CN108478752A - A kind of integration of drinking and medicinal herbs Chinese medicine composition and preparation method improving insomnia - Google Patents
A kind of integration of drinking and medicinal herbs Chinese medicine composition and preparation method improving insomnia Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/535—Perilla (beefsteak plant)
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- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8967—Lilium, e.g. tiger lily or Easter lily
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Abstract
The present invention is a kind of Chinese medicine composition and preparation method thereof improving insomnia, and raw material is：10~20 parts of 5~15 parts of perilla leaf, 5~15 parts of lily, 3~7 parts of stir-baked FRUCTUS GARDENIAE, 3~7 parts of Fermented Soybean, 5~15 parts of Prunella vulgaris, 1 part of safflower, 3~7 parts of turmeric, 5~15 parts of Gebratene Sojakeime, 3~7 parts of peppermint, raw oyster proportioning prescriptions, excipient, adhesive, appropriate corrigent；Its technological design is reasonable, and optimization aim is clear, and process conditions prediction is accurate, and this method prepares granule science, effective, convenient to take, good patient compliance.
Description
Technical field
The invention belongs to field of food, and in particular to a kind of integration of drinking and medicinal herbs granule, the integration of drinking and medicinal herbs for improving insomnia are matched
Side and its process for producing granula and purposes.
Background technology
Insomnia is the most common type sleep disturbance.This disease is characterized in having difficulty in going to sleep, and is difficult to keep after sleep
Sleep, or feel dispirited after coming to life, it is listless, work and study are difficult to superb.And to the identification of insomnia
Insufficient and insufficient therapy increases the danger that patient suffers from the other illnesss such as mental disease again, to increase health care
Cost also produces undesirable influence to routine work.Its incidence improves year by year, and having become influences the main of human health
One of disease.At present, drug therapy and non-drug therapy are mainly taken to the treatment means of insomnia.It sleeps and defends when insomnia is serious
When raw and non-drug therapy is invalid, drug therapy becomes as first choice.And medicament selection should consider the characteristics of insomnia, to examine again
The side reaction for considering drug correctly diagnoses, selects suitable drug, formulates Personalized Drug Administration scheme and is to ensure that insomnia drug therapy is pacified
Entirely, effectively, it is economically and reasonably basic.
The research of compound of Chinese herbal medicine insomnia at present is the abundantest, and main method is by dialectical, by there are many insomnias
Card type is cured with corresponding prescription.Insomnia side is clinically mostly used with decoction, is existed much not in transport and storage
Just, and taking dose is big, it has not been convenient to which factory produces in batches, has prodigious limitation to the use of classics side.The present invention is by this side
Be developed into the granule being closer to decoction in preparation method, can unit dose package, not only save the spy of original side in this way
Point and advantage, more clinical patients are provided convenience, and the dosage taken is accurately controllable.
The present invention is carrier with the side of insomnia, on the basis of lab scale after 100 times of amplification, by comparing the pass in amplification process
Key technological parameter and Key Quality attribute establish quality standard in conjunction with pharmacopeia, and analysis enlarge-effect is in order to the work to insomnia side
Skill flow conducts further research, verifies, optimizes, and reduces the influence of enlarge-effect in actual production.
Invention content
The object of the present invention is to provide a kind of integration of drinking and medicinal herbs granules and enlarged experiment technique effect for improving and having a sleepless night
Research method.
The present invention provides a kind of Chinese medicine composition improving insomnia, it is characterised in that：Raw material is：5~15 parts of perilla leaf, lily
5~15 parts, 3~7 parts of stir-baked FRUCTUS GARDENIAE, 3~7 parts of Fermented Soybean, 5~15 parts of Prunella vulgaris, 1 part of safflower, 3~7 parts of turmeric, Gebratene Sojakeime 5~
15 parts, 3~7 parts of peppermint, 10~20 parts of raw oyster；Described part is parts by weight.
Preparation process is：
Extraction time 2-4 times, extraction time 1-2 hour, extraction water measure 8-12 times again；
It is optimized for：
Extraction time 3 times, 1.5 hours extraction times, extraction water measure 10 times again；
Advanced optimize for：
(1) prepare each bulk pharmaceutical chemicals according to the parts by weight；
(2) it takes (1) raw material to add 8-12 times of water, extracts 1-2 hours, extract 1-3 times, merge extracting solution；
(3) (2) extracting solution is taken, measures relative density 1.20-1.25's when being concentrated under reduced pressure into 25 DEG C at 60 DEG C~70 DEG C
Medicinal extract obtains extraction medicinal extract；
(4) (3) medicinal extract is taken, sets and is dried in vacuum drying chamber to constant weight, 70 DEG C, pressure 0.08-0.09MPa of drying temperature,
Dry extract is obtained, dry extract be crushed into 80 mesh sieve, obtain extract powder；
(5) (4) extract powder is mixed with auxiliary material, using wet granulation, corrigent, adhesive is added；By optimised process, i.e.,
Medicinal material dry extract：Filler=1.5:1, corrigent 1-2 ‰, mixing, described part are parts by weight；Softwood processed is pelletized, and is done
Dry, whole grain is to get granule；
(6) amplify 100 times according to the parts by weight, prepare each bulk pharmaceutical chemicals；Foundation (2), (3), (4), (5) preparation method,
Pilot-scale prepares integration of drinking and medicinal herbs granule；
(7) 10 mesh are crossed and sieves wet granular processed, cross 80 mesh sieves, 60 DEG C of forced air drying 2h are weighed and calculated granularity qualification rate.
(8) assay：According to《Chinese Pharmacopoeia》2015 editions, high performance liquid chromatography (general rule 0512) measures.
Chromatographic condition and system suitability test：Octadecylsilane chemically bonded silica is filler；Using water as mobile phase A,
Using acetonitrile as Mobile phase B, gradient elution is carried out according to the regulation in following table；30 DEG C of column temperature；Detection wavelength is 238nm；Theoretical plate
Number is calculated by Gardenoside peak should be not less than 1500；
It is prepared by reference substance solution：Precision weighs Gardenoside reference substance 5.17mg, accurately weighed, sets in 25mL volumetric flasks, adds
Methanol dissolves, and is diluted to scale, shakes up to get (206.8 μ g containing Gardenoside in per 1mL).
The preparation of test solution：This product under content uniformity item is taken, it is finely ground, about 0.5g is taken, it is accurately weighed, set 25mL amounts
In bottle, add water 20mL, be ultrasonically treated, power 400W, frequency 40kHz 30 minutes, let cool, are diluted with water to scale, shake up, and filter
Cross to get.
Measuring method：It is accurate respectively to draw reference substance and each 10 μ L of test solution, inject liquid chromatograph, measure to get.
It must not be less than 1.8mg per 1g total amounts containing Gardenoside.
According to《Pharmacopoeia of People's Republic of China (2015 editions)》In requirement to granule, 3 batches each to lab scale and pilot scale, altogether
6 batches of samples carry out run-of-the-mill inspection, including granularity, heap density, angle of repose, moisture, dissolubility, hygroscopicity and content uniformity,
And it analyzes lab scale and pilot-scale experiment difference and is evaluated.
(1) particle appearance：Particle appearance is in brown color, and color and luster is consistent, gas faint scent, slightly sweet, without viscous glutinous particle agglomerate, feel
It is dry and comfortable.
(2) the rate of extract and flour extraction：Extracting solution is collected after being concentrated and dried, and weighing dry extract and dry extract must measure, and calculate
Can obtain lab scale be averaged the rate of extract be 22.10%, pilot scale be averaged the rate of extract be 15.52%；Lab scale be averaged flour extraction be 84.96%,
Pilot scale be averaged flour extraction be 93.12%.
(3) granularity：Using wet granulation, by optimised process, i.e. medicinal material dry extract：Edible dextrin=1.5:1 mixing, three
Chlorine sucrose is appropriate, and herein in order to which the later stage facilitates calculating lab scale dry extract to weigh 12g, pilot scale dry extract weighs 600g, with
80% ethyl alcohol is wetting agent, and softwood processed is sieved and pelletizes, and forced air drying particle, weighing can be calculated lab scale granularity qualification rate and be
92%, pilot scale granularity qualification rate is 85.69%.
(4) heap density：3.0g samples are weighed, are placed in 10mL graduated cylinders, it is made to be fallen from 3cm height, repeat 50 vibrations,
It reads particle and obtains volume, the average bulk density that can be calculated lab scale particle is 0.5297g/mL, the average bulk density of pilot scale particle
For 0.5775g/mL.
(5) angle of repose：Using fixed funnel method, 3 funnels are connected and are fixed on 1cm on horizontal positioned graph paper
Place, nethermost hopper outlet polish, respectively pour into three batches of granules in uppermost funnel along hopper walls in right amount, until sitting
Until the medicinal powder cone tips formed on millimeter paper touch funnel bottom end, the diameter that cone bottom is measured by graph paper is (anti-
Repetition measurement is 5 times fixed), particle angle of repose is respectively less than 40 ° after can be calculated granulation.
(6) moisture：Oven drying method：2~5g of test sample is taken, is laid in drying to the flat measuring cup of constant weight, thickness does not surpass
5mm is crossed, loose test sample is no more than 10mm, accurately weighed, and open bottle cover is 5 hours dry at 100~105 DEG C, and bottle cap is covered,
In dislocation drier, let cool 30 minutes, it is accurately weighed, then dried 1 hour in above-mentioned temperature, it lets cool, weighs, until claiming twice in succession
Until the difference of weight is no more than 5mg.According to the weight of less loss, it can be calculated moisture in test sample and be less than 8%.
(7) dissolubility：Test sample 10g is taken, water 200mL is heated, is stirred 5 minutes, is observed immediately, observe lab scale and pilot scale
There is solution slight turbid in granule, and phenomena such as a small amount of insoluble matter is arranged at bottom.
(8) hygroscopicity：The glass desicator that bottom is filled to NaCl supersaturated solutions is placed in 25 DEG C of thermostatic drying chamber
24 hours.Granule 2g is taken, it is accurately weighed in measuring cup, (weigh the cap oneself open) is placed in above-mentioned drier, in 25 DEG C
Insulating box preserves 24 hours, weighs.It is qualified to can be calculated prescription particle hydroscopicity.
(8) content uniformity：By version in 2015《Chinese Pharmacopoeia》Regulation, takes 10 bags of test sample, removes unlap, accurate respectively to claim
The weight of fixed every bag of content, it is known that empty package bag net weight 0.998g acquires the loading amount of every bag of content and average loading amount, checks
Particle net content meets the requirement of granule between acceptability limit 6.65~7.35.
The present invention provides a kind of Chinese medicine composition improving insomnia, 5~15 parts of perilla leaf, 5~15 parts of lily, stir-baked FRUCTUS GARDENIAE 3~7
Part, 3~7 parts of Fermented Soybean, 5~15 parts of Prunella vulgaris, 1 part of safflower, 3~7 parts of turmeric, 5~15 parts of Gebratene Sojakeime, 3~7 parts of peppermint, life
10~20 parts of oyster；Described part is parts by weight.
The Chinese medicine of the present invention is a kind of prescription improving insomnia, and compatibility is unique, cheap and easy to get, by perilla leaf, lily, fries Cape jasmine
Son, Fermented Soybean, Prunella vulgaris, safflower, turmeric, Gebratene Sojakeime, peppermint, raw oyster composition, Chinese medicine thinks intimately to have a sleepless night most essential
The interpretation of the cause, onset and process of an illness, diagnosis and treatment, which are had a sleepless night, should especially pay attention to the application of heat-clearing drug, and kind cold and cool medicine, and our Chinese medicine is mostly antipyretic, with nourishing heart
Calm the nerves, relieving restlessness that clears away heart-fire.
For Chinese medicine composition of the present invention by taking bead dosage form as an example, extraction process foundation and respect clinical application mode produce work
Skill is simple, intermediate obtained by the optimal extraction technology method effectively, process stabilizing, quality it is uniform.
The present invention is to ensure safety and the validity of the invention Chinese medicine composition medication, ensures product quality, in this
The method of drug composition quality control determined, including granularity, heap density, angle of repose, moisture, dissolubility, hygroscopicity and
Content uniformity, and analyze lab scale and pilot-scale experiment difference and evaluated, the quality of the Chinese medicine composition is controlled comprehensively.
Description of the drawings
Fig. 1 (a) Gardenoside reference substances (b) compound extract HPLC figures
Fig. 2 Gardenoside linear relationships
Specific implementation mode
It reiterates：Following methods are only the quality evaluating method by taking granule enlarged experiment effect as an example, are not covered by
The dosage form all with the present invention is exhausted, purpose, which is only that, illustrates Chinese medicine composition quality evaluating method of the present invention with data,
It verifies optimised process and whether ratio of adjuvant is reasonable, analyze its granule enlarged experiment effect, reduce product industrialization risk.
Embodiment 1：A kind of integration of drinking and medicinal herbs Compatible Granule improving insomnia
Raw material is：15 parts of oyster, 10 parts of coloured malt, 10 parts of Prunella vulgaris, 10 parts of lily, 10 parts of perilla leaf, 5 parts of stir-baked FRUCTUS GARDENIAE are light
5 parts of fermented soya bean, 5 parts of turmeric, 5 parts of peppermint, 1 part of safflower；Described part is parts by weight；
The Chinese herbal granules are made by following preparation method：
(1) prepare each bulk pharmaceutical chemicals according to the parts by weight；
(2) it takes (1) raw material to add 10 times of water, extracts 1.5 hours, extract 3 times, merge extracting solution；
(3) (2) extracting solution is taken, the medicinal extract of relative density 1.20 is measured when being concentrated under reduced pressure into 25 DEG C at 60 DEG C~70 DEG C,
Medicinal extract must be extracted；
(4) (3) medicinal extract is taken, sets and is dried in vacuum drying chamber to constant weight, 70 DEG C, pressure 0.08-0.09MPa of drying temperature,
Dry extract is obtained, dry extract be crushed into 80 mesh sieve, obtain extract powder；
(5) (4) extract powder is mixed with auxiliary material, using wet granulation, corrigent, adhesive is added；By optimised process, i.e.,
Medicinal material dry extract：Filler=1.5:1, corrigent 1-2 ‰, mixing, described part are parts by weight；Softwood processed is pelletized, and is done
Dry, whole grain is to get granule；
(6) amplify 100 times according to the parts by weight, prepare each bulk pharmaceutical chemicals；Foundation (2), (3), (4), (5) preparation method,
Pilot-scale prepares integration of drinking and medicinal herbs granule；
(7) 10 mesh are crossed and sieves wet granular processed, cross 80 mesh sieves, 60 DEG C of forced air drying 2h are weighed and calculated granularity qualification rate.
Above-mentioned filler is dextrin；Wetting agent is 80% ethyl alcohol；Corrigent is Sucralose.
Embodiment 2：A kind of integration of drinking and medicinal herbs Chinese medicine composition qaudrature-homogeneous design improving insomnia
1. determination water is Extraction solvent, using L9 34It is orthogonal to be tested, select extraction time, extraction time, solid-liquid ratio
As 3 factors of investigation, each factor respectively takes 3 levels.(see Tables 1 and 2)
1 factor level table of table
2 Orthogonal Experiment and Design of table
2. assay result：
It is accurate under above-mentioned chromatographic condition to draw 2,5,10,15,20,25 μ L of reference substance solution, it is automatically injected in chromatograph, with
Sample size is abscissa, and peak area is ordinate, obtains following result.
3 Gardenoside linear relationship of table is investigated
Accordingly it is found that calibration curve equation：Y=106398X-2720.3, R2=0.9999.
The 9 groups of test samples obtained under the conditions of above-mentioned orthogonal experiment under above-mentioned chromatographic condition respectively it is accurate draw 10 μ L into
Sample calculates content according to standard curve, as a result see the table below using Determination of Gardenoside as inspection target.
4 Orthogonal experiment results of table
3. range analysis
5 Orthogonal experiment results range analysis of table
As seen from the above table, it is obtained through range analysis and primary and secondary is acted on to each factor, be extraction time>Extraction time>Solid-liquid ratio,
It is A to consider optimum extraction level3B2C2, i.e. extraction conditions are the water for adding 10 times of amounts, are decocted three times, 1.5 hours every time.
Embodiment 3：A kind of Investigation of Quality Standard for the integration of drinking and medicinal herbs Compatible Granule lab scale and pilot scale improving insomnia
1. character
Particle appearance is in brown color, and color and luster is consistent, gas faint scent, slightly sweet, and without viscous glutinous particle agglomerate, feel is dry and comfortable.
2. obtaining cream amount and flour extraction
Extracting solution is collected after being concentrated and dried, and weighing dry extract and dry extract must measure, and calculate the rate of extract and flour extraction.
The rate of extract=(dry extract amount/dosage) * 100%
Small I=(16.2/76) * 100%=21.31%
Middle I=(1067.8/7600) * 100%=14.05%
Lab scale be averaged the rate of extract be 22.10%, pilot scale be averaged the rate of extract be 15.52%；
Flour extraction=(dry extract amount/dry extract amount) * 100%
Small I=(13.6/16.2) * 100%=83.95%
Middle I=(990.8/1067.8) * 100%=92.79%
Pilot scale be averaged flour extraction be 84.96%, pilot scale be averaged flour extraction be 93.12%；
The arithmetic mean of instantaneous value (X) * 100% of relative standard deviation (RSD)=standard deviation (SD)/result of calculation
6 lab scale of table and the comparison of pilot scale dry extract
(note：Small I represents lab scale first sample, and middle I represents pilot scale first sample)
As shown in Table 6, the pilot scale the rate of extract that is averaged is lower than the lab scale the rate of extract that is averaged, but pilot scale flour extraction is but higher than lab scale.
3. granularity
Using wet granulation, by optimised process, i.e. medicinal material dry extract：Edible dextrin=1.5:1 mixing, Sucralose are suitable
Amount, herein in order to which the later stage facilitates calculating lab scale dry extract to weigh 12g, pilot scale dry extract weighs 600g, is with 80% ethyl alcohol
Wetting agent, softwood processed, sieving granulation, forced air drying particle weigh and calculate granularity qualification rate.
Granularity qualification rate (%)=(material gross weight-fine powder)/material gross weight * 100%
Small I=(20-1.6)/20*100%=92%
Middle I=(1000-143.1)/1000*100%=85.69%
7 lab scale of table and the comparison of pilot scale granularity
Lab scale and pilot scale average particle size qualification rate are all higher than 85% as shown in Table 7, and judgement is qualified.
4. heap density
3.0g samples are weighed, are placed in 10mL graduated cylinders, it is made to be fallen from 3cm height, 50 vibrations is repeated, reads particle
Volume calculates granular pile density.
8 lab scale of table and the comparison of pilot scale heap density
The average bulk density of the lab scale particle is 0.5297g/mL as shown in Table 8, and the average bulk density of pilot scale particle is
0.5775g/mL can provide certain foundation for the size of finished product packing bag.
5. angle of repose
Using fixed funnel method, 3 funnels are connected and are fixed on horizontal positioned graph paper at 1cm, it is nethermost
Hopper outlet polishes, and respectively pours into three batches of granules in uppermost funnel along hopper walls in right amount, until being formed on graph paper
Medicinal powder cone tips touch funnel bottom end until, the diameter calculation angle of repose that cone bottom is measured by graph paper is (anti-
Repetition measurement is 5 times fixed), it is averaged.
Angle of repose refers to the maximum angular that the free inclined-plane that powder is piled into is formed with horizontal plane, angle of repose α=arctan (H/
R)
9 lab scale of table and the comparison of pilot scale angle of repose
As shown in Table 9, particle angle of repose is respectively less than 40 ° after granulation, shows that particle flow is preferable, meets production requirement.
6. moisture
Moisture is measured according to 2015 editions States Pharmacopoeia specifications, is taken in test sample to flat measuring cup, accurately weighed, open bottle cover exists
100~105 DEG C of dryings 5 hours, bottle cap is covered, in dislocation drier, is let cool 30 minutes, accurately weighed, then in above-mentioned temperature
It is 1 hour dry, it lets cool, weighs, until the difference weighed twice in succession is no more than 5mg.According to the weight of less loss, calculate for examination
Water content (%) in product
Weight after moisture weight=second of weighing-sample-adding
Dry weight=second of weighing-measuring cup weight
Moisture content=moisture weight/dry weight * 100%
10 lab scale of table is compared with pilot scale moisture
(it is first part of lab scale first sample to note small I-1, and middle I-1 is first part of pilot scale first sample)
As shown in Table 10, granule moisture is less than 8%, and it is qualified to measure.
7. dissolubility
Test sample 10g is taken, water 200mL is heated, stirs 5 minutes, observes immediately, phenomenon is as shown in the table.
11 lab scale of table and pilot scale solution of granule
8. hygroscopicity
The glass desicator that bottom is filled to NaCl supersaturated solutions is placed in 25 DEG C of thermostatic drying chamber 24 hours.It takes
Granule 2g, it is accurately weighed in measuring cup, it is placed in above-mentioned drier (weigh the cap oneself open), is preserved in 25 DEG C of insulating boxs
It 24 hours, weighs.Hydroscopicity is calculated as follows.
Hydroscopicity (%)=(the last first weight of weight -)/sample size * 100%
12 lab scale of table is compared with pilot scale hygroscopicity
As shown in Table 12, prescription particle hydroscopicity is qualified, and wherein pilot scale hydroscopicity is slightly higher compared with lab scale.
9. content uniformity
Pilot scale granule is packed, loading amount calculates estimated mono- bag of net content 7g according to dry extract yield, it is known that sky packet
Net weight 0.998g is packed, knows that 6.0g or more content uniformity limits are ± 5% by standards of pharmacopoeia.
13 lab scale of table and pilot scale content uniformity
As seen from the above table, check that particle net content between acceptability limit 6.65~7.35, meets the requirement of granule.
It is intended to illustrate invention above, the scope of the present invention is not limited.Those skilled in the art are to the displosure
Scheme on the basis of can carry out improvement and variation without departing from scope and spirit.
Embodiment 4：Therapeutic effect and curative effect
Present inventor passes through a large amount of clinical test and research, the integration of drinking and medicinal herbs Chinese medicine group of the improvement insomnia provided
Object is closed based on " mental-tranquilization, relieving restlessness that clears away heart-fire ", for treating so that intimately for the insomnia of main pathogenesis, there is good treatment
Effect, and sleep quality can be improved.The present invention is described in more detail below in conjunction with specific embodiment.
Model case：
Case one：Certain is shut out, man, 82 years old.First visit on December 15 in 2015.
Main suit：Insomnia 1 month.
Medical history：Patient's private prosecution is slept poor 1 month, very then gibberish, left tinnitus, the soreness of waist, frequent micturition, the red silt of tongue, yellow and greasy fur, veins string
Sliding, ruler is weak.There is hypertension history.
Diagnosis：It is insomnia (heat disturbs the mind, and extravasated blood hinders network).
Therapy：Heart fire-clearing upset-relieving, blood-promoting and mind-easing.
Prescription：Stir-baked FRUCTUS GARDENIAE 10g, Fermented Soybean 10g, turmeric 10g, peppermint 10g, Prunella vulgaris 20g, lily 20g, perilla leaf 10g are raw
Oyster 30g(being decocted first), west safflower 2g, coloured malt 20g.7 doses.It is decocted in water for oral dose, 1 dose of day.
Two examine (on December 22nd, 2015)：It sleeps peace, tinnitus is aobvious to be subtracted, and blood pressure is steady, the red silt of pale tongue point, veins string.7 in front of following the service
Agent.
Three examine (on December 29th, 2015)：It sleeps peace, there is phlegm, pale tongue to become silted up, veins string.Front adds caulis bambusae in taenian 10g, 10 doses.
Case two：Mr. Wang, female, 50 years old.First visit on March 24 in 2015
Main suit：Insomnia 1 year.
Medical history：Patient's private prosecution is often had a sleepless night over 1 year, and it is difficult to fall asleep, when left side headache, tinnitus, fiber crops when left arm, foot, the soreness of waist, stomach
It is swollen, when high blood pressure, the moon stop over two months, soft, yellow urine of defecating, pale tongue becomes silted up, moss thin yellow, left veins string.
Diagnosis：It is insomnia (heat disturbs the mind, and extravasated blood hinders network).
Therapy：Heart fire-clearing upset-relieving, blood-promoting and mind-easing.
Prescription：Stir-baked FRUCTUS GARDENIAE 10g, Fermented Soybean 10g, turmeric 10g, peppermint 10g, Prunella vulgaris 20g, lily 20g, perilla leaf 10g are raw
Oyster 30g(being decocted first), west safflower 2g, coloured malt 20g.7 doses.It is decocted in water for oral dose, 1 dose of day.
Doctor's advice：Diet is preferably light, avoids pungent food, is cold and cool, is fried, the objects such as seafood delights, mutton.
Two examine (on April 3rd, 2015)：Insomnia, tinnitus, headache is aobvious subtracts, receive can, stool is dilute, and pale tongue is become silted up, moss thin yellow, left arteries and veins
String.In front plus Radix Polygalae 5g.7 doses.
Three examine (on April 24th, 2015)：It sleeps good, remaining disease is aobvious to be subtracted, stool day time, deeptensepulse, pink tongue, moss thin yellow.Front is gone
West safflower, 10 doses of following the service.
Case three：Party, man, 24 years old.First visit on December 31 in 2015
Main suit：It has a sleepless night two weeks
Medical history：Patient's private prosecution two weeks is come through often having a sleepless night.Dysphoria with smothery sensation is uneasy, tinnitus, and pharynx is unfavorable, there is phlegm, yellow urine or heat, energy
Food, just does, and usually foot is cooler, red, the yellow,greasy and thin fur of the tip of the tongue silt, right wiry and rolling pulse.
Diagnosis：It is insomnia (heat disturbs the mind, and extravasated blood hinders network).
Therapy：Heart fire-clearing upset-relieving, blood-promoting and mind-easing.
Prescription：Stir-baked FRUCTUS GARDENIAE 10g, Fermented Soybean 10g, turmeric 10g, peppermint 10g, Prunella vulgaris 20g, lily 20g, perilla leaf 10g are raw
Oyster 30g(being decocted first), west safflower 2g, coloured malt 20g.7 doses.It is decocted in water for oral dose, 1 dose of day.
Doctor's advice：Diet is preferably light, avoids pungent food, is cold and cool, is fried, the objects such as seafood delights, mutton
Two examine (on January 7th, 2015)：Sleep improvement, the red silt of tongue, yellow and greasy fur, just row owe smooth, yellow urine subtracts, and wiry and rolling pulse, front adds
Grass-leaved sweetflag 6g, 7 doses of following the service.
Three examine (on 2 18th, 2015)：It sleeps improvement, tinnitus subtracts, and yellow urine is just soft, and tongue is red, moss thin yellow, right slippery.Front is gone
West safflower.5 doses of following the service.
Case four：Slowly so-and-so, female, 42 years old, first visit on January 5 in 2016
Patient does more than 20 years of financial affair such as one day, scrupulously abides by the duty, and quite obtains favorable comment, intermediate title of closely breaking a rule to promote.Because of neck
It leads and entrusts with an important task, cause someone discontented, spread a rumor.Therefore gloomy in the heart.In addition operating pressure is quite heavy, causes to lie awake all night then, disease
More than the moon, so that cannot adhere to working normally.Describe it is thin and pallid overworked, it is dog-tired.Vexed irritability, when be intended to get angry, and when be intended to weep with grief.It examines
The fine and smooth number of veins string, presses strong, the red silt of tongue again, and tongue floats Huang, dry and hard excrement, urine color Huang in vain.
Diagnosis：It is insomnia (heat disturbs the mind, and extravasated blood hinders network).
Therapy：Heart fire-clearing upset-relieving, blood-promoting and mind-easing.
Prescription：Stir-baked FRUCTUS GARDENIAE 10g, Fermented Soybean 10g, turmeric 10g, peppermint 10g, Prunella vulgaris 20g, lily 20g, perilla leaf 10g are raw
Oyster 30g(being decocted first), west safflower 2g, coloured malt 20g.7 doses.It is decocted in water for oral dose, 1 dose of day.
Two examine (on January 13rd, 2016)：Stool is passed unimpeded after medicine, and dysphoria all subtracts, and night can sleep peacefully 3 to 4 hours.Suffer from
Person's state of mind is become quite a different person earlier above.Still string of feeling the pulse slides number, and the red silt tongue of tongue is white, hot and suffocating not yet all clear, after with the stagnation resolvation method that clears away heart-fire.Side
With prodrug, 7 doses of following the service.
Three examine (on January 20th, 2016)：Patient heart significantly improves, and can go to sleep peacefully at nightfall, appetite increases earlier above, face
Color has shown moist.It is intended to go to work, resumes work.But think of is still had a lingering fear unavoidably, leads to insomnia again after being in fear of working.
Wiry and rolling pulse and number are examined, red tongue with thin fur is white.Still preferably preceding method is retreated.And it is advised to adhere to exercise of taking a walk daily, diet, which is worked as, avoids pungent savoury.
And notice that thought is optimistic, it is not meaning with minor matter.Go west safflower for top, 10 doses of following the service.
Case five：Sun, female, 76 years old, first visit on March 5 in 2016
It is overstrain one's nerves because of occupational relation, suffer from neurasthenia at an early age, often has a sleepless night.After old age, gradually seriously.Through
Often nervous palpitation, lies awake all night, vexed uneasiness, and must take sedative per Dinner can fall asleep.Dry and hard excrement, informal dress Maren wan begin logical.
Tongue body slight of stature, crimson tongue and dry, the tiny cunning of pulse condition string.This consumes sad spleen, after old, dirty the moon loses again, strongly fragrant because pondering over too
Accumulate in heat.When at yin deficiency hyperactivity of fire, Chinese goldthread colla corii asini chicken yellow stuff, nourishing yin and lessening fire is first used to let out Nan Bubei, restoring normal coordination between heart and kidney.Prescription：
Molten is blended at twice by raw radix rehmanniae preparata each 20g, RHIZOMA COPTIDIS from Sichuan of China 3g, donkey-hide gelatin 12g, 12 grams of Eclipta prostrata, 10 grams of the fruit of glossy privet.2 pieces of hen egg yolk, beats
It is broken stir evenly to multiply heat with the liquid decocted into and be blended into stir evenly warmly take.Seven pairs
Two examine it is vexed after (on March 13rd, 2016) medicine decrescence night can fall asleep a moment, the easily awake heart is frightened, spiritlessness and weakness, head
Dizzy forgetful, food of receiving is not good enough.Tongue is deep red have been subtracted, and the red few tongue of matter, become silted up purple on side, and arteries and veins still string is thin and counts.This disturbs the mind for heat, extravasated blood hinder network it
Card adjusts prescription, and with heart fire-clearing upset-relieving, blood-promoting and mind-easing is method.
Prescription：Stir-baked FRUCTUS GARDENIAE 10g, Fermented Soybean 10g, turmeric 10g, peppermint 10g, Prunella vulgaris 20g, lily 20g, perilla leaf 10g are raw
Oyster 30g(being decocted first), west safflower 2g, coloured malt 20g.10 doses of following the service and pacify.
Case six：Wei, man, 37 years old.First visit on July 6 in 2016
Main suit：Insomnia more than 1 year
Medical history：Patient's private prosecution is had a sleepless night, Yi Xing, and difficult after waking up to sleep, poor memory, energy is not good enough, and mood is had the fidgets, dry
Bitter taste, stomach upset or swollen, belch is just soft, yellow urine, and there are ulcer, the red silt of tongue, moss thin yellow, wiry and frequent pulse in when cheek and gum.From taking nourishing heart
Anshen Wan is more than year.
Diagnosis：It is insomnia (heat disturbs the mind, and extravasated blood hinders network).
Therapy：Heart fire-clearing upset-relieving, blood-promoting and mind-easing.
Prescription：Stir-baked FRUCTUS GARDENIAE 10g, Fermented Soybean 10g, turmeric 10g, peppermint 10g, Prunella vulgaris 20g, lily 20g, perilla leaf 10g are raw
Oyster 30g(being decocted first), west safflower 2g, coloured malt 20g.7 doses.It is decocted in water for oral dose, 1 dose of day.
Doctor's advice：Diet is preferably light, avoids pungent food, is cold and cool, is fried, the objects such as seafood delights, mutton
Two examine (on July 14th, 2016)：It sleeps improvement, gasteremphraxis subtracts, fatiguability, and mood improves, and dry mouth with bitter taste mitigates, just soft,
Sometimes yellow urine, tongue is red, moss thin yellow, veins string.Front adds Radix Polygalae 6g, 10 doses of following the service.
Three examine (on July 24th, 2016)：It sleeps peace, dry mouth with bitter taste mitigates, and gasteremphraxis is removed, and muscle power increases, pink tongue, moss thin yellow, arteries and veins
Carefully.Go west safflower in front, 10 doses of following the service.
Case seven：Mr. Wang, female, 39 years old.First visit on December 15 in 2016
Main suit：Insomnia more than 10 years.
Medical history：Regular insomnia over more than ten years of patient's private prosecution, secondary tinnitus before 8 years.Existing disease：Dizziness, look irritated, menstruation
Clot is more, when have a dysphoria with smothery sensation, the red silt of tongue is purple, wiry and frequent pulse.
Diagnosis：It is insomnia (heat disturbs the mind, and extravasated blood hinders network).
Therapy：Heart fire-clearing upset-relieving, blood-promoting and mind-easing.
Prescription：Stir-baked FRUCTUS GARDENIAE 10g, Fermented Soybean 10g, turmeric 10g, peppermint 10g, Prunella vulgaris 20g, lily 20g, perilla leaf 10g are raw
Oyster 30g(being decocted first), west safflower 2g, coloured malt 20g.7 doses.It is decocted in water for oral dose, 1 dose of day.
Doctor's advice：Diet is preferably light, avoids pungent food, is cold and cool, is fried, the objects such as seafood delights, mutton.
Two examine (on December 22nd, 2016)：Sleep peace, tinnitus is removed, and mood improves, receive can, stool is dry.Front increases stir-baked FRUCTUS GARDENIAE
To 15g.7 doses of following the service
Three examine (on December 29th, 2016)：It sleeps peace, his disease is aobvious to be subtracted, and tongue becomes silted up purple mitigate.West safflower is gone in front.10 doses of following the service.
Case eight：Lee, female, 34 years old.First visit on December 27 in 2016
Main suit：Insomnia 1 month
Medical history：Patient's private prosecution is often had a sleepless night over 1 month, and night must not sleep, and dysphoria, classical prescription is most, and amount is few, there is clot, waist
Back of the body acid, just does, dry mouth with bitter taste, and tongue silt is purple, moss thin yellow, wiry and frequent pulse.
Diagnosis：It is insomnia (heat disturbs the mind, and extravasated blood hinders network).
Therapy：Heart fire-clearing upset-relieving, blood-promoting and mind-easing.
Prescription：Stir-baked FRUCTUS GARDENIAE 10g, Fermented Soybean 10g, turmeric 10g, peppermint 10g, Prunella vulgaris 20g, lily 20g, perilla leaf 10g are raw
Oyster 30g(being decocted first), west safflower 2g, coloured malt 20g.7 doses.It is decocted in water for oral dose, 1 dose of day.
Doctor's advice：Diet is preferably light, avoids pungent food, is cold and cool, is fried, the objects such as seafood delights, mutton.
Two examine (on January 3rd, 2016)：It sleeps peace, mood improves, and dry mouth with bitter taste mitigates, and tongue is red, and extravasated blood mitigates, veins string.Front
Go west safflower, 7 doses of following the service.
Three examine (on January 10th, 2016)：It sleeps peace, no agitation, without apparent dry mouth with bitter taste, pink tongue, tongue is thin white.Front subtracts stir-fry
Cape jasmine dosage is to 8g, 10 doses of following the service.
Claims (9)
1. a kind of Chinese medicine composition improving insomnia, it is characterised in that：Raw material is：5~15 parts of perilla leaf, fries Cape jasmine at 5~15 parts of lily
3~7 parts of son, 3~7 parts of Fermented Soybean, 5~15 parts of Prunella vulgaris, 1 part of safflower, 3~7 parts of turmeric, 5~15 parts of Gebratene Sojakeime, peppermint 3~7
Part, 10~20 parts of raw oyster；Described part is parts by weight.
2. Chinese medicine composition according to claim 1, it is characterised in that：
Dosage form is particle, is made by following preparation method：
(1) prepare each bulk pharmaceutical chemicals according to parts by weight described in claim 1；
(2) it takes (1) raw material to add 8-12 times of water, extracts 1-2 hours, extract 1-3 times, merge extracting solution；
(3) (2) extracting solution is taken, the medicinal extract of relative density 1.20-1.25 is measured when being concentrated under reduced pressure into 25 DEG C at 60 DEG C~70 DEG C,
Medicinal extract must be extracted；
(4) (3) medicinal extract is taken, sets and is dried in vacuum drying chamber to constant weight, 70 DEG C of drying temperature, pressure 0.08-0.09MPa is obtained dry
Dry extract crushed 80 mesh sieve, obtains extract powder by medicinal extract；
(5) (4) extract powder is mixed with auxiliary material, using wet granulation, corrigent Sucralose, 80% ethyl alcohol of adhesive is added；
Medicinal material dry extract：Dextrin=1.5:1, Sucralose 1-2 ‰, mixing, described part are parts by weight；Softwood processed is pelletized, and is done
Dry, whole grain is to get granule；
(6) amplify 100 times according to parts by weight described in claim 1, prepare each bulk pharmaceutical chemicals；It is prepared according to (2), (3), (4), (5)
Method, pilot-scale prepare integration of drinking and medicinal herbs granule；
(7) 10 mesh are crossed and sieves wet granular processed, cross 80 mesh sieves, 60 DEG C of forced air drying 2h are weighed and calculated granularity qualification rate.
3. Chinese medicine composition according to claim 2, which is characterized in that the filler is dextrin, wetting agent 80%
Ethyl alcohol, corrigent are Sucralose.
4. a kind of preparation process of the Chinese medicine composition of improvement insomnia according to one of claim 1-3, it is characterised in that：
Method and step is as follows：
(1) the Key Quality attribute of the integration of drinking and medicinal herbs formula is determined；
(2) qaudrature-homogeneous design is used to confirm key process parameter with high performance liquid chromatography；
(3) technology stability is investigated by enlarged experiment；
(4) preparation method for the Chinese medicine composition for improving insomnia is established according to (3)；
(5) evaluation method for the Chinese medicine composition for improving insomnia is established according to (4).
5. preparation method according to claim 4, it is characterised in that：Technology assessment index is Determination of Gardenoside.
6. preparation method according to claim 4, it is characterised in that：Technology assessment index be Determination of Gardenoside, cream amount,
Flour extraction, granularity, heap density, angle of repose, moisture and dissolubility.
7. a kind of preparation process of the Chinese medicine composition of improvement insomnia according to one of claim 1-3, it is characterised in that：
Extraction time 2-4 times, extraction time 1-2 hour, extraction water measure 8-12 times again.
8. preparation method according to claim 7, it is characterised in that：Extraction time 3 times, 1.5 hours extraction times, extraction
Water measures 10 times again.
9. a kind of formulation optimization method of the Chinese medicine composition of improvement insomnia according to one of claim 1-3, feature
It is：
(1) qaudrature-homogeneous is used to design；
Determine that water is Extraction solvent, using L9 34Orthogonal to be tested, selected extraction time, extraction time, solid-liquid ratio are used as and examine
3 factors examined, each factor respectively take 3 levels；
(2) assay：High effective liquid chromatography for measuring；
Chromatographic condition and system suitability test：Octadecylsilane chemically bonded silica is filler；Using water as mobile phase A, with second
Nitrile is Mobile phase B, and gradient elution is carried out according to the regulation in following table；30 DEG C of column temperature；Detection wavelength is 238nm；Number of theoretical plate is pressed
Gardenoside peak, which calculates, should be not less than 1500；
It is prepared by reference substance solution：Precision weighs Gardenoside reference substance 5.17mg, accurately weighed, sets in 25mL volumetric flasks, adds methanol
Dissolving, be diluted to scale, shake up to get；
The preparation of test solution：It takes dry prescription medicine materical crude slice accurately weighed, adds water to cook, filter, collecting decoction, water is added after concentration
It is settled in 100mL volumetric flasks, is ultrasonically treated, power 400W, frequency 40kHz 30 minutes, are let cool, and precision draws 2mL, constant volume
Into the volumetric flask of 25mL, shake up, filtration to get；
Measuring method：It is accurate respectively to draw reference substance and each 10 μ L of test solution, inject liquid chromatograph, measure to get；
It must not be less than 1.8mg per 1g total amounts containing Gardenoside.
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| CN109125644A (en) * | 2018-10-30 | 2019-01-04 | 河南五极中医药研究院 | Relieving mental strain and helping sleep Chinese medicine composition of integration of drinking and medicinal herbs and preparation method thereof |
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