Chinese medicine preparation of treatment women subhealth state fatigue syndrome and preparation method thereof
Technical field:
The present invention relates to a kind of Chinese medicine preparation, especially treat Chinese medicine preparation of women's subhealth state fatigue syndrome and preparation method thereof, its dosage form comprises tablet, capsule, oral liquid, syrup, drop pill, belongs to field of traditional Chinese.
Background technology:
Women's fatigue syndrome (subhealth state) is women's common clinical card, belong to traditional Chinese medical science asthenia insufficiency of vital energy and blood card, mainly contain god decline body tired, have a dizzy spell, symptom such as soreness of the waist and knees, hyposexuality, shortness of breath and palpitation, forgetful insomnia, inappetence, menoxenia, health are thin and weak.With the quickening pace of modern life, the increase of professional women's life and work pressure is in state tired out for a long time, occurs above-mentioned symptom easily, brings out so easily for a long time or increases the weight of multiple disease.The most physical weakness of patient behind women puerperal, postoperative and the chemicotherapy also needs benefiting qi and nourishing blood with the enhancing immunity fast track rehabilitation in addition.
The present invention belongs to women's fatigue syndrome (subhealth state) of deficiency of both YIN and YANG, deficiency of both QI and blood just at card.The present invention has the effect of Yin-nourishing and Yang-supporting, benefiting qi and nourishing blood, invigorating brain and relieving mental uneasiness, relieving constipation skin care, building body.Cure mainly god decline body tired, have a dizzy spell, disease such as soreness of the waist and knees, hyposexuality, shortness of breath and palpitation, forgetful insomnia, constipation, inappetence, menoxenia, health are thin and weak, also can be used for the rehabilitation maintenance after puerperal, postoperative, the chemotherapy.By clinical observation, the present invention reaches 95.6% to asthenia insufficiency of vital energy and blood card patient's clinical total effective rate, and the leukopenia total effective rate of putting, cause after the chemotherapy is reached 93.3%, and the present invention can improve the human body cell immune function in addition, and do not find tangible untoward reaction, clinical effectiveness is satisfied.At present, clinically to evident in efficacy, safety good, Chinese medicine preparation easy to use is still for being badly in need of.By after the present invention and the existing similar medicine contrast, we think that curative effect of the present invention is reliable, and have one's own knack on prescription medicine, are the crystallizations of clinical experience for many years.Therefore exploitation of the present invention is expected to become a clinical safety, the desirable Chinese medicine preparation effective, cheap, easy to use of providing, and is expected to obtain better economic, social benefit after applying.
Summary of the invention:
The invention belongs to a kind of Chinese medicine preparation of the women's of treatment subhealth state fatigue syndrome.It is characterized in that by Yin-nourishing and Yang-supporting, the Chinese prescription of benefiting qi and nourishing blood forms, and comprises Gallus Domesticus (removing feather claw and intestine) 10~50%, Herba Saussureae Involueratae 0.1~2%, Ganoderma 1~10%, Cordyceps 0.1~4%, Herba Epimedii 1~10%, Semen Juglandis 0.5~5%, Herba Cistanches 0.5~5%, Radix Et Caulis Acanthopanacis Senticosi 0.5~10%, Semen Ziziphi Spinosae 0.5~5%, Radix Asparagi 0.1~8%, Fructus Lycii 0.5~10%, Bulbus Lilii 0.4~4%, the Radix Astragali 1~10%, Rhizoma Dioscoreae 0.4~8%, Poria 0.5~10%, Semen Coicis 0.4~4%, Radix Polygoni Multiflori 0.5~10%, Radix Rehmanniae Preparata 0.5~10%, Radix Angelicae Sinensis 0.4~4%, Radix Salviae Miltiorrhizae 0.5~10%, Arillus Longan 0.2~4%, Semen Nelumbinis 0.2~4%, Semen Euryales 0.2~4%, Fructus Rosae Laevigatae 0.2~4%, Fructus Crataegi 0.5~10%, Endothelium Corneum Gigeriae Galli 0.5~10%, Pericarpium Citri Reticulatae 1~10%, Fructus Jujubae 1~10%, Radix Glycyrrhizae 1~10%, Mel 10~40%.
Technical scheme of the present invention is: get Gallus Domesticus, pulverize, decoct with water twice, each 2 hours, merge extractive liquid, filtered, and filtrate adds hydrochloric acid and transfers pH value to 4~5, and cold preservation 12 hours filters filtrate for later use; Get Herba Saussureae Involueratae again, Ganoderma, Cordyceps, Herba Epimedii, Semen Juglandis, Herba Cistanches, Radix Et Caulis Acanthopanacis Senticosi, Semen Ziziphi Spinosae, Radix Asparagi, Fructus Lycii, Bulbus Lilii, the Radix Astragali (processing), Rhizoma Dioscoreae, Poria, Semen Coicis, Radix Polygoni Multiflori (system), Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Arillus Longan, Semen Nelumbinis, Semen Euryales, Fructus Rosae Laevigatae, Fructus Crataegi, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Jujubae, Radix Glycyrrhizae (processing) 28 flavors, decoct with water twice, each 2 hours, merge extractive liquid,, filter, filtrate and above-mentioned filtrate merge, be condensed into relative density and be 1.22~1.26 thick paste, add Mel, mixing, available distinct methods drying is pulverized, and is the dried medicated powder of extraction of the present invention; Or to get relative density that above-mentioned mixed liquor is concentrated into about 500ml be 1.04~1.08 concentrated solution, and cold putting 24 hours filters, and adds an amount of distilled water, adds Mel, mixing, and filtrate is the present invention and extracts medicinal liquid.The different auxiliary material that adds in the different dosage form of the present invention does not influence clinical effectiveness of the present invention, and these adjuvants comprise starch, little product cellulose, magnesium stearate, dextrin, lactose, sucrose, antiseptic, Polyethylene Glycol etc.Therefore the present invention can satisfy the requirement of numerous women's fatigue syndrome (subhealth state) patient to different dosage form.
The Chinese medicine preparation that the purpose of this invention is to provide a kind of treatment women's fatigue syndrome (subhealth state) with obvious curative effects.The Pharmacodynamic test of active extract result of this preparation shows: this preparation can obviously increase the weight of mouse immune organ thymus, and the certain increase mouse spleen weight and the trend of K value are arranged, and points out it that effect that increases the body nonspecific immunity is arranged; This preparation can obviously prolong the low temperature swimming time of mice, shows that it has cold-resistant preferably and antifatigue effect; This preparation energy significant prolongation mice hypoxia endurance time; This preparation can significantly raise, and WBC that CTX causes mice reduces and neutrophil reduces.Acute toxicity test of the present invention and long term toxicity test result show and do not see overt toxicity reaction.
Compare clinically with oral liquid treatment traditional Chinese medical science asthenia insufficiency of vital energy and blood card patient 137 examples of the present invention, and with ZHONGHUA WUJI JING.The result shows test group obvious effective rate 62.0%, total effective rate 95.6%, and matched group obvious effective rate 39.7%, and total effective rate 85.3, both have compared significant difference (P<0.05), show that this preparation is evident in efficacy to traditional Chinese medical science asthenia insufficiency of vital energy and blood card.Clinical in addition this preparation for treating of usefulness by put, leukopenia caused by cancer chemotherapy disease, and compare with FUFANG EJIAO JIANG.The result shows: test group obvious effective rate 46.7%, and total effective rate 93.3%, and matched group obvious effective rate 46.7%, total effective rate 90%, both compare there was no significant difference (P>0.05).Show this product to by put, leukopenia caused by cancer chemotherapy disease also has curative effect preferably.In the clinical trial process, do not find that this preparation has obvious toxicity, illustrate that the present invention takes safety.
Traditional Chinese medical science efficacy analysis of the present invention:
1 materials and methods
1.1 outpatient's 235 examples are observed in this clinical trial of physical data altogether, inpatient's 30 examples, Attached Hospital of Shandong College of Traditional Chinese Medicine's 144 examples wherein, Hospital Affiliated to Shandong Medical College's 60 examples, the hospital of traditional Chinese hospital, area, Heze 61 examples.All be divided into treatment group and matched group at random.Test group 137 examples are wherein tested I and are organized 137 examples, wherein male 56 examples, women 81 examples, 43.29 ± 12.90 years old mean age; Test II organizes 30 examples, wherein male 17 examples, women 13 examples, 42.13 ± 13.02 years old mean age; Matched group 98 examples, contrast I organizes 68 examples, wherein male 31 examples, women 37 examples, mean age 44.10 ± l3.26 year; Contrast II organizes 30 examples, wherein male 16 examples, women 14 examples, 42.23 ± 13.15 years old mean age.Two groups are not had significant difference in sex, age distribution.Two groups of patient's diseases are evenly distributed in addition, and no significant difference has comparability.
1.2 Therapeutic Method test group oral liquid of the present invention, each 1 (10ml), every day 2 times.Contrast I group is taken ZHONGHUA WUJI JING (being produced by Beijing wujijing factory), and is oral, each 1 (10ml), every day 2 times; Contrast II group is taken FUFANG EJIAO JIANG (being produced by Donga, Shandong Colla Corii Asini Group Plc), and is oral, each 1 (20ml), every day 2 times.Two groups was 1 course of treatment with 1 month all, finished back statistics curative effect 1 course of treatment.
1.3 observation item observe two groups before and after the treatment spiritlessness and weakness, insomnia and dreamful sleep, forgetful, shortness of breath and palpitation, have a dizzy spell, soreness of the waist and knees, numb limbs and tense tendons, inappetence, spontaneous perspiration, 10 symptoms performances of sexual hypofunction.
1.4 efficacy assessment standard comprehensive therapeutic effect evaluation criteria: with reference to " Chinese medicine (new drug) treatment senile disease clinical research guideline "; Leukopenia efficacy assessment standard: evaluate with reference to " hematopathy curative effect and diagnostic criteria ".
1.5 statistical procedures adopts Ridit to analyze and the t check is carried out statistical procedures to related data.
2 results
Clinical comprehensive therapeutic effect: see Table 1~2
Table 1 pair traditional Chinese medical science asthenia insufficiency of vital energy and blood card curative effect relatively
Group | The example number | Produce effects | Effectively | Invalid | Obvious effective rate | Total effective rate |
The test group matched group | 137 68 | 85 27 | 46 31 | 6 10 | 62.0% 39.7% | 95.6% 85.3% |
Analyze through Ridit, P<0.05, test group is better than matched group.
Table 2 pair by put, leukopenia caused by cancer chemotherapy disease curative effect relatively
Group | The example number | Produce effects | Effectively | Invalid | Obvious effective rate | Total effective rate |
The test group matched group | 30 30 | 12 13 | 16 14 | 2 3 | 40% 43.3% | 93.3% 90% |
Analyze through Ridit, P>0.05, test group and matched group do not have significant difference.
By table 1~2 as can be known, test group reaches 95.6% to 137 routine traditional Chinese medical science asthenia insufficiency of vital energy and blood card patients' treatment total effective rate, is better than matched group, and two groups of curative effects are compared process Ridit analysis significant difference (P<0.05); Test group to put, the treatment of leukopenia caused by cancer chemotherapy disease, total effective rate reaches 93.3%, compares there was no significant difference with matched group.Show the present invention for traditional Chinese medical science asthenia insufficiency of vital energy and blood card sufferer and put, the treatment of leukopenia caused by cancer chemotherapy disease all has curative effect preferably.Find in the clinical trial process that in addition the present invention is particularly remarkable to the curative effect of female patient.
Prescription of the present invention also can add the Chinese medicine that other have Yin-nourishing and Yang-supporting, benefiting qi and nourishing blood on the basis of above-mentioned 30 flavor medicines.
Using method of the present invention: oral, every day 2 times.Each 1~2 (or 10~20ml syrup, or 10~15 of drop pill, or 2~4 capsules, or 2~4 tablets of tablets, or one bag of granule).One month is a course of treatment.
The specific embodiment:
Embodiment 1:
Get Gallus Domesticus 200g, pulverize, decoct with water twice, each 2 hours, merge extractive liquid, filtered, and filtrate adds hydrochloric acid and transfers pH value to 4~5, and cold preservation 12 hours filters filtrate for later use; Get Herba Saussureae Involueratae 2g again, Ganoderma 20g, Cordyceps 2g, Herba Epimedii 10g, Semen Juglandis 4g, Herba Cistanches 8g, Radix Et Caulis Acanthopanacis Senticosi 8g, Semen Ziziphi Spinosae 6g, Radix Asparagi 5g, Fructus Lycii 10g, Bulbus Lilii 5g, the Radix Astragali (processing) 12g, Rhizoma Dioscoreae 8g, Poria 8g, Semen Coicis 5g, Radix Polygoni Multiflori (system) 8g, Radix Rehmanniae Preparata 10g, Radix Angelicae Sinensis 6g, Radix Salviae Miltiorrhizae 8g, Arillus Longan 4g, Semen Nelumbinis 8g, Semen Euryales 6g, Fructus Rosae Laevigatae 6g, Fructus Crataegi 16g, Endothelium Corneum Gigeriae Galli 12g, Pericarpium Citri Reticulatae 15g, Fructus Jujubae 12g, Radix Glycyrrhizae (processing) 15g, decoct with water twice, each 2 hours, merge extractive liquid,, filter, filtrate and above-mentioned filtrate merge, being condensed into relative density is the thick paste of 1.22~1.24 (60 ℃), add Mel 50g, mixing, dry, pulverize, be the dried medicated powder of extraction of the present invention; Or get above-mentioned mixed liquor and be concentrated into about 500ml (relative density is 1.04~1.08,60 ℃), cold putting (2~2 ℃) 24 hours filters, and adds Mel 50g, mixing, and filtrate is the present invention and extracts medicinal liquid.
Embodiment 2:
Get Gallus Domesticus 60g, pulverize, decoct with water twice, each 2 hours, merge extractive liquid, filtered, and filtrate adds hydrochloric acid and transfers pH value to 4~5, and cold preservation 12 hours filters filtrate for later use; Get Herba Saussureae Involueratae 1g again, Ganoderma 10g, Cordyceps 1g, Herba Epimedii 6g, Semen Juglandis 8g, Herba Cistanches 4g, Radix Et Caulis Acanthopanacis Senticosi 10g, Semen Ziziphi Spinosae 8g, Radix Asparagi 3g, Fructus Lycii 12g, Bulbus Lilii 5g, the Radix Astragali (processing) 6g, Rhizoma Dioscoreae 4g, Poria 10g, Semen Coicis 8g, Radix Polygoni Multiflori (system) 6g, Radix Rehmanniae Preparata 12g, Radix Angelicae Sinensis 4g, Radix Salviae Miltiorrhizae 10g, Arillus Longan 2g, Semen Nelumbinis 3g, Semen Euryales 3g, Fructus Rosae Laevigatae 3g, Fructus Crataegi 6g, Endothelium Corneum Gigeriae Galli 4g, Pericarpium Citri Reticulatae 5g, Fructus Jujubae 8g, Radix Glycyrrhizae (processing) 8g, decoct with water twice, each 2 hours, merge extractive liquid,, filter, filtrate and above-mentioned filtrate merge, being condensed into relative density is the thick paste of 1.24~1.26 (60 ℃), add Mel 80g, mixing, drying under reduced pressure, pulverize, be the dried medicated powder of extraction of the present invention; Or get above-mentioned mixed liquor and be concentrated into about 500ml (relative density is 1.04~1.08,60 ℃), cold putting (2~2 ℃) 24 hours filters, and adds Mel 80g, mixing, and filtrate is the present invention and extracts medicinal liquid.
Embodiment 3:
Get Gallus Domesticus 120g, pulverize, decoct with water twice, each 2 hours, merge extractive liquid, filtered, and filtrate adds hydrochloric acid and transfers pH value to 4~5, and cold preservation 12 hours filters filtrate for later use; Get Herba Saussureae Involueratae 1g again, Ganoderma 16g, Cordyceps 1g, Herba Epimedii 12g, Semen Juglandis 8g, Herba Cistanches 3g, Radix Et Caulis Acanthopanacis Senticosi 4g, Semen Ziziphi Spinosae 3g, Radix Asparagi 4g, Fructus Lycii 4g, Bulbus Lilii 3g, the Radix Astragali (processing) 8g, Rhizoma Dioscoreae 10g, Poria 10g, Semen Coicis 3g, Radix Polygoni Multiflori (system) 6g, Radix Rehmanniae Preparata 6g, Radix Angelicae Sinensis 10g, Radix Salviae Miltiorrhizae 6g, Arillus Longan 6g, Semen Nelumbinis 6g, Semen Euryales 5g, Fructus Rosae Laevigatae 3g, Fructus Crataegi 10g, Endothelium Corneum Gigeriae Galli 10g, Pericarpium Citri Reticulatae 12g, Fructus Jujubae 5g, Radix Glycyrrhizae (processing) 12g, decoct with water twice, each 2 hours, merge extractive liquid,, filter, filtrate and above-mentioned filtrate merge, being condensed into relative density is the thick paste of 1.22~1.24 (60 ℃), add Mel 40g, mixing, spray drying, pulverize, be the dried medicated powder of extraction of the present invention; Or get above-mentioned mixed liquor and be concentrated into about 500ml (relative density is 1.04~1.08,60 ℃), cold putting (2~2 ℃) 24 hours filters, and adds Mel 40g, mixing, and filtrate is the present invention and extracts medicinal liquid.
Embodiment 4:
Get Gallus Domesticus 150g, pulverize, decoct with water twice, each 2 hours, merge extractive liquid, filtered, and filtrate adds hydrochloric acid and transfers pH value to 4~5, and cold preservation 12 hours filters filtrate for later use; Get Herba Saussureae Involueratae 0.5g again, Ganoderma 25g, Cordyceps 1.5g, Herba Epimedii 6g, Semen Juglandis 8g, Herba Cistanches 8g, Radix Et Caulis Acanthopanacis Senticosi 6g, Semen Ziziphi Spinosae 8g, Radix Asparagi 6g, Fructus Lycii 6g, Bulbus Lilii 5g, the Radix Astragali (processing) 8g, Rhizoma Dioscoreae 8g, Poria 16g, Semen Coicis 6g, Radix Polygoni Multiflori (system) 10g, Radix Rehmanniae Preparata 10g, Radix Angelicae Sinensis 10g, Radix Salviae Miltiorrhizae 10g, Arillus Longan 2g, Semen Nelumbinis 2g, Semen Euryales 2g, Fructus Rosae Laevigatae 5g, Fructus Crataegi 6g, Endothelium Corneum Gigeriae Galli 6g, Pericarpium Citri Reticulatae 12g, Fructus Jujubae 12g, Radix Glycyrrhizae (processing) 8g, decoct with water twice, each 2 hours, merge extractive liquid,, filter, filtrate and above-mentioned filtrate merge, being condensed into relative density is the thick paste of 1.24~1.26 (60 ℃), add Mel 60g, mixing, dry, pulverize, be the dried medicated powder of extraction of the present invention; Or get above-mentioned mixed liquor and be concentrated into about 500ml (relative density is 1.04~1.08,60 ℃), cold putting (2~2 ℃) 24 hours filters, and adds Mel 60g, mixing, and filtrate is the present invention and extracts medicinal liquid.
Embodiment 5: syrup
With any one extracting and to add 0.3% sodium benzoate in the medicinal liquid in the foregoing description, add sucrose 300g, xanthan gum 100g makes the 1000ml syrup, syrup of the present invention.
Embodiment 6: oral liquid
To any one extract and to add 0.3% sodium benzoate in the medicinal liquid in the foregoing description, the 400ml distilled water, sterilization, the 1000ml oral liquid is made in fill, oral liquid of the present invention.
Embodiment 7: granule
Will be in the foregoing description any one extracts and adds lactose 200g in the dried medicated powder, and dextrin 600g granulates, and granulate sieves, and makes the 1000g granule, granule of the present invention.
Embodiment 8: granule
Will be in the foregoing description any one extracts and adds starch 125g in the dried medicated powder, mixes, and granulates, and sieves, and adorns 1000 capsules, capsule of the present invention.
Embodiment 9: tablet
Will be in the foregoing description any one extracts and adds 130g starch in the dried medicated powder, and mixing is granulated, and oven dry is sieved, and adds the 20g microcrystalline Cellulose, the 2g magnesium stearate, mixing is pressed into 1000, tablet of the present invention.
Embodiment 10: drop pill
Be heated among fused Polyethylene Glycol-6000800g any one extracting in the dried medicated powder in the foregoing description, adding, stirring and dissolving is dripped and is made 1000 balls, drop pill of the present invention.
According to prescription of the present invention, can also make the preparation of other dosage forms such as muddy outstanding agent.