CN1391919A - Lifuji oral liquor - Google Patents

Lifuji oral liquor Download PDF

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Publication number
CN1391919A
CN1391919A CN 01114111 CN01114111A CN1391919A CN 1391919 A CN1391919 A CN 1391919A CN 01114111 CN01114111 CN 01114111 CN 01114111 A CN01114111 A CN 01114111A CN 1391919 A CN1391919 A CN 1391919A
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parts
radix
volatile oil
group
medicine
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CN1238041C (en
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刘宇晖
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Harbin Traditional Chinese Medicine Four Factory Co Ltd
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Abstract

The Lifuji oral liquor is a medicine for treating chronic fatigue syndrome with high curative effect. The technological scheme includes extracting volatile oil from curcuma root, bupleurum root, amomum fruit, nutagrass flatsedge rhizome and Chuanxiong rhizome; decocting red sage, astragalus root, milkwort root, cape jasmine, arisaema with bile and the medicine residue after extracting volatile oil; merging the volatile oil and the decoction; concentration; fitlering after ethanol dissolving, recovering filtrate, centrifuging, adding Tween-80, and mixing with syrup and water.

Description

Lifuji oral liquor
The present invention relates to a kind of oral liquid for the treatment of chronic fatigue syndrome.
In developed country, the prevalence of suffering from chronic fatigue syndrome is about 3/1000ths.According to statistics, existing 200~6,000,000 people of the U.S. are ill.Japanese this disease that claims is overworking death, and there are 150 mayors in Japan because of overworked for a long time in nearly 5 years, suffers from this disease and deadly dying.China does not still have statistics at present, but not rarely seen according to clinical observation, and is many with the brain worker.Along with Chinese economic development, modern fast pace and competition, increasing from the pressure of each side such as life, work, study, the sickness rate of fatigue syndrome is in rising trend.1988 by the Center for Disease Control definite designation.In October, 1999, new edition " practical internal medicine " has been recorded chronic fatigue syndrome.Should disease only be clinical diagnosis at present, its fatigue can not solve by having a rest, and does not find to cause tired internal medicine or psychiatric department disease, so still can not make laboratory diagnosis, does not also propose effective Therapeutic Method.Therefore still there is not this sick Chinese and western drugs of treatment.Because the primary disease course of disease is longer, generally more than half a year, several years very then, have a strong impact on patient's study and work efficiency.Therefore, the active drug of development treatment chronic fatigue syndrome disease is one of research topic of present medical educational circles concern, is significant, and has good prospect again.At present, the medicine of treatment chronic fatigue syndrome still belongs to blank.
The object of the present invention is to provide a kind of medicine that can effectively treat chronic fatigue syndrome.
Technical scheme of the present invention: claim 1.
Beneficial effect of the present invention: medicine of the present invention carries out clinical trial with the attached First Academy of Heilongjiang Province university of TCM, the Heilongjiang Province Fifth Academy of Aerospace Industry, Affiliated Hospital of Heilongjiang Inst. of Integration of Traditional Chinese and Western Medicine (C three tame provincial hospitals.Test objective: investigate leading position and the safety of its curative effect in similar drug, so set up matched group, the contrast medicine is selected eutherapeutic Radix Et Caulis Acanthopanacis Senticosi brain ichor for use, has observed 432 examples altogether, and medicine wherein of the present invention is observed 325 examples, and matched group is observed 107 examples.Result of the test shows: medicine of the present invention is taken safe and reliable, and is without any side effects, and significant treatment, the work and rest irregular chronic fatigue syndrome that cause overworked because of working and learning arranged.Disease is seen fatigue and weakness, dizziness and distending sensation of the head, and thinking is not concentrated, distending pain over the hypochondrium, bitter taste in the mouth and dry throat or pharyngalgia, anorexia, it is uncomfortable to defecate, being irritable and getting angry easily, tension headache, myalgia, insomnia forgetfulness or drowsiness etc.(for details see attached table 1~2) table 1 observe two groups take medicine before and after symptom variation relatively
Main symptom grade main symptom grade symptom U P
++++ +++ ++ + - ++++ +++ ++ + -
Spiritlessness and sparing of words controls preceding 32 160 84 49 0 11 53 26 17 0
4.12 <0.05
Fatigue and asthenia is controlled back 7 45 84 87 102 5 32 28 26 18
Control preceding 15 90 136 52 32 5 28 49 17 8
5.75 <0.05
The stomach poor appetite is controlled back 3 16 53 104 149 2 15 36 32 22 less
Dull pain in the epigastrium controls preceding 43 103 72 58 49 14 35 24 19 15
1.96 <0.05
Abdominal distention after meal is controlled back 14 62 78 79 92 9 21 28 30 19 and is seen big loose stool and control preceding 0 45 86 87 107 pairs 0 14 29 28 36
2.11 <0.05
The not well back 0 21 66 108 120 02 18 42 45 of controlling
The breast side of body, few abdomen control preceding 66 68 83 86 12 21 23 27 29 7
2.36 <0.05
Distending pain is controlled back 28 36 59 151 51 13 18 31 30 15
Belch controls preceding 0 26 95 87 117 08 31 29 39
1.97 <0.05
Acid regurgitation is controlled back 0 17 68 99 141 01 17 29 51
Control preceding 52 113 108 52 0 16 38 36 17 0
Control back 8 49 86 103 79 according to 6 12 48 28 13 2.79<0.05 examines irritated irritability
Insomnia and dreamful sleep or control preceding 38 92 133 62 0 13 31 44 19 0
2.51 <0.05
Hypersomnia is controlled back 8 37 78 90 112 6 20 36 42 8
Bitter taste, dry pharynx control preceding 6 82 107 90 40 2 28 35 29 13
3.37 <0.05
Or pharyngalgia is controlled back 1 23 70 117 114 3 20 29 46 9
The dizziness and distending sensation of the head thinking controls preceding 88 93 116 28 0 27 32 38 10 0
3.42 <0.05
Concentrated, forgetful back 14 38 66 81 126 17 22 28 33 7 groups of headaches, muscle controlled are controlled preceding 32 73 182 38 0 group 10 18 61 18 0
3.18 <0.05
Bitterly, arthralgia is controlled back 2 18 125 76 104 26 54 31 14
Nervous breathing hard controls preceding 0 12 97 173 43 04 32 57 14
1.00 >0.05
Or back 07 64 169 75 02 26 58 21 is controlled in sweating
Through carrying out statistical procedures with the Ridit check, the present invention is remarkable to the chronic fatigue syndrome therapeutic effect, and there were significant differences with observation group.
Table 2 is observed two groups of back invalid % of the Comparison of therapeutic table group n recovery from illness % effective % of produce effects % that take medicine and is more shown total effectively % observation group 325 88 (27.1) 115 (35.3) 98 (30.2) 24 (7.4) 62.5 92.6 matched groups 107 28 (24.3) 30 (28.0) 32 (30.0) 17 (5.9) 54.21 81.1 of %
Analyze u=-2.05, P<0.05 through Ridit.
Toxicity test: through animal acute toxicity test and long term toxicity test, this medicine is without any side effects.(for details see attached table 3~6)
Table 3 the present invention is to rat body weight gain result (g, X ± SD)
Weight increase weight % after the body weight administration before group number of animals (only) administration
Blank 20 94.8 ± 10.1 235.37 ± 8.1 136.7 141.0
Low dose group 20 102.2 ± 9.9 231.7 ± 11.6 120.1 125.6
Middle dosage group 20 97.1 ± 8.2 230.2 ± 10.8 132.6 140.5
High dose group 20 93.8 ± 9.1 238.2 ± 13.1 138.6 143.9
Table 4 the present invention is to rat hematological indices testing result (X ± SD)
Group number of animals RBC Hb WBC WBC classify (%)
(only) (* 10 12/ L) (g/L) (* 10 9/ L) LY GR
Blank 20 4.10 ± 0.32 128 ± 9.2 7.24 ± 1.61 68.7 ± 5.4 25.1 ± 3.4
Low dose group 20 4.86 ± 0.42 130 ± 10.5 8.01 ± 1.85 71.4 ± 4.6 20.6 ± 5.8
Middle dosage group 20 4.71 ± 0.56 127 ± 8.2 7.65 ± 2.13 69.2 ± 3.2 24.1 ± 4.3
High dose group 20 4.80 ± 0.31 131 ± 11.7 7.95 ± 1.74 72.8 ± 5.8 21.7 ± 5.6
Table 5 the present invention learns index testing result (X ± SD) to the rat blood biochemical
Group number of animals BUN Grea SGPT SGOT
(only) be (μ mol/L) (nmol/L) (nmol/L) (mmol/L)
Blank 20 5.7 ± 0.9 80.1 ± 10.5 71.5 ± 11.6 113.8 ± 30.4
Low dose group 20 6.1 ± 1.0 76.8 ± 12.4 64.2 ± 11.4 111.7 ± 17.9
Middle dosage group 20 5.5 ± 1.5 78.2 ± 8.8 69.3 ± 8.9 108.9 ± 25.4
High dose group 20 6.1 ± 1.2 77.9 ± 12.1 70.0 ± 12.4 110.8 ± 19.9
Table 6 the present invention is to big white mouse Main Organ Coefficients result of calculation (dosage group 20 0.49 ± 0.03 3.54 ± 0.25 0.25 ± 0.04 0.86 ± 0.17 0.72 ± 0.15 high dose group 20 0.51 ± 0.03 3.61 ± 0.32 0.27 ± 0.03 0.90 ± 0.15 0.68 ± 0.11 in group number of animals (only) heart liver spleen lungs kidney blank 20 0.50 ± 0.03 3.61 ± 0.32 0.31 ± 0.01 0.90 ± 0.13 0.74 ± 0.13 low dose group 20 0.52 ± 0.04 3.40 ± 0.27 0.28 ± 0.03 0.82 ± 0.14 0.65 ± 0.11 of % X ± SD)
Pharmacodynamics test: the present invention carries out pharmacodynamic experiment with basic, normal, high three dosage groups, and experimental result shows that this medical instrument has analgesia, calmness, improvement study, memory, anti-hypoxia, resisting fatigue, and the effect that improves immune function.(for details see attached table 7~13)
Table 7 the present invention is to the analgesic activity of rat (hot plate method X ± SD)
Different time (branch) 30 threshold of pain differences 60 behind group number of animals (only) dosage g (ml)/kg medicine
Low dosage 20 6.9 2.05 ± 2.35 2.85 ± 3.03
Middle dosage 20 13.8 4.45 ± 5.62 3.85 ± 3.99
High dose 20 27.6 5.35 ± 4.55 3.35 ± 5.09
Sun is to medicine 20 (2.6) 48.5 ± 2.69 48.5 ± 2.69 "
Matched group 20 equivalent 1.15 ± 2.75 1.45 ± 2.95
Compare * P<0.05 * * P<0.01 with matched group.
Table 8 the present invention is to the analgesic activity of rat (writhing method X ± SD)
Group number of animals (only) dosage g (ml)/kg turned round the body number of times in 20 minutes
Low dosage 20 6.9 19.7 ± 6.87**
Middle dosage 20 13.8 13.2 ± 11.6**
High dose 20 27.6 12.2 ± 4.62**
Sun is to medicine 20 (2.6) 0.1 ± 0.3***
Contrast medicine 20 equivalent 48.4 ± 17.5
Compare * * P<0.01, * * * P<0.001 with the blank group.
Table 9 the present invention is to the sedation of rat (X ± SD)
The movable number of times (inferior) of group number of animals (only) dosage g (ml)/kg
Low dosage 20 6.9 227.5 ± 52.3**
Middle dosage 20 13.8 187.6 ± 49.7**
High dose 20 27.6 160.7 ± 51.7**
Sun is to medicine 20 2.6 199.3 ± 52.1**
Matched group 20 358.2 ± 60.8** and matched group be p<0.01 relatively.Table 10 the present invention remembers the improvement effect (X ± SD) of obstacle again to rat due to the scopolamine
Dosage number of animals errors number group in incubation period 5
(/kg po) (only) (second) (inferior) contrast (tap water) 20ml 20 1.88 ± 1.36 1.29 ± 4.33
Δ P<0.05, Δ Δ P<0.01 are compared with control group in dosage group+moulding 13.8g 20 16.41 ± 15.34 4.76 ± 5.83* low dose group+moulding 6.9g 20 16.82 ± 19.14 5.29 ± 6.423 in moulding hyoscine 2mg 20 22.12 ± 16.68 Δ Δs 9.12 ± 5.19 Δs positive drug+moulding 2.6g 20 17.65 ± 17.94 4.24 ± 4.76* high dose group+moulding 27.6g 20 18.06 ± 16.71 4.82 ± 6.64. (dosage 20 13.8 21.65 ± 1.98** low dosage 20 6.9 23.13 ± 2.78** sun is to the blank group of medicine 20 (2.6) 20.12 ± 3.32* 20 15.77 ± 3.74 each medication group and blank group control group * P<0.05 relatively, * * P<0.01 among group number of animals (only) dosage g (ml)/kg swimming time (min) the high dose 20 27.6 28.89 ± 2.17** of X ± SD) to the impact of rats'swimming time in table 11 the present invention. (dosage 20 13.8 22.54 ± 1.99** low dosage 20 6.9 18.55 ± 3.35** sun is to the blank group of medicine 20 (2.6) 24.13 ± 2.78** 20 12.97 ± 1.87 each medication group and blank group * P<0.05 relatively, * * P<0.01 among group number of animals (only) dosage g (ml)/kg time-to-live (min) the high dose 20 27.6 29.76 ± 2.90** of X ± SD) to the effect of rat normal pressure resistant anoxia in table 12 the present invention. (the group number of animals dosage serum HD50 refers to serum coagulation spleen coefficient to the Rats with Spleen-deficiency Immune Effects in table 13 the present invention of X ± SD)
(only), (g/kg) number, (HC50) index, (K), (mg/g) dosage 20 13.8 885 ± 234* 176 among high dose 20 2.76 897 ± 290 189 ± 22.3* 4.56 ± 0.89 ± 19.8 4.21 ± 0.73 low dosages 20 6.9 852 ± 215 181 ± 20.0*, 4.77 ± 0.94 sun are to medicine 20, (2.6) 813 ± 228 190 ± 26.6* 4.11 ± 0.67 blank group 20/997 ± 287* 213 ± 28.9** 5.81 ± 1.06** model group 20/685 ± 199 185 ± 25.7 3.87 ± 1.02
Each medication group compares * p<0.05, * * p<0.01 with blank group.
A most preferred embodiment of the present invention is described in detail in detail below, get Radix Ginseng Rubra 2.9g, Radix Bupleuri 4.0g, Radix Astragali 5.1g, Radix Curcumae 2.1g, Rhizoma Cyperi 2.1g, Radix Polygalae 2.5g, Rhizoma Chuanxiong 2.1g, Fructus Gardeniae 2.1g, Arisaema Cum Bile 1.5g, Fructus Amomi 0.8g, with Radix Curcumae, Radix Bupleuri, Fructus Amomi, Rhizoma Cyperi, Rhizoma Chuanxiong extracts volatile oil, medicinal liquid behind the extraction volatile oil filters, filtrate and medicinal residues are standby, all the other Radix Ginseng Rubra, the Radix Astragali, Radix Polygalae, Fructus Gardeniae, Arisaema Cum Bile is given as one thinks fit cataclasm, add above-mentioned medicinal residues, decoct with water three times, each 2 hours, collecting decoction, filter, merge with the medicinal liquid of carrying behind the oil, heating is concentrated to the clear paste of relative density 1.10~1.15 (80 ℃ of heat are surveyed), adds ethanol and makes and contain the alcohol amount and reach 70%, left standstill 24 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and residual liquid adds 2 times of water gagings makes dispersion, the centrifugal precipitate that goes, centrifugal liquid adds with the dissolved volatile oil of an amount of Tween 80, and it is an amount of to add water behind the adding simple syrup mix homogeneously, and the packing sterilization forms.Oral each 2-3 props up, every day 3 times, every 10ml.
Second most preferred embodiment of the present invention, get Radix Ginseng Rubra 2.5g, Radix Bupleuri 4.4g, Radix Astragali 5.5g, Radix Curcumae 2.5g, Rhizoma Cyperi 2.5g, Radix Polygalae 2.9g, Rhizoma Chuanxiong 2.5g, Fructus Gardeniae 2.5g, Arisaema Cum Bile 1.9g, Fructus Amomi 1.2g, with Radix Curcumae, Radix Bupleuri, Fructus Amomi, Rhizoma Cyperi, Rhizoma Chuanxiong extracts volatile oil, medicinal liquid behind the extraction volatile oil filters, filtrate and medicinal residues are standby, all the other Radix Ginseng Rubra, the Radix Astragali, Radix Polygalae, Fructus Gardeniae, Arisaema Cum Bile is given as one thinks fit cataclasm, add above-mentioned medicinal residues, decoct with water three times, each 2 hours, collecting decoction, filter, merge with the medicinal liquid of carrying behind the oil, heating is concentrated to the clear paste of relative density 1.10~1.15 (80 ℃ of heat are surveyed), adds ethanol and makes and contain the alcohol amount and reach 70%, left standstill 24 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and residual liquid adds 2 times of water gagings makes dispersion, the centrifugal precipitate that goes, centrifugal liquid adds with the dissolved volatile oil of an amount of Tween 80, and it is an amount of to add water behind the adding simple syrup mix homogeneously, and the packing sterilization forms.Oral each 2-3 props up, every day 3 times, every 10ml.

Claims (1)

1, Lifuji oral liquor, it is a kind of medicine for the treatment of chronic fatigue syndrome, it is characterized in that: composition that drug formulation is contained and shared parts by weight are 2.5~2.9 parts of Radix Ginseng Rubra, 4.0~4.4 parts of Radix Bupleuri, 5.1~5.5 parts of the Radixs Astragali, 2.1~2.5 parts of Radix Curcumaes, 2.1~2.5 parts of Rhizoma Cyperis, 2.5~2.9 parts of Radix Polygalaes, 2.1~2.5 parts of Rhizoma Chuanxiongs, 2.1~2.5 parts of Fructus Gardeniaes, 1.5~1.9 parts of Arisaema Cum Bile, 0.8~1.2 part of Fructus Amomi, with Radix Curcumae, Radix Bupleuri, Fructus Amomi, Rhizoma Cyperi, Rhizoma Chuanxiong extracts volatile oil, medicinal liquid behind the extraction volatile oil filters, filtrate and medicinal residues are standby, all the other Radix Ginseng Rubra, the Radix Astragali, Radix Polygalae, Fructus Gardeniae, Arisaema Cum Bile, give as one thinks fit cataclasm, add above-mentioned medicinal residues, decoct with water three times, each 2 hours, collecting decoction, filter, merge with the medicinal liquid of carrying behind the oil, heating is concentrated to the clear paste of relative density 1.10~1.15 (80 ℃ of heat are surveyed), add ethanol and make and contain alcohol amount and reach 70%, left standstill 24 hours, filter, filtrate recycling ethanol is to there not being the alcohol flavor, residual liquid adds 2 times of water gagings makes dispersion, the centrifugal precipitate that goes, and centrifugal liquid adds with the dissolved volatile oil of an amount of Tween 80, it is an amount of to add water behind the adding simple syrup mix homogeneously, and the packing sterilization forms.
CN 01114111 2001-06-18 2001-06-18 Lifuji oral liquor Expired - Lifetime CN1238041C (en)

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CN1238041C CN1238041C (en) 2006-01-25

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