circulation is arranged, and estimates relevant with alleviation dysmenorrheal caused by qi stagnation and blood stasis patient symptom.Do not find untoward reaction and toxic and side effects in the clinical treatment observation.Taking convenience is easy to carry about with one, and is subjected to the welcome of extensive patients deeply, so this product is a kind of medicine of ideal treatment dysmenorrhea.
Do following test at the preparation method of compound motherwort tablet of the present invention:
One, the Herba Leonuri extraction process determines
Herba Leonuri is the strongest medicine of physiologically active in this prescription, and its effective ingredient is an alkaloid.Wherein leonurine (Leonurine) has excited uterus, the effect of antihypertensive diuretic; Stachydrine (Stachydrine) has excited uterus, the effects such as frog heart contraction frequency of slowing down.Because the Herba Leonuri alkaloid is water-soluble alkaloid, so the water extraction that adopts extracts more.According to the literature, even press the ext leonuri sibirici liq of " pharmacopeia " regulation prepared, in storage process, also very easily produce precipitation.In this technical study, also run into similar problem, Herba Leonuri water extracting liquid refrigerator is placed (2～4 a ℃) week, filter once every day, should have precipitation to generate, by analysis, this is precipitated as inert matter, has investigated the influence of different extraction processes to the effective ingredient stachydrine content for this reason.
Test example 2: the comparison of water extraction and decoction and alcohol sedimentation technique technology stachydrine content
1. the preparation of sample and reference substance solution
Water extraction process: get Herba Leonuri 250g, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, all add 8 times of water yields, collecting decoction filters, and it is 1.12～1.14 (60 ℃) that filtrate is concentrated into relative density, cold preservation 24 hours, filter, filtrate is concentrated into the concentrated solution that every ml contains the 2.5g crude drug, and is standby.
Aqueous extraction-alcohol precipitation technology: get Herba Leonuri 250g, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, all add 8 times of water yields, collecting decoction, filter, it is 1.12～1.14 (60 ℃) that filtrate is concentrated into relative density, adds ethanol, makes to contain the alcohol amount and reach 60%, cold preservation 24 hours, filter, filtrate recycling ethanol, and be concentrated into the concentrated solution that every ml contains the 2.5g crude drug.Standby.
The preparation of need testing solution: with the medicinal liquid of water extraction and the preparation of water body alcohol deposition method, get 1ml respectively, be equipped with sample liquid by [assay] below legal system, standby.
The preparation of reference substance solution: by [assay] below method preparation.
2. the assay of different process sample: with the sample liquid of water extraction and decoction and alcohol sedimentation technique preparation, be prepared into test sample liquid, carry out assay in accordance with the law, the results are shown in Table 4 by [assay] below method.
Table 4 water extraction and decoction and alcohol sedimentation technique stachydrine content are relatively
| Stachydrine content (mg/ml) | Paste-forming rate % | ||||
| 1 | 2 | 3 | 4 | ||
| Water extraction | 2.93 | 2.80 | 2.79 | 2.84 | 16.3 |
| Decoction and alcohol sedimentation technique | 2.84 | 2.88 | 2.91 | 2.88 | 12.2 |
| The Herba Leonuri medical material | 0.164％ | ||||
Table 4 is the result show, water extraction and two kinds of technology stachydrine contents of decoction and alcohol sedimentation technique no significant difference.Measure through medical material, the stachydrine extraction ratio is all more than 50%.But water extraction sample liquid thickness, evaluated error is bigger; And paste-forming rate is higher, and it is many to contain inert matter, so determine to adopt decoction and alcohol sedimentation technique.
Test example 3: the different water extraction times are to the influence of stachydrine content
Further investigated of the influence of different extraction times to stachydrine content
Get Herba Leonuri 100g, get 3 parts altogether, put respectively in the 2000ml round-bottomed flask, difference extracting in water 5h (3h, 2h), 4h (2h, 2h), 3h (2h, 1h) all adds 8 times of water yields, collecting decoction, filter, merging filtrate is concentrated into the concentrated solution that every ml contains the 2.5g crude drug respectively, by method under [assay] item, the content results of measuring difference extraction time stachydrine sees Table 5.
Table 5 different extraction times are to the influence of stachydrine content
| Different process | Extraction time | Amount of water (multiple) | Stachydrine content (ml/ml) | ||
| Water is carried 3h | 2h | 1h | 10 | 8 | 1.97 |
| Water is carried 4h | 2h | 2h | 10 | 8 | 2.11 |
| Water is carried 5h | 3h | 2h | 10 | 8 | 2.45 |
| The Herba Leonuri medical material | 0.134％ | ||||
Table 5 is the result show, water is carried 5h (3h, 2h), and stachydrine content is higher.
Test example 4: the preparation of different alcohol precipitation concentrations
1. the preparation of sample liquid: get Herba Leonuri 750g, extract, concentrated solution is divided into 3 parts by aqueous extraction-alcohol precipitation technology, carry out precipitate with ethanol with 50%, 60%, 70% alcohol precipitation concentration respectively, cold preservation 24 hours, remainder is still made the medicinal liquid that every ml contains the 2.5g crude drug by the aqueous extraction-alcohol precipitation technology method for making, and is standby.
With the medicinal liquid of different alcohol precipitation concentrations, be equipped with need testing solution by [assay] below legal system.
2. the assay of different process sample: get the need testing solution of above-mentioned different alcohol precipitation concentrations,, measure in accordance with the law, the results are shown in Table 6 by [assay] following method.
The different alcohol precipitation concentrations of table 6 are to the influence of stachydrine content
| Stachydrine content (mg/ml) | ||||
| 1 | 2 | 3 | 4 | |
| 50% precipitate with ethanol solution, 60% precipitate with ethanol solution, 70% precipitate with ethanol solution | 2.63 2.84 2.56 | 2.69 2.88 2.49 | 2.59 2.91 2.61 | 2.64 2.88 2.55 |
Measurement result shows that 60% alcohol precipitation concentration stachydrine content is higher, therefore determines to adopt 60% alcohol precipitation concentration.
Two, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Aucklandiae extraction process determines
Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Aucklandiae three flavor medicines, consider its effective ingredient and site of action multidigit volatile oil, lactone, pure soluble components such as alkaloid, and owing to contain a large amount of saccharides when giving back, account for 40%, so extracting solution contains the thick substances filtration difficulty, oven dry, granulate, the tabletting all effected, the finished product moisture absorption is bigger, has investigated the influence to ferulaic acid content, paste-forming rate, dried cream powder moisture absorption of different determining alcohols and different alcohol extraction number of times, extraction process for this reason.
Test example 5: different alcohol extraction concentration and different extraction time are to the influence of ferulaic acid content
(1) get Radix Angelicae Sinensis 68g, Rhizoma Chuanxiong 34g, Radix Aucklandiae 12.5g gets 4 parts altogether, above-mentioned each medical material is put in the 2000ml round-bottomed flask, and wherein 3 parts add 8 times of amount 50%, 60%, 70% ethanol respectively, reflux, extract, 3h filters, filtrate recycling ethanol, and be concentrated into the concentrated solution that about 1ml contains 1g Radix Angelicae Sinensis crude drug; Another part adds 8 times of amount 70% alcohol reflux secondaries, and the 1st time 2 hours, the 2nd time 1 hour, 8 times of amounts of the 2nd adding ethanol, merge extractive liquid, filters, and filtrate recycling ethanol also is concentrated into the concentrated solution that about 1ml contains 1g Radix Angelicae Sinensis crude drug.
The preparation of need testing solution: get the concentrated solution that above-mentioned 4 technologies respectively are equivalent to 1g Radix Angelicae Sinensis medical material, the accurate title, decide, add water 10ml respectively and make dissolving, transfer pH=1-2, with water saturated ether extraction 4 times with hydrochloric acid, each 10ml, merge ether solution, volatilize, residue adds methanol 2ml makes dissolving, and be settled to scale, as the need testing solution of different process.
The preparation of reference substance solution: get the ferulic acid reference substance, the accurate title, decide, and adds methanol and make the reference substance solution that every 1ml contains 0.98ml.
(2) chromatography condition
Silica gel g thin-layer plate: get silica gel G, add an amount of 0.2%CMC-Na, the bed board device is paved into the lamellae of 0.3mm automatically, dries, and in 105 ℃ of activation 1h, puts in the exsiccator standby.
Developing solvent: benzene-ethyl acetate-glacial acetic acid (4: 2: 0.2), launch below 10 ℃.
(3) thin layer chromatography
Accurate each 4ul of different process need testing solution that draws, reference substance solution 1ul, 2ul, put respectively on same silica gel g thin-layer plate, launch by above-mentioned condition, exhibition is taken out apart from 10cm, dry, put uviol lamp 365nm place and inspect, ferulic acid shows blue and white fluorescence speckle, must extremely well separate with other composition speckles.
(4) thin slice scan is quantitative
The instrument condition of scanning: wavelength X s=322nm, λ R=370nm; Linear dimensions Sx=3.
Stability test: accurate absorption reference substance solution and need testing solution are put on lamellae, and leafing volatilizes solvent, scanning immediately, and again every 20 minutes run-downs, the result shows that the ferulic acid speckle is stable in 1 hour.
The precision test: same reference substance speckle continuous sweep 5 times, record RSD=0.02%, each reference substance speckle of 5 same amounts records area on the lamellae, calculates RSD=2.06%, has better precision.
The drafting of standard curve: accurate ferulic acid reference substance solution (1mg/ml) 1.0,2.0,3.0,4.0, the 5.0ul of drawing, put on plate respectively, by above-mentioned condition leafing scanning, with the point sample amount is abscissa, recording the speckle peak area is vertical coordinate, mapping, regression equation r=3637.9X-390.28, γ=1.000.The result shows that ferulic acid reference substance point sample amount is linear with its peak area value in the 1-5ug scope.
(5) sample determination: record ferulaic acid content in each need testing solution of different technology conditions as stated above, the results are shown in Table 7.
The different determining alcohols of table 7 extract ferulaic acid content and measure
| Technology | Extraction time (h) | Ferulaic acid content (mg/g) | |
| The 1st time | The 2nd time | ||
| 50% alcohol extraction process | 3 | 0.844 | |
| 60% alcohol extraction process | 3 | 0.866 | |
| 70% alcohol extraction process | 3 | 0.878 | |
| 70% alcohol extraction process | 2 | 1 | 0.881 |
Table 7 is the result show, different alcohol extraction technologies, and 50% alcohol extraction process ferulaic acid content is lower, 60% and 70% alcohol extraction process content no significant difference; Different extraction time experimental results show, extract 1 time (3h) and extract 2 (2h, 1h) no significant differences, consider the big time-saving energy-saving of producing, and adopt 70% alcohol extraction 3h so determine Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Aucklandiae, add 8 times of amount ethanol.
Test example 6: different alcohol extraction processes are to the influence of paste-forming rate and dried cream powder moisture absorption
Measure Radix Angelicae Sinensis 136g, Rhizoma Chuanxiong 68g, Radix Aucklandiae 25g by prescription, get 3 parts altogether, respectively with 50%, 60%, 70% ethanol (all adding 8 times of amounts) reflux, extract, 3h, filter, filtrate recycling ethanol is concentrated into thick paste, and oven dry is standby.
Get the dried cream powder of above-mentioned 3 kinds of determining alcohols extraction and weigh, calculate the baking needed time, and 1g dried cream powder room temperature (humidity 50%) was placed 1 day, measure moisture, observe the dried cream powder moisture absorption, the results are shown in Table 8.
Table 8 different process paste-forming rate, drying time and moisture absorption
| Paste-forming rate % | Drying time h | Moisture % | ||
| Before the placement | After the placement | |||
| 50% alcohol extraction | 39.5 | 54 | 6.56 | 12.21 |
| 60% alcohol extraction | 36.3 | 38 | 3.86 | 6.04 |
| 70% alcohol extraction | 30.9 | 32 | 2.54 | 3.22 |
The result of table 8 shows that different determining alcohols extract influential slightly to paste-forming rate, but the thick paste that 50% and 60% determining alcohol extracts is more owing to containing saccharide, drying time is long, and the dried cream powder moisture absorption is strong, brings difficulty for next step technology, therefore, adopt 70% ethanol extraction optimum.
Three, tablet formulation technical study
Test example 7: through repeatedly technology exploration, adopt 95% ethanol to granulate, and adopt the stomach dissolution type thin membrane coated tablet, through test, adopt ethanol: water (7: 3) is solvent (experimental result sees Table 9) (W/W), and controls 70 ℃ of inlet temperature, 36～38 ℃ of sheet bed tempertaures, spray gun pressure 1.5kg/cm
2, 12～14 rev/mins of pot rotating speeds are bundled into film-coat, and coating solution solid-liquid content is 8%, and clothing film dissolution time 1.5 minutes has been determined tablet formulation worker fiber skill and film coating procedure.Through groping, the used starch of this product is 2～10% of total medical material amount, and magnesium stearate is 1% of a dried particles total amount, and the used hydroxypropyl emthylcellulose of film coating is 2～3% of total medicated powder amount.
Table 9 coating choice of Solvent
| Solvent (W/W) | Coating effect |
| Water | Viscosity is big, can not spray film continuously, and bonding phenomenon (between sheet and the sheet) is arranged during beginning slightly, and the clothing film is inhomogeneous, and skin effect phenomenon is arranged. |
| Ethanol: water (3: 7) | Can not spray film continuously, there is a little pit on the sheet surface, and the clothing film has skin effect phenomenon individually. |
| Ethanol: water (5: 5) | Can not spray film continuously, the clothing film is even, and fineness is poor slightly. |
| Ethanol: water (7: 3) | Can spray film continuously, the clothing film is even, and fineness is good. |
In sum:
1. according to of the influence of different extraction processes, determine that Herba Leonuri adopts aqueous extraction-alcohol precipitation technology and 60% alcohol precipitation concentration to carry out precipitate with ethanol to stachydrine content in the Herba Leonuri.The water extraction alcohol precipitation process is the water extraction secondary, the 1st time 3 hours, 2 hours for the second time, adds 8 times of water gagings at every turn, merge extractive liquid, filters, and it is 1.12～1.14 (60 ℃) that filtrate is concentrated into relative density, adds ethanol and makes that to contain the alcohol amount be 60%, stir evenly, cold preservation 24 hours filters filtrate recycling ethanol.
2 Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Aucklandiae three flavors, according to different determining alcohols extract and different extraction time to the investigation of ferulaic acid content; Again since 50%, 60% determining alcohol to extract the thick paste drying time long, and the easy moisture absorption of dried cream powder, so determine employing 70% determining alcohol extraction 3 hours, alcohol adding amount is 8 times.
3. tablet formulation technology is decided to be and adopts 95% ethanol to granulate.The used amount of starch scope of this product is 2%～10% of total medical material amount, and magnesium stearate is 1% of total medicated powder, and film coating agent is 2～3% of total medicated powder amount.
4. coating adopts ethanol: water (7: 3) is solvent (W/W), 70 ℃ of inlet temperature, 36～38 ℃ of sheet bed tempertaures, spray gun pressure 1.5kg/cm
2, 12～14 rev/mins of pot rotating speeds are bundled into film-coat, and coating solution solid-liquid content is 8%, clothing film dissolution time 1.5 minutes.
Embodiment 1:
(a) get Herba Leonuri 1355g, put in the extraction pot, add 10.84g water, ebuillition of heated 3 hours filters, and filtrate keeps, medicinal residues add 10.84kg water, and ebuillition of heated 2 hours filters, twice filtrate is merged, and being concentrated into relative density is 1.12～1.14 (60 ℃), adds ethanol and makes that to contain the alcohol amount be 60%, stir evenly, cold preservation 24 hours filters, filtrate recycling ethanol gets concentrated solution, and is standby;
(b) get Radix Angelicae Sinensis 680g, Rhizoma Chuanxiong 340g, Radix Aucklandiae 125g puts in the extraction pot, adds 70% ethanol 9.16kg, reflux 3 hours, filter, behind the filtrate recycling ethanol, be concentrated into the thick paste that relative density is 1.30～1.35 (60 ℃) with above-mentioned concentrated solution merging, add starch 200g, vacuum drying is pulverized, use 95% alcohol granulation, drying adds 1% magnesium stearate mixing of dried particles total amount, presses 0.5g/ sheet tabletting, the bag film-coat, promptly.
Embodiment 2:
(a) get Herba Leonuri 1250g, put in the extraction pot, add 10kg water, ebuillition of heated 3 hours filters, and filtrate keeps, medicinal residues add 10kg water, and ebuillition of heated 2 hours filters, twice filtrate is merged, and being concentrated into relative density is 1.12～1.14 (60 ℃), adds ethanol and makes that to contain the alcohol amount be 60%, stir evenly, cold preservation 24 hours filters, filtrate recycling ethanol gets concentrated solution, and is standby;
(b) get Radix Angelicae Sinensis 620g, Rhizoma Chuanxiong 300g, Radix Aucklandiae 100g puts in the extraction pot, adds 70% ethanol 8.16kg, reflux 3 hours, filter, behind the filtrate recycling ethanol, be concentrated into the thick paste that relative density is 1.30～1.35 (60 ℃) with above-mentioned concentrated solution merging, add starch 181g, vacuum drying is pulverized, use 95% alcohol granulation, drying adds 1% magnesium stearate mixing of dried particles total amount, presses 0.5g/ sheet tabletting, the bag film-coat, promptly.
Embodiment 3:
(a) get Herba Leonuri 1400g, put in the extraction pot, add 11.2kg water, ebuillition of heated 3 hours filters, and filtrate keeps, medicinal residues add 11.2kg water, and ebuillition of heated 2 hours filters, twice filtrate is merged, and being concentrated into relative density is 1.12～1.14 (60 ℃), adds ethanol and makes that to contain the alcohol amount be 60%, stir evenly, cold preservation 24 hours filters, filtrate recycling ethanol gets concentrated solution, and is standby;
(b) get Radix Angelicae Sinensis 720g, Rhizoma Chuanxiong 380g, Radix Aucklandiae 150g puts in the extraction pot, adds 70% ethanol 10kg, reflux 3 hours, filter, behind the filtrate recycling ethanol, be concentrated into the thick paste that relative density is 1.30～1.35 (60 ℃) with above-mentioned concentrated solution merging, add starch 212g, vacuum drying is pulverized, use 95% alcohol granulation, drying adds 1% magnesium stearate mixing of dried particles total amount, presses 0.5g/ sheet tabletting, the bag film-coat, promptly.
Claims (2)
1, a kind of compound motherwort tablet is characterized in that: it is to be made by following raw materials by weight proportions: Herba Leonuri 1250～1400g, Radix Angelicae Sinensis 620～720g, Rhizoma Chuanxiong 300～380g, the Radix Aucklandiae 100～150g.
2, a kind of preparation method of compound motherwort tablet is characterized in that, step is as follows:
(a) get Herba Leonuri and decoct with water, filter, filtrate concentrates, and adds ethanol, stirs evenly, and cold preservation or leave standstill filters, filtrate recycling ethanol, concentrated solution 1, standby;
(b) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Aucklandiae three flavors in addition, add alcohol reflux, filter, filtrate recycling ethanol merges with above-mentioned concentrated solution 1, be condensed into thick paste, add starch, drying is pulverized, and adds ethanol and mixes, granulate, drying adds the compacting of magnesium stearate mix homogeneously in flakes, the bag film-coat, promptly.
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| CN (1) | CN1985882A (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101966225A (en) * | 2010-09-30 | 2011-02-09 | 安徽新华学院 | Preparation method of semifluid extract of motherwort |
| CN102526229A (en) * | 2011-12-27 | 2012-07-04 | 陕西兴邦药业有限公司 | Chinese medicinal composition for regulating menstruation, nourishing blood, regulating flow of qi and dissipating blood stasis and preparation method thereof |
| CN102988736A (en) * | 2012-11-28 | 2013-03-27 | 青岛文创科技有限公司 | Chinese medicinal composition for treating postpartum abdominal pain |
| CN109187780A (en) * | 2018-08-30 | 2019-01-11 | 江苏康缘药业股份有限公司 | A kind of detection method of the female particle of compound benefit |
| CN111939240A (en) * | 2020-08-10 | 2020-11-17 | 国人健康管理(杭州)有限公司 | Medicinal moxibustion for regulating qi and blood and improving dysmenorrhea and preparation method thereof |
-
2006
- 2006-12-14 CN CN 200610134770 patent/CN1985882A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101966225A (en) * | 2010-09-30 | 2011-02-09 | 安徽新华学院 | Preparation method of semifluid extract of motherwort |
| CN101966225B (en) * | 2010-09-30 | 2011-12-28 | 安徽新华学院 | Preparation method of semifluid extract of motherwort |
| CN102526229A (en) * | 2011-12-27 | 2012-07-04 | 陕西兴邦药业有限公司 | Chinese medicinal composition for regulating menstruation, nourishing blood, regulating flow of qi and dissipating blood stasis and preparation method thereof |
| CN102526229B (en) * | 2011-12-27 | 2013-08-07 | 陕西兴邦药业有限公司 | Chinese medicinal composition for regulating menstruation, nourishing blood, regulating flow of qi and dissipating blood stasis and preparation method thereof |
| CN102988736A (en) * | 2012-11-28 | 2013-03-27 | 青岛文创科技有限公司 | Chinese medicinal composition for treating postpartum abdominal pain |
| CN109187780A (en) * | 2018-08-30 | 2019-01-11 | 江苏康缘药业股份有限公司 | A kind of detection method of the female particle of compound benefit |
| CN109187780B (en) * | 2018-08-30 | 2021-06-15 | 江苏康缘药业股份有限公司 | Detection method of compound motherwort granules |
| CN111939240A (en) * | 2020-08-10 | 2020-11-17 | 国人健康管理(杭州)有限公司 | Medicinal moxibustion for regulating qi and blood and improving dysmenorrhea and preparation method thereof |
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