CN103055131A - Pharmaceutical composition for preventing and treating chronic fatigue and preparation method of pharmaceutical composition - Google Patents
Pharmaceutical composition for preventing and treating chronic fatigue and preparation method of pharmaceutical composition Download PDFInfo
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- CN103055131A CN103055131A CN2011103247125A CN201110324712A CN103055131A CN 103055131 A CN103055131 A CN 103055131A CN 2011103247125 A CN2011103247125 A CN 2011103247125A CN 201110324712 A CN201110324712 A CN 201110324712A CN 103055131 A CN103055131 A CN 103055131A
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Abstract
The invention discloses a pharmaceutical composition for preventing and treating chronic fatigue. The active ingredients of the pharmaceutical composition are prepared from the following raw materials in parts by weight: 28 to 32 parts of honey-fried astragalus root, 13 to 17 parts of roasted bighead atractylodes rhizome, 6 to 10 parts of American ginseng, 10 to 14 parts of poria cocos, 8 to 12 parts of divaricate saposhnikovia root, 13 to 17 parts of polygonatum kingianum, and 7 to 11 parts of costus root. The pharmaceutical composition consists of pure Chinese medicinal herbs, does not contain animal medicaments such as penis, turtle and fur seal and does not contain hormone or chemical synthetic medicaments, so the pharmaceutical composition does not have toxic or side effect through experiments and clinical research. According to the pharmaceutical composition, health-care medicaments are prepared by using the holistic view of the Chinese medical theory core as guidance, using the holistic human factors as basis and using the innovative ideas of invigorating spleen, replenishing qi and eliminating the chronic fatigue, so that sugarless granules prepared from the pharmaceutical composition have an obvious effect of eliminating the chronic fatigue through primary clinical observation.
Description
Technical field
The present invention relates to medical technical field, be specifically related to a kind of Pharmaceutical composition of preventing and treating confirmed fatigue and preparation method thereof.
Background technology
Along with the high speed development of economic society, the quickening of work, rhythm of life is for the development of cause, people often feel easily that in keen competition with among striving body and mind is all tired, and the sub-health state of confirmed fatigue occurs, occur tired weak, body is empty perspires the situations such as easy catching a cold.This not only affects daily work and life, and the time has been grown, and also may cause some chronic diseases, and serious also may suffer from malignant tumor.
Observe from daily life, the proportion of confirmed fatigue sub-health state increases along with the variation of rhythm of life.We once in the Hefei ,Anhui, Distributions in Liaocheng of Shandong Province and the Macao Special Administrative Region investigation fast pace personnel 3324 people, wherein subhealth state people 2622 people account for 78.88%; Healthy People 158 people account for 4.75%; Disease people 544 people account for 16.37%.Male's subhealth state people 3015 people account for 79.43% of male's number; Women's subhealth state people 227 people account for 71.15% of women's number.Wherein belong to confirmed fatigue type sub-health state person and account for 1/4th of sub-health population, wherein more in the majority with the women.As seen, the effective health care medicine of intervening the confirmed fatigue sub-health state of research and development is necessary.
Theory of Chinese medical science is thought: The spleen has the function to transport and transform nutrients, the lucid yang sending up, is the foundation of acquired constitution; Spleen governing muscles, main extremity.Spleen can be converted into essence of water and grain with the ingesta that human body is taken in, and essence of water and grain is absorbed, transfers each internal organs of whole body, comprises muscle, extremity, to keep the normal of human life activity.As " Plain Questions. the very dirty opinion of beautiful machine " say: " the spleen being a solitary ZANG-organ, central authorities soil is other to fill with four ", " Plain Questions. the opinion of fainting ": " the spleen transporting the nutritious substance in the stomach person is also ", " Plain Questions. the five internal organs generate a piece of writing ": " The spleen has the function to transport and transform nutrients foodstuff essence is to give birth to and bring up muscle, so main meat." " Plain Questions. the bright opinion of lunar sun ": " four limbs receiving QI from the stomach and must not be to warp, must because of in spleen be report also.Modern dysfunction of the spleen in transporting essential substances from the stomach to the whole body, extremity must not be reported the water essence derived from food, gas day, sering was unfavorable to decline, muscles and bones muscle all depletion of QI with life, so need not be also." if deficiency of spleen-QI can not absorb, transfer essence of water and grain well, then viscera tissue, muscle, extremity can not get the nourishing of enough essence of water and grain, neurolysis, limbs fatigue then can occur, easily perspire, the performance such as many flu.The sub-health state of confirmed fatigue that Here it is.As not intervening in time, then might be diseases induced.
Li Zhongzi's " abstracts of classic of internal medicine " speech: " the spleen being the foundation of acquired constitution " illustrates the healthy and vigorous significance to human body of temper.Deficiency-weakness of spleen-QI then is the main cause that the confirmed fatigue sub-health state occurs.
At present, although have the health food of some resisting fatigue or health care medicine to sell on the market, make for raw material mainly with vitamin, Chinese medicine Radix Ginseng, Radix Panacis Quinquefolii, Ganoderma etc., have following main weak point:
1, many is single medicinal material or little compound recipe, act on comprehensive not, and the clinical trial that combines of shortage and modern life science research and analyze its mechanism of action.
2, some also contains the medicine of tonifying YANG effect, have in addition present " viagra " figure surprisingly.Though may temporarily occur the clear-headed sensation of brain after taking, can only make brain temporarily excited, after the drug effect, more tired situation can appear.
3, existing health product complaint is more, comprises anti-fatigue health-product containing.For profit-seeking, the name of subhealth state is being beaten by the good manufacturer of nothing, and the invalid product of manufacturing in a rough and slipshod way uses way of promotion lack of standardization, and consumer is had dust thrown into the eyes.
To containing the anti-fatigue health-product containing of forbidden drug, not only unhelpful after taking, instead might bring harm to health.
Summary of the invention
The objective of the invention is provides a kind of Pharmaceutical composition of intervening the confirmed fatigue sub-health state take " the foundation of acquired constitution " spleen as object, does not contain animal kind medicine, amcinonide, chemosynthesis class medicine, has no side effect.
The technical scheme that solves the problems of the technologies described above is as follows:
A kind of Pharmaceutical composition of preventing and treating confirmed fatigue, the active component of described Pharmaceutical composition are mainly made by following weight portion raw material: Radix Astragali Preparata 28-32 part, Rhizoma Atractylodis Macrocephalae (parched) 13-17 part, Radix Panacis Quinquefolii 6-10 part, Poria 10-14 part, Radix Saposhnikoviae 8-12 part, Rhizoma Polygonati 13-17 part, Radix Aucklandiae 7-11 part.
Preferably, the active component of described Pharmaceutical composition is mainly made by following weight portion raw material: 30 parts of Radix Astragali Preparatas, 15 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 8 parts of Radix Panacis Quinquefoliis, 12 parts in Poria, 10 parts of Radix Saposhnikoviaes, 15 parts of Rhizoma Polygonatis, 9 parts of the Radix Aucklandiae.
Preferably, the medicine made of described Pharmaceutical composition is sugar free granule.
The active component effect of Pharmaceutical composition of the present invention is as follows:
Radix Astragali Preparata, sweet, tepor.Return spleen, lung meridian.Compendium of Material Medica is said: " element is said: the sweet Wen Chunyang of the Radix Astragali, and it is with having five: mend all empty deficiencies, one also; Benefit vigour, two also; Strong taste, three also; Go flesh heat, four also; The evacuation of pus pain relieving, the hemopoietic of invigorating blood circulation, the expelling the toxic substance from the body with tonic carbuncle of yin nature is persons particularly liable to develop skin infection's panacea, five also." this product can enriching spleen-QI, sending up the lucid YANG, benefit is defended consolidating superficial resistance; Again can inducing diuresis to remove edema, holder skin ulcer granulation promoting.Be conditioning deficiency of the spleen causing weakness of QI, the key medicine of fatigue and weakness.Often join the Rhizoma Atractylodis Macrocephalae with air making-up and spleen enlivening, join Radix Ginseng to strengthen its QI invigorating effect.Be the monarch drug in the Pharmaceutical composition of the present invention.
Rhizoma Atractylodis Macrocephalae (parched) is bitter, sweet, warm.Return spleen, stomach warp." book on Chinese herbal medicine converges and says " said: " Rhizoma Atractylodis Macrocephalae is to copy taste, and the wet dissipation eliminating impediment helps digestion except the key medicine of painful abdominal mass.Insufficiency of the spleen unstrong, art can be mended it; Insufficiency of stomach is not received, and art can help it." the special air making-up and spleen enlivening of this product merit, can also the dampness diuretic, strengthening superficial resistance to stop perspiration, antiabortive, for middle QI invigorating, invigorating the spleen and stomach is nursed one's health the key medicine of insufficiency of the spleen weak, spontaneous perspiration.Be the ministerial drug in the Pharmaceutical composition of the present invention.
Radix Panacis Quinquefolii, hardship, little sweet, cold.GUIXIN, lung, stomach warp." Records of Tradition Chinese and Western Medicine in Combination " said: " Radix Panacis Quinquefolii is cool in nature and mend, and all wishs are not subjected to the temperature compensation person of the Radix Ginseng with Radix Ginseng, all can this generation it." this product merit arrogates to oneself tonifying QI to produce body fluid, it can lung benefiting gas, with the merit of the QI invigorating that strengthens the Radix Astragali, the Rhizoma Atractylodis Macrocephalae; It is cool in nature, can restrict the temperature of its medicine, and make full side's involution in peace; Its YIN nourishing and the production of body fluid promoting is also got negative and positive functional activities of the body fluid alternate, and the meaning of YANG promoting growth while YIN promoting generation is said just as Zhang Jingyue: " kind YANG invigorating person must be in treating YANG within YIN, then positive cloudy helping and biochemical infinite ".Be the ministerial drug in the Pharmaceutical composition of the present invention.
Poria, sweet, light, flat.GUIXIN, spleen, kidney channel.Shennong's Herbal is said: " the contrary gas of the main breast side of body, melancholy is angerd frightened evil, probably throbs with fear ... diuresis, and clothes peace soul is reposed for a long time, and is not hungry, prolongs life." this product merit arrogates to oneself spleen-benefiting mind-tranquilizing, can also promoting diuresis to eliminate damp pathogen.Its sweet providing additional supplies is oozed, and effect peace is partially without cold and heat, and is effective to nursing one's health insufficiency of the spleen fatigue and asthenia person.Be the ministerial drug in the Pharmaceutical composition of the present invention.
Radix Saposhnikoviae, suffering, sweet, tepor.Return bladder, liver, spleen channel.Shennong's Herbal: " sweet in the mouth, temperature, nontoxic.Control large dizziness due to wind pain, aversion to wind, ailment said due to cold or exposure, blindness is in fashion the whole body, joint arthralgia aggravated by cold, stuffy sensation with restlessness without finding." this moral character rises loosely, the benefaction whole body has the effect of expelling pathogenic wind from the body surface, is the general product that dispel the wind.And tepor is not dry, and sweet slow not high, the efficacy of a drug relaxes, and with the same usefulness of invigorating QI to consolidate the body surface resistance medicine, more can prevent ailment said due to cold or exposure invasion and attack human body.Be the adjuvant drug in the Pharmaceutical composition of the present invention.
Rhizoma Polygonati, sweet, flat.Return spleen, lung, kidney channel." Mingyi Bielu " said: " main invigorating the spleen and replenishing QI, except rheumatism, settling five organs.For a long time clothes make light of one's life by commiting suicide prolong life not hungry." this product can the nourishing kidney lung moistening, also has the effect of invigorating the spleen and replenishing QI, every and the air making-up and spleen enlivening medicines such as Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae are with being used for fatigue and weakness, the empty soft person of arteries and veins.Be the adjuvant drug in the Pharmaceutical composition of the present invention.
The Radix Aucklandiae, suffering, hardship, temperature.Return spleen, stomach, large intestine, gallbladder meridian.Compendium of Material Medica is said: " Radix Aucklandiae is the medicine of three warmers edema caused by disorder of QI, can all gas of lifting." gas that stagnates of the especially kind current taste large intestine of this product, good circulation of qi promoting effect is arranged, the product benefit that can make the tonifications such as the Radix Astragali, Radix Panacis Quinquefolii, Rhizoma Polygonati of joining in this prescription and oiliness.Be the medicine that makes in the Pharmaceutical composition of the present invention.
Pharmaceutical composition of the present invention has benefiting QI for strengthening the superficies, and the effect of allaying tiredness is applicable to fatigue, and body is empty, easily perspires, and normal flu etc. is the confirmed fatigue type sub-health state person of main manifestations.
The Chinese medical theory of Pharmaceutical composition of the present invention institute foundation is:
Critical role-the spleen being the foundation of acquired constitution of spleen in human body, source of generating QI and blood.
The physiological function of spleen: 1. main transporting: spleen can turn to cereal nutrient to ingesta (water paddy), and cereal nutrient is delivered to each internal organs of whole body; 2. main the lucid yang sending up: spleen has failing on the essence of water and grain in the head, the heart, lung, and the effect by cardiopulmonary turns to QI and blood, with the nutrition whole body; 3. spleen governing limbs, muscle.
The physiological function of gas: 1. impetus: refer to have the effect that excites and promote human body physiological function; 2. warm effect: refer to have warm, fumigation action (gasification themogenesis); 3. defense reaction: refer to have the effect of escorting the machine table, resisting pathogen; 4. astringency inducing effect: refer to gas to the liquid in the body (blood, body fluid, essence) and abdominal viscera etc. solid protection arranged, have under one's command, control action; 5. gasification: refer to the various variations that the motion by gas produces; 6. Nutrition: refer to that gas organizes nutritious effect to viscera, meridians etc., to keep its physiological activity.
Pharmaceutical composition of the present invention is pressed the principles of formulating prescriptions prescription of science of TCM formulas " monarch ", with Radix Astragali enriching spleen-QI, and sending up the lucid YANG, it is monarch drug that benefit is defended consolidating superficial resistance.With Rhizoma Atractylodis Macrocephalae (parched) and middle QI invigorating, strengthening superficial resistance to stop perspiration; Sweet the providing additional supplies of Poria oozed spleen-benefiting mind-tranquilizing; The Radix Panacis Quinquefolii using tonifying Qi reinforcing lungs promotes the production of body fluid, and is ministerial drug altogether.Hot loose with Radix Saposhnikoviae, can prevent the ailment said due to cold or exposure invasion and attack; The Rhizoma Polygonati nourishing the lung and kidney, invigorating the spleen and replenishing QI more has the wonderful of YANG promoting growth while YIN promoting generation, is adjuvant drug altogether.The hot warm circulation of qi promoting of the Radix Aucklandiae can make the product benefit of all tonifications and oiliness, for making medicine.
By the mentioned above principle prescription, make Pharmaceutical composition of the present invention have benefiting QI for strengthening the superficies, the main effect of allaying tiredness.
Another object of the present invention provides a kind of preparation method of preventing and treating the Pharmaceutical composition of confirmed fatigue.
Concrete technical scheme is as follows:
A kind of preparation method of preventing and treating the Pharmaceutical composition of confirmed fatigue may further comprise the steps:
(1) take by weighing in proportion Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Radix Panacis Quinquefolii, Poria, Radix Saposhnikoviae, Rhizoma Polygonati, the Radix Aucklandiae totally 7 kinds of crude drugs, immersion is for subsequent use half an hour after cleaning;
(2) boil extraction 3 times, each 1-3 hour with adding 6-10 times of distilled water in the crude drug after soaking in the step (1) and the soak input extraction pot;
(3) extracting solution that step (2) is obtained merges, filters, and gets filtrate;
(4) filtrate decompression that step (3) is obtained is concentrated, namely gets the Pharmaceutical composition of concentrated solution type, and the relative density during 80 ℃ of described concentrated solutions is 1.15-1.25.
Preferably, described preparation method also comprises the steps:
The concentrated solution that obtains in the step (4) is carried out spray granulation, and the process conditions of described spray granulation are: the dry materials temperature is 85-100 ℃; Atomizing pressure is 0.1-0.3MPa; The spraying frequency is 7.5-9.5Hz, and concentrated solution is passed through the agent of spray granulation equipment granulation according to above-mentioned process conditions, namely gets granule dosage form Pharmaceutical composition.
Preferably, the preparation method of described Pharmaceutical composition may further comprise the steps:
(1) take by weighing in proportion Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Radix Panacis Quinquefolii, Poria, Radix Saposhnikoviae, Rhizoma Polygonati, the Radix Aucklandiae totally 7 kinds of crude drugs, immersion is for subsequent use half an hour after cleaning;
(2) boil extraction 3 times, each 2 hours with adding 8 times of distilled water in the crude drug after soaking in the step (1) and the soak input extraction pot;
(3) extracting solution that step (2) is obtained concentrates, filters;
(4) filtrate decompression that step (3) is obtained is concentrated, and relative density is 1.15 concentrated solution when getting 80 ℃;
(5) concentrated solution that obtains in the step (4) is carried out spray granulation, the process conditions of described spray granulation are: the dry materials temperature is 85 ℃; Atomizing pressure is 0.1MPa; The spraying frequency is 7.5Hz, and concentrated solution is passed through the agent of spray granulation equipment granulation according to above-mentioned process conditions, namely gets granule dosage form Pharmaceutical composition.
Advantage of the present invention and good effect:
1, Pharmaceutical composition of the present invention consist of the natural Chinese medicines plant amedica, without animal kind medicine thing such as whip class, Trionyx sinensis Wiegmann class, fur seal etc., do not contain hormone and chemosynthesis class medicine, effective through experiment and clinical research confirmation, do not find toxic and side effects.
2, Pharmaceutical composition of the present invention is take theory of Chinese medical science core Overall View as guidance, take people's whole factor as this, with invigorating the spleen and replenishing QI, eliminates the innovative idea of confirmed fatigue and develops health care medicine.So that the made sugar free granule of Pharmaceutical composition of the present invention through Preliminary Clinical Observation, has the effect of obvious elimination confirmed fatigue.
Description of drawings
Fig. 1 is the HPLC chromatogram of astragaloside control sample, pharmaceutical composition of the present invention (QI invigorating eliminating fatigue granule sample) and Radix Astragali negative sample;
Fig. 2 is 2 logarithm methods of astragaloside correction graph in the accuracy experiment;
Fig. 3 is that astragaloside is in the logarithm correction graph of 0.63-3.9 μ g scope;
Fig. 4 is 2 logarithm methods of astragaloside correction graph in the sample determination experiment.
The specific embodiment
Below in conjunction with embodiment, the present invention is further elaborated.
The described active component of preventing and treating the pharmaceutical composition (agent of QI invigorating eliminating fatigue granule) of confirmed fatigue of present embodiment is mainly made by following crude drug:
Radix Astragali Preparata 900 grams, Rhizoma Atractylodis Macrocephalae (parched) 450 grams, Radix Panacis Quinquefolii 240 grams, Poria 360 grams, Radix Saposhnikoviae 300 grams, Rhizoma Polygonati 450 grams, the Radix Aucklandiae 270 grams.
The preparation method of the described Pharmaceutical composition of present embodiment is as follows:
(1) take by weighing Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Radix Panacis Quinquefolii, Poria, Radix Saposhnikoviae, Rhizoma Polygonati, Radix Aucklandiae crude drug by above-mentioned weight, immersion is for subsequent use half an hour after cleaning;
(2) boil extraction 3 times, each 2 hours with adding 8 times of amount distilled water in the crude drug after soaking in the step (1) and the soak input extraction pot;
(3) extracting solution that step (2) is obtained merges, filters;
(4) filtrate decompression that step (3) is obtained is concentrated, and getting relative density is the concentrated solution of 1.15 (80 ℃ of mensuration);
(5) concentrated solution that obtains in the step (4) is added dextrin and make 900g, carry out spray granulation, the dry materials temperature is 85 ℃; Atomizing pressure is 0.1MPa; The spraying frequency is 7.5Hz, and concentrated solution is passed through the agent of spray granulation equipment granulation according to above-mentioned process conditions, namely gets granule dosage form Pharmaceutical composition.
(6) with moulding the packing of aluminum packer, every bag of 15g takes twice every day, each 1 bag.
Embodiment 2
The described active component of preventing and treating the pharmaceutical composition (agent of QI invigorating eliminating fatigue granule) of confirmed fatigue of present embodiment is mainly made by following crude drug:
Radix Astragali Preparata 840 grams, Rhizoma Atractylodis Macrocephalae (parched) 540 grams, Radix Panacis Quinquefolii 240 grams, Poria 420 grams, Radix Saposhnikoviae 240 grams, Rhizoma Polygonati 450 grams, the Radix Aucklandiae 330 grams.
The preparation method of the described Pharmaceutical composition of present embodiment is as follows:
(1) take by weighing Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Radix Panacis Quinquefolii, Poria, Radix Saposhnikoviae, Rhizoma Polygonati, Radix Aucklandiae crude drug by above-mentioned weight, immersion is for subsequent use half an hour after cleaning;
(2) boil extraction 3 times, each 1 hour with adding 6 times of distilled water in the crude drug after soaking in the step (1) and the soak input extraction pot;
(3) extracting solution that step (2) is obtained merges, filters;
(4) filtrate decompression that step (3) is obtained is concentrated, namely gets the Pharmaceutical composition of concentrated solution type, and the relative density of described concentrated solution is 1.20;
(5) concentrated solution that obtains in the step (4) is added dextrin and make 900g, carry out spray granulation, the dry materials temperature is 85 ℃; Atomizing pressure is 0.1MPa; The spraying frequency is 7.5Hz, and concentrated solution is passed through the agent of spray granulation equipment granulation according to above-mentioned process conditions, namely gets granule dosage form Pharmaceutical composition;
(6) with moulding the packing of aluminum packer, every bag of 15g takes twice every day, each 1 bag.
Embodiment 3
The described active component of preventing and treating the pharmaceutical composition (agent of QI invigorating eliminating fatigue granule) of confirmed fatigue of present embodiment is mainly made by following crude drug:
Radix Astragali Preparata 960 grams, Rhizoma Atractylodis Macrocephalae (parched) 390 grams, Radix Panacis Quinquefolii 180 grams, Poria 300 grams, Radix Saposhnikoviae 360 grams, Rhizoma Polygonati 390 grams, the Radix Aucklandiae 210 grams.
The preparation method of the described Pharmaceutical composition of present embodiment is as follows:
(1) take by weighing Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Radix Panacis Quinquefolii, Poria, Radix Saposhnikoviae, Rhizoma Polygonati, Radix Aucklandiae crude drug by above-mentioned weight, immersion is for subsequent use half an hour after cleaning;
(2) boil extraction 3 times, each 3 hours with adding 10 times of distilled water in the crude drug after soaking in the step (1) and the soak input extraction pot;
(3) extracting solution that step (2) is obtained merges, filters;
(4) filtrate decompression that step (3) is obtained is concentrated, gets relative density and be 1.25 concentrated solution;
(5) concentrated solution that obtains in the step (4) is added dextrin and make 900g, carry out spray granulation, the dry materials temperature is 100 ℃; Atomizing pressure is 0.3MPa; The spraying frequency is 9.5Hz, and concentrated solution is passed through the agent of spray granulation equipment granulation according to above-mentioned process conditions, namely gets granule dosage form Pharmaceutical composition;
(6) with moulding the packing of aluminum packer, every bag of 15g takes twice every day, each 1 bag.
Embodiment 4
The described active component of preventing and treating the pharmaceutical composition (agent of QI invigorating eliminating fatigue granule) of confirmed fatigue of present embodiment is mainly made by following crude drug:
Radix Astragali Preparata 900 grams, Rhizoma Atractylodis Macrocephalae (parched) 450 grams, Radix Panacis Quinquefolii 300 grams, Poria 360 grams, Radix Saposhnikoviae 330 grams, Rhizoma Polygonati 540 grams, the Radix Aucklandiae 270 grams.
The preparation method of the described Pharmaceutical composition of present embodiment is as follows:
(1) take by weighing Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Radix Panacis Quinquefolii, Poria, Radix Saposhnikoviae, Rhizoma Polygonati, Radix Aucklandiae crude drug by above-mentioned weight, immersion is for subsequent use half an hour after cleaning;
(2) boil extraction 3 times, each 2 hours with adding 7 times of distilled water in the crude drug after soaking in the step (1) and the soak input extraction pot;
(3) extracting solution that step (2) is obtained merges, filters;
(4) filtrate decompression that step (3) is obtained is concentrated, and getting relative density is the concentrated solution of 1.20 (80 ℃ of mensuration);
(5) concentrated solution that obtains in the step (4) is added dextrin and make 900g, carry out spray granulation, the dry materials temperature is 90 ℃; Atomizing pressure is 0.2MPa; The spraying frequency is 8.5Hz, and concentrated solution is passed through the agent of spray granulation equipment granulation according to above-mentioned process conditions, namely gets granule dosage form Pharmaceutical composition;
(6) with moulding the packing of aluminum packer, every bag of 15g takes twice every day, each 1 bag.
Embodiment 5: pharmacodynamics test
Macao University of Science and Technology's hospital clinical is observed:
1. inclusive criteria:
(1) meet the diagnostic criteria of present subhealth state, but under fatigue, weakness, the soreness of waist, the vigor degradation as main manifestations;
(2) previously without system's organic diseases such as circulation, breathing, digestion, urinary system, endocrine, and through the normal person of physical examination;
(3) being ready to accept research observes
(4) age was at 25～55 years old;
(5) tired relevant scoring 〉=45 minute.
2. exclusion standard:
(1) is diagnosed as on inspection chronic fatigue syndrome, digestive system disease, respiratory system disease, anxiety-depression mental sickness and other diseases person;
(2) just the drug administration person;
(3) the acute medical history persons such as diseases caused by exogenous pathogenic factor, wound were arranged in nearly 1 month;
(4) gestation and women breast-feeding their children.
3. culling level:
(1) do not finish according to plan the experimenter because of certain reason;
(2) the infull person of observed and recorded;
(3) because of the untoward reaction interrupter, do not include the curative effect statistics in, but include untoward reaction and the rate statistics of spreading pesticides in.
4. Informed Consent Form:
The sub-health state volunteer that all accept this clinical research all signs informed consent sheet.
5. clinical observation flow process:
By this seminar collection, provide individual and the newspaper approach such as publish an article, recruit the tested volunteer of confirmed fatigue sub-health state.After the volunteer comes this hospital, get health check-up table, health check-up to MEC by the reception personnel after registering, clinician and medical fitness person sign Informed Consent Form, carry out questionnaire, open the health care medicine prescription, then provide health care medicine (QI invigorating eliminating fatigue granule) by the special messenger.Carry out phone with examining by the clinician afterwards, the clinician takes health care medicine to the experimenter and returns institute's questionnaire after 30 days, fills in tested qualified paper, sends the special messenger with the tested qualified paper of clinician's signature, and the experimenter signs to provide and thanks with a gift gold.
Observe oral QI invigorating eliminating fatigue granule (preparing the gained pharmaceutical composition by embodiment 1 method) 23 examples
Instructions of taking is: each 1 bag sooner or later, and warm boiled water, 30 days is 1 course for the treatment of.
6. observation index:
Because medical circle is to the diagnostic assessment of subhealth state at present, also neither one unified, the recognized standard, the resulting related data of sub-health state Epidemiological study that we do according to related documents and our early stage, formulated sub-health state clinical evaluation scale, for scale each group effect has been passed judgment on.The intensity of variation of fatigue, energy, vigor, work efficiency aspect before and after main observation experimenter takes medicine;
7. untoward reaction
Untoward reaction refers to that the uncomfortable reaction of body or side effect appear in the experimenter in drug administration process, and no matter whether whether they relevant with drug administration.Be divided into:
0 grade: do not have untoward reaction;
1 grade: slight, need not to process;
2 grades: moderate, symptom is more obvious, need take medicine or other processing;
3 grades: severe needs to be in hospital and processes.
8. observed result:
Clinical research shows that pharmaceutical composition of the present invention (QI invigorating eliminating fatigue granule) can obviously improve the relevant performance of fatigue of sub-health state, wherein feel fatigue (p＜0.001), easily tired (P＜0.001), listless (p＜0.001), energy are not concentrated (p＜0.001) performance, effect highly significant; Doze off daytime (P＜0.01), work efficiency low (P＜0.01), 3 performances of limbs fatigue (p＜0.01), effect is remarkable.Show the symptoms such as this drug regimen has obvious elimination experimenter's the fatigue that is easy to, and energy is not concentrated, and is weak.Specifically see Table 1.
Table 1 is prevented and treated confirmed fatigue pharmaceutical composition (QI invigorating eliminating fatigue granule) administration front and back efficacy analysis
Annotate: * * * P＜0.001 * * P＜0.01 * P＜0.05
Do not find untoward reaction in the whole observation process.
The pharmaceutical composition of embodiment 2-4 gained has also carried out identical test, and result of the test represents obviously to improve the relevant performance of fatigue of sub-health state, and whole process of the test is not all observed untoward reaction, and concrete test data omits.
Embodiment 6: preparation technology and the quality standard of preventing and treating the Pharmaceutical composition (agent of QI invigorating eliminating fatigue granule) of confirmed fatigue
The method for making of imitation Chinese medicine decoction, hot water is extracted spray drying, dry granulation.
1. spray granulation technique:
(1) the spray granulation technological parameter is preferred:
Spray granulation claims again one-step method to granulate, be with the extractum oven dry, pulverize, granulate, numerous and diverse multistep operation such as dry merges into a step, have occupation of land less, production efficiency and automaticity be high, meet that GMP requires, high quality.According to knowhow and the pertinent literature of spray granulation, we select intuitively to reflect the spray granulation production efficiency of production efficiency and cost height, the evaluation index of the preferred spray granulation technique of finished particle recovery rate conduct.Considering main chemical compositions and the pharmacological component of the monarch drug Radix Astragali in the astragaloside side of being, also is the index components of this prescription particle content measuring; Therefore, select the rate of transform of astragaloside in the spray granulation process as the evaluation index of spray granulation optimal process.
1. equipment and material
PGL-120 type Fluidbedgranulatingdrier (drying equipment engineering company of wide summer of Chongqing), the infrared fast tester for water content of METTLER LJ16 (Switzerland's prunus mume (sieb.) sieb.et zucc. Teller maker), ten thousand/electronic balance sartoriusBP221S type (Germany), ultrasonic cleaner SK250H type (Shanghai High Kudos Science Instrument Co., Ltd.).
Dextrin (Fructus Vitis viniferae sugar refinery, Eastern Mountain, Dongguan).
2. factor level design
EXPERIMENTAL DESIGN adopts orthogonal experiment, according to production actual selection L9 (34) table extractum relative density, dry materials temperature, atomizing pressure and four factors of spraying frequency of affecting spray granulation technique are carried out orthogonal test (factor level sees Table 2), the optimum process condition of preferred spray granulation.Medical material is divided into three batches feeds intake by Radix Astragali Preparata 30 weight portions, Rhizoma Atractylodis Macrocephalae (parched) 15 weight portions, Radix Panacis Quinquefolii 8 weight portions, Poria 12 weight portions, Radix Saposhnikoviae 10 weight portions, Rhizoma Polygonati 15 weight portions, the Radix Aucklandiae 9 weight ratios, decoct with water respectively three times, 3 hours for the first time, second and third time each 2 hours; Collecting decoction filters; First medical material filtrate is concentrated into relative density to about 1.15 (80 ℃ of mensuration), and second batch filtrate is concentrated into relative density to 1.20 (80 ℃), and it is 1.25 (80 ℃) that the 3rd batch of filtrate is concentrated into relative density.Carry out respectively spray granulation by table 2 arrangement, each tested number repeats 3 times.
Table 2 factor level
(2) test method and result
The dextrin that has sieved is dropped on the airflow-distribution board of fluidized bed granulation chamber; start aerator; send into hot blast, make the dextrin preheating, after room temperature reaches predetermined dry materials temperature 3min; beginning spray concentration liquid; after spray granulation was finished, the unit that changes another same dried condition over to continued to make the grain fluidized water content that is dried to reach inner quality standard, shut down; discharging, granulate.The content of astragaloside in the sampling and measuring finished particle, and calculate the rate of transform of astragaloside in the finished particle, calculate finished particle recovery rate and production efficiency.
Finished particle recovery rate computational methods:
The result of spray granulation optimal process parameter shows: drug regimen be concentrated into 1.15 (80 ℃ of mensuration), the dry materials temperature is got 85 ℃, atomizing pressure is got 0.1MPa, spraying 7.5Hz, the content of astragaloside, the yield of granule, energy consumption, man-hours requirement is best.
2. quality standard
The Radix Astragali is the monarch drug of this composition of medicine, and ratio is maximum in composition of medicine.Astragaloside is that Nat'l Pharmaceutical ﹠ Biological Products Control Institute provides and the Radix Astragali quality control material of assert.This medicine adopts astragaloside as the assay project of this drug regimen.
Methodological study
(1) instrument and reagent
High performance liquid chromatograph: model: Agilent 1100
Detector: Allteach ELSD 2000ES
Chromatographic work station: Chemstation 10.02
Chromatographic column: Thermo ODS-2Hypersil (150mm * 4.6mm, 5 μ m)
Millipore demineralizer: milli-Q
Reagent: acetonitrile is chromatographically pure; Water is the Millipore deionized water; N-butyl alcohol, methanol are analytical pure.
Reference substance: astragaloside (lot number: 0781-200311, Nat'l Pharmaceutical ﹠ Biological Products Control Institute)
(2) preparation of need testing solution
According to the result of study of documents and materials, design prevents and treats the extracting method of astragaloside in the pharmaceutical composition (QI invigorating eliminating fatigue granule) of confirmed fatigue: 1. methanol ultrasonic-saturated n-butanol extraction-ammonia solution washing; 2. methanol Soxhlet extraction-saturated n-butanol extraction-ammonia solution washing method; 3. saturated n-butyl alcohol supersound extraction-ammonia solution washing method.
This experimental result shows: 1., 2. 3. the extraction efficiency of method all is higher than; Although 1. the operation of method is comparatively simple, quick, but its extraction ratio is lower than 2. method less, so 2. this paper finally selected method as the need testing solution preparation method of Determination of Astragaloside in the pharmaceutical composition of the present invention (QI invigorating eliminating fatigue granule), specific as follows:
Get this product, porphyrize is got 10g, and is accurately weighed, put in the apparatus,Soxhlet's, add methanol 100ml, reflux 4 hours, extracting solution reclaims solvent and is concentrated into dried, residue adds water 20ml, and slight fever makes dissolving, extracts 4 times with the water-saturated n-butanol jolting, each 40ml, merge n-butyl alcohol liquid, fully wash 2 times with ammonia solution, each 40ml, discard ammoniacal liquor, n-butyl alcohol liquid evaporate to dryness, residue is with dissolve with methanol and be transferred in the 5ml measuring bottle, add methanol to scale, shake up, and get final product.
(3) preparation of reference substance solution
It is an amount of that precision takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains astragaloside 0.15mg, and get final product.
(4) selection of chromatographic condition
With reference to " the content assaying method of astragaloside under Chinese pharmacopoeia (the 2005 editions an one) Radix Astragali item, practical situation in conjunction with this preparation, chromatographic condition is optimized, and the result shows: take octadecylsilane chemically bonded silica as filler, take acetonitrile-water (30: 70) as mobile phase; Evaporative light scattering detector: 105 ℃ of drift tube temperatures, carrier gas flux: 2.8L/min; Column temperature: 30 ℃, be separation condition, the sample baseline is steady, separating degree good and negative noiseless (result asks for an interview Fig. 1).So select above chromatographic condition as the analytical method of astragaloside in the pharmaceutical composition of the present invention (QI invigorating eliminating fatigue granule).
(5) method validation
(1) accuracy (recovery test)
Get Pharmaceutical composition (the QI invigorating eliminating fatigue granule sample lot number: 20100910) 6 parts of preventing and treating confirmed fatigue, every part of about 3.5g, accurately weighed, astragaloside reference substance solution (0.1569mg/ml) 5ml is got in every group of interpolation respectively successively, make need testing solution in accordance with the law, press chromatographic condition and measure, calculate recovery rate the results are shown in Table 3.
Table 3 recovery test result
Annotate: 2 logarithm methods of * checking list sees Table 4, and calibration trace is seen Fig. 2.
The response rate (%)=(measured quantity-sample size)/addition * 100%
2 logarithm methods of table 4 calibration trace table
Experiment shows: the response rate of method is good, is fit to the requirement of assay.
(2) precision
Get the Pharmaceutical composition of preventing and treating confirmed fatigue (QI invigorating eliminating fatigue granule sample lot number: 20100910) 6 parts, every part of about 10g, accurately weighed, prepare sample solution by " preparation of need testing solution " method, measure in accordance with the law, the results are shown in Table 5.
Table 5 replica test result
Experiment shows: the repeatability of method is good, is fit to the requirement of assay.
(3) specificity
Get the about 10g of Radix Astragali negative control, accurately weighed, make negative control solution with the preparation method of need testing solution, press chromatographic condition and measure, as a result feminine gender noiseless (result asks for an interview Fig. 1).
(4) linearity and the range of linearity
Get the mixing contrast solution under " preparation of reference substance solution " item, sample introduction 4,6,10,20,25 μ l record peak area respectively, and the logarithm of getting peak area and concentration value carries out linear regression.The results are shown in Table 6, Fig. 3
Table 6 astragaloside calibration trace result of calculation
The result shows: astragaloside log-linear relation in 0.63-3.9 μ g scope is good.
Astragaloside is seen Fig. 3 at the logarithm calibration trace of 0.63-3.9 μ g scope
(5) stability
Get the Pharmaceutical composition of preventing and treating confirmed fatigue (QI invigorating eliminating fatigue granule sample lot number: 20100910) about 10g, accurately weighed, prepare need testing solution in accordance with the law, the sample introduction successively at 0,12,15,18,30 hour respectively, the comparison peak area value the results are shown in Table 7.
Table 7 stability of solution measurement result
(6) sample determination
Get 12 batches of Pharmaceutical compositions (QI invigorating eliminating fatigue granule) preventing and treating confirmed fatigue, each 10g of scale sample is accurately weighed respectively, prepares need testing solution in accordance with the law, and sample introduction the results are shown in Table 8 respectively.
Table 8 is prevented and treated the middle Determination of Astragaloside result of Pharmaceutical composition (QI invigorating eliminating fatigue granule) of confirmed fatigue
Annotate: 2 logarithm methods of * checking list sees Table 9, and calibration trace is seen Fig. 4.
Computing formula:
2 logarithms of table 9 are proofreaied and correct the result
Experimental result shows: the 12 batches of Pharmaceutical compositions of surveying (QI invigorating eliminating fatigue granule sample), the content of astragaloside between 0.168-0.195mg/g, meansigma methods 0.183mg/g.Consider the impact that Radix Astragali changes of contents is large and production process is brought of separate sources in the pharmaceutical composition (QI invigorating eliminating fatigue granule), the tentative content of preventing and treating the middle astragaloside of pharmaceutical composition (QI invigorating eliminating fatigue granule) of confirmed fatigue must not be less than 0.10mg/g.
Embodiment 7: Toxicity enperiment
Prevent and treat the acute toxicity test in mice of the Pharmaceutical composition (agent of QI invigorating eliminating fatigue granule) of confirmed fatigue
Purpose: observe the prescription granule (being the Pharmaceutical composition of embodiment 1 gained) that the disposable gavage of mice gives the spray art preparation, the acute toxic reaction that produces and death condition are calculated LD
50Value and 95% credibility interval, or measure its maximum dosage-feeding, observe the toxicity situation of medicine.
(1) experiment material:
Medicine: prevent and treat the Pharmaceutical composition (every g is equivalent to the 1.63g crude drug) of confirmed fatigue,
Animal: Kunming mouse, body weight 18～22g, male and female half and half are raised three in advance to conform before the experiment.
Experiment mice is provided by Nanfang Medical Univ's Experimental Animal Center.
(2) LD
50Measure
Materials and methods (summary)
The animal grouping: get 60 of Kunming mouses, male and female half and half are by being divided at random 3 groups, 20 every group (10 heros, 10 female), each 2 the dosage group (high and low two dosage, Normal group) of granule of namely writing out a prescription.
The dosage design of medicine and the preparation of tested medicine: the prescription granule is established 2 dosage groups, is respectively 384g crude drug/Kg and 309g crude drug/kg, and dose ratio is 1: 0.8 between group.Isometric(al) is the isoconcentration gastric infusion not, and the administration volume is 0.4ml/10g (mice).In this test the prescription granule with normal saline dilution after, be modulated into respectively the suspension that can pass through the gavage syringe needle, Cmax is 9.6g crude drug/ml.Calculate by gavage 0.4ml/10g, the high dose that mice is accepted is 384g crude drug/Kg, and low dosage is the 309g crude drug.
Experimental technique: respectively organize mice fasting 12 hours before the administration, freely drink water.Design respectively the gavage granule of writing out a prescription by test dose, Normal group gives the equal-volume normal saline, observes immediately and record poisoning symptom and the death condition of animal after the administration, and dead animal is done postmortem, carries out histological examination if any abnormality.Observation period is two days.
Result of the test: in the administration six days mice without death, movable, look normal.Loose stool appears in mice after the administration, recovers afterwards normal in 1 day, urine amount and color, all normal by hair, the colour of skin, breathing, and nose, eye, oral cavity are without unusual secretions.
Table 10 prescription granule per os gastric infusion mice LD
50Mensuration
As seen, the pharmaceutical composition of preventing and treating confirmed fatigue does not measure LD
50
The prescription granule, the disposable maximum possible dosage that gives (behind the gastric infusion of 384g crude drug/kg), is observed 48 hours without dead mouse, also Non Apparent Abnormality.Prompting LD50 can't measure.Safety coefficient is high.
Experiment conclusion: the prescription granule that the disposable respectively gavage of mice is sprayed and prepared, through the LD of trial test prompting prescription granule
50All can't measure, carry out the maximum dosage-feeding test according to the pertinent regulations of " provisions for new drugs approval ".The result shows that the dosage of the mouse stomach administration maximum of prescription granule is crude drug 576g/Kg, is equivalent to 524 times of clinical dosage.Maximal dose owing to having given to give still can not cause the death of animal subject.Therefore, the prescription granule all can't be measured LD
50Under the gavage condition of maximum possible (injection volume with can by the mobile administration of gavage syringe needle) also not observe animal subject dead or unusually obvious.Prompting, the prescription granule is not observed acute toxicity.
More than be for the specifying of possible embodiments of the present invention, but this embodiment limits claim of the present invention, allly do not break away from the equivalence that skill spirit of the present invention does and implement or change, all should be contained in the claim of the present invention.
Claims (6)
1. Pharmaceutical composition of preventing and treating confirmed fatigue, it is characterized in that the active component of described Pharmaceutical composition is mainly made by following weight portion raw material: Radix Astragali Preparata 28-32 part, Rhizoma Atractylodis Macrocephalae (parched) 13-17 part, Radix Panacis Quinquefolii 6-10 part, Poria 10-14 part, Radix Saposhnikoviae 8-12 part, Rhizoma Polygonati 13-17 part, Radix Aucklandiae 7-11 part.
2. Pharmaceutical composition according to claim 1, it is characterized in that the active component of described Pharmaceutical composition is mainly made by following weight portion raw material: 30 parts of Radix Astragali Preparatas, 15 parts of Rhizoma Atractylodis Macrocephalae (parched)s, 8 parts of Radix Panacis Quinquefoliis, 12 parts in Poria, 10 parts of Radix Saposhnikoviaes, 15 parts of Rhizoma Polygonatis, 9 parts of the Radix Aucklandiae.
3. Pharmaceutical composition according to claim 1 and 2 is characterized in that, the medicine that described Pharmaceutical composition is made is sugar free granule.
4. a method for preparing each described Pharmaceutical composition of claim 1-3 is characterized in that, may further comprise the steps:
(1) take by weighing in proportion Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Radix Panacis Quinquefolii, Poria, Radix Saposhnikoviae, Rhizoma Polygonati, the Radix Aucklandiae totally 7 kinds of crude drugs, immersion is for subsequent use half an hour;
(2) boil extraction 3 times, each 1-3 hour with adding 6-10 times of distilled water in the crude drug after soaking in the step (1) and the soak input extraction pot;
(3) extracting solution that step (2) is obtained merges, filters, and gets filtrate;
(4) filtrate decompression that step (3) is obtained is concentrated, namely gets the Pharmaceutical composition of concentrated solution type, and the relative density during 80 ℃ of described concentrated solutions is 1.15-1.25.
5. preparation method according to claim 4 is characterized in that, described preparation method also comprises the steps:
The concentrated solution that obtains in the step (4) is carried out spray granulation, and the process conditions of described spray granulation are: the dry materials temperature is 85-100 ℃; Atomizing pressure is 0.1-0.3MPa; The spraying frequency is 7.5-9.5Hz, namely gets granule dosage form Pharmaceutical composition.
6. preparation method according to claim 5 is characterized in that, may further comprise the steps:
(1) take by weighing in proportion Radix Astragali Preparata, Rhizoma Atractylodis Macrocephalae (parched), Radix Panacis Quinquefolii, Poria, Radix Saposhnikoviae, Rhizoma Polygonati, the Radix Aucklandiae totally 7 kinds of crude drugs, immersion is for subsequent use half an hour;
(2) boil extraction 3 times, each 2 hours with adding 8 times of distilled water in the crude drug after soaking in the step (1) and the soak input extraction pot;
(3) extracting solution that step (2) is obtained concentrates, filters;
(4) filtrate decompression that step (3) is obtained is concentrated, and relative density is 1.15 concentrated solution when getting 80 ℃;
(5) concentrated solution that obtains in the step (4) is carried out spray granulation, the preferred processing condition of described spray granulation is: the dry materials temperature is 85 ℃; Atomizing pressure is 0.1MPa; The spraying frequency is 7.5Hz, and concentrated solution is passed through the agent of spray granulation equipment granulation according to above-mentioned process conditions, namely gets granule dosage form Pharmaceutical composition.
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| CN1712063A (en) * | 2005-07-15 | 2005-12-28 | 卫永生 | Compound Chinese medicinal preparation for treating chronic effort syndrome |
| CN101019921A (en) * | 2006-02-15 | 2007-08-22 | 李佳旺 | Medicine composition for invigorating spleen and benefiting lung |
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