CN100438894C - Donky-hide bone-strengthening composition and its production method - Google Patents
Donky-hide bone-strengthening composition and its production method Download PDFInfo
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- CN100438894C CN100438894C CNB2004100464002A CN200410046400A CN100438894C CN 100438894 C CN100438894 C CN 100438894C CN B2004100464002 A CNB2004100464002 A CN B2004100464002A CN 200410046400 A CN200410046400 A CN 200410046400A CN 100438894 C CN100438894 C CN 100438894C
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Abstract
A donkey-hide gelatin bone-strengthening composition contains effective ingredients prepared by donkey-hide gelatin, oyster, medlar, radix astragali and dangshen and/or pharmaceutically acceptable adjuvant. Said composition possesses effects of the liver and kidney nourishing, essence making-up and bone strengthening, can cure primary osteoporosis and rickets. Furthermore, it also exerts functions of improving cell immunity, humoral immunity and non-specific immunity, is safe and convenient to admit.
Description
Technical field
The invention belongs to medicinal preparation and field of production thereof, is a kind of Colla Corii Asini bone strengthening compositions and production method thereof, and this compositions is specially adapted to treat rickets of child and primary osteoporosis.
Background technology
Primary osteoporosis and rickets of child all are common clinicals, frequently-occurring disease.Described according to the 60th to 63 page of a book of " Chinese bone injury " (the bright wrout iron of history is write for publication in 1996, Wang Luowei): person's osteoporosis sickness rate is 21% more than 50 years old; The person is 58% more than 60 years old; The person is 94% more than 70 years old; The person is 100% more than 80 years old.According to another＜railway medical science〉(published in 1997, Wu Xiaotao writes) page 3 is described to page 5, and the sickness rate of osteoporosis accounts for the first place in metabolic osteopathy, become China and to worldwide problem.Because the population ages trend is aging, number of the infected is in rising trend, the fracture of its merging, and serious harm people's health is called noiseless epidemic diseases by people; By the end of the year 1994, China aged sum reaches 1.1 hundred million, and wherein sufferers of osteoporosis face accounts for more than 25%; We yellow is one of ethnic group of the most easily suffering from, and rickets is not rare in department of pediatrics is clinical, and particularly meals its sickness rate of youngster of sharing the weal and woe together bad, that lack outdoor activities is higher.For the present multiselect of osteoporosis and rachitic treatment with calcium preparation class, activated vitamin D, estrogen etc., these medicines or because of side effect big, or take the initiation intercurrent disease for a long time, or cost an arm and a leg, or the definite and nonideal inadequately medicine of curative effect, and Chinese medicine is accumulating rich experience aspect treatment osteoporosis and the rickets, but it is less to require to form the new drug person in strict accordance with Chinese medicine.
Calcium is to constitute one of maximum element of human body, account for the 1.5-2.0% of human body body weight, as Chinese osteoporosis periodical publisher publish, as described in the 134th to 135 page of " basic research of calcium preparation and clinical practice " book of the honest and tolerant editor of Chinese institute of Rehabilitation Medicine Liu, calcium ion is closely related with the function of organs such as nerve, endocrine, circulation, digestion, urinary system, reproductive system, the minor variations of blood calcium, can directly influence the distribution of the inside and outside calcium concentration of cell, and even cause the change of a series of physiology and pathology, therefore, say that calcium is Source of life, inundue at all.According to Chinese osteoporosis periodical publisher publish, the 13rd to 15 page of " basic research of calcium preparation and clinical practice " book of the honest and tolerant editor of Chinese institute of Rehabilitation Medicine Liu be described: China belongs to low calcium and takes in country, find according to extensive dietary survey, 500 milligrams of China resident calcium intake every day less thaies are lower than middle 800 milligrams the standard of stipulating adult's every day of relevant nutrient meals recommended amounts standard (RDA) that China NI formulated in 1988; Present calcium preparation mainly contains following several, and the one, inorganic calcium salt mainly is a calcium carbonate etc., the 2nd, organic calcium, as calcium gluconate, citron calcium etc., the 3rd, natural origin calcium is as Concha Ostreae, bone mud, Margarita etc.; The factor that influences the calcium preparation bioavailability is more, and in a sense, the calcium preparation bioavailability is the synthesis result of some processes, is the function of dissolubility, digestion degree, trap, intake and age, endocrine and nutritional status; And existing calcium preparation all is single calsium supplement of replenishing the calcium, thereby makes the bioavailability of existing calcium preparation lower.
Summary of the invention
The invention provides a kind of Colla Corii Asini bone strengthening compositions.
The present invention also provides this Colla Corii Asini bone strengthening composition manufacturing method.
The present invention also provides the purposes of this Colla Corii Asini bone strengthening compositions at preparation treatment rickets of child or primary osteoporosis medicine.
Technical scheme of the present invention realizes by following measure:
Colla Corii Asini bone strengthening compositions of the present invention is made up of effective ingredient and/or acceptable accessories, and wherein said effective ingredient is to be made by the raw material of following consumption: 4 to 10% Colla Corii Asini, 2.9 to 4% Concha Ostreae, 15 to 25% Radix Rehmanniae Preparata, 10 to 20% Fructus Lycii, 15 to 25% Radixs Astragali and 10 to 20% Radix Codonopsis.
Wherein effective ingredient can preferably make by following step:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 10 times of ethanol of 60% to adding medical material gross weight, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, extracts medicinal liquid with the first step and merges, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 3rd step medicinal liquid;
In the 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid.
Wherein effective ingredient also can preferably make by following step:
The first step, the Concha Ostreae of getting aequum added 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filtered, and discarded residue, obtained the first step and extracted medicinal liquid;
Second step, get the Radix Astragali of aequum, add 5 to 10 times to adding medical material gross weight 60% ethanol, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, merges with first step extracting solution, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
The 3rd step, get Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating digestion 1.5 to 3 hours, incline and medicinal liquid, in medicinal residues, add 8 times again to the water of adding medical material gross weight, heating digestion 0.5 to 1 hour, inclining medicinal liquid and discards medicinal residues, extract medicinal liquid with second step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for the 3rd step and extract medicinal liquid under 20 ℃ to relative density of medicine liquid;
In the 4th step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 4th step medicinal liquid;
In the 5th step, the 3rd step was extracted medicinal liquid mix with the 4th step medicinal liquid.
Wherein effective ingredient also can preferred following step make:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating digestion 1.5 to 3 hours, incline and medicinal liquid, in medicinal residues, add 5 to 8 times again to the water of adding medical material gross weight, heating digestion 0.5 to 1 hour, inclining medicinal liquid and discards medicinal residues, extract medicinal liquid with the first step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 80 ℃ of control Colla Corii Asini solution temperatures, and the time is 0.5 to 1 hour, obtains the 3rd step medicinal liquid;
In the 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid.
The active ingredient of Colla Corii Asini bone strengthening compositions of the present invention can be made various dosage forms with acceptable accessories, as tablet, capsule, granule or oral liquid etc., preferred oral liquid.
If preparation oral liquid, adjuvant can be the conventional adjuvants of oral liquid, preferred preservative, correctives and water, the preferred sorbic acid of antiseptic wherein, correctives is preferably simple syrup, Mel or aspartame.
One of Colla Corii Asini bone strengthening composition manufacturing method of the present invention is to be undertaken by following step:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 10 times of ethanol of 60% to adding medical material gross weight, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, extracts medicinal liquid with the first step and merges, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 3rd step medicinal liquid;
In the 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid; And/or
In the 5th step, be prepared into various dosage forms with acceptable accessories.
Preferably with the admixing medical solutions heated and boiled 0.5 to 1.5 hour in the 4th step, the antiseptic, correctives and the moisturizing that add aequum are to Total Water, and the pH value of control solution is 4.0 to 6.0, filter then finished product.
The preferred sorbic acid of antiseptic wherein, correctives is preferably simple syrup, Mel or aspartame.
Two of Colla Corii Asini bone strengthening composition manufacturing method is to be undertaken by following step:
The first step, the Concha Ostreae of getting aequum added 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filtered, and discarded residue, obtained the first step and extracted medicinal liquid;
Second step, get the Radix Astragali of aequum, add 5 to 10 times to adding medical material gross weight 60% ethanol, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, merges with first step extracting solution, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
The 3rd step, get Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating digestion 1.5 to 3 hours, incline and medicinal liquid, in medicinal residues, add 8 times again to the water of adding medical material gross weight, heating digestion 0.5 to 1 hour, inclining medicinal liquid and discards medicinal residues, extract medicinal liquid with second step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for the 3rd step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 4th step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 4th step medicinal liquid;
The 5th step, the 3rd step was extracted medicinal liquid mix with the 4th step medicinal liquid, and/or
In the 6th step, be prepared into various dosage forms with acceptable accessories.
Preferably with the admixing medical solutions heated and boiled 0.5 to 1.5 hour in the 5th step, the antiseptic, correctives and the moisturizing that add aequum are to Total Water, and the pH value of control solution is 4.0 to 6.0, filter then finished product.
The preferred sorbic acid of antiseptic wherein, correctives is preferably simple syrup, Mel or aspartame.
Three of Colla Corii Asini bone strengthening composition manufacturing method is to be undertaken by following step:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating digestion 1.5 to 3 hours, incline and medicinal liquid, in medicinal residues, add 5 to 8 times again to the water of adding medical material gross weight, heating digestion 0.5 to 1 hour, inclining medicinal liquid and discards medicinal residues, extract medicinal liquid with the first step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid:
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 80 ℃ of control Colla Corii Asini solution temperatures, and the time is 0.5 to 1 hour, obtains the 3rd step medicinal liquid;
In the 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid; And/or
In the 5th step, be prepared into various dosage forms with acceptable accessories.
Preferably with the admixing medical solutions heated and boiled 0.5 to 1.5 hour in the 4th step, the antiseptic, correctives and the moisturizing that add aequum are to Total Water, and the pH value of control solution is 4.0 to 6.0, filter then finished product.
The preferred sorbic acid of antiseptic wherein, correctives is preferably one or more in simple syrup, Mel and the aspartame.
Colla Corii Asini bone strengthening oral liquid is to be made by following raw materials by weight percent: 4 to 10% Colla Corii Asini, 2.90 to 4% Concha Ostreae, 15 to 25% Radix Rehmanniae Preparata, 10 to 20% Fructus Lycii, 15 to 25% Radixs Astragali, 10 to 20% Radix Codonopsis, 0.1 to 0.25% sorbic acid, 10 to 15% simple syrup, 15 to 20% Mel, 0.20 to 0.30% aspartame and the water of surplus.
One of production method of this Colla Corii Asini bone strengthening oral liquid is to be undertaken by following step:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 10 times of ethanol of 60% to adding medical material gross weight, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, extracts medicinal liquid with the first step and merges, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 3rd step medicinal liquid;
The 4th step, second step was extracted medicinal liquid mixes with the 3rd step medicinal liquid, with admixing medical solutions heated and boiled 0.5 to 1.5 hour, Total Water was arrived in sorbic acid, simple syrup, Mel and aspartame and the moisturizing of adding aequum, control solution pH value be 4.0 to 6.0, filter then finished product.
Two of the production method of this Colla Corii Asini bone strengthening oral liquid is to be undertaken by following step:
The first step, the Concha Ostreae of getting aequum added 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filtered, and discarded residue, obtained the first step and extracted medicinal liquid;
Second step, get the Radix Astragali of aequum, add 5 to 10 times to adding medical material gross weight 60% ethanol, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, merges with first step extracting solution, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
The 3rd step, get Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating digestion 1.5 to 3 hours, incline and medicinal liquid, in medicinal residues, add 8 times again to the water of adding medical material gross weight, heating digestion 0.5 to 1 hour, inclining medicinal liquid and discards medicinal residues, extract medicinal liquid with second step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places 12 to 24 hours, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain the 3rd step extraction medicinal liquid under 20 ℃ to relative density of medicine liquid;
In the 4th step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 4th step medicinal liquid;
The 5th step, the 3rd step was extracted medicinal liquid mixes with the 4th step medicinal liquid, with admixing medical solutions heated and boiled 0.5 to 1.5 hour, Total Water was arrived in sorbic acid, simple syrup, Mel and aspartame and the moisturizing of adding aequum, control solution pH value be 4.0 to 6.0, filter then finished product.
Three of the production method of this Colla Corii Asini bone strengthening oral liquid is to be undertaken by following step:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating digestion 1.5 to 3 hours, incline and medicinal liquid, in medicinal residues, add 5 to 8 times again to the water of adding medical material gross weight, heating digestion 0.5 to 1 hour, inclining medicinal liquid and discards medicinal residues, extract medicinal liquid with the first step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 80 ℃ of control Colla Corii Asini solution temperatures, and the time is 0.5 to 1 hour, obtains the second step medicinal liquid;
The 4th step, second step was extracted medicinal liquid mixes with the 3rd step medicinal liquid, with admixing medical solutions heated and boiled 0.5 to 1.5 hour, Total Water was arrived in sorbic acid, simple syrup, Mel and aspartame and the moisturizing of adding aequum, control solution pH value be 4.0 to 6.0, filter then finished product.
Colla Corii Asini bone strengthening oral liquid of the present invention has the effect of liver and kidney tonifying and replenishing essence bone strengthening, can treat primary osteoporosis and rickets, and in addition, it also has cellular immunization, humoral immunization and the nonspecific immunity effect of raising, takes safe ready.
The specific embodiment
The present invention is not subjected to the restriction of following embodiment, can determine concrete embodiment according to technical scheme of the present invention and practical situation.
Below in conjunction with embodiment the present invention is further described:
Embodiment 1:
Colla Corii Asini bone strengthening oral liquid contains 4.00% Colla Corii Asini, 2.90% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 15% the Radix Astragali, 10% Radix Codonopsis, 0.15% sorbic acid and the water of surplus by weight percentage.
Embodiment 2:
Colla Corii Asini bone strengthening oral liquid contains 5.00% Colla Corii Asini, 4.00% Concha Ostreae, 20% Radix Rehmanniae Preparata, 15% Fructus Lycii, 20% the Radix Astragali, 15% Radix Codonopsis, 0.15% sorbic acid and the water of surplus by weight percentage.
Embodiment 3:
Colla Corii Asini bone strengthening oral liquid contains 10.00% Colla Corii Asini, 4.00% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 25% the Radix Astragali, 10% Radix Codonopsis, 0.15% sorbic acid and the water of surplus by weight percentage.
Embodiment 4:
Colla Corii Asini bone strengthening oral liquid contains 4.00% Colla Corii Asini, 4.00% Concha Ostreae, 20% Radix Rehmanniae Preparata, 20% Fructus Lycii, 20% the Radix Astragali, 10% Radix Codonopsis, 0.1% sorbic acid and the water of surplus by weight percentage.
Embodiment 5:
Colla Corii Asini bone strengthening oral liquid contains 10.00% Colla Corii Asini, 2.90% Concha Ostreae, 20% Radix Rehmanniae Preparata, 10% Fructus Lycii, 20% the Radix Astragali, 10% Radix Codonopsis, 0.15% sorbic acid and the water of surplus by weight percentage.
Embodiment 6:
Colla Corii Asini bone strengthening oral liquid contains 4.00% Colla Corii Asini, 2.90% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 20% the Radix Astragali, 10% Radix Codonopsis, 0.15% sorbic acid and the water of surplus by weight percentage.The production method of above-mentioned example 1 to 6 Colla Corii Asini bone strengthening oral liquid is carried out (four step rule) by following step:
The first step is got the Concha Ostreae of aequum and is put in the appropriate containers, adds 3 times of amounts or 4 times of amounts or 5 times of amount 50% or 60% or 70% or 80% lactic acid extraction 30 minutes or 45 minutes or 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, the Radix Astragali with aequum, Fructus Lycii, Radix Codonopsis, Radix Rehmanniae Preparata adds in the normal pressure extraction pot, add 5 times or 7 times or 10 times 60% ethanol to adding medical material gross weight, soak after 3 hours or 4 hours or 5 hours, heating and refluxing extraction 3 hours or 4 hours or 5 hours, incline and medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 times of amounts or 6 times of amounts or 8 times of amounts again, reflux, extract, 3 hours or 4 hours or 5 hours, inclining medicinal liquid and discards medicinal residues, extracts medicinal liquid with the first step and merges, placed 12 hours or 18 hours or 24 hours, filtering liquid medicine, and the ethanol in the released liquor are that 1.07 or 1.18 or 1.3 (20 ℃) obtain second step extraction medicinal liquid to relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 ℃ or 85 ℃ or 100 ℃ of control solution temperatures, and the time is 0.5 hour or 1 hour, obtains the 3rd step medicinal liquid;
The 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid, heated and boiled 0.5 hour or 1 hour or 1.5 hours, Total Water is arrived in the antiseptic sorbic acid and the moisturizing that add aequum, control solution pH value be 4.0 or 6.0, filter then finished product Colla Corii Asini bone strengthening oral liquid.
Embodiment 7:
Colla Corii Asini bone strengthening oral liquid contains 4.00% Colla Corii Asini, 2.90% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 15% the Radix Astragali, 10% Radix Codonopsis, 0.1% sorbic acid and the water of surplus by weight percentage.
Embodiment 8:
Colla Corii Asini bone strengthening oral liquid contains 5.00% Colla Corii Asini, 2.90% Concha Ostreae, 15% Radix Rehmanniae Preparata, 15% Fructus Lycii, 15% the Radix Astragali, 15% Radix Codonopsis, 0.1% sorbic acid and the water of surplus by weight percentage.
Embodiment 9:
Colla Corii Asini bone strengthening oral liquid contains 5.00% Colla Corii Asini, 4.00% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 15% the Radix Astragali, 10% Radix Codonopsis, 0.15% sorbic acid and the water of surplus by weight percentage.The production method of above-mentioned example 7 to 9 Colla Corii Asini bone strengthening oral liquids is carried out (five-step approach) by following step:
The first step is got the Concha Ostreae of aequum and is put in the appropriate containers, adds 3 times of amounts or 4 times of amounts or 5 times of amount 50% or 60% or 70% or 80% lactic acid extraction 30 minutes or 45 minutes or 60 minutes, filters, and discards residue, obtains the first step and extracts medicinal liquid;
Second step, the Radix Astragali of aequum is added in the normal pressure extraction pot, add 5 times or 7 times or 10 times 60% ethanol to adding medical material gross weight, soak after 3 hours or 4 hours or 5 hours, heating and refluxing extraction 3 hours or 4 hours or 5 hours, incline and medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 times of amounts or 6 times of amounts or 8 times of amounts again, reflux, extract, 3 hours or 4 hours or 5 hours, inclining medicinal liquid and discards medicinal residues, extracts medicinal liquid with the first step and merges, placed 12 hours or 18 hours or 24 hours, filtering liquid medicine, and the ethanol in the released liquor are that 1.07 or 1.18 or 1.3 (20 ℃) obtain second step extraction medicinal liquid to relative density of medicine liquid;
The 3rd step, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum are added in the normal pressure extraction pot, add 5 times or 6 times or 7 times or 8 times to the water of adding medical material gross weight, soak after 8 hours or 12 hours or 16 hours, heating digestion 1.5 hours or 2 hours or 2.5 hours or 3 hours, incline and medicinal liquid, in medicinal residues, add 8 times again to the water of adding medical material gross weight, heating digestion 0.5 hour or 1 hour, incline and medicinal liquid and discard medicinal residues, extract medicinal liquid with second step and merge, it is 1.20 to 1.60 (20 ℃) that concentrated medicament is put relative density; Adding ethanol is 60% to containing the alcohol amount, places 12 to 24 hours, and filtering liquid medicine, and the ethanol in the released liquor are that 1.07 to 1.3 (20 ℃) obtain the 3rd step extraction medicinal liquid to relative density of medicine liquid;
In the 4th step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 ℃ or 85 ℃ or 100 ℃ of control solution temperatures, and the time is 0.5 hour or 1 hour, obtains the 4th step medicinal liquid;
The 5th step, the 3rd step was extracted medicinal liquid mix with the 4th step medicinal liquid, heated and boiled 0.5 hour or 1 hour or 1.5 hours, Total Water is arrived in the antiseptic sorbic acid and the moisturizing that add aequum, control solution pH value be 4.0 or 6.0, filter then finished product Colla Corii Asini bone strengthening oral liquid.
Embodiment 10:
Colla Corii Asini bone strengthening oral liquid contains 4.00% Colla Corii Asini, 4.00% Concha Ostreae, 25% Radix Rehmanniae Preparata, 20% Fructus Lycii, 25% the Radix Astragali, 20% Radix Codonopsis, 0.25% sorbic acid and the water of surplus by weight percentage.
Embodiment 11:
Colla Corii Asini bone strengthening oral liquid contains 5.00% Colla Corii Asini, 4.00% Concha Ostreae, 25% Radix Rehmanniae Preparata, 20% Fructus Lycii, 25% the Radix Astragali, 20% Radix Codonopsis, 0.25% sorbic acid and the water of surplus by weight percentage.
Embodiment 12:
Colla Corii Asini bone strengthening oral liquid contains 10.00% Colla Corii Asini, 2.90% Concha Ostreae, 20% Radix Rehmanniae Preparata, 15% Fructus Lycii, 25% the Radix Astragali, 10% Radix Codonopsis, 0.25% sorbic acid and the water of surplus by weight percentage.
The production method of above-mentioned example 10 to 12 Colla Corii Asini bone strengthening oral liquids is carried out (four step rule) by following step:
The first step is got the Concha Ostreae of aequum and is put in the appropriate containers, adds 3 times of amounts or 4 times of amounts or 5 times of amount 50% or 60% or 70% or 80% lactic acid extraction 30 minutes or 45 minutes or 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum are added in the normal pressure extraction pot, add 5 times or 6 times or 7 times or 8 times to the water of adding medical material gross weight, soak after 8 hours or 12 hours or 16 hours, heating digestion 1.5 hours or 3 hours, incline and medicinal liquid, in medicinal residues, add 5 times or 6 times or 7 times or 8 times again to the water of adding medical material gross weight, heating digestion 0.5 hour or 1 hour, incline and medicinal liquid and discard medicinal residues, extract medicinal liquid with the first step and merge, it is 1.20 or 1.60 (20 ℃) that concentrated medicament is put relative density; Adding ethanol is 60% to containing the alcohol amount, places 12 hours or 18 hours or 24 hours, and filtering liquid medicine, and the ethanol in the released liquor are that 1.07 or 1.3 (20 ℃) obtain second step extraction medicinal liquid to relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 ℃ or 80 ℃ of control Colla Corii Asini solution temperatures, and the time is 0.5 hour or 1 hour, obtains the 3rd step medicinal liquid;
The 4th step, second step was extracted medicinal liquid mixes with the 3rd step medicinal liquid, heated and boiled 0.5 hour or 1.5 hours, Total Water is arrived in the antiseptic sorbic acid and the moisturizing that add aequum, the pH value of controlling solution is 4.0 or 6.0, filter then finished product Colla Corii Asini bone strengthening oral liquid.
Embodiment 13:
Colla Corii Asini bone strengthening oral liquid contains 4.00% Colla Corii Asini, 2.90% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 15% the Radix Astragali, 10% Radix Codonopsis, 0.15% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
Embodiment 14:
Colla Corii Asini bone strengthening oral liquid contains 5.00% Colla Corii Asini, 4.00% Concha Ostreae, 20% Radix Rehmanniae Preparata, 15% Fructus Lycii, 15% the Radix Astragali, 15% Radix Codonopsis, 0.15% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
Embodiment 15:
Colla Corii Asini bone strengthening oral liquid contains 10.00% Colla Corii Asini, 4.00% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 25% the Radix Astragali, 10% Radix Codonopsis, 0.15% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
The production method of above-mentioned example 13 to 15 Colla Corii Asini bone strengthening oral liquids is carried out (four step rule) by following step:
The first step is got the Concha Ostreae of aequum and is put in the appropriate containers, adds 3 times of amounts or 5 times of amount 50% or 60% or 70% or 80% lactic acid extraction 30 minutes or 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, the Radix Astragali with aequum, Fructus Lycii, Radix Codonopsis, Radix Rehmanniae Preparata adds in the normal pressure extraction pot, add 5 times or 7 times or 10 times 60% ethanol to adding medical material gross weight, soak after 3 hours or 5 hours, heating and refluxing extraction 3 hours or 5 hours, incline and medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 times of amounts or 6 times of amounts or 8 times of amounts again, reflux, extract, 3 hours or 5 hours, inclining medicinal liquid and discards medicinal residues, extracts medicinal liquid with the first step and merges, placed 12 hours or 18 hours or 24 hours, filtering liquid medicine, and the ethanol in the released liquor are that 1.07 or 1.3 (20 ℃) obtain second step extraction medicinal liquid to relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 ℃ or 85 ℃ or 100 ℃ of control solution temperatures, and the time is 0.5 hour or 1 hour, obtains the 3rd step medicinal liquid;
The 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid, heated and boiled 0.5 hour or 1.5 hours, the antiseptic, correctives and the moisturizing that add aequum are to Total Water, control solution pH value be 4.0 or 6.0, filter then finished product Colla Corii Asini bone strengthening oral liquid; Wherein, antiseptic is a sorbic acid, and correctives is simple syrup, Mel, aspartame.
Embodiment 16:
Colla Corii Asini bone strengthening oral liquid contains 4.00% Colla Corii Asini, 2.90% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 15% the Radix Astragali, 10% Radix Codonopsis, 0.1% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
Embodiment 17:
Colla Corii Asini bone strengthening oral liquid contains 5.00% Colla Corii Asini, 2.90% Concha Ostreae, 15% Radix Rehmanniae Preparata, 15% Fructus Lycii, 15% the Radix Astragali, 15% Radix Codonopsis, 0.1% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
Embodiment 18:
Colla Corii Asini bone strengthening oral liquid contains 5.00% Colla Corii Asini, 4.00% Concha Ostreae, 15% Radix Rehmanniae Preparata, 10% Fructus Lycii, 15% the Radix Astragali, 10% Radix Codonopsis, 0.15% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
The production method of above-mentioned example 16 to 18 Colla Corii Asini bone strengthening oral liquids is carried out (five-step approach) by following step:
The first step is got the Concha Ostreae of aequum and is put in the appropriate containers, adds 3 times of amounts or 5 times of amount 50% or 60% or 70% or 80% lactic acid extraction 30 minutes or 45 minutes or 60 minutes, filters, and discards residue, obtains the first step and extracts medicinal liquid;
Second step, the Radix Astragali of aequum is added in the normal pressure extraction pot, add 5 times or 8 times or 10 times to adding medical material gross weight 60% ethanol, soak after 3 hours or 5 hours, heating and refluxing extraction 3 hours or 5 hours, incline and medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 times of amounts or 6 times of amounts or 8 times of amounts again, reflux, extract, 3 hours or 5 hours, inclining medicinal liquid and discards medicinal residues, merges with first step extracting solution, placed 12 hours or 18 hours or 24 hours, filtering liquid medicine, and the ethanol in the released liquor are that 1.07 or 1.3 (20 ℃) obtain second step extraction medicinal liquid to relative density of medicine liquid;
The 3rd step, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum are added in the normal pressure extraction pot, add 5 times or 6 times or 8 times to the water of adding medical material gross weight, soak after 8 hours or 16 hours heating digestion 1.5 hours or 3 hours, incline and medicinal liquid, in medicinal residues, add 8 times again to the water of adding medical material gross weight, heating digestion 0.5 hour or 1 hour, inclining medicinal liquid and discards medicinal residues, extract medicinal liquid with second step and merge, it is 1.20 or 1.60 (20 ℃) that concentrated medicament is put relative density; Adding ethanol is 60% to containing the alcohol amount, places 12 hours or 18 hours or 24 hours, and filtering liquid medicine, and the ethanol in the released liquor are that 1.07 or 1.3 (20 ℃) obtain the 3rd step extraction medicinal liquid to relative density of medicine liquid;
In the 4th step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 ℃ or 85 ℃ or 100 ℃ of control solution temperatures, and the time is 0.5 hour or 1 hour, obtains the 4th step medicinal liquid;
The 5th step, the 3rd step was extracted medicinal liquid mixes with the 4th step medicinal liquid, heated and boiled 0.5 hour or 1 hour, Total Water is arrived in the antiseptic, correctives and the moisturizing that add aequum, the pH value of controlling solution is 4.0 or 6.0, filter then finished product Colla Corii Asini bone strengthening oral liquid; Wherein, antiseptic is a sorbic acid, and correctives is simple syrup, Mel, aspartame.
Embodiment 19:
Colla Corii Asini bone strengthening oral liquid contains 4.00% Colla Corii Asini, 4.00% Concha Ostreae, 25% Radix Rehmanniae Preparata, 20% Fructus Lycii, 25% the Radix Astragali, 20% Radix Codonopsis, 0.25% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
Embodiment 20:
Colla Corii Asini bone strengthening oral liquid contains 5.00% Colla Corii Asini, 4.00% Concha Ostreae, 25% Radix Rehmanniae Preparata, 20% Fructus Lycii, 25% the Radix Astragali, 20% Radix Codonopsis, 0.25% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
Embodiment 21:
Colla Corii Asini bone strengthening oral liquid contains 10.00% Colla Corii Asini, 2.90% Concha Ostreae, 20% Radix Rehmanniae Preparata, 15% Fructus Lycii, 25% the Radix Astragali, 10% Radix Codonopsis, 0.25% sorbic acid, 10.0% simple syrup, 15% Mel, 0.20% aspartame and the water of surplus by weight percentage.
The production method of the foregoing description 19 to 21 Colla Corii Asini bone strengthening oral liquids is carried out (four step rule) by following step:
The first step is got the Concha Ostreae of aequum and is put in the appropriate containers, adds 3 times of amounts or 4 times of amounts or 5 times of amount 50% or 60% or 70% or 80% lactic acid extraction 30 minutes or 45 minutes or 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum are added in the normal pressure extraction pot, add 5 times or 6 times or 7 times or 8 times to the water of adding medical material gross weight, soak after 8 hours or 16 hours, heating digestion 1.5 hours or 3 hours, incline and medicinal liquid, in medicinal residues, add 5 times or 6.5 times or 8 times again to the water of adding medical material gross weight, heating digestion 0.5 hour or 1 hour, incline and medicinal liquid and discard medicinal residues, extract medicinal liquid with the first step and merge, it is 1.20 or 1.60 (20 ℃) that concentrated medicament is put relative density; Adding ethanol is 60% to containing the alcohol amount, places 12 hours or 18 hours or 24 hours, and filtering liquid medicine, and the ethanol in the released liquor are that 1.07 or 1.3 (20 ℃) obtain second step extraction medicinal liquid to relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 ℃ or 80 ℃ of control Colla Corii Asini solution temperatures, and the time is 0.5 hour or 1 hour, obtains the second step medicinal liquid;
The 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid, heated and boiled 0.5 hour or 1.5 hours, the antiseptic, correctives and the moisturizing that add aequum are to Total Water, control solution pH value be 4.0 or 6.0, filter then finished product Colla Corii Asini bone strengthening oral liquid; Wherein, antiseptic is a sorbic acid, and correctives is simple syrup, Mel, aspartame.
Experimental example:It is as follows that the Colla Corii Asini bone strengthening oral liquid of embodiment 1 to 21 is carried out pharmacodynamics test:
The influence of 1. pairs of mices of experimental example " YANG asthenia disease ".
The LONGMU ZHUANGGU CHONGJI of producing with the strong people pharmaceutical factory of Colla Corii Asini bone strengthening oral liquid of the present invention and Wuhan compares test.Choose 100 of Kunming mouses, male and female half and half (body weight 20 ± 2g) is divided into 5 groups at random, 20 every group, be respectively matched group (the intramuscular injection normal saline, 0.1ml/20g); Model group (the intramuscular injection hydrocortisone, 125mg/kg, below respectively organize identical); The LONGMU ZHUANGGU CHONGJI group, 5g/kg irritates stomach, and Colla Corii Asini bone strengthening oral liquid group gavages 0.15,0.30 respectively, 0.45ml/10g.Continuous gastric infusion of mice and intramuscular injection hydrocortisone carried out an inspection such as body weight, body temperature and sexual organ, and measure serum Ca, P, ALP activity after two weeks.The result organizes a mean t check.As a result, Colla Corii Asini bone strengthening oral liquid does not all have reverse effect to " yang deficiency syndrome " mouse temperature, body weight, uterus weight, but can make testis, seminal vesicle weight of prostate apparently higher than model group.Model group serum calcium, phosphorus content are starkly lower than the NS group; 3 dosage groups of Colla Corii Asini bone strengthening oral liquid all make blood calcium, middle heavy dose make serum paraoxonase be significantly higher than model group.
2. pairs of oral retinoic acid of experimental example cause the preventive and therapeutic effect of rats with osteoporosis
Method and result: 60 of wistar male rats, body weight 180 ± 20g is divided into 6 groups at random; The normal saline matched group, model group (retinoic acid 70mg/kg gavages, every day 1 time, totally 2 weeks), LONGMU ZHUANGGU CHONGJI group (5g/kg), Colla Corii Asini bone strengthening oral liquid (1.0,2.0,3.0ml/200g3 dosage group gavages).Test group animal bushing is taken medicine outside the thing, gavages 2 weeks of retinoic acid simultaneously, withdraw retinoic acid after, continue 4 weeks of administration.Half an hour after the last administration, the tail vein is got the hematometry serum calcium, phosphorus and phosphatase activity.Get blood next day with rat with pentobarbital anesthesia after, take pictures through X-ray, observe and respectively organize the rat bony structures, the X-ray condition is 25mA, 50KV, 0.1s.Then put to death rat, strip bone position heart plasma light quantity instrument and measure bone calcium, phosphorus content.
As a result, Colla Corii Asini bone strengthening oral liquid and LONGMU ZHUANGGU CHONGJI all can make experimental osteoporosis rat femur and serum calcium, phosphorus content apparently higher than model group (p＜0.01), and the ALP vigor then descends, and promote pathological changes sclerotin bone density to recover.The X-ray sheet shows that the model group rat is compared than normal rats, degrees of osteoporotic occurs, and cortical bone is thin, and the spongy bone bone density reduces, and serves as obvious with vertebra, femur especially.Osteoporosis is respectively organized in medication in various degree improvement.
3. couples of D that are deficient in vitamin of experimental example cause the preventive and therapeutic effect of rickets rat
Method and result: take out to give birth to 60 of 20 days healthy wistar rats, the male and female dual-purpose is divided into 6 groups at random, is the NS matched group, the rickets model group, LONGMU ZHUANGGU CHONGJI group and Colla Corii Asini bone strengthening be little, in, heavy dose of group.Except that the normal control group was given the conventional raising of mixed feed, all the other each groups all improved vitamin D deficiency feedstuff lucifuge and raise, and respectively group gavages administration simultaneously.Rat tail vein was got blood in the 60th day, measured serum calcium, phosphorus and alkaline phosphatase activities, and took the photograph the X-ray sheet according to said method, measured rat femur calcium, phosphorus content.
As a result, Colla Corii Asini bone strengthening oral liquid can make rickets rat model serum calcium be higher than model group, especially when middle dosage.The X-ray sheet shows that model group has changes such as obvious osteomalacia, and administration group X-ray sheet has clear improvement.
Experimental example 4. Colla Corii Asini bone strengthening are to the influence of inflammation
(1) to the influence of rat chronic granuloma induced by implantation of cotton pellets
Method and result: get rat wistar 180 ± 20g, male and female dual-purpose, random packet, 8 every group.It is subcutaneous to be embedded in the rat armpit respectively with sterilized cotton ball 50mg2 piece, sew up wound thereafter, and operation awarded rats gavaged Colla Corii Asini bone strengthening 1.0ml the same day, 2.0ml, 3.0ml/200g and dexamethasone, once a day, continuous 8 days.Put to death rat, cut open and get cotton balls, baking is 12 hours in 60 ℃ of baking ovens, takes by weighing the granuloma dry weight after the oven dry.
As a result, the Colla Corii Asini bone strengthening in, can obviously reduce bullate weight when heavy dose of, but effect is significantly less than dexamethasone.
(2) to influence by the inductive chmice acute inflammation of carrageenin
Method and result: 50 of Kunming mouses (it is the same to originate) are divided into 5 groups, i.e. normal saline group, aspirin (Xinjiang pharmaceutical factory provides) group, 3 dosage groups of Colla Corii Asini bone strengthening at random.Gavage 7 days continuously, after last administration half an hour, in right back sufficient plantar subcutaneous injection 1% carrageenin of mice (institute of materia medica, Liaoning Province product) 0.05ml, measure the thickness of the sufficient sole of the foot of injection with micrometer, and measure left back sufficient sole of the foot thickness simultaneously and do contrast, represent the swelling degree with two parapodum sole of the foot thickness differences, measure to give behind the proinflammatory agent 4,8,16 hours swelling degree of the paw.
As a result, inflammation has obvious inhibitory action due to the Colla Corii Asini bone strengthening on Carrageenan of 3 dosage.
Experimental example 5. Colla Corii Asini bone strengthening oral liquids are to the influence by the inductive writhing response of acetic acid
Method and result: 50 of Kunming mouses (it is the same to originate), body weight 20 ± 2g, male and female dual-purpose.Be divided into aspirin (it is the same to originate) group, Colla Corii Asini bone strengthening (0.15 at random, 0.3,0.45ml/10g) and the normal saline group, irritated the stomach one-time continuous every day 7 days, after the last administration 1 hour, lumbar injection 10% acetic acid (is produced from the Beijing Chemical Plant, AR) 0.1ml, and that observes that mice is taken place in the 15min turns round the body number of times.
As a result, the Colla Corii Asini bone strengthening of 3 dosage causes the mouse writhing reaction to acetic acid the obvious suppression effect.
6. pairs of effect of immunologic function of experimental example
1. to the influence of the inductive mice of SRBC foot sole of the foot hair style allergy (DTH)
Material: the NIT mice, animal housing of endemic diseases epidemic research institute of Xinjiang Huashidan Pharmaceutical Co., Ltd provides.Dexamethasone sodium phosphate, Changzhou second pharmaceutical factory produces.Sheep red blood cell (SRBC) (SRBC) is from the sheep blood drawing autogamy of Xinjiang Medical College animal housing.Colla Corii Asini bone strengthening oral liquid, it is the same to originate.
Method and result: get 50 of NIH healthy mices, male and female dual-purpose, body weight 21.5 ± 1.8g are divided into the Colla Corii Asini bone strengthening oral liquid group of normal saline matched group (NS), dexamethasone positive controls and various dose at random according to body weight.Give the left back sufficient plantar subcutaneous injection of each group mice (sc) 10%SRBC suspension 50 immune mouses, the right back sufficient sole of the foot with the commensurability attack of method, with micrometer callipers is measured left and right sides metapedes sole of the foot thickness after 24 hours with SRBC after 4 days, represents the swelling degree with its thickness difference.Gastric infusion (ig), once a day, continuous 7 days, immunity was carried out in administration after 3 days.As a result, the Colla Corii Asini bone strengthening oral liquid of 3 dosage all makes the allergy of mice hair style strengthen to some extent, and middle the group with NS when heavy dose of relatively has statistical significance.
2. to the influence of mice serum IgG content
Material: NIH mice, Colla Corii Asini bone strengthening oral liquid are originated the same.Mice IgG standard substance and sheep anti-mouse igg serum are available from pre-Wei Ke bio-engineering corporation (homemade) in Beijing.The cyclophosphamide injection, Shanghai the 12nd pharmaceutical factory's product.
Method and result: get 50 of healthy NIH mices, the male and female dual-purpose, body weight 21 ± 2g is divided into the NS matched group at random according to the body weight equilibrium, the Colla Corii Asini bone strengthening oral liquid group of cyclophosphamide positive controls and 3 various dose.The ig administration, every day 1 time, continuous 8 days.After the last administration 2 hours, each Mus was extractd eyeball and gets blood and prepare serum.Get this serum 10 μ l according to unidirectional agar diffusion method, point sample is cultivated in the plate hole in the agar that contains sheep anti-mouse igg serum, and 37 ℃ of incubations 24 hours are measured the diameter (d) of immunoprecipitation circle.Under the same conditions, the standard curve of being done with mice standard I gG concentration (C) is: C=124.127d2-4343.1, r=0.9992.As a result, the Colla Corii Asini bone strengthening oral liquid of 3 various dose all can make mice serum IgG content increase.
3. to the influence of Turnover of Mouse Peritoneal Macrophages phagocytic function
Material: NIH mice, dexamethasone and Colla Corii Asini bone strengthening oral liquid source are the same.The RPMI-1640 culture medium, U.S. Life Techologies Inc product.New-born calf serum (NSC), produce in kind cattle farm, Xinjiang.[3H]-TdR, 740GBq/L, China Atomic Energy Science Research Institute produces.The Fructus Vins coccus, Xinjiang Medical College microorganism teaching and research room provides.G-49 type glass fiber filter, produce in HONGGUANG paper mill, Shanghai.Liquid glimmer instrument LKB-1217 type, Finland produces.96 porocyte culture plates, U.S.'s product.
Method and result: get 6 of NIH mices, aseptic condition is drawn peritoneal macrophage (PM), and is 3 * 106/ml with 15%NCS-1640 nutritional solution (including 15%NCS, HEPES20/L, NaHCO324mmol/L, Sodium Pyruvate 100mmol/L and each 100u/ml of penicillin and streptomycin) adjustment PM concentration.1640 nutritional solutions, the 100 μ l mixings of getting this cell suspension 100 μ l, Fructus Vins coccus liquid (λ=620nm place transfers A to 0.5,32 times of redilution with NS) 100 μ l and containing different dilution factor Colla Corii Asini bone strengthening oral liquids add in each hole of 96 orifice plates.Be divided into no PM group successively, normal saline matched group, the Colla Corii Asini bone strengthening oral liquid group of Dexamethasone group and 3 variable concentrations.37 ℃ of CO2 incubator incubations are after 1 hour, and every hole adds [3H]-TDR37KBq, continue incubation 1 hour.Filter membrane method is measured dpm.The result: various dose Colla Corii Asini bone strengthening oral liquid all can make PM engulf the raising of Fructus Vins coccus function.
Result: through the following drug effect of our experimentation Colla Corii Asini bone strengthening oral liquid tools: (1) has the part reverse effect to the symptom of mice that hydrocortisone is made a speech " yang deficiency syndrome " model, heavily is work with rising serum calcium, phosphorus and testis.(2) in the osteoporosis rat model that retinoic acid causes, the Colla Corii Asini bone strengthening of various dose can make rat blood serum calcium, phosphorus content increase, and ALP is active to be reduced, and femoral bmd gos up, and the calcium phosphorus content increases.X-ray sheet osteoporosis symptom alleviates.(3) cause the rickets model with D feedstuff lucifuge nursing rat childhood that is deficient in vitamin, Colla Corii Asini bone strengthening oral liquid raises this model group rat blood serum calcium content, and ALP is active to be reduced, and makes femur calcium, phosphorus content be higher than model group.X-ray sheet rickets improves.(4) in inflammation due to granuloma induced by implantation of cotton pellets and the carrageenin, Colla Corii Asini bone strengthening oral liquid has certain effect to acute and chronic inflammation.(6) can improve cellular immunization, humoral immunization and nonspecific immunity function.
The clinical verification that 7. pairs of Colla Corii Asini bone strengthening oral liquids of the present invention of experimental example carry out
1. to the treatment of primary osteoporosis:
The treatment group is 151 examples, takes this Colla Corii Asini bone strengthening oral liquid, each 10ml, every day 3 times; Matched group is 60 examples, takes Gaierqi D (vitamin D3 and calcium carbonate) curative effect (pharmaceutical Co. Ltd provides by the Suzhou Rieter), each 1, and every day 1 time.The result shows: the obvious effective rate that Colla Corii Asini bone strengthening oral liquid treatment primary osteoporosis differential diagnosis in tcm belongs to the tcm syndrome curative effect of deficiency of the liver and kindey card is 67.55%; Effective percentage is 88.08%, and the obvious effective rate and the effective percentage of osteodynia curative effect is respectively 61.59%, 85.43%.Respectively with matched group relatively, analyze through RIDI, P all＞0.05, there was no significant difference.
2. to the treatment of rickets of child:
The treatment group is 150 examples, takes this Colla Corii Asini bone strengthening oral liquid, the each oral 5ml of 3-6 monthly age infant, every day 2 times; June to 1 year old each oral 5ml of person, every day 3 times; The each oral 10ml of 1-3 year person, every day 2 times.Matched group 60 examples are taken LONGMU ZHUANGGU CHONGJI (building people pharmaceutical factory by Wuhan provides), the each oral 2.5g of 3-6 month infant, every day 2 times; The each oral 2.5g of person's June-1 years old, every day 3 times; The each oral 5g of 1-3 year person, every day 2 times.The result shows: the obvious effective rate that Colla Corii Asini bone strengthening oral liquid treatment rickets differential diagnosis in tcm belongs to the deficiency of the liver and kindey card is 64.66%, effective percentage is 84.67%, the obvious effective rate and the effective percentage of tcm syndrome are respectively 72.00%, 90.00%, compare with matched group respectively, analyze through RIDIT, P all＞0.05, there was no significant difference.
Do not find to take the untoward reaction of Colla Corii Asini bone strengthening oral liquid in the clinical trial, every safety detects all no abnormal variation of index.
Claims (17)
1. Colla Corii Asini bone strengthening compositions, it is characterized in that it is made up of effective ingredient and/or acceptable accessories, wherein said effective ingredient is to be made by the raw material of following consumption: 4 to 10% Colla Corii Asini, 2.9 to 4% Concha Ostreae, 15 to 25% Radix Rehmanniae Preparata, 10 to 20% Fructus Lycii, 15 to 25% Radixs Astragali and 10 to 20% Radix Codonopsis.
2. according to the described Colla Corii Asini bone strengthening of claim 1 compositions, wherein effective ingredient can make by following step:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 10 times of ethanol of 60% to adding medical material gross weight, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, extracts medicinal liquid with the first step and merges, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 3rd step medicinal liquid;
In the 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid.
3. according to the described Colla Corii Asini bone strengthening of claim 1 compositions, wherein effective ingredient can make by following step:
The first step, the Concha Ostreae of getting aequum added 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filtered, and discarded residue, obtained the first step and extracted medicinal liquid;
Second step, get the Radix Astragali of aequum, add 5 to 10 times to adding medical material gross weight 60% ethanol, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, merges with first step extracting solution, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
The 3rd step, get Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating decocted 1.5 to 3 hours, incline and medicinal liquid, add 8 times again to the water of adding medical material gross weight in medicinal residues, heating decocted 0.5 to 1 hour, and inclining medicinal liquid and discard medicinal residues, extract medicinal liquid with second step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for the 3rd step and extract medicinal liquid under 20 ℃ to relative density of medicine liquid;
In the 4th step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 4th step medicinal liquid;
In the 5th step, the 3rd step was extracted medicinal liquid mix with the 4th step medicinal liquid.
4. according to the described Colla Corii Asini bone strengthening of claim 1 compositions, wherein effective ingredient can make by following step:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating decocted 1.5 to 3 hours, incline and medicinal liquid, add 5 to 8 times again to the water of adding medical material gross weight in medicinal residues, heating decocted 0.5 to 1 hour, and inclining medicinal liquid and discard medicinal residues, extract medicinal liquid with the first step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 80 ℃ of control Colla Corii Asini solution temperatures, and the time is 0.5 to 1 hour, obtains the 3rd step medicinal liquid;
In the 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid.
5. according to any one described Colla Corii Asini bone strengthening compositions among the claim 1-4, it is an oral liquid.
6. Colla Corii Asini bone strengthening compositions according to claim 5, wherein adjuvant is antiseptic, correctives and water.
7. according to the described Colla Corii Asini bone strengthening of claim 6 compositions, wherein adjuvant is that antiseptic is a sorbic acid; Correctives is one or more in simple syrup, Mel and the aspartame.
8. according to the described Colla Corii Asini bone strengthening of claim 7 compositions, it is made by following raw materials by weight percent: 4 to 10% Colla Corii Asini, 2.90 to 4% Concha Ostreae, 15 to 25% Radix Rehmanniae Preparata, 10 to 20% Fructus Lycii, 15 to 25% Radixs Astragali, 10 to 20% Radix Codonopsis, 0.1 to 0.25% sorbic acid, 10 to 15% simple syrup, 15 to 20% Mel, 0.20 to 0.30% aspartame and the water of surplus.
9. Colla Corii Asini bone strengthening composition manufacturing method according to claim 2 is characterized in that by following step preparation:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 10 times of ethanol of 60% to adding medical material gross weight, soaked 3 to 5 hours, heating and refluxing extraction, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, extracts medicinal liquid with the first step and merges, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 3rd step medicinal liquid;
In the 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid; And/or
In the 5th step, be prepared into various dosage forms with acceptable accessories.
10. Colla Corii Asini bone strengthening composition manufacturing method according to claim 9, it is characterized in that admixing medical solutions heated and boiled 0.5 to 1.5 hour with the 4th step, the antiseptic, correctives and the moisturizing that add aequum are to Total Water, and the pH value of control solution is 4.0 to 6.0, filter then finished product; Wherein, antiseptic is a sorbic acid, and correctives is simple syrup, Mel and aspartame.
11., it is characterized in that being undertaken by following step according to the described Colla Corii Asini bone strengthening of claim 3 composition manufacturing method:
The first step, the Concha Ostreae of getting aequum added 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filtered, and discarded residue, obtained the first step and extracted medicinal liquid;
Second step, get the Radix Astragali of aequum, add 5 to 10 times to adding medical material gross weight 60% ethanol, soak, heating and refluxing extraction 3 to 5 hours, inclining medicinal liquid, 60% the ethanol that in medicinal residues, adds 4 to 8 times of amounts again, reflux, extract, 3 to 5 hours, inclining medicinal liquid and discards medicinal residues, merges with first step extracting solution, place, filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
The 3rd step, get Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating decocted 1.5 to 3 hours, incline and medicinal liquid, add 8 times again to the water of adding medical material gross weight in medicinal residues, heating decocted 0.5 to 1 hour, and inclining medicinal liquid and discard medicinal residues, extract medicinal liquid with second step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for the 3rd step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 4th step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 100 ℃ of control solution temperatures, and the time is 0.5 to 1 hour, obtains the 4th step medicinal liquid;
In the 5th step, the 3rd step was extracted medicinal liquid mix with the 4th step medicinal liquid; And/or
In the 6th step, be prepared into various dosage forms with acceptable accessories.
12. Colla Corii Asini bone strengthening composition manufacturing method according to claim 11, it is characterized in that admixing medical solutions heated and boiled 0.5 to 1.5 hour with the 4th step, the antiseptic, correctives and the moisturizing that add aequum are to Total Water, and the pH value of control solution is 4.0 to 6.0, filter then finished product; Wherein, antiseptic is a sorbic acid, and correctives is simple syrup, Mel and aspartame.
13., it is characterized in that being undertaken by following step according to the described Colla Corii Asini bone strengthening of claim 4 composition manufacturing method:
The first step, the Concha Ostreae of getting aequum adds 3 to 5 times of amount 50 to 80% lactic acid extraction 30 to 60 minutes, filters, and discards residue step of winning to extract medicinal liquid;
Second step, get the Radix Astragali, Fructus Lycii, Radix Codonopsis, the Radix Rehmanniae Preparata of aequum, add 5 to 8 times to the water of adding medical material gross weight, soak, heating decocted 1.5 to 3 hours, incline and medicinal liquid, add 5 to 8 times again to the water of adding medical material gross weight in medicinal residues, heating decocted 0.5 to 1 hour, and inclining medicinal liquid and discard medicinal residues, extract medicinal liquid with the first step and merge, it is 1.20 to 1.60 that concentrated medicament is put under 20 ℃ of the relative densities; Adding ethanol to the alcohol amount of containing is 60%, places, and filtering liquid medicine, and the ethanol in the released liquor are 1.07 to 1.3 to obtain for second step and extract medicinal liquid to 20 ℃ of the relative density of medicine liquid;
In the 3rd step, the Colla Corii Asini of getting aequum places in the steam-jacked kettle, adds 10% water of total water weight, 70 to 80 ℃ of control Colla Corii Asini solution temperatures, and the time is 0.5 to 1 hour, obtains the second step medicinal liquid;
In the 4th step, second step was extracted medicinal liquid mix with the 3rd step medicinal liquid; And/or
In the 5th step, be prepared into various dosage forms with acceptable accessories.
14. Colla Corii Asini bone strengthening composition manufacturing method according to claim 13, it is characterized in that admixing medical solutions heated and boiled 0.5 to 1.5 hour with the 4th step, the antiseptic, correctives and the moisturizing that add aequum are to Total Water, and the pH value of control solution is 4.0 to 6.0, filter then finished product; Wherein, antiseptic is a sorbic acid, and correctives is simple syrup, Mel and aspartame.
15. any one described Colla Corii Asini bone strengthening composition manufacturing method among the claim 9-14 is wherein used following raw materials by weight percent: 4 to 10% Colla Corii Asini, 2.90 to 4% Concha Ostreae, 15 to 25% Radix Rehmanniae Preparata, 10 to 20% Fructus Lycii, 15 to 25% Radixs Astragali, 10 to 20% Radix Codonopsis, 0.1 to 0.25% sorbic acid, 10 to 15% simple syrup, 15 to 20% Mel, 0.20 to 0.30% aspartame and the water of surplus.
16. any one described Colla Corii Asini bone strengthening compositions is in the purposes of preparation treatment rickets of child medicine among the claim 1-8.
17. any one described Colla Corii Asini bone strengthening compositions is in the purposes of preparation treatment primary osteoporosis medicine among the claim 1-8.
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| CNB2004100464002A CN100438894C (en) | 2003-08-05 | 2004-06-09 | Donky-hide bone-strengthening composition and its production method |
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| CN101822366B (en) * | 2009-03-05 | 2012-12-19 | 成仲阳 | Donkey-glue calcium particle |
| CN108402460B (en) * | 2018-05-11 | 2021-07-13 | 沈阳百岁生物科技发展有限公司 | Multifunctional food composition for increasing bone mineral density and preparation method thereof |
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| CN1137918A (en) * | 1996-05-15 | 1996-12-18 | 赵翠兰 | Traditional Chinese medicine-"Zengxuening" for regulating organism balance |
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