CN1872204A - Medication composition for treating neurasthenia, preparation technique, and method for testing quality - Google Patents
Medication composition for treating neurasthenia, preparation technique, and method for testing quality Download PDFInfo
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Abstract
A Chinese medicine for treating neurasthenia, insomnia, palpitation, etc is prepared from lotus plumule, wild jujube, tangerine peel, and honey. Its preparing process and quality test method are also disclosed.
Description
Technical field
The present invention relates to neurasthenic pharmaceutical composition of a kind of treatment and preparation technology thereof, quality determining method.
Background technology
The whole world has nearly 1/4 people to be subjected to the insomnia puzzlement, and China also has 10% people to have sleep disorder.With the quickening pace of modern life with the increasing of struggle for existence pressure, the white collar personage misery of extremely having a sleepless night especially of the mental work worker more than 80% almost, insomniac's self-induction fails fully to have a rest and regain one's vigor, thereby body tiredness, lethargy, drowsiness, aprosexia, the thinking difficulty is reacted slow Tun, and is depressed, impatient, and then influence inter personal contact, reduce autoimmunity, getting involved aspect body and spiritual two, have a strong impact on the personal lifestyle quality even cause or increase the weight of other diseases.
According to statistics, in the U.S. because the traffic accident that causes of insomnia accounts for 7% of whole traffic accident incidence rate, the various contingencies that cause because of not having enough sleep cause death toll reaches 24000 people every year, economic loss that causes thus and the directly Downturn in production, sick leave, the contingency that cause of medical expense, insomnia, increases the weight of hundred million dollars of the economic loss 300-359 (" Qiqihar Medical College's journal " 2004 the 25th volumes the 7th phase 778-779 page or leaf) that other diseases causes.
Insomnia can be divided into one by its time of origin length and cross aypnia, i.e. insomnia once in a while; The short-term insomnia refers to schedule to last the insomnia of 2-3 week or several months; Chronic insomnia, the course of disease is in the regular insomnia more than 6 months.By the order of severity be divided into slightly, moderate, severe.The method of Cure for insomnia has non-drug therapy and pharmacotherapy, the First Principles of non-drug therapy is a Sleep hygiene, this insomnia that a variety of causes is caused all foot is necessary,, insomnia serious and Sleep hygiene and non-drug therapy imitate Drug therapy insomnia necessitate (the 1194th page of " the Shaanxi traditional Chinese medical science " 2005 the 26th volumes o. 11th) when can not gathering.
The chemicals of Cure for insomnia has benzodiazepine medicine, non-benzodiazepine medicine, barbiturate.Barbiturate has toxic and side effects in various degree, can cause liver, nephrotoxicity, and can produce toleration and dependency, has savings to poison.The benzodiazepine medicine is to the receptor non-selectivity, can cause dizziness on daytime, sleepy, lassitude etc., particularly when high dose and long-term prescription more so.Non-benzodiazepine medicine is better to receptor-selective, but side effect such as drowsiness, nauseating, xerostomia, dizziness, headache are arranged, the long-term prescription hang-up can cause bouncing aypnia, nightmare, feel sick, vomiting, anxiety, distending pain, (the 10th volume the 6th phase 772-773 page or leaf in " clinical lung section magazine " November in 2005) trembles.The insomnia that the treatment by Chinese herbs neurasthenia causes, dreaminess, cardiopalmus, dysphoria with smothery sensation have unique advantage.It is reach mind calming by adjusting internal organs imbalance of YIN and YANG, disharmony between QI and blood, calm the nerves, nourish blood, the effect of clearing heat and relieving fidgetness.Neither can addiction, do not produce dependency yet, and have no side effect, the incomparable advantage of chemical medicine is arranged in this field.
Summary of the invention
The object of the present invention is to provide neurasthenic pharmaceutical composition of a kind of treatment and preparation technology thereof, quality determining method.
Technical solution of the present invention is achieved in that its active ingredient made by the crude drug of hundred parts of ratios of following weight:
Plumula Nelumbinis 10-30% Semen Ziziphi Spinosae 15-30% Pericarpium Citri Reticulatae 20-50%
Mel 10-45%
Extraction process: get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae and decoct with water 2-3 time, each 1-3 hour, collecting decoction filters, and filtrate is concentrated into and surveys relative density in the time of 70 ℃ is the clear paste of 1.01-1.25, be placed into room temperature, add ethanol and make and contain alcohol amount and reach 55% to 85%, stir cold preservation 24-48 hour, get supernatant, reclaim ethanol and be concentrated into relative density that to survey relative density in the time of 70 ℃ be the clear paste of 1.10-1.30.
Get above-mentioned clear paste, add Mel, make a gift of sugar, stir, filter, being concentrated into and surveying relative density in the time of 70 ℃ is the clear paste of 1.35-1.38, promptly gets soft extract.
Get above-mentioned clear paste, other gets Mel, sucrose, sodium benzoate, boils, and leaves standstill, and filters, and joins in the clear paste, is made into full dose, and embedding promptly gets syrup.
Get Mel, add starch and the calcium sulfate of crossing 100 mesh sieves respectively, stir, be added to again in the above-mentioned cream that disappears, granulate, drying, encapsulated, get hard capsule.
Get Mel, add the microcrystalline cellulose 2 of crossing 100 mesh sieves respectively, low-substituted hydroxypropyl cellulose, mixing joins in the above-mentioned clear paste again, and mixing is granulated, and adds magnesium stearate, tabletting, sugar coating or film-coat promptly get tablet.
Get Mel, add the cane sugar powder of crossing 100 mesh sieves respectively, microcrystalline Cellulose, mixing joins in the above-mentioned clear paste again, granulates, drying, packing gets granule.
Get above-mentioned clear paste, added the starch of 100 mesh sieves, mixing gets mixture, and is standby; Big honeyed pills is made jointly with preceding mixture in Mel refining back.
Get above-mentioned clear paste, add mannitol, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, the mixing of crossing 200 mesh sieves respectively, add Mel again, granulate, tabletting gets oral cavity disintegration tablet.
Pharmaceutical composition of the present invention has the effect of clearing away heart-fire for tranquillization, is used for the neurasthenia, and disease is seen insomnia, dreaminess, cardiopalmus, dysphoria with smothery sensation.
Quality determining method 1, discriminating: the compositions oral liquid 10ml that gets it filled, add n-butyl alcohol 10ml, jolting is extracted, and divides and gets butanol solution, and evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the Hesperidin reference substance, adds methanol and makes the solution that every 1ml contains 0.4mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw above-mentioned two kinds of each 10ul of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with ethyl acetate-methanol-water (25: 4: 3) is developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with the aluminum chloride test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
2, assay: the photograph high performance liquid chromatography (" appendix VID of Chinese pharmacopoeia version in 2005) measure.
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-water (19: 81) is a mobile phase: the detection wavelength is 283nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 1500.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the Hesperidin reference substance, adds methanol and make the solution that every 1ml contains 0.4mg, promptly.
The preparation of need testing solution: the accurate drug composition oral liquid 5ml that draws, put in the 60ml separatory funnel, extract (15,10,10,10ml) 4 times with water saturated n-butyl alcohol jolting, merge n-butyl alcohol liquid, evaporate to dryness, residue add methanol makes dissolving, be transferred in the 10ml measuring bottle, add methanol to scale, shake up, promptly.
Algoscopy: accurate respectively reference substance solution and the need testing solution 5ul of drawing, inject chromatograph of liquid, measure, promptly.The every 1ml of this product contains Hesperidin (C
28H
34O
15) must not be less than 0.3mg.
Experiment one: to the influence of mice normal pressure anoxia enduring
Get 48 of white mice, body weight 17.0 ± 0.6g, the male and female dual-purpose is divided into four groups at random: (1) normal saline group; (2) compositions high dose group (0.167ml/kg); (3) compositions low dose group (0.083ml/kg); (4) SHENRONG FENGWANG JIANG group (0.16ml/kg), respectively by above dosage gastric infusion, 1 time/day, continuous 3 days, after the last administration 50 minutes, mice is put in the 125ml wide mouthed bottle that fills 2g soda lime, close plug writes down each Mus in the following time-to-live of anoxia condition, result such as table 1.
Table 1 pharmaceutical composition is to the influence of Mus anoxia enduring existence
| Group | Dosage (ml/kg) | Number of animals (only) | Hypoxia endurance time (min) |
| Normal saline group compositions high dose group compositions low dose group SHENRONG FENGWANG JIANG group | 0.17 0.167 0.083 0.167 | 12 12 12 12 | 26.08±4.8 32.56±6.0 ** 30.03±5.7 46.66±7.8 ** |
Compare with the normal saline group:
*P＜0.01
Table 1 result shows that pharmaceutical composition high dose group energy significant prolongation mice anoxia enduring life span (p＜0.01) is similar to the SHENRONG FENGWANG JIANG effect, and low dosage also prolonged to some extent to the mice anoxia enduring time-to-live.
Experiment two: to the influence of spontaneous activity in mice
40 of mices, body weight 20.9 ± 2.7g, the male and female dual-purpose, be divided into 4 groups of (1) normal saline groups (2) compositions high dose group (0.167ml/kg) (3) compositions low dose group (0.083ml/kg) (4) BABAO JINGFENG SAN groups (1.8g/kg) at random, respectively by above dosage gastric infusion, 1 time/day, continuous 3 days, after the last administration 1 hour, mice is counted spontaneous activity in mice number of times in 2 minutes by only being put in YSD-4 type animal activity counting box (productions of honeybee port radio two factories), the results are shown in Table 2.
Table 2 pharmaceutical composition is to the influence of spontaneous activity in mice
| Group | Dosage (ml/kg) | Number of animals (only) | Spontaneous activity number of times (inferior) |
| Normal saline group compositions high dose group compositions low dose group BABAO JINGFENG SAN | 0.2 0.167 0.083 1.8 | 10 10 10 10 | 50.0±13.9 27.9±11.5 ** 27.8±13.0 ** 41.2±17.6 |
Compare with the normal saline group:
*P＜0.01
Can significantly reduce spontaneous activity in mice number of times (P＜0.01) by the visible pharmaceutical composition of table 2 result.
Experiment three: to the influence of hemolysin formation in the sheep red blood cell (SRBC) sensitized mice body
40 of mices, the male and female dual-purpose, body weight 17.16 ± 0.4g is divided into 4 groups at random by method 1, the difference gastric infusion, 1 time/day, continuous 6 days, in administration second day, every Mus is lumbar injection sheep red blood cell (SRBC) suspension (erythrocyte: 0.2ml sensitization normal saline=3: 5) respectively, the 5th day mouse orbit got blood after sensitization, presses literature method and measures mice half hemolysis value, result such as table 3.Table 3 result shows that high dose composition can significantly increase the formation (P＜0.01) of hemolysin in the mice body, and the low dose group compound also forms hemolysin in the mice body and strengthens to some extent.
The influence that table 3 pharmaceutical composition forms hemolysin in the silk cotton sheep red blood cell sensitized mice body
| Group | Dosage (ml/kg) | Number of animals (only) | Half hemolysis value |
| Normal saline group compositions high dose group compositions low dose group SHENRONG FENGWANG JIANG group | 0.17 0.167 0.083 0.167 | 10 10 10 10 | 129.06±55.6 214.63±66.4 ** 180.31±68.4 166.3±42.5 |
Compare with the normal saline group:
*P＜0.01
Experiment four: chloroform is caused the ARR influence of mice
64 of mices, male and female are held concurrently bright, body weight 23.02 ± 1.4g, be divided into 4 groups at random: (1) normal saline group (2) pharmaceutical composition high dose group (0.167ml/kg) (3) pharmaceutical composition low dose group (0.083ml/kg) (4) DIAOXINXUE KANG group (200mg/kg), respectively by above dosage gastric infusion, 1 time/day, continuous 9 days, after the last administration 1 hour, mice by only being put in the inverted 600ml beaker that contains 3ml chloroform cotton balls, is treated that mouse breathing stops, taking out recording ecg (II leads) immediately, and cut open breast and line-of-sight observation ventricular fibrillation situation, result such as table 4.
Table 4 is the result show, pharmaceutical composition can significantly resist the mice arrhythmia that chloroform causes, through X
2Check, P＜0.01, similar to the DIAOXINXUE KANG effect.
Table 4 pharmaceutical composition causes the influence of mice arrhythmia to chloroform
| Group | Dosage (ml/kg) | Number of animals (only) | Half hemolysis value |
| Normal saline group compositions high dose group compositions low dose group DIAOXINXUE KANG | 0.17 0.167 0.083 0.20 | 15 13 16 16 | 80.0 30.7 ** 37.5 ** 25.0 ** |
Compare with the normal saline group:
*P＜0.01
Above-mentioned experimental result shows that pharmaceutical composition can resist the mice arrhythmia that chloroform causes; Reduce the spontaneous activity in mice number of times; Prolong the mice hypoxia endurance time; Promote the formation of hemolysin in the very thin born of the same parents' sensitized mice of the sheep body, improve antibody horizontal in the body, illustrate this oral liquid have clear away heart-fire, calm the nerves, sedation, and can the enhancing human body immunity function, enhancing body has certain tonic effect to the adaptive capacity of adverse circumstances.
The Main Ingredients and Appearance liensinine of pharmaceutical composition has blood pressure lowering and reaches the antiarrhythmic effect; Pericarpium Citri Reticulatae has dual regulation to the body cardiovascular system; Semen Ziziphi Spinosae has tranquilizing effect, cures mainly the neurasthenia.Pharmacological tests cures mainly consistent with function.
Clinical trial shows, is the checking group with the pharmaceutical composition, and NAOXINSHU is a matched group.The checking group compositions syrup 10ml that at every turn takes medicine adds 1 time 20ml every day 3 times before heavy person sleeps, the oral NAOXINSHU oral liquid of matched group 10ml adds 1 time 20ml every day 3 times before heavy person sleeps, and 20 days is a course of treatment.280 examples are organized in checking, matched group 140 examples, two groups of ages, the state of an illness, course of disease there was no significant difference.Observe that insomnias before and after two groups of patient's medications, dizziness, cardiopalmus, spirit are tired, poor appetite, feelings will change situation, lab testing blood, urine, just conventional, treatment front and back respectively 1 time, the untoward reaction observation of symptoms, write down once every day.Clinical trial shows, pharmaceutical composition total effective rate 93.22%, produce effects 65.36%, effective 27.86%, invalid 6.79%, matched group total effective rate 92.86%, produce effects 63.57%, effective 29.29%, invalid 7.14%, two group all has better curative effect, and there was no significant difference.Liver function GOT, GPT before and after two groups of treatments, renal function BUN, Gr all in normal range, do not see the electrocardiographic abnormality report yet, do not find untoward reaction.
The specific embodiment
Embodiment 1
Plumula Nelumbinis 120g Semen Ziziphi Spinosae 110g Pericarpium Citri Reticulatae 170g Mel 100g
Get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae and decoct with water secondary, each 2 hours, add 10 times of water gagings for the first time, add for the second time 8 times of water gagings, collecting decoction filters, and filtrate decompression is concentrated into and surveys relative density in the time of 70 ℃ is 1.10 clear paste, place room temperature, add ethanol and make and contain alcohol amount and reach 70%, cold preservation 24-48 hour, get supernatant, reclaim ethanol, continue to be concentrated into that to survey relative density in the time of 70 ℃ be 1.20 clear paste.Other gets Mel 100g, and sucrose 700g is heated to 85-95 ℃ of insulation 1 hour, adds sodium benzoate 3g, filters, and joins in the above-mentioned clear paste, and adding distil water is mixed with 1000ml, stirs evenly, and filters, and packing gets syrup.Each clothes 10ml, every day 3 times.
Embodiment 2
Plumula Nelumbinis 80g Semen Ziziphi Spinosae 130g Pericarpium Citri Reticulatae 170g Mel 200g
Get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae and decoct with water secondary, each 2 hours, add 10 times of water gagings for the first time, add for the second time 8 times of water gagings, collecting decoction filters, and filtrate decompression is concentrated into and surveys relative density in the time of 70 ℃ is 1.10 clear paste, place room temperature, add ethanol and make and contain alcohol amount and reach 70%, cold preservation 24-48 hour, get supernatant, reclaim ethanol, continue to be concentrated into that to survey relative density in the time of 70 ℃ be 1.20 clear paste.Add Mel, continue heating and be concentrated into that to survey relative density in the time of 70 ℃ be 1.36 thick paste, soft extract.
Embodiment 3
Plumula Nelumbinis 330g Semen Ziziphi Spinosae 490g Pericarpium Citri Reticulatae 490g Mel 330g
Get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae and decoct with water secondary, each 2 hours, add 10 times of water gagings for the first time, add for the second time 8 times of water gagings, collecting decoction filters, and filtrate decompression is concentrated into and surveys relative density in the time of 70 ℃ is 1.10 clear paste, place room temperature, add ethanol and make and contain alcohol amount and reach 65%, cold preservation 24-48 hour, get supernatant, reclaim ethanol, continue to be concentrated into that to survey relative density in the time of 70 ℃ be 1.20 clear paste.Other gets Mel, adds starch and the calcium sulfate of crossing 100 mesh sieves respectively, and mixing joins in the above-mentioned clear paste again, granulates, and granulate in the hard capsule of packing into, is made 1000, obeys 3, every day 3 times at every turn.
Embodiment 4
Plumula Nelumbinis 350g Semen Ziziphi Spinosae 400g Pericarpium Citri Reticulatae 450g Mel 300g
Get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae and decoct with water secondary, each 2 hours, add 10 times of water gagings for the first time, add for the second time 8 times of water gagings, collecting decoction filters, and filtrate decompression is concentrated into and surveys relative density in the time of 70 ℃ is 1.10 clear paste, place room temperature, add ethanol and make and contain alcohol amount and reach 70%, cold preservation 24-48 hour, get supernatant, reclaim ethanol, continue to be concentrated into that to survey relative density in the time of 70 ℃ be 120 clear paste.Other gets low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, and mixing with the Mel mixing, joins in the above-mentioned clear paste, granulates, and adds magnesium stearate, is pressed into 1000, and bag film-coat or sugar-coat get tablet.3 of each clothes, every day 3 times.
Embodiment 5
Plumula Nelumbinis 350g Semen Ziziphi Spinosae 400g Pericarpium Citri Reticulatae 450g Mel 300g
Get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae and decoct with water secondary, each 2 hours, add 10 times of water gagings for the first time, add for the second time 8 times of water gagings, collecting decoction filters, and filtrate decompression is concentrated into and surveys relative density in the time of 70 ℃ is 1.10 clear paste, place room temperature, add ethanol and make and contain alcohol amount and reach 70%, cold preservation 24-48 hour, get supernatant, reclaim ethanol, continue to be concentrated into that to survey relative density in the time of 70 ℃ be 1.20 clear paste.Other gets mannitol, low-substituted hydroxypropyl cellulose, the polyvinylpolypyrrolidone of crossing 200 mesh sieves respectively, joins in the Mel, and cold drying is pulverized, and crosses 200 mesh sieves, joins in the above-mentioned clear paste again, granulates, and is pressed into 1000, gets oral cavity disintegration tablet.
Embodiment 6
Plumula Nelumbinis 80g Semen Ziziphi Spinosae 100g Pericarpium Citri Reticulatae 150g Mel 200g
Get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae and decoct with water secondary, each 2 hours, add 10 times of water gagings for the first time, add for the second time 8 times of water gagings, collecting decoction filters, and filtrate decompression is concentrated into and surveys relative density in the time of 70 ℃ is 1.10 clear paste, place room temperature, add ethanol and make and contain alcohol amount and reach 70%, cold preservation 24-48 hour, get supernatant, reclaim ethanol, continue to be concentrated into that to survey relative density in the time of 70 ℃ be 1.20 clear paste.Other got the starch of 100 mesh sieves, joined in the above-mentioned clear paste, and mixing with it after the Mel refining is made 1 00 big honeyed pills, takes 1 ball, every day 3 times at every turn.
Embodiment 7
Plumula Nelumbinis 100g Semen Ziziphi Spinosae 150g Pericarpium Citri Reticulatae 180g Mel 70g
Get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae and decoct with water secondary, each 2 hours, add 10 times of water gagings for the first time, add for the second time 8 times of water gagings, collecting decoction filters, and filtrate decompression is concentrated into and surveys relative density in the time of 70 ℃ is 1.10 clear paste, place room temperature, add ethanol and make and contain alcohol amount and reach 70%, cold preservation 24-48 hour, get supernatant, reclaim ethanol, continue to be concentrated into that to survey relative density in the time of 70 ℃ be 1.20 clear paste.Other gets cane sugar powder, the microcrystalline Cellulose of crossing 100 mesh sieves respectively, mixes with Mel, joins in the above-mentioned clear paste, granulates, and drying gets granule 1000g, and packing gets granule.Each clothes 10g, every day 3 times.
Quality determining method:
1, differentiates
The compositions oral liquid 10ml that gets it filled adds n-butyl alcohol 10ml, and jolting is extracted, and divides and gets butanol solution, and evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the Hesperidin reference substance, adds methanol and makes the solution that every 1ml contains 0.4mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw above-mentioned two kinds of each 10ul of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with ethyl acetate-methanol-water (25: 4: 3) is developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with the aluminum chloride test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
2, assay
Measure according to high performance liquid chromatography (" appendix VID of Chinese pharmacopoeia version in 2005).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-water (19: 81) is a mobile phase: the detection wavelength is 283nm.Number of theoretical plate calculates by the Hesperidin peak should be not less than 1500.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the Hesperidin reference substance, adds methanol and make the solution that every 1ml contains 0.4mg, promptly.
The preparation of need testing solution: the accurate drug composition oral liquid 5ml that draws, put in the 60ml separatory funnel, extract (15,10,10,10ml) 4 times with water saturated n-butyl alcohol jolting, merge n-butyl alcohol liquid, evaporate to dryness, residue add methanol makes dissolving, be transferred in the 10ml measuring bottle, add methanol to degree of remembering, shake up, promptly.
Algoscopy: accurate respectively reference substance solution and the need testing solution 5ul of drawing, inject chromatograph of liquid, measure, promptly.The every 1ml of this product contains Hesperidin (C
28H
34O
15) must not be less than 0.3mg.
Claims (6)
1, the neurasthenic pharmaceutical composition of a kind of treatment is characterized in that this pharmaceutical composition made Plumula Nelumbinis 10-30%, Semen Ziziphi Spinosae 15-30%, Pericarpium Citri Reticulatae 20-50%, Mel 10-45% by the following raw materials by weight percent medicine.
2, the neurasthenic pharmaceutical composition of treatment according to claim 1 is characterized in that its raw material weight percentage ratio is:
Plumula Nelumbinis 20% Semen Ziziphi Spinosae 20% Pericarpium Citri Reticulatae 40% Mel 20%.
3, the neurasthenic preparation of pharmaceutical compositions technology of a kind of claims 1 described treatment, it extracts preparation method: get Plumula Nelumbinis, Semen Ziziphi Spinosae, Pericarpium Citri Reticulatae decocts with water 2-3 time, each 1-3 hour, collecting decoction, filter, filtrate decompression is concentrated into and surveys relative density in the time of 30-70 ℃ is the clear paste of 1.01-1.25, be placed into room temperature, add ethanol and make and contain alcohol amount and reach 55% to 85%, stir cold preservation 24-48 hour, get supernatant, reclaim ethanol and be concentrated into relative density that to survey relative density in the time of 30-70 ℃ be the clear paste of 1.10-1.30, add adjuvant, make oral formulations.
4, a kind of neurasthenic preparation of drug combination technology that is used for the treatment of according to claim 3 is characterized in that: oral formulations is meant that soft extract, oral liquid, tablet, capsule, pill, drop pill, granule and application release the above-mentioned dosage form that fast technology is made.
5, a kind of neurasthenic preparation of drug combination technology that is used for the treatment of according to claim 4, it is characterized in that: adjuvant is meant starch, dextrin, sucrose, makes a gift of sugar, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, polyvinylpolypyrrolidone, mannitol, calcium sulfate, magnesium stearate, sodium benzoate, can be one or more composite uses.
6, the quality determining method of the neurasthenic pharmaceutical composition of the described treatment of a kind of claim 1, it is characterized in that: its quality determining method is, compositions oral liquid 10ml gets it filled, add n-butyl alcohol 10ml, jolting is extracted, and divides and gets butanol solution, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets the Hesperidin reference substance, adds methanol and makes the solution that every 1ml contains 0.4mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw above-mentioned two kinds of each 10ul of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with ethyl acetate-methanol-water (25: 4: 3) is developing solvent, launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with the aluminum chloride test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
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| CN101642176B (en) * | 2009-06-11 | 2012-02-15 | 杭州六易科技有限公司 | Method for preparing wild jujube honey tea for relieving neurasthenia |
| CN103372144A (en) * | 2012-04-28 | 2013-10-30 | 宋艳洁 | Traditional Chinese medicine preparation for treating neurasthenia and preparation method thereof |
| CN105031179A (en) * | 2015-08-07 | 2015-11-11 | 石东秀 | Tablet for treating fever and preparation method thereof |
Family Cites Families (1)
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| CN1742837B (en) * | 2005-09-19 | 2010-04-28 | 江西天施康中药股份有限公司 | Compound lotus core oral liquid and its preparing method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101850001A (en) * | 2009-03-31 | 2010-10-06 | 北京因科瑞斯医药科技有限公司 | Pharmaceutical composition with function of improving sleep and preparation method thereof |
| CN101850001B (en) * | 2009-03-31 | 2013-08-28 | 北京因科瑞斯医药科技有限公司 | Pharmaceutical composition with function of improving sleep and preparation method thereof |
| CN101642176B (en) * | 2009-06-11 | 2012-02-15 | 杭州六易科技有限公司 | Method for preparing wild jujube honey tea for relieving neurasthenia |
| CN103372144A (en) * | 2012-04-28 | 2013-10-30 | 宋艳洁 | Traditional Chinese medicine preparation for treating neurasthenia and preparation method thereof |
| CN103372144B (en) * | 2012-04-28 | 2016-01-20 | 宋艳洁 | One treats neurasthenic Chinese medicine preparation and preparation method |
| CN105031179A (en) * | 2015-08-07 | 2015-11-11 | 石东秀 | Tablet for treating fever and preparation method thereof |
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|---|---|
| CN1872204B (en) | 2012-03-21 |
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