CN1233387C - Chinese compound medicine for treating anhypnosis and its preparation metod - Google Patents
Chinese compound medicine for treating anhypnosis and its preparation metod Download PDFInfo
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- CN1233387C CN1233387C CN 03158248 CN03158248A CN1233387C CN 1233387 C CN1233387 C CN 1233387C CN 03158248 CN03158248 CN 03158248 CN 03158248 A CN03158248 A CN 03158248A CN 1233387 C CN1233387 C CN 1233387C
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Abstract
The present invention discloses Chinese compound medicine for treating insomnia, and a preparation method thereof. The Chinese compound medicine for treating insomnia adopts the following raw materials, or alcohol and water, or water extracts of the following materials, or eluate passing through macroporous adsorptive resin, as active components. The raw materials comprise 500 to 1200g of lily, 600 to 1500g of acanthopanax, 500 to 1200g of caulis polygoni multiflori, 200 to 688g of albizia flower, 500 to 1200g of nacre, 400 to 988g of gypsum, 200 to 688g of seed of wild jujube, 50 to 488g of tuckahoe, 200 to 688g of senega, 200 to 688g of figwort, 200 to 688g of (raw) rehmannia root, 200 to 688g of lilyturf root, 200 to 688g of schisandra, 50 to 488g of common rush and 200 to 688g of red sage root; alcohol or water or eluate passing through macroporous resin of the fifteen raw materials is uniformly mixed and is prepare the Chinese compound medicine. The Chinese compound medicine for treating insomnia has the functions of nourishing Yin, clearing heat, tranquilizing and nourishing the heart. The Chinese compound medicine for treating insomnia is used for treating liver depression yin-deficiency type insomnia, or difficult sleep falling, or multiple dreams, or multiple semiconsciousness, or insomnia after waking or dizziness and weakness, or dysphoria and irritability, or palpitation, etc.
Description
Affiliated technical field
The present invention relates to a kind of compound Chinese medicinal preparation of Cure for insomnia disease, comprise composition of this Chinese medicine preparation and preparation method thereof.
Background technology
Sleep has occupied for human about 1/3 time, and it affects everyone work efficiency, quality of life and life-span, modal sleep disorder is insomnia, insomnia is meant because of the brain excitement raising, cause the length of one's sleep not enough or sleep not yet done, clinically mostly both and deposit.At present, the medicine of domestic and international Cure for insomnia, based on Western medicine, but Western medicine all has addiction in various degree, side effect and untoward reaction such as the rebound of having a sleepless night after dependency and the drug withdrawal; Dizzy, weak, drowsiness reaching behind the clothes that have to the heart, liver, kidney damage etc.Therefore, the natural plants Chinese patent medicine of Cure for insomnia is the urgent needs in the society.Adopt the modern Chinese medicine novel technology for extracting, the Chinese medicine preparation that refining refinement forms proves by clinical experimental research: it can regulate the physiological function of human body, obviously shorten time for falling asleep, prolong the length of one's sleep, improve Depth of sleep, reducing awake number of times at night, is a kind of comparatively ideal Chinese patent medicine preparation.
Summary of the invention
The invention provides compound Chinese medicinal preparation of a kind of Cure for insomnia disease and preparation method thereof
The present invention is a kind of compound Chinese medicinal preparation of Cure for insomnia disease, it mainly by the extract of the extract of the alcohol and water of following raw materials according or following raw materials according or following raw materials according water or the eluate by macroporous adsorbent resin as active component, the consisting of of raw material:
Bulbus Lilii 500-1200g Radix Et Caulis Acanthopanacis Senticosi 600-1500g Caulis Polygoni Multiflori 500-1200g
Flos Albiziae 200-688g Concha Margaritifera 500-1200g Gypsum Fibrosum 400-988g
Semen Ziziphi Spinosae 200-688g Poria 50-488g Radix Polygalae 200-688g
Radix Scrophulariae 200-688g Radix Rehmanniae 200-688g 200-688g Radix Ophiopogonis
Fructus Schisandrae Chinensis 200-688g Medulla Junci 50-488g Radix Salviae Miltiorrhizae 200-688g.
Raw material weight proportioning preferable in above-mentioned Chinese medicine is:
Bulbus Lilii 500-1200g Radix Et Caulis Acanthopanacis Senticosi 600-1500g Caulis Polygoni Multiflori 500-1200g
Flos Albiziae 200-688g Concha Margaritifera 500-1200g Gypsum Fibrosum 400-988g
Semen Ziziphi Spinosae 200-688g Poria 50-488g Radix Polygalae 200-688g
Radix Scrophulariae 200-688g Radix Rehmanniae 200-688g 200-688g Radix Ophiopogonis
Fructus Schisandrae Chinensis 200-688g Medulla Junci 50-488g Radix Salviae Miltiorrhizae 200-688g.
Best group of the present invention becomes:
Bulbus Lilii 800g Radix Et Caulis Acanthopanacis Senticosi 1200g Caulis Polygoni Multiflori 800g
Flos Albiziae 400g Concha Margaritifera 800g Gypsum Fibrosum 600g
Semen Ziziphi Spinosae 400g Poria 200g Radix Polygalae 400g
Radix Scrophulariae 400g Radix Rehmanniae 400g 400g Radix Ophiopogonis
Fructus Schisandrae Chinensis 400g Medulla Junci 200g Radix Salviae Miltiorrhizae 400.
Above-mentioned Chinese medicine preparation, it can be the dosage form of recording in any pharmacopeia such as granule, capsule, tablet, oral liquid, syrup, pill or powder, the preparation of Chinese medicine preparation also can be carried out with reference to the method for conventional Chinese medicine preparation, but in order to improve drug effect, reduce dosage, compound Chinese medicinal preparation of the present invention preferably adopts following preparation method.
The preparation technology who above-mentioned Chinese medicine is made Chinese traditional compound medicine of the present invention is:
(1) take by weighing following traditional Chinese medicines and make raw material:
Bulbus Lilii 500-1200g Radix Et Caulis Acanthopanacis Senticosi 600-1500g Caulis Polygoni Multiflori 500-1200g
Flos Albiziae 200-688g Concha Margaritifera 500-1200g Gypsum Fibrosum 400-988g
Semen Ziziphi Spinosae 200-688g Poria 50-488g Radix Polygalae 200-688g
Radix Scrophulariae 200-688g Radix Rehmanniae 200-688g 200-688g Radix Ophiopogonis
Fructus Schisandrae Chinensis 200-688g Medulla Junci 50-488g Radix Salviae Miltiorrhizae 200-688g.
(2) with above-mentioned Flos Albiziae, Semen Ziziphi Spinosae, Radix Scrophulariae, Radix Rehmanniae, Radix Ophiopogonis, Medulla Junci, Radix Salviae Miltiorrhizae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Fructus Schisandrae Chinensis alcohol or water reflux, backflow passes through macroporous adsorbent resin, collect the eluent of water or alcohol, the eluent that obtains is as active component I;
(3) Bulbus Lilii fleece-flower root rattan water or pure hot reflux are extracted, the extracting solution that obtains is as active component II;
(4) with Concha Margaritifera, Gypsum Fibrosum and Poria, water or pure hot reflux are extracted, and the extracting solution that obtains is as active component III;
(5), and make required dosage form with above-mentioned active component I, II and III mix homogeneously.
Magnolia vine fruit kernel alcohol extract deoxyschizandrin, second element etc., it can obviously prolong the length of one's sleep of mice to pentobarbital sodium or ciclobarbital soluble; Isofraxidin and polygalytol extract in the Radix Et Caulis Acanthopanacis Senticosi alcohol soluble components have tangible sedation; In step (2), the preferred hot reflux number of times of Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Fructus Schisandrae Chinensis is a secondary, backflow is the alcoholic solution of 40-80%, the hot reflux time is 3 hours for the first time, 2 hours for the second time, quantity of solvent is 10 times of amounts for the first time, 8 times of amounts for the second time, and most preferred backflow is 50% alcoholic solution.Semen Ziziphi Spinosae, Radix Rehmanniae, Medulla Junci, Radix Salviae Miltiorrhizae, Flos Albiziae, Radix Ophiopogonis, the preferred hot reflux number of times of Radix Scrophulariae are three times in addition, and backflow is a water, 2 hours for the first time, and second and third time each 1 hour, quantity of solvent is 10 times of amounts first time, each 8 times of amount of second and third time.With merging with water extract behind the above-mentioned alcohol extraction recovery ethanol,, and then use the appropriate solvent eluting by absorption with macroporous adsorbent resin.Preferred macroporous adsorbent resin model is D
101Type, eluting solvent is the alcoholic solution of 50-80%, absorption and elution speed all are controlled between the 0.01-0.1ml/min.ml (resin volume), and wherein Zui Jia eluant is 70% alcoholic solution, and optimal adsorption and elution speed all are controlled at 0.05ml/min.ml (resin volume).
Main component in the Caulis Polygoni Multiflori in main component emodin, chrysophanol, physcione and the Bulbus Lilii (multiple alkaloid) is pure soluble substance, in step (3), preferred hot reflux number of times is twice, backflow is the alcoholic solution of 30-65%, the hot reflux time is 3 hours for the first time, and 2 hours for the second time, quantity of solvent was 6 times of amounts first time, 4 times of amounts for the second time, most preferred backflow is 50% alcoholic solution.
Active component is water soluble ingredient in Concha Margaritifera, the Gypsum Fibrosum.The Poria decoct has sedation to mice.In step (4), preferred hot reflux number of times is three times, and backflow is a water, and the hot reflux time is 2 hours for the first time, second and third time each 1 hour, and quantity of solvent is 10 times of amounts first time, 8 times of amounts of second and third time more help the extraction of active ingredient.
The specific embodiment
Below by embodiment, the present invention is further described:
Embodiment one is the preparation of Chinese medicinal capsule a of the present invention:
(1) press column weight amount proportioning and take by weighing each component:
Bulbus Lilii 800g stings five power 1200g Caulis Polygoni Multiflori 800g
Flos Albiziae 400g Concha Margaritifera 800g Gypsum Fibrosum 600g
Semen Ziziphi Spinosae 400g Poria 200g Radix Polygalae 400g
Radix Scrophulariae 400g Radix Rehmanniae 400g 400g Radix Ophiopogonis
Fructus Schisandrae Chinensis 400g Medulla Junci 200g Radix Salviae Miltiorrhizae 400g.
(2) take by weighing Flos Albiziae, Semen Ziziphi Spinosae, Radix Scrophulariae, Radix Rehmanniae, Radix Ophiopogonis, Medulla Junci, Radix Salviae Miltiorrhizae, water reflux by said ratio, reflux, extract, three times adds 10 times of water gagings for the first time, 2 hours, second and third time respectively added 8 times of water gagings, and each is 1 hour, decoction liquor filters, and gets filtrate, as standby I;
(3) take by weighing Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Fructus Schisandrae Chinensis by said ratio,, add 10 times of amount 50% alcohol refluxs 3 hours for the first time with 50% alcoholic solution heating and refluxing extraction twice, add for the second time 8 times of amount 50% alcohol refluxs 2 hours, filter merging filtrate, reclaim ethanol to there not being the alcohol flavor, as standby II;
(4) merge I and II, through absorption with macroporous adsorbent resin, adsorption rate is 0.05ml/min.ml (a resin volume), after the absorption fully, earlier colourless to eluate with the water elution resin column, carry out eluting with 70% ethanol liquid then, elution speed is 0.05ml/min.ml (a resin volume), collects eluent stand-by (it is colourless to be washed till eluate).
(5) by above-mentioned weight proportion, take by weighing Concha Margaritifera, Gypsum Fibrosum, Poria, add hydro-thermal and reflux three times, add 10 times of amounts 2 hours for the first time, second and third time respectively adds 8 times of amounts each 1 hour, and collecting decoction leaves standstill after 24 hours and gets supernatant.
(6) take by weighing Bulbus Lilii, Caulis Polygoni Multiflori by above-mentioned weight proportion, secondary is extracted in the ethanol water hot reflux with 50%, adds 6 times of amount 50% ethanol waters for the first time, refluxes 3 hours, adds 4 times of amount 50% ethanol waters for the second time, refluxes 2 hours, filters merging filtrate.
(7) merge (4) and (6) medicinal liquid, reclaim ethanol to most.
(8) merge (5) and (7) medicinal liquid, concentrate and receive cream, drying under reduced pressure below 80 ℃, (to dried cream moisture≤5%) gets dry extract.
(9) get above-mentioned dried cream, pulverized 24 orders, the powder that gets dry extract, the starch of adding dried cream powder amount 8%, mix homogeneously, drying under reduced pressure below 80 ℃, moisture≤1.0%, the capsule of packing into No. 1, every 0.27g promptly gets the made capsule a of the present invention, and every g medicated powder is equivalent to raw medicinal herbs 28.9 grams.
Embodiment two is the preparation of Chinese medicinal capsule b of the present invention
(1) press column weight amount proportioning and take by weighing each component:
Bulbus Lilii 750g, Radix Et Caulis Acanthopanacis Senticosi 950g, Caulis Polygoni Multiflori 800g,
Flos Albiziae 350g, Concha Margaritifera 700g, Gypsum Fibrosum 600g,
Semen Ziziphi Spinosae 400g, Poria 200g, Radix Polygalae 350g,
Radix Scrophulariae 350g, Radix Rehmanniae (life) 500g, Radix Ophiopogonis 500g,
Fructus Schisandrae Chinensis 350g, Medulla Junci 200g, Radix Salviae Miltiorrhizae 500g
(2) take by weighing Flos Albiziae, Semen Ziziphi Spinosae, Radix Scrophulariae, Radix Rehmanniae, Radix Ophiopogonis, Medulla Junci, Radix Salviae Miltiorrhizae, wash earth by said ratio, dust, add 10 times of water gagings of crude drug, soak to boil after 2 hours and carry, open computation time with water, boil for the first time and carry 2 hours, add 6 times of water gagings for the second time and boil and carry 1.5 hours, add 5 times of water gagings for the third time and boil and carry 1 hour; Merge three times extracting solution, placed liquid, extract supernatant, add ethanol, carry out precipitate with ethanol routinely, promptly vacuum decompression is concentrated into relative density after 1: 1, adds 95% ethanol, make and contain alcohol amount and reach 70%, the limit adds that the ethanol limit is powerful stirs hour, places and spends the night (about 24 hours), extracts supernatant, reclaiming ethanol is concentrated into than weighing spray drying 1: 1.5;
(3) take by weighing Radix Et Caulis Acanthopanacis Senticosi by said ratio, Radix Polygalae, Fructus Schisandrae Chinensis, Bulbus Lilii fleece-flower root rattan, with 50% ethanol water heating and refluxing extraction three times, add for the first time 10 times of amount 50% alcohol refluxs 3 hours, second, respectively adding 8 times of amount 50% ethanol for three times respectively refluxed 2 hours, three backflow are merged, reclaim ethanol to there not being the alcohol flavor, as the upper prop medicinal liquid, this medicinal liquid is through macroporous adsorbent resin, adsorption rate is 0.08ml/min.ml (a resin volume), after the absorption fully, it is colourless to eluate to wash the deresination post earlier with water, carries out eluting with 70% ethanol water liquid then, elution speed is 0.08ml/min.ml (a resin volume), collect eluent, behind the recovery ethanol, concentrate, dry;
(4) take by weighing Concha Margaritifera, Gypsum Fibrosum, Poria by above-mentioned weight proportion, add hydro-thermal backflow three times, measured 3 hours for 8 times for the first time, second and third time respectively adds 6 times of amounts each 1.5 hours, and collecting decoction left standstill 24 hours, got supernatant, and is concentrated, dry.
(5) get dry thing mixing in (2), (3) and (4), pulverize, cross 60 mesh sieves, add the micropowder silica gel of dried cream powder amount 2%, fill is in No. 0 capsule, and every dress 0.32g promptly obtains the made capsule b of the present invention, and every 1g medicated powder is equivalent to raw medicinal herbs about 24.1 and restrains.
Embodiment three is the preparation of Chinese medicinal capsule C of the present invention
(1) press column weight amount proportioning and take by weighing each component:
Bulbus Lilii 700g, Radix Et Caulis Acanthopanacis Senticosi 1200g, Caulis Polygoni Multiflori 700g,
Flos Albiziae 500g, Concha Margaritifera 700g, Gypsum Fibrosum 700g,
Semen Ziziphi Spinosae 500g, Poria 200g, Radix Polygalae 500g,
Radix Scrophulariae 500g, Radix Rehmanniae (life) 500g, Radix Ophiopogonis 200g,
Fructus Schisandrae Chinensis 500g, Medulla Junci 200g, Radix Salviae Miltiorrhizae 500g
(2) take by weighing Flos Albiziae, Semen Ziziphi Spinosae, Radix Scrophulariae, Radix Rehmanniae, Radix Ophiopogonis, Medulla Junci, Radix Salviae Miltiorrhizae by said ratio, water heating and refluxing extraction three times adds 10 times of water gagings 3 hours for the first time, second and third time respectively adds 8 times of amounts, and each refluxed 1.5 hours, merges decoction liquor, filter, get filtrate.Filtrate is through absorption with macroporous adsorbent resin, adsorption rate is 0.15ml/min.ml (a resin volume), after the absorption fully, wash deresination earlier with water, colourless to eluate, carry out eluting with 50% ethanol then, elution speed is 0.10ml/min.ml (a resin volume), collect eluent, reclaim ethanol to there not being the alcohol flavor, standby.
(3) take by weighing Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae, Fructus Schisandrae Chinensis, Bulbus Lilii, Caulis Polygoni Multiflori by above-mentioned weight proportion, secondary is extracted in ethanol water hot reflux with 70%, adding for the first time 8 times of amount 70% ethanol waters refluxed 3 hours, adding for the second time 6 times of amount 70% ethanol waters refluxed 2 hours, merge secondary raffinate, placement is spent the night.Extract supernatant, add entry, carry out water precipitating according to a conventional method, the supernatant after water intaking is heavy.
(4) by above-mentioned weight proportion, take by weighing Concha Margaritifera, Gypsum Fibrosum, Poria, add hydro-thermal backflow secondary, add 10 times of amounts 2 hours for the first time, add 8 times of amounts 1 hour for the second time, collecting decoction, leave standstill 24 hours after, get supernatant.
(5) merge (2), (3), (4) extracting solution, concentrated, drying gets dry extract.
(6) with broken mistake 24 mesh sieves of dried cream powder, add the starch of dried cream amount 6%, mix homogeneously is filled in No. 1 capsule, and every 0.3g promptly obtains the made capsule C of the present invention, and per 1 gram medicated powder is equivalent to about 27 grams of raw medicinal herbs.
Embodiment four is the preparation of Chinese medicine compound granule of the present invention:
Press embodiment one described method, but gained medicated powder routinely the preparation method of Chinese medicine granules make granule, every packed 5 grams contain medicated powder 1.2g approximately, per 1 gram medicated powder is equivalent to about 20 grams of raw medicinal herbs.
Embodiment five is the preparation of Chinese medicine compound tablet of the present invention:
By implementing a described method, but gained medicated powder routinely the preparation method of Chinese medicinal tablet make tablet, every agreement that contracts a film or TV play to an actor or actress contains medicated powder 0.4g, per 1 gram medicated powder is equivalent to raw medicinal herbs 20 grams.
Embodiment six is the preparation of Chinese medicine compound pill of the present invention
By implementing a described method, but gained medicated powder routinely the preparation method of Chinese medicine medicine pill make pill, every ball contains medicated powder 0.3g approximately, per 1 gram medicated powder is equivalent to raw medicinal herbs 20 grams.
Animal embodiment one: the animal acute toxicity test of capsule a of the present invention
One, experimental technique
After once irritating stomach dosage by acute toxicity test method prerun, the minimum doses that animal is all dead and whole maximal doses of survival intend being divided into 6 dosage groups tests, 10 of every treated animals, male and female half and half between minimum dose and maximal dose.Observe after the administration and record administration seven days in toxicity, dead animal number and postmortem that animal occurred, postmortem is then done histology's microscopy if any pathological tissues, the result press Bliss method microcomputor program calculating LD
50, 95% confidence limit and slope B.Room temperature is controlled at 20～25 ℃ in the experimentation.
Two, result
Capsule a suspension solution is with 0.8ml/20g volume gastric infusion, the minimum dose that animal is all dead and the maximal dose of all survivals are respectively 19.13g/kg, and 10.68g/kg is divided into 6 dosage groups by the geometric ratio level, than being 0.89, experimental result sees Table 1 between the dosage.Observe in the test, the dead animal majority was death in second day, and dead preceding visible pumped storage erects hair, movable minimizing, breathes and slow down, and until death, dead animal postmortem naked eyes are not seen obvious pathological changes.
Table 1 mouse stomach administration median lethal dose(LD 50)-LD
50(Bliss) (weighted linear recurrence)
| Dosage (g/kg) | Log10 dose (X) | Number of animals (only) | Death toll (only) | Mortality rate (%) | Probability unit (Y) |
| 10.68 | 1.0286 | 10 | 0 | 0 | 3.0000 |
| 12.00 | 1.0792 | 10 | 2 | 20 | 4.1584 |
| 13.48 | 1.1297 | 10 | 4 | 40 | 4.7466 |
| 15.15 | 1.1804 | 10 | 7 | 70 | 5.5244 |
| 17.02 | 1.2310 | 10 | 9 | 90 | 6.2815 |
| 19.136 | 1.2817 | 10 | 10 | 100 | 7.4000 |
E(Y)＝16.4234X-13.8045 B＝16.4234
LD
50＝13.96g/kg
95% confidence limit: 13.16-14.82g/kg
The animal long term toxicity test of animal embodiment two capsule a of the present invention
One, test method
(1) grouping and dosage
80 rats evenly are divided into four groups at random by the sex body weight, and 20 every group, male and female half and half, per 5 same sex rats are raised with cage.
Low dose group: every group of dosage 0.4g dry powder/kg is equivalent to about 12 times of human dosage (0.0338g/kg).
Middle dosage group: every group of dosage 1.5g dry powder/kg is equivalent to about 44 times of human dosage.
High dose group: every group of dosage 3.0g dry powder/kg is equivalent to about 89 times of human dosage.
Matched group: with the normal saline of capacity such as administration group.
(2) medication
Gastric infusion, once a day, 6 days weekly, successive administration two months.Irritate gastric capacity: the 1ml/100g body weight.
(3) test item
1, body weight and overview: before the experiment and experiment beginning back two weeks weigh once, and adjust dosage by body weight, observe the outer of record animal also every day, behavioral activity, feces situation with sign.24 hours broken ends cut open 7/10 following inspection of rat work extremely after testing the last administration in end (after the administration two months).
2, hematological indices: erythrocyte and reticulocyte count, hemoglobin (Hb), total white blood cells and classification thereof, platelet, clotting time.Measure with Cou-Tter2F6 type blood group calculating instrument.
3, routine urianlysis: get every animal urine and make routine urianlysis.
4, blood parameters: asparagine acidic group conversion enzyme (millet straw acid AST), ALT (the paddy third enzyme ALT), alkali phosphatase (ALT), blood urea nitrogen (BUN), total protein (TP), albumin (ALB), blood glucose (GLU), total bilirubin (T-BIL), flesh liver (Crea), T-CHOL (T-CHO), measure with the IL-508 automatic biochemistry analyzer.
5, system becomes celestial and histopathologic examination
(1) each organ disease of perusal
(2) organ coefficient: the heart, brain, lung, liver,spleen,kidney, adrenal gland, gonad, prostate, thyroid are weighed, and ask the organ coefficient (organ coefficient=organ weights/body weight) * 100% of calculating each internal organs).
(3) histological examination: zoological specimens are fixed with 10% formalin solution, each animal is cored respectively, brain, lung, lung, spleen, kidney, stomach, intestinal, pancreas, bladder, prostate, adrenal gland, thyroid, born of the same parents' gland, gonad (male testis, female uterus, ovary), optic nerve, bone marrow, lymph node etc., get one respectively at random and make paraffin section, HE dyeing.Before the microscopic examination, randomly draw two examples for every group, pathological changes is observed by collective with the bull mirror, and observed and recorded again divides into groups after the unified standard.2nd, 3,4,5 are the experiment end, and broken end is got blood, cut open and carry out after animal is got main organs extremely.
6, convalescent period observes: after the last administration in experiment end, after 3/10 the rat drug withdrawal that stays observed for 2 weeks, live in killing again and check.
Experiment end, the hematuria routine, liver, renal function of observing two week of drug withdrawal back rats all in normal range, the histological examination of internal organs, no obvious pathological changes and difference between each group.
The Pharmacodynamic test of active extract of animal embodiment three capsule a of the present invention
Dosage equipment and medication
1, tried thing: high dose group: 2g dry powder/kg is equivalent to human dosage (0.0338g dry powder/kg) 59 times
Middle dosage group: 1g dry powder/kg is equivalent to 30 times of human dosage
Low dose group: 0.5g dry powder/kg is equivalent to 15 times of human dosage
2, positive control: stable group 0.0005g/kg
3, blank group: normal saline
More than be gastric infusion, dosage is 0.5ml/20g.
One, sedation
1, method: after selecting each treated animal difference administration 60min of female mice for use, put into diameter 17cm, in the lucite box of high 9cm, behind the adaptation 5min, walk about in the note 2min time and act pair forelimb number of times.
2, result: experimental result such as following table 1
Table 1 capsule a to the sedation of mice (X ± SD, N=10)
Group dosage (g/kg) is walked about the time and is lifted number of times on (S) forelimb
(inferior)
Normal saline 103.67 ± 11.62 16.67 ± 6.09
Capsule a 0.5 83.50 ± 14.87* 17.80 ± 5.05
1 82.83±15.18* 14.43±5.54
2 76.71±10.75** 13.57±4.96
Stable 0.0005 21.56 ± 9.69**, 2.03 ± 1.61**
Annotate: compare * 0.05＞P＞0.01 with the normal saline group; * P＜0.01
3, conclusion: gavage behind the capsule a influential slightly to the mice normal activity; the performance mice time of walking about is within a certain period of time compared to have slightly with physiology saline control group mice and reduces 0.5g/kg and 1g/kg dosage group statistics and go up that there were significant differences, on the 2g/kg dosage group statistics highly significant difference is arranged.
Two, syngignoscism
1, prolongs the length of one's sleep of pentobarbital sodium
(1) method: each is organized healthy mice and is tried back 60min respectively, and every Mus lumbar injection pentobarbital sodium 50mg/kg is the sleep index with the righting reflex loss, writes down the length of one's sleep.
(2) result: experimental result sees Table 2
The syngignoscism of table 2 capsule a (X ± SD, N=10)
Group dosage (g/kg) length of one's sleep (min)
Normal saline 69.5 ± 15.5
Capsule a 2 93.0 ± 21.0*
1 86.1±16.8*
0.5 78.8±16.4
Stable 0.0005 298.6 ± 28.3**
Annotate: compare 0.01＜P＜0.05 with matched group; * P＜0.01
(3) conclusion: the central inhibitory action that can work in coordination with pentobarbital sodium behind the mouse gavaging capsule a, prolong the length of one's sleep, wherein 2g/kg, 1g/kg dosage group all can make mouse sleep time prolong, upward there were significant differences to compare statistics with matched group, and 0.5g/kg dosage group is compared statistics and gone up no significant difference with matched group.Be shorter than stable 5mg/kg dosage group the length of one's sleep of above-mentioned each group.
2, pentobarbital sodium sub-threshold lull dosage test
(1) method: gavage earlier and be subjected to the reagent thing, 30min pneumoretroperitoneum injection pentobarbital sodium 25mg/kg, righting reflex loss reaches the above person of 1min and is designated as and sleeps, and calculates each group generation percentage rate of sleeping.
(2) result: result of the test sees Table 3
Table 3 pentobarbital subliminal hypnosis dosetest
Group dosage (g/kg) number of animals (only) the sleeping percentage rate (%) of number of animals (only) of falling asleep
Physiology salt 10 00
Water
Capsule a 2 10 10 100
1 10 10 100
0.5 10 9 90
Stable 0.0005 10 10 100
(3) conclusion: share with pentobarbital sodium threshold dose and capsule a, observe the synergism of capsule a and pentobarbital,, then can use the sleeping number of mice to increase if any synergism.Test shows the synergism that all can show behind the mouse gavaging capsule a with pentobarbital sodium, the sleeping percentage rate of 2g/kg and 1g/kg dosage group mice is 100%, 0.5g/kg the sleeping percentage rate of dosage group is 90%, the sleeping percentage rate of matched group is 0% by contrast, therefore reflects that capsule a has collaborative syngignoscism.
Three, anticonvulsant action
1, method: behind each treated animal gastric infusion 60min, back subcutaneous injection strychnine nitrate 1.5mg/kg (concentration 0.15mg/ml, injection volume 0.2gml/20g), the incubation period between record injection end to the reaction of fainting from fear occurs.
2, result: result of the test such as table 4
The anticonvulsant action of table 4 capsule a (X ± SD, N=10)
Group dosage (g/kg) is fainted from fear incubation period (min)
Normal saline 4.96 ± 0.84
Capsule a 2 8.98 ± 1.59**
1 6.33±1.09**
0.5 6.11±1.09
Stable 0.0005 does not occur fainting from fear
Annotate: compare * 0.05＞P＞0.01 with the normal saline group; * P＜0.01
3, conclusion: strychnine is to the selective excitation of spinal cord, and heavy dose of strychnine can cause the animal tonic convulsion, mice to cause frightened dosage be 1.5mg/kg (subcutaneous or lumbar injection).The capsule a of mouse gavaging test dose can not resist the convulsions effect that strychnine causes, the convulsions incidence rate of the following dosage group of 2g/kg is 100%, can resist the convulsions effect that the 1.5mg/kg strychnine causes fully behind the stable 5mg/kg of mouse gavaging.Capsule a can prolong the incubation period of faint from fear taking place, and the convulsions of 2g/kg and 1g/kg dosage group is compared with matched group incubation period highly significant difference on the statistics, and 0.5g/kg dosage group statistics goes up that there were significant differences.The people is last to find out that capsule a has more weak anticonvulsant action.
Conclusion
Above-mentioned result of the test shows that capsule a capsule can obviously reduce the animal spontaneous activity, prolongs the convulsions generation incubation period that strychnine causes.With the pentobarbital sodium synergism, can significantly increase the sleeping number of mice of its sub-threshold dose, the capsule a capsule of the above dosage of 1g/kg can be worked in coordination with the pentobarbital sodium effect and be prolonged mouse sleep time.Therefore, this medical instrument has certain calmness, hypnosis and weak anticonvulsant action.
The clinical protocol of application examples four capsule a Cure for insomnias of the present invention
This research has been carried out the randomized, double-blind dual analog to 401 routine insomnia patientses and has been enlarged clinical trial (open group), first group 100 examples wherein, second group 100 examples, open group 201,405 examples are observed in outpatient service, and 196 examples that are hospitalized for observation are to case source and distribution situation, sex age, pathology distribution situation, case cardinal symptom distribution situation, PSQI score degree distribution situation before the treatment, tongue, arteries and veins distribution situation before the case treatment are learned by statistics and are handled, the P value is all greater than 0.05, there was no significant difference between group.
Result of study shows:
1, this result of the test shows, first, second is showing better effects aspect the primary symptom curative effect of the insomnia of treatment syndrome of hyperactivity of fire due to deficiency of YIN for two groups.Its total obvious effective rate, total effective rate are respectively 41%, 88% and 21%, 70% for two groups, learn by statistics and handle, and first, second is all having significant difference (P＜0.01) aspect total obvious effective rate, the total effective rate for two groups, illustrate that first group medication effect is better than the second group.And its difference mainly is reflected in treatment severe insomniac, also treats severe insomnia first group in other words and is better than second group (P＜0.05).
2, this result of the test also shows, the treatment that two groups of medicines of first, second are waited traditional Chinese medical science syndrome of hyperactivity of fire due to deficiency of YIN also has curative effect preferably.Self compares before and after each symptom treatment, the first group all has utmost point significant difference (P＜0.01), the second group is except that tinnitus, forgetful improvement are not good, surplus disease all there are utmost point significance and different (P＜0.01), between two groups of first, second relatively, improve the length of one's sleep, sleep quality, insomnia frequency, dizzy aspect, two groups of comparing differences have significance meaning (P＜0.05).Explanation is better than the second group in first group aspect the tcm syndrome curative effect.
3, this clinical trial has been quoted Pittsburgh index (PSQI) to estimate the situation that influences to sleep quality of two groups of medicines of first, second, its result shows, two groups of medicines of first, second all reduce each composition score value of PSQI, relatively two groups of first, second are aspect time for falling asleep, the length of one's sleep, Sleep efficiency, daytime function, and its significant difference has significance meaning (P＜0.05-P＜0.01).Illustrate that first class medicine therapeutic effect in these areas obviously is better than the second group.
4, simultaneously, small sample sleep electroencephalogram check result shows that patient's sleep state and sleep quality are better after the first group Drug therapy.But because sample too little (first group 15 examples, second group 10 examples) is learned by statistics and handled, first, second compares there was no significant difference (P＞0.05) for two groups.
5, in whole test, each is organized safety indexes there are no significant and changes, and shows all safety relatively of institute's trial drug.
Capsule a function nourishing YIN and clearing away heat, tranquilizing by nourishing the heart.Function cures mainly insomnia due to the hyperactivity of fire caused by deficiency of YIN.Its disease is seen insomnia or dreaming often and waking easily, dizziness and tinnitus, dry mouth and throat, feverish sensation in the palms and soles, palpitation and amnesia, the few tongue of red tongue, thready and rapid pulse.
Claims (9)
1, a kind of compound Chinese medicinal preparation of Cure for insomnia disease, it is characterized in that said preparation be by the extract of the alcohol and water of following raw materials according or following raw materials according or water extract or the eluate by macroporous adsorbent resin as active component, its raw material consists of:
Bulbus Lilii 500-1200g Radix Et Caulis Acanthopanacis Senticosi 600-1500g Caulis Polygoni Multiflori 500-1200g
Flos Albiziae 200-688g Concha Margaritifera 500-1200g Gypsum Fibrosum 400-988g
Semen Ziziphi Spinosae 200-688g Poria 50-488g Radix Polygalae 200-688g
Radix Scrophulariae 200-688g Radix Rehmanniae 200-688g 200-688g Radix Ophiopogonis
Fructus Schisandrae Chinensis 200-688g Medulla Junci 50-488g Radix Salviae Miltiorrhizae 200-688g.
2, compound Chinese medicinal preparation according to claim 1 is characterized in that its raw material consists of:
Bulbus Lilii 688-1100g Radix Et Caulis Acanthopanacis Senticosi 898-1400g Caulis Polygoni Multiflori 788-1055g
Flos Albiziae 298-500g Concha Margaritifera 688-1100g Gypsum Fibrosum 498-800g
Semen Ziziphi Spinosae 298-500g Poria 118-400g Radix Polygalae 298-500g
Radix Scrophulariae 298-500g Radix Rehmanniae 298-500g 298-500g Radix Ophiopogonis
Fructus Schisandrae Chinensis 298-500g Medulla Junci 118-400g Radix Salviae Miltiorrhizae 298-500g.
3, compound Chinese medicinal preparation according to claim 1 and 2 is characterized in that raw material consists of:
Bulbus Lilii 800g Radix Et Caulis Acanthopanacis Senticosi 1200g Caulis Polygoni Multiflori 800g
Flos Albiziae 400g Concha Margaritifera 800g Gypsum Fibrosum 600g
Semen Ziziphi Spinosae 400g Poria 200g Radix Polygalae 400g
Radix Scrophulariae 400g Radix Rehmanniae 400g 400g Radix Ophiopogonis
Fructus Schisandrae Chinensis 400g Medulla Junci 200g Radix Salviae Miltiorrhizae 400g.
4, a kind of preparation method of compound Chinese medicinal preparation of Cure for insomnia disease
(1) takes by weighing following traditional Chinese medicines and make raw material
Bulbus Lilii 500-1200g Radix Et Caulis Acanthopanacis Senticosi 600-1500g Caulis Polygoni Multiflori 500-1200g
Flos Albiziae 200-688g Concha Margaritifera 500-1200g Gypsum Fibrosum 400-988g
Semen Ziziphi Spinosae 200-688g Poria 50-488g Radix Polygalae 200-688g
Radix Scrophulariae 200-688g Radix Rehmanniae 200-688g 200-688g Radix Ophiopogonis
Fructus Schisandrae Chinensis 200-688g Medulla Junci 50-488g Radix Salviae Miltiorrhizae 200-688g;
(2) with above-mentioned Flos Albiziae, Semen Ziziphi Spinosae, Radix Scrophulariae, Radix Rehmanniae, Radix Ophiopogonis, Medulla Junci, Radix Salviae Miltiorrhizae, Radix Et Caulis Acanthopanacis Senticosi, Radix Polygalae and Fructus Schisandrae Chinensis alcohol or water reflux, backflow is collected water or pure eluent by macroporous adsorbent resin, and the eluent that obtains is as active component I;
(3) Bulbus Lilii fleece-flower root rattan water or pure hot reflux are extracted, the extracting solution that obtains is as active component II;
(4) with Concha Margaritifera, Gypsum Fibrosum and Poria alcohol or hydro-thermal reflux, extract, thing, the extract that obtains is as active component III;
(5), and make required dosage form with above-mentioned active component I, II and III mix homogeneously.
5, refluxing in the preparation method according to claim 4, its step (2) is three times, and backflow is the alcoholic solution of 40-80%, and eluent is the alcoholic solution of 40-80%.
6, preparation method according to claim 5, the backflow of its step (2) are that 50% alcoholic solution eluent also is 50% alcoholic solution.
7, the hot reflux number of times is a secondary in the preparation method according to claim 4, its step (3), and backflow is the alcoholic solution of 30-80%, and the hot reflux time is 3 hours for the first time, 2 hours for the second time.
8, preparation method according to claim 7, the backflow of its step (3) are 50% alcoholic solution.
9, preparation method according to claim 4, the hot reflux number of times in its step (4) is three times, backflow is water, hot reflux time 2 hours for the first time, second and third time each 1 hour.
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Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100355433C (en) * | 2005-12-15 | 2007-12-19 | 深圳市人民医院 | Chinese medicine preparation for treating insomnia |
| CN101485796B (en) * | 2008-01-14 | 2013-05-29 | 北京亚东生物制药有限公司 | Chinese medicinal composition for treating insomnia as well as preparation method thereof |
| CN101244195B (en) * | 2008-02-17 | 2010-12-22 | 李毅 | Medicament for treating aypnia |
| CN101954006B (en) * | 2010-09-06 | 2012-02-29 | 姜秀芹 | Chinese medicament for treating insomnia |
| CN102217885B (en) * | 2011-03-17 | 2014-05-07 | 上海韬鸿化工科技有限公司 | Traditional Chinese medicine pillow for treating nervous headache |
| CN103372071B (en) * | 2012-04-25 | 2016-05-11 | 重庆希尔安药业有限公司 | A kind of pharmaceutical composition for the treatment of of insomnia patients |
| CN102793165A (en) * | 2012-07-20 | 2012-11-28 | 惠州市鑫福来实业发展有限公司 | Health care deep sleep capsule for improving sleep quality and preparation method thereof |
| CN102805812B (en) * | 2012-08-01 | 2013-08-21 | 张素兰 | Preparation method of traditional Chinese medicine for treating insomnia due to garlic adephagia |
| CN104096069A (en) * | 2014-06-03 | 2014-10-15 | 烟台恒迪克能源科技有限公司 | Chinese medicinal capsule for improving sleep and preparation method thereof |
| CN105832885A (en) * | 2016-04-29 | 2016-08-10 | 朱增伟 | Traditional Chinese medicine composition for treating insomnia |
| CN106266907A (en) * | 2016-05-28 | 2017-01-04 | 张伟 | A kind of Chinese medicine decoction of tranquilizing by nourishing the heart |
| US10722547B2 (en) | 2016-09-02 | 2020-07-28 | Pharmacogenetics Limited | Compositions of medicinal plants for reducing the effects of aging, prevention and treatment of age-related neurodegenerative diseases, and treatment of anxiety and sleep disorders |
| CN106728824B (en) * | 2016-12-15 | 2021-05-11 | 扬子江药业集团江苏龙凤堂中药有限公司 | Drying process of compound traditional Chinese medicine extract for treating insomnia |
| CN107319523A (en) * | 2017-06-23 | 2017-11-07 | 天津金匮堂生物科技有限公司 | A kind of insufficiency of heart yin that improves causes health products of insomnia and preparation method thereof |
| CN112370510B (en) * | 2020-12-11 | 2022-12-09 | 扬子江药业集团有限公司 | Purification process of compound traditional Chinese medicine extract for treating insomnia |
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Effective date of registration: 20211221 Address after: 225300 No. 9, Longfeng Tang Road, Yongan Town, Taizhou, Jiangsu. Patentee after: YANGZIJIANG PHARMACEUTICAL GROUP JIANGSU LONGFENGTANG TRADITIONAL CHINESE MEDICINE Co.,Ltd. Patentee after: YANGTZE RIVER PHARMACEUTICAL GROUP Co.,Ltd. Address before: 225321 No. 1 Jiangnan Road, Taizhou, Jiangsu Patentee before: YANGTZE RIVER PHARMACEUTICAL GROUP Co.,Ltd. |
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