CN102397462A - Oral liquid used for resisting aging, preparation method thereof, and quality controlling method thereof - Google Patents
Oral liquid used for resisting aging, preparation method thereof, and quality controlling method thereof Download PDFInfo
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Abstract
The invention relates to an oral liquid used for resisting aging. The oral liquid is prepared from traditional Chinese medicines of prepared fleeceflower root, epimedium, prepared Siberian solomonseal rhizome, medlar, Mongolian milkvetch root, and salvia miltiorrhiza of different parts by weight. The invention also relates to a preparation method and a quality controlling method of the oral liquid. The oral liquid provided by the invention provides functions of vital energy benefiting, blood nourishing, and liver and kidney nourishing. With the oral liquid, climacteric syndrome, neurasthenia, and chronic fatigue syndrome can be treated. The oral liquid can also be used for treating phenomena of senility and physical weakness, lethargy, insomnia, amnesia, dim eyesight, deafness, and early-canities caused by insufficiency of vital energy and blood and deficiency of liver and kidney. As a result of acute toxicity tests, no obvious adverse reaction is caused by the oral liquid. Therefore, the preparation is a safe and effective Chinese patent medicine which is suitable to be clinically applied and popularized.
Description
Technical field
The present invention relates to field of medicaments, particularly, the present invention relates to a kind of antidotal oral liquid and preparation method thereof and method of quality control of being used for.
Background technology
Because present people's rhythm of life is accelerated, reasons such as operating pressure increase cause that (Chronic FatigueSyndrome, CFS) etc. the sickness rate of disease obviously increases such as climacteric syndrome, neurasthenia, chronic fatigue syndrome.CFS is because the high-pressure or the mental burden of secular muscle power and mental aspect are overweight, makes the people produce general syndromes such as hypomnesis, absent minded, sleep disorder, spirit are sleepy, myasthenia of limbs.The Center for Disease Control prediction, CFS will become 21 century influences a subject matter of human health, does not still have the specific treatment medicine so far.
Chinese patent medicine preparation can be through integrally-regulated body peroxidating balance, and slow down aging is regulated and improved body's immunity, vital tissue organ dysfunction and antifatigue effects such as protection brain, liver, endocrine, and side effect is low, and safe and effective.The inventor does not see the Chinese patent medicine preparation of diseases such as can treating climacteric syndrome, neurasthenia, chronic fatigue syndrome through the inquiry to domestic and foreign literature and patent.
Summary of the invention
The purpose of this invention is to provide a kind of defying age that is used for, the oral liquid of treatment climacteric syndrome, neurasthenia, chronic fatigue syndrome.
The present invention also aims to provide the method for preparing of this oral liquid.
The present invention also aims to provide the method for quality control of this oral liquid.
In order to realize the object of the invention, the present invention provides a kind of defying age that is used for, and the oral liquid of treatment climacteric syndrome, neurasthenia, chronic fatigue syndrome, it is by the Chinese medicine medical material of following weight portion proportioning and according to following 1) to 4) step process:
Radix Polygoni Multiflori Preparata 50～150 Herba Epimedii, 15～45 Rhizoma Polygonatis (system) 22～66
Fructus Lycii 15～45 Radixs Astragali 22～66 Radix Salviae Miltiorrhizaes 11～33
1) get Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, the Fructus Lycii decocte with water three times of above-mentioned weight portion, collecting decoction filters, and it is 1.10～1.40 (60 ℃) that filtrating is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 70%, filters; In filtrating, add ethanol again and make and contain the alcohol amount and reach 80%, filter, regulate the filtrating pH value, filter to 7.8-8.2; Re-adjustment filtrating pH value reclaims ethanol to 6.8-7.2, and medicinal liquid is subsequent use;
2) get Herba Epimedii, the Rhizoma Polygonati decocte with water secondary of above-mentioned weight portion, collecting decoction filters, and it is 1.10～1.30 (50 ℃) that filtrating is concentrated into relative density, adds ethanol and reaches 65% to containing the alcohol amount, filters; In filtrating, add ethanol again and make and contain the alcohol amount and reach 80%, filter, regulate the filtrating pH value, filter to 7.8-8.2; Re-adjustment filtrating pH value reclaims ethanol to 6.8-7.2, and medicinal liquid is subsequent use;
3) get the Radix Astragali decocte with water three times of above-mentioned weight portion, collecting decoction filters, and it is 1.10～1.40 (25 ℃) that filtrating is concentrated into relative density, and medicinal liquid is subsequent use;
4) merge above-mentioned three kinds of subsequent use medicinal liquids, stir, filter, filtrating is added the water standardize solution and regulates pH value to 7.0-7.5, make every 100ml aqueous solution be equivalent to contain 100g Radix Polygoni Multiflori Preparata medical material.
Preferred weight part proportioning that preparation the present invention is used for the Chinese medicine medical material of antidotal oral liquid is: Radix Polygoni Multiflori Preparata 75～125, Herba Epimedii 22.5～37.5, Rhizoma Polygonati (system) 33～55, Fructus Lycii 22.5～37.5, the Radix Astragali 33～55, Radix Salviae Miltiorrhizae 16.5～27.5; Preferred Chinese medicine medical material weight portion proportioning is: Radix Polygoni Multiflori Preparata 100, Herba Epimedii 30, Rhizoma Polygonati (system) 44, Fructus Lycii 30, the Radix Astragali 44, Radix Salviae Miltiorrhizae 22.
The present invention also provides the method for preparing of this oral liquid, and this method comprises:
1) takes by weighing Chinese medicine medical material Radix Polygoni Multiflori Preparata, Herba Epimedii, Rhizoma Polygonati (system), Fructus Lycii, the Radix Astragali, Radix Salviae Miltiorrhizae;
2) get Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and it is 1.10～1.40 (60 ℃) that filtrating is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 70%, filters; In filtrating, add ethanol again and make and contain the alcohol amount and reach 80%, filter, regulate the filtrating pH value, filter to 7.8-8.2; Re-adjustment filtrating pH value reclaims ethanol to 6.8-7.2, and medicinal liquid is subsequent use;
3) get Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and it is 1.10～1.30 (50 ℃) that filtrating is concentrated into relative density, adds ethanol and reaches 65% to containing the alcohol amount, filters; In filtrating, add ethanol again and make and contain the alcohol amount and reach 80%, filter, regulate the filtrating pH value, filter to 7.8-8.2; Re-adjustment filtrating pH value reclaims ethanol to 6.8-7.2, and medicinal liquid is subsequent use;
4) get Radix Astragali decocte with water three times, collecting decoction filters, and it is 1.10～1.40 (25 ℃) that filtrating is concentrated into relative density, and medicinal liquid is subsequent use;
5) merge above-mentioned three kinds of subsequent use medicinal liquids, stir, filter, filtrating is added the water standardize solution and regulates pH value to 7.0-7.5, make every 100ml aqueous solution be equivalent to contain 100g Radix Polygoni Multiflori Preparata medical material.
The present invention also provides the method for quality control of this oral liquid, and this method comprises:
1) character: said oral liquid is brown liquid; It is sweet, little puckery to distinguish the flavor of.
2) differentiate:
(a) get said oral liquid 20ml, extract 3 times with the chloroform jolting, each 15ml, combined chloroform liquid reclaims chloroform, and residue adds ethanol 1ml makes dissolving, as need testing solution.Other gets the emodin reference substance, adds ethanol and processes the solution that every 1ml contains 0.05mg, as reference substance solution.According to thin layer chromatography (2005 editions " Chinese pharmacopoeia appendix VIB) test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; With benzene-ethyl acetate-methanol (15: 2: 0.2) is developing solvent, launches, and takes out; Dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.
(b) get said oral liquid 10ml, extract 3 times with the ethyl acetate jolting, each 10ml merges ethyl acetate liquid, reclaims ethyl acetate, and residue adds 4ml ethanol makes dissolving, as need testing solution.Other gets the icariine reference substance, adds ethanol and processes the solution that every 1ml contains 0.5mg, as reference substance solution.According to thin layer chromatography (2005 editions " Chinese pharmacopoeia appendix VIB) test, draw each 4 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; (10: 1: 1: 1) be developing solvent, expansion was taken out with ethyl acetate-butanone-formic acid-water; Dry; Spray, is put under the ultra-violet lamp (365nm) and is inspected in 105 ℃ of bakings 5～10 minutes with 5% aluminum chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical yellow-green fluorescence speckle.
3) inspection:
(a) relative density: should be not less than 1.05 (2005 editions " Chinese pharmacopoeia appendix VIIA pycnometric method).
(b) pH value: should be 5.0～7.0 (2005 editions " Chinese pharmacopoeia appendix VIIG).
(c) other: should meet each item relevant under mixture item regulation (2005 editions " Chinese pharmacopoeia appendix IJ).
4) assay: the photograph HPLC (2005 editions " Chinese pharmacopoeia appendix VID) measure.
(a) chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filler; With methanol-0.2% phosphoric acid solution (57: 43) is mobile phase; The detection wavelength is 271nm; Column temperature is 40 ℃; Number of theoretical plate calculates by the icariine peak should be not less than 2500.
(b) preparation of reference substance solution: precision takes by weighing the about 10mg of icariine reference substance, puts in the 100ml measuring bottle, with dissolve with methanol and be diluted to scale, shakes up, and promptly gets (containing icariine 100 μ g among every 1ml).
(c) preparation of need testing solution: precision is measured said oral liquid 1.0ml, is added in the polyamide column [get polyamides 5g (75～180nm), wet method dress post (post footpath 20mm) is cleaned subsequent use]; Water 100ml eluting discards eluent, reuse ethanol 150ml eluting; Eluent is in 50 ℃ of following evaporated under reduced pressure, and residue is used dissolve with methanol, puts in the 25ml measuring bottle; Add methanol to scale, shake up, promptly get.
(d) algoscopy: precision is measured reference substance solution and each 10 μ l of need testing solution respectively, injects chromatograph of liquid, measures, and promptly gets.
The every 1ml of said oral liquid contains icariine (C
33H
40O
15) must not be less than 0.5mg.
At oral liquid Orally-administrable according to the invention, one time 10 milliliters, 1 time on the one.
In the Chinese medicine medical material prescription of oral liquid according to the invention, be monarch drug with the Radix Polygoni Multiflori, enrich and benefit essence and blood, nourishing the liver and kidney.Minister is with Rhizoma Polygonati, Fructus Lycii nourishing kidney replenishing essence.Assistant is with the Herba Epimedii kidney invigorating and YANG supporting; Radix Astragali qi-supplementing, blood-engendering; The Radix Salviae Miltiorrhizae promoting blood circulation to remove obstruction in the collateral, and make all medicine tonifys without causing stagnation.All medicines cooperate, and play QI replenishing and blood tonifying altogether, and the merit of nourishing the liver and kidney has the body of adjusting peroxidating balance; Slow down aging is regulated and is improved body's immunity, and vital tissue organ dysfunction and antifatigue effects such as protection brain, liver, endocrine are in the treatment climacteric syndrome; The neurasthenia, chronic fatigue syndrome, and old, lethargy; Insomnia forgetfulness, dim eyesight is deaf, has tangible advantage on the comprehensive therapeutic effects such as alopecia or early whitening of hair.And do not find in the clinical observation that said oral liquid has tangible untoward reaction yet, explain that said preparation is a kind of safe and effective Chinese patent medicine, is worth in clinical, promoting the use.
The specific embodiment
Below description through the specific embodiment the present invention is described further; But this is not to be limitation of the present invention; Those skilled in the art are according to basic thought of the present invention; Can make various modifications or improvement, but only otherwise break away from basic thought of the present invention, all within scope of the present invention.
Embodiment 1 oral liquid preparation example of the present invention
With Radix Polygoni Multiflori Preparata 1000g, Radix Salviae Miltiorrhizae 220g, Fructus Lycii 300g decocte with water three times, collecting decoction filters, and filtrating is concentrated into syrupy shape (60 ℃ time relative density be 1.2), puts cold; Add ethanol and make and contain alcohol amount and reach 70%, place, filter, filtrating adds ethanol again to be made and contains the alcohol amount and reach 80%; Place, filter, will filtrate and regulate pH value to 8.0, place with 10% sodium hydroxide solution; Filter, will filtrate and regulate pH value to 7.0 with 10% hydrochloric acid solution, reclaim ethanol, medicinal liquid is subsequent use;
With Herba Epimedii 300g, Rhizoma Polygonati (system) 440g decocte with water secondary, collecting decoction filters, and leaves standstill, and it is 1.2 (50 ℃) that filtrating is concentrated into relative density; Put coldly, add ethanol and reach 65% to containing alcohol amount, leave standstill, filter, filtrating adds ethanol to be made and contains the alcohol amount and reach 80%; Leave standstill, filter, will filtrate and regulate pH value to 8.0, leave standstill with 10% sodium hydroxide solution; Filter, will filtrate and regulate pH value to 7.0 with 10% hydrochloric acid solution, reclaim ethanol, medicinal liquid is subsequent use;
With Radix Astragali 440g Radix Astragali decocte with water three times, collecting decoction filters, and it is 1.15 (25 ℃) that filtrating is concentrated into relative density, and medicinal liquid is subsequent use.
Merge above three kinds of subsequent use medicinal liquids, stir, leave standstill, filter, filtrating is added water to 1000ml, and regulate pH value to 7.0 with 10% sodium hydroxide solution, be distributed into every 10ml, crude drug content is that 27g/ props up.
Embodiment 2 oral liquid mice oral tolerances of the present invention are measured
1. test material
(1) experimental animal
10 of healthy SD white mice, body weight 17g～22g, male and female half and half are provided by Sichuan Industrial Institute of Antibiotics's Experimental Animal Center, the animal quality certification number: No. the 32nd, the real moving pipe in river.
(2) trial drug
According to the prepared oral liquid of embodiment 1, brown liquid, every 10ml, crude drug content are that 27g/ props up.
2. test method
(1) route of administration, dosage
Above-mentioned 10 mices, are once irritated stomach and give oral liquid 240.975g crude drug of the present invention/kg body weight (because mouse stomach is limited by gastric capacity, so this tests the 3.57 times concentrated solutions of used medicinal liquid for embodiment 1 prepared oral liquid) after 12 hours in fasting.
(2) detect index: the behavioral activity of mice during the observation administration
3. result of the test
Mice is movable in the back of taking medicine, food is all normal, does not see any tangible poisoning symptom.After the administration 3 days, none death.
People's consumption of oral liquid of the present invention is 27g/ day, and adult's average weight is in 50kg, and then mouse tolerance dose is equivalent to 446 times of people's consumption.
4 conclusions
The results suggest that above-mentioned mice oral tolerance is measured, it is lower that the present invention is used for antidotal oral liquid toxicity, and it is safe being used for human body oral.
The clinical trial of embodiment 3 oral liquid treatment climacteric syndromes of the present invention
1. clinical trial sample:
88 examples are more than 40 years old or after the excision bilateral ovaries, and menoxenia or menopause have the patient of tangible menopause syndrome.The patient is divided into two groups at random: 46 examples are organized in treatment, 46～52 years old age, average 59 years old; Matched group 42 examples, 45～50 years old age, average 47.5 years old.Two groups of patient's ordinary circumstances do not have the significance difference opposite sex.Chemical examination hemogram, hepatic and renal function before all patient treatments.
2. Therapeutic Method
The treatment group is taken the oral liquid of the present invention according to embodiment 1 preparation, each 10mL, 1 time/day; Matched group is taken oryzanol tablets, each 20mg, 3 times/day.Two groups was 1 course of treatment with 90 days all, added up curative effect after 1 course of treatment.Statistical method adopts X 2 test and variance analysis.
3. observation item and method
The observation patient warms the improvement situation of clinical symptoms such as sweating, insomnia and dreamful sleep, irritated irritability, dizziness headache, dysphoria with feverish sensation in the chest palms and soles, check hemogram, hepatic and renal function.Estradiol (E2) and t lymphocyte subset crowd CD4+, CD8+ clearly have a blood test before and after the treatment group treatment.E2 adopts radioimmunoassay (test kit is provided by Shenzhen La Erwen biological engineering company limited), and the T cell subsets detects and adopts APAAP method (test kit is provided by Military Medical Science Institute biological preparation center), all operates by the reagent operation instruction.And with 30 routine healthy subjects contrasts (46～50 years old age, average 48 years old).
4. efficacy assessment standard
Produce effects: transference cure; Take a turn for the better: symptom alleviates to some extent; Invalid: symptom does not have improvement.
5. result of the test
(1) two group of curative effect compares (seeing table 1)
Table 1 liang group curative effect is [example (%)] relatively
| Group | n | Produce effects | Effectively | Invalid | Total effective rate (%) |
| The treatment group | 46 | 10(21.7) | 28(57.1) | 8(21.2) | 78.8 |
| Matched group | 42 | 3(7.1) | 20(47.7) | 19(45.2) | 54.8 |
Annotate: two groups relatively, P＜0.05
(2) situation of change (seeing table 2) of t lymphocyte subset crowd and E2 before and after the treatment
The variation (mean+SD) of t lymphocyte subset crowd and E2 before and after table 2 treatment
Annotate: compare with the health group,
*P＜0.05,
*P＜0.01; P＞0.05 is organized relatively with healthy in the treatment back
(3) clinical symptoms is improved situation and untoward reaction
The treatment group responder doing well,improving time, matched group responder doing well,improving occurred after 2 months usually usually in medication after 1 month.Two groups all have no adverse reaction and anaphylaxis, blood change and hepatic and renal function injure all do not occur.
6. conclusion
Climacteric syndrome is a kind of commonly encountered diseases, and is how relevant with the endocrine disturbance.Oral liquid of the present invention can be protected endocrine organ and endocrine regulation function, regulates the content of E2, thereby improves symptom.With age, thymus generation atrophy and hypofunction can cause cellular immune function decreased, cause that especially percentage of lymphocyte imbalance and function reduce.The T lymphocyte is immunity regulatory cell and effector lymphocyte main in the body, and the CD4+T cell promotes immune cell propagation, differentiation, coordinates cell interaction, excites immunne response, and the CD8+T cell suppresses immunne response.Climacteric syndrome patient CD4+ is starkly lower than normal control, and CD4+/CD8+ is higher than normal control, and CD4+/CD8+ obviously reduces, and the morbidity of prompting climacteric syndrome maybe be relevant with the cellular immune function disorder with the endocrine disturbance.And oral liquid of the present invention possibly be to play a role with the adjusting cellular immune function through the function of regulating hypothalamus one hypophysis one gonad axis, makes patient's cellular immune function recover normal.
The neurasthenic clinical trial of Test Example 4 oral liquid treatments of the present invention
1. clinical trial sample:
Neurastheniac 176 examples, 75 of men, 101 of woman, 18～70 years old, average 32.3 ± 1.6 years old.Be divided equally into treatment group (A group) and matched group (B group) at random.A organizes male 40 examples, women 48 examples, average 31.5 soil 1.6 years old; B organizes male 35 examples, women 53 examples, average 32.6 ± 1.7 years old.All cases all meet the Liver and kidney essence and blood deficiency of neurosal combination of Chinese and Western medicine medicine typing standard, and meet the neurasthenic diagnostic criteria of doctor trained in Western medicine neurosis; Two groups of data no difference of science of statistics.
2. Therapeutic Method
The oral oral liquid of the present invention of A group according to embodiment 1 preparation, one day twice, each 10ml; B organizes oral nourishing blood to tranquillize the mind syrup, and one day three times, each 15ml.Observe clinical symptoms in the back of taking medicine after the 1st, 2,3,4 weeks respectively, and carry out symptom score and efficacy determination.
3. method for estimating curative effect and standard
Comparison before and after employing SCL-90 and tcm symptom scalar quantization standard are treated between two groups.Wherein the evaluation content of SCL-90 comprises: total points, always divide equally, positive items, negative item number, the positive symptom is divided equally and factor branch, comprise somatization, force symptom, interpersonal relation sensitivity disease, depression, anxiety, hostile, terrified, bigoted, psychotic disease, other, sleep divides.
The clinical recovery of efficacy assessment standard reduces >=95% for the SCL-90 total points, and the Liver and kidney essence and blood loses empty clinical symptoms, Signs disappears or basic the disappearance, and the syndrome integration reduces >=95%; Produce effects reduces >=70% for the SCL-90 total points, and the Liver and kidney essence and blood loses empty clinical symptoms, Signs obviously to be improved, and the syndrome integration reduces >=70%; Effectively for the SCL-90 total points reduces >=30%, the Liver and kidney essence and blood loses empty clinical symptoms, Signs and all take a favorable turn, and the syndrome integration reduces >=30%; Invalid for the SCL-90 total points reduces＜30%, even all having obvious improvement, thanks to empty clinical symptoms, the Signs of Liver and kidney essence and blood do not increase the weight of, the syndrome integration reduces＜30%.
Get rid of neurosal other typings of Liver and kidney essence and blood deficiency; Schizophrenia, depression person; Neurosal other hypotypes (phobia, anxiety neurosis, obsession, somatoform disorder) person; Chronic fatigue syndrome; Merge serious disease and/or severe malnutrition persons such as liver, kidney, hemopoietic system, hormonal system; Trimester of pregnancy or women breast-feeding their children are to this ingredient allergy and allergic constitution person; Used the other treatment medicine; Critical being difficult to of the state of an illness made definite estimator to the effectiveness and the safety of this medicine.
4. data statistics
All meet research approach, serve completely and observe the course of treatment, and compliance is good, and accomplish the case of CRF regulation fill substance, and the statistical analysis curative effect adopts the SPSS11.5 statistical software to calculate.
5. result of the test
(1) two group of curative effect relatively
Obvious effective rate, effective percentage, the total effective rate of A group on SCL-90 and tcm clinical practice is respectively 25%, 46.5% and 71.59%; The B group then is respectively 6.82%, 40.91%, 47.73%, and the obvious effective rate total effective rate of treatment group obviously is superior to matched group, through χ
2Check shows statistical significance (P＜0.05).
(2) scoring before and after the treatment group treatment relatively
The A group divides the treatment back before the treatment obvious minimizing (P＜0.01) to be arranged in total points, positive items, negative item number, the positive symptom of SCL-90; Always divide equally the treatment back and reduce (P＜0.05) before the treatment.Matched group in the total points of SCL-90, always divide equally, negative item number, the positive symptom divide the treatment back before the treatment obvious minimizing (P＜0.01) to be arranged; (P＜0.05) (table 3) reduced before the treatment in positive items treatment back.
Table 3SCL-90 relevant item scoring (n=88)
Compare on the same group:
*P＜0.01; Compare before and after the treatment on the same group:
*P＜0.05
6. conclusion
Most scholars is thought at present, and the neurasthenia is a kind of disease that exists really clinically.It belongs to deficiency of qi and blood in theory of Chinese medical science, should nourish blood benefiting vital QI for tranquillizing.
Research shows, the oral fluid power of the present invention is the most outstanding insomnia in the relieving neurasthenia effectively.Body can produce oxygen-derived free radicals in metabolic process, and causes human senility through infringement cell and cell membrane.Oral liquid of the present invention is tonic essence and blood prescription, and superoxide dismutase content is increased, and plays antidotal effect.
There were significant differences (P＜0.05) for the clinical obvious effective rate of the SCL-90 of oral liquid group of the present invention, total effective rate and nourishing blood to tranquillize the mind syrup group, and the obvious effective rate of two groups of tcm syndrome integration treatment front and back has notable difference (P＜0.05).Consider the compliance that the patient takes medicine, only taken 28 days continuously, as take the long time, curative effect maybe be more obvious.
Claims (5)
1. one kind is used for antidotal oral liquid, it is characterized in that, it is by the Chinese medicine medical material of following weight portion proportioning and according to following 1) to 4) step process:
Radix Polygoni Multiflori Preparata 50～150 Herba Epimedii, 15～45 Rhizoma Polygonatis (system) 22～66
Fructus Lycii 15～45 Radixs Astragali 22～66 Radix Salviae Miltiorrhizaes 11～33
1) get Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, the Fructus Lycii decocte with water three times of above-mentioned weight portion, collecting decoction filters, and it is 1.10～1.40 (60 ℃) that filtrating is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 70%, filters; In filtrating, add ethanol again and make and contain the alcohol amount and reach 80%, filter, regulate the filtrating pH value, filter to 7.8-8.2; Re-adjustment filtrating pH value reclaims ethanol to 6.8-7.2, and medicinal liquid is subsequent use;
2) get Herba Epimedii, the Rhizoma Polygonati decocte with water secondary of above-mentioned weight portion, collecting decoction filters, and it is 1.10～1.30 (50 ℃) that filtrating is concentrated into relative density, adds ethanol and reaches 65% to containing the alcohol amount, filters; In filtrating, add ethanol again and make and contain the alcohol amount and reach 80%, filter, regulate the filtrating pH value, filter to 7.8-8.2; Re-adjustment filtrating pH value reclaims ethanol to 6.8-7.2, and medicinal liquid is subsequent use;
3) get the Radix Astragali decocte with water three times of above-mentioned weight portion, collecting decoction filters, and it is 1.10～1.40 (25 ℃) that filtrating is concentrated into relative density, and medicinal liquid is subsequent use;
4) merge above-mentioned three kinds of subsequent use medicinal liquids, stir, filter, filtrating is added the water standardize solution and regulates pH value to 7.0-7.5, make every 100ml aqueous solution be equivalent to contain 100g Radix Polygoni Multiflori Preparata medical material.
2. according to claim 1ly be used for antidotal oral liquid, the proportioning of wherein said Chinese medicine medical material weight portion is:
Radix Polygoni Multiflori Preparata 75～125 Herba Epimedii, 22.5～37.5 Rhizoma Polygonatis (system) 33～55
Fructus Lycii 22.5～37.5 Radixs Astragali 33～55 Radix Salviae Miltiorrhizaes 16.5～27.5
3. according to claim 2ly be used for antidotal oral liquid, the proportioning of wherein said Chinese medicine medical material weight portion is:
Radix Polygoni Multiflori Preparata 100 Herba Epimedii, 30 Rhizoma Polygonatis (system) 44
Fructus Lycii 30 Radixs Astragali 44 Radix Salviae Miltiorrhizaes 22
4. each described method for preparing that is used for antidotal oral liquid of claim 1 to 3, this method comprises:
1) takes by weighing Chinese medicine medical material Radix Polygoni Multiflori Preparata, Herba Epimedii, Rhizoma Polygonati (system), Fructus Lycii, the Radix Astragali, Radix Salviae Miltiorrhizae;
2) get Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Fructus Lycii decocte with water three times, collecting decoction filters, and it is 1.10～1.40 (60 ℃) that filtrating is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 70%, filters; In filtrating, add ethanol again and make and contain the alcohol amount and reach 80%, filter, regulate the filtrating pH value, filter to 7.8-8.2; Re-adjustment filtrating pH value reclaims ethanol to 6.8-7.2, and medicinal liquid is subsequent use;
3) get Herba Epimedii, Rhizoma Polygonati decocte with water secondary, collecting decoction filters, and it is 1.10～1.30 (50 ℃) that filtrating is concentrated into relative density, adds ethanol and reaches 65% to containing the alcohol amount, filters; In filtrating, add ethanol again and make and contain the alcohol amount and reach 80%, filter, regulate the filtrating pH value, filter to 7.8-8.2; Re-adjustment filtrating pH value reclaims ethanol to 6.8-7.2, and medicinal liquid is subsequent use;
4) get Radix Astragali decocte with water three times, collecting decoction filters, and it is 1.10～1.40 (25 ℃) that filtrating is concentrated into relative density, and medicinal liquid is subsequent use;
5) merge above-mentioned three kinds of subsequent use medicinal liquids, stir, filter, filtrating is added the water standardize solution and regulates pH value to 7.0-7.5, make every 100ml aqueous solution be equivalent to contain 100g Radix Polygoni Multiflori Preparata medical material.
5. each described method of quality control that is used for antidotal oral liquid in the claim 1 to 3, this method comprises:
1) character: said oral liquid is brown liquid; It is sweet, little puckery to distinguish the flavor of.
2) differentiate:
(a) get said oral liquid 20ml, extract 3 times with the chloroform jolting, each 15ml, combined chloroform liquid reclaims chloroform, and residue adds ethanol 1ml makes dissolving, as need testing solution.Other gets the emodin reference substance, adds ethanol and processes the solution that every 1ml contains 0.05mg, as reference substance solution.According to thin layer chromatography (2005 editions " Chinese pharmacopoeia appendix VIB) test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; With benzene-ethyl acetate-methanol (15: 2: 0.2) is developing solvent, launches, and takes out; Dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.
(b) get said oral liquid 10ml, extract 3 times with the ethyl acetate jolting, each 10ml merges ethyl acetate liquid, reclaims ethyl acetate, and residue adds 4ml ethanol makes dissolving, as need testing solution.Other gets the icariine reference substance, adds ethanol and processes the solution that every 1ml contains 0.5mg, as reference substance solution.According to thin layer chromatography (2005 editions " Chinese pharmacopoeia appendix VIB) test, draw each 4 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; (10: 1: 1: 1) be developing solvent, expansion was taken out with ethyl acetate-butanone-formic acid-water; Dry; Spray, is put under the ultra-violet lamp (365nm) and is inspected in 105 ℃ of bakings 5～10 minutes with 5% aluminum chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical yellow-green fluorescence speckle.
3) inspection:
(a) relative density: should be not less than 1.05 (2005 editions " Chinese pharmacopoeia appendix VIIA pycnometric method).
(b) pH value: should be 5.0～7.0 (2005 editions " Chinese pharmacopoeia appendix VIIG).
(c) other: should meet each item relevant under mixture item regulation (2005 editions " Chinese pharmacopoeia appendix IJ).
4) assay: the photograph HPLC (2005 editions " Chinese pharmacopoeia appendix VID) measure.
(a) chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filler; With methanol-0.2% phosphoric acid solution (57: 43) is mobile phase; The detection wavelength is 271nm; Column temperature is 40 ℃; Number of theoretical plate calculates by the icariine peak should be not less than 2500.
(b) preparation of reference substance solution: precision takes by weighing the about 10mg of icariine reference substance, puts in the 100ml measuring bottle, with dissolve with methanol and be diluted to scale, shakes up, and promptly gets (containing icariine 100 μ g among every 1ml).
(c) preparation of need testing solution: precision is measured said oral liquid 1.0ml, is added in the polyamide column [get polyamides 5g (75～180nm), wet method dress post (post footpath 20mm) is cleaned subsequent use]; Water 100ml eluting discards eluent, reuse ethanol 150ml eluting; Eluent is in 50 ℃ of following evaporated under reduced pressure, and residue is used dissolve with methanol, puts in the 25ml measuring bottle; Add methanol to scale, shake up, promptly get.
(d) algoscopy: precision is measured reference substance solution and each 10 μ l of need testing solution respectively, injects chromatograph of liquid, measures, and promptly gets.
The every 1ml of said oral liquid contains icariine (C
33H
40O
15) must not be less than 0.5mg.
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Application publication date: 20120404 |