CN106334032A - Oral liquid for improving immunity - Google Patents
Oral liquid for improving immunity Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention provides an oral liquid for improving immunity. Main aw materials are made of traditional Chinese medicine raw materials as foods and drugs, barbary wolfberry fruit, Chinese dates and hawthorn are taken as main drugs, poria cocos, lentinula edodes, flammulina velutipes and white fungus serve as adjuvants, a main ingredient is crude polysaccharide. According to a process, after water extraction concentration is performed, production is performed according to a technological process of an ordinary oral liquid. The process comprises extraction, concentration, cold storage standing, mixing and constant volume, filtration, encapsulation, sterilization, light inspection and packaging. According to the oral liquid, scientific combination is performed, an ideal control effect can be achieved, and the oral liquid is safe, simple and convenient in manufacturing process, has no toxic or side effect and is convenient to administrate, easy to manufacture and low in cost.
Description
Technical field
The present invention relates to the field of Chinese medicines, particularly to a kind of oral liquid for enhance immunity and preparation method thereof.
Background technology
Immunity refers to the body identification of people and the function of exclusion antigenicity foreign body, and that is, body distinguishes oneself and oneself work(non-
Energy.Immune system is to resist the immunologic barrier of affect, by immune organs such as bone marrow, lymph node, tonsil, lymphoid tissues and
The immunocyte composition such as its lymphocyte producing and macrophage, their function is to remove the pathogen of invasion and attack human body at any time
Or foreign body, remove the Self substances of old and feeble degeneration.In a word, immune system can protect body from the stimulation of harmful substance, thus
Protection body is in the steady statue of a relative equilibrium.Once it is possible to there is disease in the multilated of this kind of balance.
The traditional Chinese medical science is particular about " preventive treatment of disease ".So-called " not disease " is exactly disease state, or the sign of certain disease, be qualitative change be disease
The quantitative change cumulative process of disease, that is, so-called sub-health state.Sub-health state is human body by " YIN and YANG in a relative equilibrium " to " negative and positive are lost
Adjust " in the dynamic process of starting stage, transitive state from health to disease, i.e. " not disease " state, that is, the traditional Chinese medical science " end disease
Front morbid state in " or latent morbid state.Often hypoimmunity in the people being in sub-health state, fatigue and weak, lassitude,
Absent minded, or even the change of the Physiological Psychology aspect such as agitation, hypomnesis.The serious moment is with stomachache, cardiopalmus etc.
Performance.
The traditional Chinese medical science think generation, development and the change of disease of disease be all due to human body with paathogenic factor good and evil struggle in just not
Enemy is evil, leads to the imbalance of YIN and YANG of body."Nei Jing" has the teaching of " being gathered of heresy, its gas must be empty ".Its gas must empty gas just refer to
It is healthy energy.The old maxim of " healthy energy deposit in, heresy can not be done " that is, can drive away when healthy energy is vigorous inside and outside pathogenic factor, safeguard being good for of human body
Health state；When the positive QI-insufficiency of human body, and the situation that immunologic function is defective or low, then not competent defendance body is strong
The responsibility of health, and there are various diseases.Healthy energy in Chinese medicine refers to human body and all goes well physiological function activity, and resists disease
The general performance of evil ability, is summarized as three function performances of modern immunity medical science: defence disease, from steady function, function for monitoring.
The method of enhance immunity is confined to give nutrition at present, community's energy enhance immunity from food；Temper body
Body enhance immunity, however from food picked-up energy come enhance immunity to prevent helpful, to adjust immunity low
Under patient not helpful, therefore research and develop a kind of absorb fast, the oral formulations of the enhancings enhance immunity of instant effect are necessity
's.
From retrieval existing document result from the point of view of, the medicine of most of enhance immunities is all based on controlling, medicine be all with
The preparation of plant, animal or raw mineral materials, such prescription drug is directed to has handed over the patient of hypoimmunity or as other
The ancillary drug of disease uses, however not one kind can good absorbing effect, there is the health-related product of preventing and treating dual function.
Content of the invention
The technical problem to be solved is, there is provided a kind of formula is simple, processing technology is easy, nontoxic secondary work
With and convenient drug administration, medicament is easily fabricated, with low cost, good absorbing effect, has the health-related new drug of preventing and treating dual function.
The primary raw material of the present invention is made up of the raw material of Chinese medicine of medicine-food two-purpose, with Fructus Lycii, Fructus Jujubae, Fructus Crataegi as principal agent, with
Poria, Lentinus Edodess, Flammulina velutiper (Fr.) Sing, Tremella are accessory drugss, and main component is crude polysaccharides, after process selection water extraction concentrates, according to typically oral
The technological process of liquid is processed producing.Process Route Planning is as follows: extraction → concentration → cold preservation standing → allotment, constant volume → mistake
Filter → embedding → sterilizing → lamp inspection → packaging；The present invention has carried out scientific compatibility, can reach preferable prevention effect, safety, system
Make simple process, have no toxic side effect, and convenient drug administration, medicament is easily fabricated, with low cost.
For solving above-mentioned technical problem, the invention provides the invention provides a kind of oral for enhance immunity
Liquid, its crude drug is with Fructus Lycii, Fructus Jujubae, Fructus Crataegi as principal agent, with Poria, Lentinus Edodess, Flammulina velutiper (Fr.) Sing, Tremella as accessory drugss, all medicines share
Correction gas, adjusts negative and positive to resist pathogenic factor, has QI and blood regulating, relieving restlessness that clears away heart-fire, Regulate the flow of vital energy Xie Yu, stomach function regulating are aid digestion, effect of foster the five internal organs,
Mainly for the sub-health population with hypoimmunity, improve and can effectively take into account whole body correlation while promoting extremities blood circulation not
Suitable, improve the quality of life of patient, also there is preventive effect, equal effect is significant, non-for patients such as fatiguabilities simultaneously
Often it is suitable for immunocompromised patients to take, especially diabeticss.
Side's solution is as follows: because human righteousness is oneself that sucked by the congenital essence-QI of kidney, the essence-QI from water and grain of spleen transporting and lung
So boundary's clearing heat in QI system is constituted, so, dirty close with immune relationship with kidney, spleen, lung three.Fructus Lycii returns liver and kidney channel.Nourishing the liver and kidney.Kidney is
" the congenital foundation ", " store essential substances gas ", can excite and promote the physiological activity of each histoorgan of whole body.The equal returns spleen of Lentinus Edodess, Fructus Jujubae, Fructus Crataegi
Warp, spleen is " the foundation of acquired constitution ", " source of generating QI and blood ", main transporting, system blood, and healthy energy power depends on the nourishing of spleen.Poria: return
Lung, spleen channel, lung governing qi, closes fur, main a surname sends out fall respectful.Fur is the table of the whole body, including skin, sweat gland, hair etc., can secrete
Perspiration, moistening skin, resist exopathogen.Energy surname dissipate defend gas to lung again, and lung a surname sends out normal gas of then defending and fills, and defends outer defence capability by force, machine
Body is not easy to being invaded by exogenous pathogen；Insufficiency of lung-QI is then declared and is sent out powerless, and exopathogen is taken advantage of a weak point and led to disease.And Lentinus Edodess, Flammulina velutiper (Fr.) Sing, Tremella are equal
The edible treasure commonly used at all times for China, nutrition, medical value are high, and contained polysaccharide component all can play the guarantor of enhancing immunity
Strong effect.In side, all medicines share has supplementary vitality of human body, clearing heat and relieving fidgetness, calms the nerves and allays excitement, play altogether nourishing the liver and kidney, invigorating the spleen and replenishing QI it
Effect, makes human body reach " healthy energy deposit in, heresy can not be done ".Each raw material all no incompatibility relations in side, the consumption symbol of Chinese crude drug
Close one each kind consumption lower limit of " Chinese Pharmacopoeia " version in 2010 claimed below.
The property of medicine of medicine selected by the present invention and pharmacology are respectively as follows:
Fructus Lycii:
[nature and flavor] are sweet, put down, enter liver, stomach two warp, simultaneous enter lung meridian；
[indication] the kidney invigorating and essence nourishing, nourishing the liver to improve visual acuity, blood-enriching tranquillizing, promoting the production of body fluid to quench thirst, nourishing the lung to arrest cough.Cure mainly: control middle dizziness due to wind pathogen
Dizzy, asthenia, all see blood disorder, blood of coughing, flaccidity, faint, contraction, disappear miasma, and wound is dry, seminal emission, reddish and whitish turbid urine, tinea pedis, the arthroncus of knee.
Fructus Jujubae:
[meridian distribution of property and flavor] is sweet, temperature, returns spleen, stomach；
[indication] invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.For spleen eating less, weak loose stool, woman hysteria.
Fructus Crataegi:
[nature and flavor] sour in the mouth, sweet, slightly warm in nature.
[indication] appetite-stimulating indigestion-relieving, the stagnant removing food stagnancy of change, promoting blood circulation to remove blood stasis, resolving sputum circulation of qi promoting.For the stagnant long-pending, lump in the abdomen of meat,
Abdominal distention feeling of fullness, stasis blocking stomachache, phlegm retention, have loose bowels, discharging fresh blood stool etc..
Poria:
[nature and flavor] sweet in the mouth, light, put down；GUIXIN, lung, spleen, kidney channel.
[indication] promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming；For edema oliguria, phlegm retention anti-dazzle nervous, spleen eating less, have loose bowels in loose stool,
Irritability, insomnia of palpitating with fear.
Lentinus Edodess:
Lentinus Edodess be rich in vitamin b group, ferrum, potassium, vitamin d former (change into vitamin d), sweet in the mouth after Exposure to Sunlight, mild-natured.Cure mainly
Loss of appetite, few gas is weak.
Flammulina velutiper (Fr.) Sing:
Flammulina velutiper (Fr.) Sing is cold in nature, sweet in the mouth, salty, has functions that tonifying liver, beneficial stomach, anticancer, cures mainly hepatopathy, gastrointestinal tract inflammation, bursts
The diseases such as infectionss, tumor.In Flammulina velutiper (Fr.) Sing, Zn content is higher, more helpful to prevention prostatic diseases.And Flammulina velutiper (Fr.) Sing is still
Hyperkalemia hyponatremia food, can prevent and treat hypertension, also beneficial to old people.
Tonifying liver, beneficial stomach, anticancer；Cure mainly the diseases such as hepatopathy, gastrointestinal tract inflammation, ulcer, carcinoma, Fructus Alpiniae Oxyphyllae.
Ion Absorption of Flammulina Velutipes vitamin containing b, vitamin c, carbohydrate, mineral, carotene, several amino acids, plant
Hemagglutinin, polysaccharide, taurine, eritadenine, sterol Radix Ophiopogonis, cell dissolving toxin, Flammulina velutipes cytotoxin etc..
Tremella:
Tremella sweet in the mouth, light, mild-natured, nontoxic, effect of existing spleen reinforcing appetizing, play the role of QI invigorating bowel relieving, nourishing YIN and moistening the lung again.
Body immunity can be strengthened, the tolerance to Radiotherapy chemotherapy for the tumor patient can be strengthened again.Tremella is rich in natural plant colloid,
Additional its has the effect of YIN nourishing, is can be with the good skin moistening food of long-term taking.
A kind of oral liquid for enhance immunity it is characterised in that in described Chinese medicine preparation various crude drug weight
Portion rate is: Fructus Lycii 25-35 part, Fructus Jujubae 15-25 part, Fructus Crataegi 15-25 part, Poria 5-15 part, Lentinus Edodess 25-35 part, Flammulina velutiper (Fr.) Sing
5-15 part, Tremella 5-15 part.
A kind of oral liquid for enhance immunity it is characterised in that in described Chinese medicine preparation various crude drug weight
Portion rate is: Fructus Lycii 28-32 part, Fructus Jujubae 18-22 part, Fructus Crataegi 18-22 part, Poria 8-12 part, Lentinus Edodess 28-32 part, Flammulina velutiper (Fr.) Sing
8-12 part, Tremella 8-12 part.
A kind of oral liquid for enhance immunity it is characterised in that in described Chinese medicine preparation various crude drug weight
Portion rate is: 30 parts of Fructus Lycii, 20 parts of Fructus Jujubae, 20 parts of Fructus Crataegi, 10 parts of Poria, 30 parts of Lentinus Edodess, 10 parts of Flammulina velutiper (Fr.) Sing, 10 parts of Tremella.
A kind of oral liquid for enhance immunity is it is characterised in that to prepare finished product method as follows:
Step 1, extracts, filters:
By formula proportion by Fructus Lycii, Fructus Jujubae, Fructus Crataegi cleans plus distilled water 100-200 part is soaked 2 hours, is ground with fiberizer
Become juice, be heated to boiling 10 minutes, filter and be cooled to room temperature, make extracting solution after purification standby；
Remaining medical material is put in multi-function extractor, adds appropriate water, soak 1 hour, extract 2 times, add 8 times every time
The water of amount, extraction time is 2.0h, and 200 mesh filter clothes crossed by medicinal liquid, and it is standby that 2 filtrates of merging are cooled to room temperature；
Step 2, concentrating under reduced pressure: it is placed in concentration tank after two kinds of standby filtrates are merged, concentration condition controls 60～
80 DEG C, vacuum 0.04～0.06mpa, it is concentrated into relative density 1.10 about (60 DEG C of surveys), obtain concentrated solution, standby；
Step 3, cold preservation stands: by concentrated solution, under the conditions of 4～10 DEG C, cold preservation stands more than 12 hours, extracts supernatant,
Standby；
Step 4, allotment, constant volume: supernatant is placed in preparing tank, plus purified water, to close to constant volume, adjusts solution ph
It is worth for 3.5～6.5, be further continued for adding purified water to constant volume scale in solution, stir；
Step 5, filters: solution is passed through pipeline and filters to flame filter press, be then fed into subsequent processing；
Step 6, embedding:
6.1 wash bottle
Check qualified empty bottle first to be cleaned with ultrasound wave, then rinsed 2 times with purified water, clean compressed air blows off, 150
DEG C dry；
6.2 wash bottle lids
Bottle cap is first slightly washed 1 time through drinking water, then with purified water fine purifiation 2 times, dries for 80～85 DEG C；
6.3 embedding
On filling machine, the loading amount requirement fill solution that props up by 20ml/, then gland, loading amount should control and is no less than
19.5ml, checks a content uniformity and gland compactness in every 30 minutes；The complete container containing of embedding installs, and puts neat, leads to
Cross transmission channels to deliver between sterilizing；
Step 7, sterilizing:
Semi-finished product after embedding are loaded in sterilizing cabinet, 115 DEG C of sterilizing 30min.After sterilizing terminates, after temperature drop, open
Open cabinet door, take out and be sterilized product, be placed on intermediate station and keep in；
Step 8, lamp inspection:
Under lamp inspection desk, viewing has free from admixture, foreign body, has or not leakage etc., if any exception it is necessary to choose.Pine must not be had to cover,
Split the phenomenons such as bottle, mildew, variable color；
Step 9, packaging, warehouse-in:
After every for semi-finished product labelling-on-bottle, mounted box, 8/box, every box puts a bag suction pipe；Vanning, packing；Treat that product inspection is closed
Warehouse-in formality is handled after lattice.
Dosage form selection advantage is as follows:
The selection of product forms needs the property from raw material, and the aspect such as production cost and the requirement to production technology is comprehensively examined
Consider.We are designed to oral liquid, have the advantage that
(1) advantage remaining decoction, effective ingredient equalizes, and absorbs fast, effective rapid；
(2) outward appearance is clean and tidy, is easy to take, easy to carry；
(3) in good taste, easily accepted；
(4) simple production process, maturation, quality controllable.
Specific embodiment:
Embodiment 1, formula: Fructus Lycii 25kg, Fructus Jujubae 15kg, Fructus Crataegi 15kg, Poria 5kg, Lentinus Edodess 25kg, Flammulina velutiper (Fr.) Sing 5kg,
Tremella 5kg；
Step 1, extracts, filters:
By formula proportion by Fructus Lycii, Fructus Jujubae, Fructus Crataegi cleans plus distilled water 100-200 part is soaked 1 hour, is ground with fiberizer
Become juice, be heated to boiling 10 minutes, filter and be cooled to room temperature, make extracting solution after purification standby；
Remaining medical material is put in multi-function extractor, adds appropriate water, soak 1 hour, extract 2 times, add 8 times every time
The water of amount, extraction time is 2.0h, and 200 mesh filter clothes crossed by medicinal liquid, and it is standby that 2 filtrates of merging are cooled to room temperature；
Step 2, concentrating under reduced pressure: it is placed in concentration tank after two kinds of standby filtrates are merged, concentration condition controls 60～
80 DEG C, vacuum 0.04～0.06mpa, it is concentrated into relative density 1.10 about (60 DEG C of surveys), obtain concentrated solution, standby；
Step 3, cold preservation stands: by concentrated solution, under the conditions of 4～10 DEG C, cold preservation stands more than 12 hours, extracts supernatant,
Standby；
Step 4, allotment, constant volume: supernatant is placed in preparing tank, plus purified water, to close to constant volume, adjusts solution ph
It is worth for 3.5～6.5, be further continued for adding purified water to constant volume scale in solution, stir；
Step 5, filters: solution is passed through pipeline and filters to flame filter press, be then fed into subsequent processing；
Step 6, embedding:
6.1 wash bottle
Check qualified empty bottle first to be cleaned with ultrasound wave, then rinsed 2 times with purified water, clean compressed air blows off, 150
DEG C dry；
6.2 wash bottle lids
Bottle cap is first slightly washed 1 time through drinking water, then with purified water fine purifiation 2 times, dries for 80～85 DEG C；
6.3 embedding
On filling machine, the loading amount requirement fill solution that props up by 20ml/, then gland, loading amount should control and is no less than
19.5ml, checks a content uniformity and gland compactness in every 30 minutes；The complete container containing of embedding installs, and puts neat, leads to
Cross transmission channels to deliver between sterilizing；
Step 7, sterilizing:
Semi-finished product after embedding are loaded in sterilizing cabinet, 115 DEG C of sterilizing 30min.After sterilizing terminates, after temperature drop, open
Open cabinet door, take out and be sterilized product, be placed on intermediate station and keep in；
Step 8, lamp inspection:
Under lamp inspection desk, viewing has free from admixture, foreign body, has or not leakage etc., if any exception it is necessary to choose.Pine must not be had to cover,
Split the phenomenons such as bottle, mildew, variable color；
Step 9, packaging, warehouse-in:
After every for semi-finished product labelling-on-bottle, mounted box, 8/box, every box puts a bag suction pipe；Vanning, packing；Treat that product inspection is closed
Warehouse-in formality is handled after lattice.
Embodiment 2, formula: Fructus Lycii 28kg, Fructus Jujubae 18kg, Fructus Crataegi 18kg, Poria 8kg, Lentinus Edodess 28kg, Flammulina velutiper (Fr.) Sing 8kg,
Tremella 8kg.
Preparation method is same as Example 1.
Embodiment 3, formula: Fructus Lycii 30kg, Fructus Jujubae 20kg, Fructus Crataegi 20kg, Poria 10kg, Lentinus Edodess 30kg, Flammulina velutiper (Fr.) Sing
10kg, Tremella 10kg.
Preparation method is same as Example 1.
Embodiment 4, formula: Fructus Lycii 32kg, Fructus Jujubae 22kg, Fructus Crataegi 22kg, Poria 12kg, Lentinus Edodess 32kg, Flammulina velutiper (Fr.) Sing
12kg, Tremella 12kg.
Preparation method is same as Example 1.
Embodiment 5, formula:
Fructus Lycii 35kg, Fructus Jujubae 25kg, Fructus Crataegi 25kg, Poria 15kg, Lentinus Edodess 35kg, Flammulina velutiper (Fr.) Sing 15kg, Tremella 15kg.
Preparation method is same as Example 1.
Treatment model case: Wang female patient women, 35 years old, driving school staff, feel fatigue throughout the year, weak,
Forgetful, brain is usually felt to swell, and goes to hospital to clap what problem slice, thin piece brain does not have yet, doctor allows and has a good rest, treatment: mouth
Take Chinese medicine oral liquid of the present invention, after 15 days, patient's symptom disappears, consolidate one month afterwards again, do not recur so far.
Treatment model case: patient Liu so-and-so, women, 30 years old.Work in bank after graduating from university, bright and new beautiful before people,
But it is very big that bank promotes pressure, usually has a sleepless night, one to evening, lies on a bed and how also cannot sleep peacefully, it is almost all Bearss daily
Opal, with the working of big eye pouch, work also tends to have error, poor appetite, can't have dinner, oral Chinese medicine oral liquid 20 of the present invention
Its symptom is obviously improved, and sleep is good, and the mental status is good, has consolidated one month afterwards again, so far not in recurrence.
Pharmacological toxicity is tested
1st, acute toxicity test
Application mouse carries out acute toxicity testing and shows: the Chinese medicine oral liquid of the Mouse oral gavage present invention, in 488.8g
Under crude drug/kg dosage, after administration, light activity minimizing in mice, recovers within 1 hour about normal, Continuous Observation 7 days after administration,
None animal dead, its overall health of patients, diet, to take the photograph water, urine and body weight increase all normal, test result indicate that: Mouse oral
The maximum dosage-feeding of the Chinese medicine oral liquid of the gavage present invention is 488.8g crude drug/kg/d (ld 50 ＞ 488.8g crude drug/kg).This
The Chinese medicine oral liquid daily clinical application total amount of invention is 0.1g crude drug/kg/d；By weighing machine, the Chinese medicine of the mouse stomach present invention
The dosis tolerata of preparation is 4888 times of clinical patient.Point out this medicine acute toxicity low, clinical application safety.
2nd, long term toxicity test
From sd rat, give the Chinese medicine preparation of the present invention of variable concentrations (18.0,6.0,2.0g crude drug/kg), daily
Once, continuous 90 days, 1/2 animal (male and female half and half) was killed in each group work in 24 hours after last dose to gavage, and remaining 1/2 animal continues to see
After examining 2 weeks, work is killed.The outward appearance of observation animal, general behavior, food ration, body weight change, latter 90 days of administration and drug withdrawal 2 during test
Zhou Jinhang hematology (rbc, hb, reticulocyte, plt, ct, wbc and classification) and blood biochemical (ast, alt, alp, glu,
Bun, crea, tp, t.bil, alb, chol), urine biochemistry, organ coefficient, the index checking such as histopathology.Result of the test table
Bright: invention formulation is good in high, medium and low dosage group animal general state, appearance sign, behavioral activity, food-intake and body weight
Increase change all without exception；Three dosage groups and matched group hematological examination, blood biochemical analysis, urine biochemical analysis are all normal
Scope, no significant difference between group；Each group main organs histopathological examination shows no obvious abnormalities.After These parameters are discontinued 2 weeks
Also have no change.This test dosage is respectively 180,60,20 times of clinical medicine dose, according to the result of the test present invention's
Chinese medicine preparation has no significant effect to rat in high, medium and low three dosage (18.0,6.0,2.0g crude drug/kg) administration in continuous 90 days,
No clear and definite toxicity target organ and sensitive indicator, convalescent period observes and also has no retardance toxic reaction, points out the Chinese medicine of the present invention
The dose safety of preparation clinical practice is higher.
3rd, animal local excitation test:
The allergic reaction on guinea pigs of invention formulation and Rat-rectum medication irritation test.Result shows: skin mistake
Quick test, high dose group 0.8g (medicated powder)/kg, low dose group 0.1g (medicated powder)/kg, it is respectively equivalent to intend clinical people's consumption
20 times, 2.5 times of [0.04g (medicated powder)/kg], through percutaneous drug delivery, are showed no animal and produce allergy；Rectal application zest
Test high dose group 5.0g (medicated powder)/kg, low dose group 3.2g (medicated powder)/kg, be respectively equivalent to intend clinical people's consumption 125,
80 times, observe the mucous membrane of rectum all no phenomenon such as hyperemia, edema, histopathologic examination and blank control group within the time of regulation
Relatively no significant difference, has no the obvious irritative response of appearance, its overall health of patients of Some Animals of every group of retention, body weight, exhales
Suction, circulation, central nervous system and extremity activity etc., equal Non Apparent Abnormality reaction.
Clinical data
1 object and method
1.1 subject patient 200, are randomly divided into matched group 5o example, male 35, female 15, treatment group 150, man 90,
Female 60, two groups of ages are all between 18-80 year.
1.2 diagnostic criterias are with reference to clinical manifestation:
Have a delicate constitution, malnutrition, lethargy, fatigue and weak, appetite reduce, sleep disorder.
1.3 Therapeutic Method treatment groups: take oral liquid of the present invention, take in three times within one day, a 10ml, treatment in seven days
Journey.
Matched group: transfusion: liquid of glucose, oral multi-vitamin and other health care medications；
1.4 efficacy assessment standards (1) clinical recovery: clinical symptoms, sign disappear, functional activity recovers normal, checks each
Item index is recovered.
(2) effective: symptom substantially mitigates.(3) effective: symptom mitigates slightly.(4) invalid: clinical symptoms, sign no change
Become.
I.5 statistical procedures carry out statistical analysiss using spss 12.0 software, and each group asks that mean compares using single factor test side
Difference is analysed, and group is asked and compared employing two-by-two.Inspection.P < 0.05 has significance for difference.
2 results
Matched group is fully recovered 22, accounts for 44%；Effective 11, account for 22%；Effective 8, account for 16%；No effect 9, accounts for 18%,
Total effective rate 82%.
Treatment group fully recovers 98, accounts for 65.33%；Effective 32, account for 21.33%；Effective 15, account for 10%；Invalid 5,
Account for 3.33%.Total effective rate accounts for 96.66%.
Through checking two groups of differences to have significance (p < o.05).
The determination process of outstanding feature composition of oral liquid of the present invention and foundation
This product is that each raw material is equal with Fructus Lycii, Lentinus Edodess, Fructus Jujubae, Fructus Crataegi, Poria, Flammulina velutiper (Fr.) Sing, Tremella for main formula material
Containing polysaccharide constituents.Herbal polysaccharide passes through activating macrophage, strengthens macrophages phagocytic capacity, improves nk cell and lak
Cell (LAK) activity, affects dendritic cell, promotes the aspects such as cytokine secretion to adjust body
Immunologic function【25】.Accordingly, it is determined that using crude polysaccharides as this product outstanding feature composition.
The science of Process Route Planning, product form and dosage form selection, reasonability, feasibility and foundation
Dosage form selection
The selection of product forms needs the property from raw material, and the aspect such as production cost and the requirement to production technology is comprehensively examined
Consider.We are designed to oral liquid, have the advantage that
(1) advantage remaining decoction, effective ingredient equalizes, and absorbs fast, effective rapid；
(2) outward appearance is clean and tidy, is easy to take, easy to carry；
(3) in good taste, easily accepted；
(4) simple production process, maturation, quality controllable.
Process Route Planning
The primary raw material of this product is Chinese crude drug and edible funguses class, and main component is crude polysaccharides, and process selection water extraction concentrates
Afterwards, it is processed producing according to the technological process of general oral liquid.Process Route Planning is as follows: extraction → concentration → cold preservation standing
→ allotment, constant volume → filtration → embedding → sterilizing → lamp inspection → packaging.
The research of 1 extraction process
The determination of 1.1 extraction times
Weigh 2 parts of the medical material of 1/10 formula ratio: Fructus Lycii 300g, Lentinus Edodess 300g, Fructus Jujubae 200g, Fructus Crataegi 200g, Poria
100g, Flammulina velutiper (Fr.) Sing 100g, Tremella 100g.Extracted by design, extracting solution carries out filtering, concentrates, after constant volume, survey respectively
The content of crude polysaccharides in every part of sample when extracting for fixed each time.
Result is as shown in table 1.
The crude polysaccharides content of the different extraction time of table 1
From upper table, with the increase of extraction time, crude polysaccharides content no substantially increases, when extracting third time, slightly
The numerical value that polysaccharide increases is even more less than second, from the aspect of shortening process time, energy saving cost, with selective extraction 2
Secondary for suitable.
1.2 Orthogonal Experiment and Design and interpretation of result
By consulting literatures, reference material, on the basis of determining extraction time, determine that the influence factor of water extraction has: leaching
Bubble time, extraction time, amount of water, we adopt l9(34) Orthogonal Experiment and Design, with crude polysaccharides content as index, investigate above-mentioned 3
The impact to extraction effect for the individual factor, studies to extraction process.Factor level arrangement is shown in Table 2.
Weigh 9 parts of the medical material of 1/10 formula ratio: Fructus Lycii 300g, Lentinus Edodess 300g, Fructus Jujubae 200g, Fructus Crataegi 200g, Poria
100g, Flammulina velutiper (Fr.) Sing 100g, Tremella 100g.Extracted by design, extracting solution carries out filtering, concentrates, after constant volume, survey respectively
The content of crude polysaccharides in fixed every part of sample.
Table 2 orthogonal test factor level table
Table 3 l9(34) orthogonal test scheme and analytical table directly perceived
Table 4 analysis of variance table
Note: f0.05(2,2)=19.00, f0.01(2,2)=99.00
From table 3, table 4, the orthogonal experiments with crude polysaccharides as evaluation index, be can determine whether by the size of extreme difference value r
The impact size going out three factors on test results is followed successively by c ＞ b ＞ a；Judged between each factor varying level by the size of average
Impact size be: a3＞ a2＞ a1, b2＞ b3＞ b1, c3＞ c2＞ c1；Optimal extraction conditions are a3b2c3, wherein c factor pair
Experiment has a significant impact (p ＜ 0.05), and a, b factor has no significant effect (p ＞ 0.05) to experiment.
According to above-mentioned analysis result, in conjunction with practical condition it is considered to reducing production cost, saving energy consumption, shorten production
The problems such as cycle, accordingly, it is determined that the extracting factor selecting is a2b2c3, that is, soak 1 hour, extract 2 times, add water 8 every time
Times, extract 2.0 hours.And can see from the data result of table 3, under this process conditions, the content of crude polysaccharides is highest.
2nd, pilot scale research
21st, pilot scale purpose
For investigating stability and the maturity of technique further, we on the basis of lab scale, by formula ratio expand into
Row feeds intake, and according to the process route drafted and operating procedure, has carried out three batches of pilot scale researches respectively, result see table:
Three batches of scale up test data of table
22nd, pilot-scale experiment
By to product pilot scale the result, every product quality indicator all meets company standard and requires, and yield rate all exists
More than 90%, meet regulation, production each operation is smooth, easy operational verification this product production technology is reasonable.
The Expected Results of oral liquid of the present invention is as follows:
1st, the Analysis of Development Prospect to product after launch products
Health product have regulation function of human body, salubrious function.Stepping up with people's living standard, to certainly
The healthy pay attention to day by day of body, increasingly heats up to the demand of health product, is that health investment has become as a kind of trend.In the market
Sell have enhancing immunity function health food species very many, enhancing immunity class product ranking health product sale list
First it is seen that people are very big to the demand of enhancing immunity class health food.Except vitamin and mineral are health care foods
Outside the conventional raw material of product, Chinese medicine, plant amedica increasingly occupy critical role in health food.The traditional Chinese medical science medication of Chinese tradition and
The way to keep in good health, have anti-, control combination, the advantage of few toxic and side effects, be increasingly subject in the world pay attention to, become in developed country
For a kind of fashion.My company is devoted to the research and development of Healthy relevant products, and this product is just located at the health care of enhancing immunity
Functionally, aim at immunocompromised person's design, the working condition of application modernization produces, and focuses on product quality, takes charge of by me
Promotional, inherently favored by consumer, wide market.
2nd, the Social benefit and economic benefit assessment of product
In the last few years, health products trade had developed rapidly becomes a unique industry, and health products trade certainly will will become
The economic new growing point of China and strategic industry, China's health products trade will enter the high speed development stage.Increase with economic high speed
Long, the health preserving consciousness of compatriots is constantly lifted, and health products trade welcomes the golden period of development.By the end of the year 2011, National Health Foods
The market output value has reached more than 200,000,000,000 yuan, and is still increased with annual 15% speed.During by 2015, pre-capita consumption reaches 300
Unit, the overall market capacity breaks through 450,000,000,000 yuan., every year more than hundred billion yuan, China's health-product market potentiality are huge for domestic health-product market
Greatly.1～December in 2011,3.83 hundred million dollars of Chinese health product import-export volume, rise 31.01% on year-on-year basis, wherein export amount 1.05
Hundred million dollars, increase by 26.21% on a year-on-year basis；2.78 hundred million dollars of import volume, increases by 38.28% on a year-on-year basis.Immunity is body disease resistance
Ability, after this product is put on market, health-product market will be enriched further, meet many big consumer demands；Improve China
The present situation of resident's hypoimmunity, promotes the development of China's health cause.Country and the medical expense of society can be reduced simultaneously,
Realize economic benefit and social benefit synchronized development.
All above-mentioned this intellectual properties of primary enforcement, do not set this new product of enforcement limiting other forms
And/or new method.Those skilled in the art will be using this important information, and the above is changed, to realize similar execution feelings
Condition.But, all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above, be only presently preferred embodiments of the present invention, is not the restriction that the present invention is made with other forms, appoints
What those skilled in the art possibly also with the disclosure above technology contents changed or be modified as equivalent variations etc.
Effect embodiment.But every without departing from technical solution of the present invention content, according to the present invention technical spirit to above example institute
Any simple modification, equivalent variations and the remodeling made, still falls within the protection domain of technical solution of the present invention.
Claims (3)
1. a kind of oral liquid for enhance immunity it is characterised in that in described Chinese medicine preparation various crude drug weight portion
Number ratio is: Fructus Lycii 25-35 part, Fructus Jujubae 15-25 part, Fructus Crataegi 15-25 part, Poria 5-15 part, Lentinus Edodess 25-35 part, Flammulina velutiper (Fr.) Sing 5-
15 parts, Tremella 5-15 part；
Oral liquor is as follows:
Step 1, extracts, filters:
By formula proportion by Fructus Lycii, Fructus Jujubae, Fructus Crataegi cleans plus distilled water 100-200 part is soaked 1 hour, wears into juice with fiberizer
Liquid, is heated to boiling 10 minutes, filters and is cooled to room temperature, makes extracting solution standby after purification；
Remaining medical material is put in multi-function extractor, adds appropriate water, soak 1 hour, extract 2 times, add 8 times amount every time
Water, extraction time is 2.0h, and 200 mesh filter clothes crossed by medicinal liquid, and it is standby that 2 filtrates of merging are cooled to room temperature；
Step 2, concentrating under reduced pressure: it is placed in concentration tank after two kinds of standby filtrates are merged, concentration condition controls at 60～80 DEG C,
Vacuum 0.04～0.06mpa, is concentrated into relative density 1.10 about (60 DEG C of surveys), obtains concentrated solution, standby；
Step 3, cold preservation stands: by concentrated solution, under the conditions of 4～10 DEG C, cold preservation stands more than 12 hours, extracts supernatant, standby；
Step 4, allotment, constant volume: supernatant is placed in preparing tank, plus purified water to close to constant volume, adjusting solution ph is
3.5～6.5, it is further continued for adding purified water to constant volume scale in solution, stir；
Step 5, filters: solution is passed through pipeline and filters to flame filter press, be then fed into subsequent processing；
Step 6, embedding:
6.1 wash bottle
Check qualified empty bottle first to be cleaned with ultrasound wave, then rinsed 2 times with purified water, clean compressed air blows off, 150 DEG C of bakings
Dry；
6.2 wash bottle lids
Bottle cap is first slightly washed 1 time through drinking water, then with purified water fine purifiation 2 times, dries for 80～85 DEG C；
6.3 embedding
On filling machine, the loading amount requirement fill solution that props up by 20ml/, then gland, loading amount should control no less than 19.5ml, often
Check a content uniformity and gland compactness within 30 minutes；The complete container containing of embedding installs, and puts neat, by transmission channels
Deliver between sterilizing；
Step 7, sterilizing:
Semi-finished product after embedding are loaded in sterilizing cabinet, 115 DEG C of sterilizing 30min.After sterilizing terminates, after temperature drop, open cabinet
Door, takes out and is sterilized product, is placed on intermediate station and keeps in；
Step 8, lamp inspection:
Under lamp inspection desk, viewing has free from admixture, foreign body, has or not leakage etc., if any exception it is necessary to choose.Must not there is pine lid, split
The phenomenons such as bottle, mildew, variable color；
Step 9, packaging, warehouse-in:
After every for semi-finished product labelling-on-bottle, mounted box, 8/box, every box puts a bag suction pipe；Vanning, packing；After product inspection is qualified
Handle warehouse-in formality.
2. a kind of oral liquid for enhance immunity according to claim 1 is it is characterised in that in described Chinese medicine preparation
The ratio of weight and number of various crude drug is: Fructus Lycii 28-32 part, Fructus Jujubae 18-22 part, Fructus Crataegi 18-22 part, Poria 8-12 part, perfume (or spice)
Mushroom 28-32 part, Flammulina velutiper (Fr.) Sing 8-12 part, Tremella 8-12 part.
3. a kind of oral liquid for enhance immunity according to claim 1 or 2 any one is it is characterised in that institute
The ratio of weight and number stating various crude drug in Chinese medicine preparation is: 30 parts of Fructus Lycii, 20 parts of Fructus Jujubae, 20 parts of Fructus Crataegi, 10 parts of Poria, perfume
30 parts of mushroom, 10 parts of Flammulina velutiper (Fr.) Sing, 10 parts of Tremella.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108041363A (en) * | 2017-12-13 | 2018-05-18 | 广州白云山汉方现代药业有限公司 | A kind of polysaccharide drink and its preparation process |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899068A (en) * | 2006-07-14 | 2007-01-24 | 李为国 | Mushroom and jujube tea and its producing method |
| CN102178235A (en) * | 2011-04-26 | 2011-09-14 | 无限极（中国）有限公司 | Health care food with spleen and stomach tonifying function and immunity enhancing function and preparation method thereof |
| CN104068398A (en) * | 2014-06-20 | 2014-10-01 | 广东长兴生物科技股份有限公司 | Health-care product with immunity enhancing function and preparation method thereof |
| CN105796697A (en) * | 2016-05-04 | 2016-07-27 | 武汉博海生物工程有限公司 | Oral liquid and preparation method thereof |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899068A (en) * | 2006-07-14 | 2007-01-24 | 李为国 | Mushroom and jujube tea and its producing method |
| CN102178235A (en) * | 2011-04-26 | 2011-09-14 | 无限极（中国）有限公司 | Health care food with spleen and stomach tonifying function and immunity enhancing function and preparation method thereof |
| CN104068398A (en) * | 2014-06-20 | 2014-10-01 | 广东长兴生物科技股份有限公司 | Health-care product with immunity enhancing function and preparation method thereof |
| CN105796697A (en) * | 2016-05-04 | 2016-07-27 | 武汉博海生物工程有限公司 | Oral liquid and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108041363A (en) * | 2017-12-13 | 2018-05-18 | 广州白云山汉方现代药业有限公司 | A kind of polysaccharide drink and its preparation process |
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