CN102579773A - Preparation method of Chinese medicinal tablets and capsules for tonifying kidney and strengthening yang - Google Patents

Preparation method of Chinese medicinal tablets and capsules for tonifying kidney and strengthening yang Download PDF

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CN102579773A
CN102579773A CN2012100491447A CN201210049144A CN102579773A CN 102579773 A CN102579773 A CN 102579773A CN 2012100491447 A CN2012100491447 A CN 2012100491447A CN 201210049144 A CN201210049144 A CN 201210049144A CN 102579773 A CN102579773 A CN 102579773A
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kidney invigorating
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尹子郡
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YANGLING WUWEI PHARMACEUTICAL GROUP CO Ltd
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YANGLING WUWEI PHARMACEUTICAL GROUP CO Ltd
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Abstract

The invention discloses a preparation method of Chinese medicinal tablets and capsules for tonifying kidney and strengthening yang. The method comprises the following steps of: 1, weighing 150-250 parts by weight of fructus rosae laevigatae, 30-100 parts by weight of gecko, 500-600 parts by weight of epimedium herb, 30-100 parts by weight of semen allii tuberose and 200-300 parts by weight of dogwood; 2, pulverizing 52.5 parts by weight of gecko and 52.5 parts by weight of semen allii tuberose into fine powder, and pulverizing the remaining gecko and semen allii tuberose into coarse powder; 3, decocting the coarse powder, the fructus rosae laevigatae, the epimedium herb and the dogwood twice, filtering and combining filtrate and concentrating to thick paste; and 4, adding the fine powder into the thick paste to prepare the Chinese medicinal tablets and capsules for tonifying kidney and strengthening yang. According to the preparation method provided by the invention, the transfer rates for active ingredients of the medicaments are that: the transfer rate of rosa lacvigata michx polysaccharide reaches 98.6 percent, the transfer rate of icariin reaches 96.7 percent and the transfer rate of loganin reaches 95.8 percent; the transfer rates are obviously higher than those in the conventional method; meanwhile, the leaching of the inactive ingredients is reduced; the pharmaceutical effect is improved; and the cost is reduced.

Description

The method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal tablet, capsule
Technical field
The invention belongs to medical technical field, be specifically related to the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal tablet, capsule.
Background technology
The traditional Chinese medical science thinks that kidney is very important organ in people's life process, people's numerous disease is all closely related with the function of kidney like obstacle of sexual function aspect etc.
Fructus Rosae Laevigatae is the dry mature fruit of rosaceous plant Rosa laeuigata Michx, gathers when 10~November, fruit maturation reddened, and drying is removed deburring and pit.Contain rich nutrient substances in the Fructus Rosae Laevigatae, be rich in vitamin C, B 1, B 2, carotene, aminoacid, inorganic salt, trace element and steroidal, terpenoid, tannin, saponin, multiple composition such as carbohydrate, its main active is a Fructus Rosae Laevigatae polysaccharides.Fructus Rosae Laevigatae polysaccharides is made up of glucose, mannose, galactose, rhamnose, arabinose, xylose, can supply essence, gas, god, is the surge power of exciting human, and essence is the door of life, and gas is the ability of life, and god is the light of life.The life basis comes from essence, and vital movement depends on gas, and biosis shows as god.Essence is full, gas is sufficient, the refreshing prosperous performance that is only true health, and the Trinity is inseparable, deposits then and all deposits, and dies and then all dies.Energetic, just can produce huge impact power; Gas gulps down ten thousand li, just can not let out lastingly, continues to power; God fills then stiffness of the body, just can the function of human body be nursed one's health optimum state, lets you remain at a kind of fitness form, follows one's bent.
Herba Epimedii is the dried leaves of Berberidaceae plant Herba Epimedii (Epimedium brevicornu Maxim).Gather during leafiness summer and autumn, dries or dry in the shade.Chemical constituent is reported 74 kinds at present, is mainly flavonoid, is polysaccharide, lignanoids, phenolic glycoside class, ionone class, sesquiterpenoids, phenethyl alcohol glycosides, alkaloids secondly.Daucosterol, P-hydroxybenzoic acid, 2 have also been found in addition; 4-resorcylic acid, isoliquiritigenin, glycyrrhizic acid, astragaloside, kaempferide, 2-hydroxyl-3; 4,6,7-tetramethoxy-9; 10-dihydro phenanthrene, luteolin, emodin, 3-hydroxy-2-methyl-pyrone, and volatile oil, ceryl alcohol hentriacontane, plant sterol, Palmic acid, stearic acid, linolenic acid, ginnol, glucose and fructose etc.Effective ingredient icariin (C in the Herba Epimedii 33H 40O 15) can human activin the secretion of sex gland hormones, cause human body self testosterone hormone to increase, cause male's sexual function improving; Through improving the testosterone hormone in the intravital concentration of people, the blood flow of penis is continued to increase, the spongy body and the blood capillary of expansion penis, more blood pushes the empty chamber of penis, thereby excites the regrowth of penis diameter and length to grow.The other effect of icariin can be expanded the cavernous body of penis smooth muscle exactly, and the spongy body of penis mainly is made up of specificity spongy body smooth muscle, in the ordinary course of things, and the domination of the excited norepinephrine neurotransmitter of receptor and keep relaxed state.Sexual excitation normally begins from the non-adrenal gland of perineal nerves clump and the neurotransmission of non-acetylcholine, and sexual intercourse stimulates cavernous body of penis blood vessel endothelium system to discharge NO, under the effect of icariin, causes the intracellular Ca2+ level to reduce; Calcium ion reduces the smooth muscle relaxation that then causes cavernous body of penis, and then blood flow increases greatly, and erection intensity increases, time lengthening.
Fructus Corni is the drying and ripening sarcocarp of Fructus Evodiae section plant Fructus Corni (Cornus officinalis Sieb.et Zucc).The picking fruit when time of the year when autumn changes into winter, fruit reddened with slow fire baking or put after the boiling water part omitted scalds, in time removes removal core, drying.Oil in the fruit wherein has 9 kinds of monoterpene hydrocarbon, 6 kinds of sesquiterpene hydrocarbon, 7 kinds of monoterpene alcohol, 6 kinds of aliphatic alcohol, 4 kinds of monoterpene aldehyde and ketone, 3 kinds of fatty aldehydes and ketone, 4 kinds of acid, 8 kinds of fat and 15 kinds of aromatic compounds through gas phase layer analysis proof.Contain ursolic acid, 2, oleanolic acid in the sarcocarp, gallic acid, malic acid, tartaric acid, protocatechuic acid and 3,5-resorcylic acid and vitamin A also contain 5-hydroxymethylfurfural, 5,5-dimethyl furfural ether and cupreol.The glycoside composition is also got 8 kinds of monomers except that cornin (comin), verbenalin (verbenalin), that content is the highest is loganin (C 17H 26O 10) and morroniside (morroniside).Loganin has tangible controlling nocturnal emission with astringent drugs reducing urination and anti-aging effects, and for premature ejaculation, seminal emission, the enuresis, frequent micturition have special effect; Obviously physical strength reinforcing and anti-fatigue ability improve the physical and mental of people, make the people energetic; The vigor of remaining youthful forever further strengthens people's sex life ability.
In raw material of Chinese medicine, Fructus Rosae Laevigatae polysaccharides content accounts for 42.5% of Fructus Rosae Laevigatae; Icariin content accounts for 0.6% of Herba Epimedii; Loganin content accounts for 0.85% of Fructus Corni.Present domestic Chinese patent medicine is lower to the extraction rate of transform of above three kinds of effective ingredient, all about 20%~30%.
Summary of the invention
Technical problem to be solved by this invention is to above-mentioned deficiency of the prior art the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal tablet, capsule to be provided.This method makes the rate of transform of active constituents of medicine Fructus Rosae Laevigatae polysaccharides reach 98.6%, and the rate of transform of icariin reaches 96.7%, and the rate of transform of loganin reaches 95.8%.
For solving the problems of the technologies described above, the technical scheme that the present invention adopts is: a kind of method for preparing of kidney invigorating and YANG supporting Chinese medicinal tablet is characterized in that this method may further comprise the steps:
Step 1, get Fructus Rosae Laevigatae 150-250 part by weight, Gecko 30-100 part, Herba Epimedii 500-600 part, Semen Allii Tuberosi 30-100 part, Fructus Corni 200-300 part;
Step 2, get each 52.5 parts of Gecko described in the step 1 and Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use; Said fine powder is pressed Pharmacopoeia of the People's Republic of China standard code, refers to all to sieve (sieve aperture internal diameter meansigma methods 180 μ m ± 7.6 μ m) through No. five, and contains and can be no less than 95% powder through No. six sieves (sieve aperture internal diameter meansigma methods 150 μ m ± 6.6 μ m); Said coarse powder is pressed Pharmacopoeia of the People's Republic of China standard code, refers to can be no more than 40% powder through No. four sieves (sieve aperture internal diameter meansigma methods 250 μ m ± 9.9 μ m) but be mixed with all through No. two sieves (sieve aperture internal diameter meansigma methods 850 μ m ± 29 μ m);
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is 15~25 times of need decocting herbs gross weight; The amount of water that decocts for the second time is for needing 8~12 times of decocting herbs gross weight, and decocting time is 2~4 hours for the first time, and decocting time is 1~3 hour for the second time; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.30~1.35 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and granulates, and drying adds adjuvant, mixing, and tabletting, sugar coating obtains the kidney invigorating and YANG supporting Chinese medicinal tablet.
The method for preparing of above-mentioned a kind of kidney invigorating and YANG supporting Chinese medicinal tablet, the medical material of respectively distinguishing the flavor of described in the step 1 is counted by weight: 200 parts of Fructus Rosae Laevigatae, 60 parts of Geckos, 555 parts of Herba Epimedii, 60 parts of Semen Allii Tuberosi, 250 parts of Fructus Corni.
The method for preparing of above-mentioned a kind of kidney invigorating and YANG supporting Chinese medicinal tablet, the amount of water that decocts for the first time described in the step 3 be for needing 20 times of decocting herbs gross weight, and the amount of water that decocts for the second time is for needing 10 times of decocting herbs gross weight.
The method for preparing of above-mentioned a kind of kidney invigorating and YANG supporting Chinese medicinal tablet, the medical material that will decoct earlier before decocting for the first time described in the step 3 soaked 2 hours, said first time decocting time and the second time decocting time be 2 hours.
The method for preparing of above-mentioned a kind of kidney invigorating and YANG supporting Chinese medicinal tablet, adjuvant described in the step 4 are one or more in Pulvis Talci, starch, magnesium stearate, dextrin, sucrose, cyclodextrin and the sodium benzoate.
The method for preparing of above-mentioned a kind of kidney invigorating and YANG supporting Chinese medicinal tablet, the addition of adjuvant described in the step 4 are 0.5% of dry back granular mass.
The present invention also provides the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal capsule agent, it is characterized in that, this method may further comprise the steps:
Step 1, get Fructus Rosae Laevigatae 150-250 part by weight, Gecko 30-100 part, Herba Epimedii 500-600 part, Semen Allii Tuberosi 30-100 part, Fructus Corni 200-300 part;
Step 2, get each 52.5 parts of Gecko described in the step 1 and Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use; Said fine powder is pressed Pharmacopoeia of the People's Republic of China standard code, refers to all to sieve (sieve aperture internal diameter meansigma methods 180 μ m ± 7.6 μ m) through No. five, and contains and can be no less than 95% powder through No. six sieves (sieve aperture internal diameter meansigma methods 150 μ m ± 6.6 μ m); Said coarse powder is pressed Pharmacopoeia of the People's Republic of China standard code, refers to can be no more than 40% powder through No. four sieves (sieve aperture internal diameter meansigma methods 250 μ m ± 9.9 μ m) but be mixed with all through No. two sieves (sieve aperture internal diameter meansigma methods 850 μ m ± 29 μ m);
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is 15~25 times of need decocting herbs gross weight; The amount of water that decocts for the second time is for needing 8~12 times of decocting herbs gross weight, and decocting time is 2~4 hours for the first time, and decocting time is 1~3 hour for the second time; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.30~1.35 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and crosses 65 mesh sieves, and is encapsulated, obtains the agent of kidney invigorating and YANG supporting Chinese medicinal capsule.
The method for preparing of above-mentioned a kind of kidney invigorating and YANG supporting Chinese medicinal capsule agent, the medical material of respectively distinguishing the flavor of described in the step 1 is counted by weight: 200 parts of Fructus Rosae Laevigatae, 60 parts of Geckos, 555 parts of Herba Epimedii, 60 parts of Semen Allii Tuberosi, 250 parts of Fructus Corni.
The method for preparing of above-mentioned a kind of kidney invigorating and YANG supporting Chinese medicinal capsule agent, the amount of water that decocts for the first time described in the step 3 be for needing 20 times of decocting herbs gross weight, and the amount of water that decocts for the second time is for needing 10 times of decocting herbs gross weight.
The method for preparing of above-mentioned a kind of kidney invigorating and YANG supporting Chinese medicinal capsule agent, the medical material that will decoct earlier before decocting for the first time described in the step 3 soaked 2 hours, said first time decocting time and the second time decocting time be 2 hours.
Said weight portion can be weight metering units such as gram, two, jin, kilogram, ton.
The kidney being the origin of congenital constitution, and kidney yang is that yang-energy is basic all over the body.If nephropathy impairment of YANG with the passing of time, or his dirty yang deficiency involves in kidney, or suffers from a deficiency of the kidney in high year, and excess of sexual intercourse etc. all can cause insufficiency of kidney-YANG.The present invention institute of filling a prescription controls all cards all because of insufficiency of kidney-YANG, smart close solid due to.Kidney storing essence gas, for reproduction this, interior residence fire from the gater of life is the viscus with functions of reproduction and development, so-called " sun is moving then to be lifted, and depletion of YANG is then quiet ".Advanced age, sun declined or the damage sun of indulging in sensual pleasures, and the weak flame of the gate of vitality can not be jerked by warm penis, so cause hyposexuality, sexual impotence erectile problem; Kidney position waist, kidney yang deficiency, passages through which vital energy circulates lose supports, and then spinal column knee joint soreness of the shank pain is weak; Kidney governing storage, void is dysfunction of the kidney in storing essence then, and so smart closing admittedly is the seminal emission lingering diarrhea; Exterior and interior relation between kidney and bladder, insufficiency of kidney-YANG is hungry, and bladder loses in constraint, dribbling urination then, so YANG declining when YIN growing at nightfall is the outstanding frequency of nocturia; Dai channel grows wild, and leads in conception vessel, and suffering from a deficiency of the kidney undermines conception vessel, and dai channel is failed to keep an appointment, so leukorrhagia; Light red tongue and fat, deficient and weak pulse, chi portion is heavy thin, is all levying of insufficiency of kidney-YANG.Control suitable kidney invigorating and YANG supporting, the method for arresting seminal emission.
Fructus Rosae Laevigatae is sour and astringent in the present invention prescription goes into kidney, has the merit of controlling nocturnal emission with astringent drugs, reducing urination, leukorrhagia stopping, " book on Chinese herbal medicine is looked for the truth " call its " but puckery anti-avulsion, but sweet invigorating middle warmer, acid can be received the moon, so can be apt to manage the nocturnal emission metrorrhagia and leukorrhagia enuresis "; Gecko Cheng Ping goes into kidney, and the matter profit is not dry, and the kidney invigorating helps the beneficial intensive culture blood of the double ability of kidney, Compendium of Material Medica meaning its " supporing yang road ", " benefiting essence-blood ".Two medicines are harmonious, and kidney invigorating and YANG supporting is to effect a permanent cure, and arresting seminal emission is a monarch drug to take stopgap measures altogether.Herba Epimedii is hot sweet and warm, goes into the kidney Liver Channel, is longer than kidney invigorating and YANG supporting, controls the impotence due to deficiency of the kidney seminal emission, and " Japan hanako materia medica " called its " control all cold wind consumptive disease, mend the waist knee joint, heart tonifying power, the husband is exhausted, and sun does not rise "; Semen Allii Tuberosi is hot sweet and warm, goes into the kidney Liver Channel, and reinforcing the kidney and supporting YANG has the property of astringent therapy concurrently and can controlling nocturnal emission with astringent drugs ends and losing; The reducing urination leukorrhagia stopping is longer than the treatment kidney yang deficiency, and the sexual impotence erectile problem of below element deficiency and cold, the seminal emission enuresis, leucorrhea are excessive in vain, and two medicines share; Principal drug assistance kidney invigorating and YANG supporting, controlling nocturnal emission with astringent drugs end to be lost, and is ministerial drug altogether.Urosolic acid tepor matter profit is mended and not high, can the kidney invigorating and essence nourishing, and again can the controlling nocturnal emission with astringent drugs reducing urination; The merit of tool envelope Tibetans again among tonification is the key medicine that controlling nocturnal emission with astringent drugs ends somethings lost, " property of medicine opinion " call its " the kidney invigorating gas; Xing Yangdao adds marrow ... only the old man urinates and does not save "; In order to cooperate monarch, ministerial drug the kidney invigorating and essence nourishing, the controlling nocturnal emission with astringent drugs reducing urination uses to be adjuvant drug.All medicines share, and play kidney invigorating and YANG supporting altogether, the merit of controlling nocturnal emission with astringent drugs reducing urination.
The compatibility characteristics of Chinese medicinal tablet of the present invention and capsule are: it is main that kidney invigorating and YANG supporting plays flaccidity, and it is auxilliary that reinforcing the kindey to control nocturnal emission is ended something lost, and invigorating middle warmer has solid, giving consideration to both the incidental and fundamental, and gentle not dry, character is gentle.
The kidney invigorating and YANG supporting Chinese medicinal tablet of the present invention preparation is a coated tablet, shows sepia after removing sugar-coat; Bitter in the mouth, sweet, little puckery, specification are the heavy 0.3g of every plain sheet; The kidney invigorating and YANG supporting Chinese medicinal capsule agent of preparation is a hard capsule, and content is a chocolate brown powder, bitter in the mouth, sweet, little puckery, and specification is the 0.3g/ grain.Adopt the kidney invigorating and YANG supporting Chinese medicinal tablet and the capsule of method preparation of the present invention to can be used for treating hyposexuality, sexual impotence, seminal emission, premature ejaculation, nocturia, dribbling urination, leukorrhagia, soreness of the waist and knees.
Medicine amount of water in the process of carrying out twice decoction that the present invention adopts orthogonal test need decoct Fructus Rosae Laevigatae, Gecko, Herba Epimedii, Semen Allii Tuberosi, the Fructus Corni five tastes is that the multiple of institute's decocting herb material total amount carries out preferably, and twice decocting time carried out preferably.Through the great mass of data inquiry, the effective ingredient of Fructus Rosae Laevigatae treatment primary disease is a Fructus Rosae Laevigatae polysaccharides; The effective ingredient of barrenwort for treating primary disease is an icariin; The effective ingredient of Fructus Corni treatment primary disease is a loganin, so with the foundation of these three kinds of effective ingredient as the design weight coefficient.
With the amount of water of decoction for the second time and the time of twice decoction is the investigation factor, carries out three factors, three horizontal L 9(3 4) orthogonal test, because above-mentioned three kinds of compositions are the effective ingredient of treatment primary disease, so with its foundation as the design weight coefficient; With above-mentioned three kinds of effective ingredient of decocting out respectively in each flavor medical material shared quality percentage composition be evaluation index; Because in these three kinds of effective ingredient, icariin is maximum to treatment primary disease role, and shared ratio is maximum in each raw material weight umber; So its weight coefficient is decided to be 0.4; The weight coefficient of all the other two kinds of effective ingredient all is decided to be 0.3, and with the measurement index of comprehensive grading as extraction effect, filters out the best amount of water of each decoction.
Experimental technique: take by weighing Fructus Rosae Laevigatae 200g, Gecko 7.5g, Herba Epimedii 555g, Semen Allii Tuberosi 7.5g; Fructus Corni 250g sets amount of water for the first time and decocts for needing 20 times of decocting herbs gross weight, soaking after 2 hours, and the decocting that add different multiples the second time boils; Each different time that decocts carries out decocting by the orthogonal test condition and extracts, and filters merging filtrate; Being concentrated into relative density is the thick paste of 1.30~1.35 (60 ℃), and 100 mesh sieves were pulverized in oven dry, and fine powder gets dry extract; The accurate title, decided dried cream fine powder total amount, measures above-mentioned three kinds of content of effective respectively, calculates this effective ingredient quality percentage composition in this medical material respectively.The orthogonal test condition is seen table 1, and result of the test is seen table 2.
Table 1 kidney invigorating and YANG supporting Chinese medicine decocting extracts orthogonal test factor level table
Figure BDA0000139491850000071
Table 2 kidney invigorating and YANG supporting Chinese medicine decocting extracts orthogonal test table
Figure BDA0000139491850000072
Annotate: decocting extracts three evaluation indexes of orthogonal test; Adopt the comprehensive grading method to carry out data analysis; Icariin content weight coefficient is 0.4; The weight coefficient of all the other two kinds of effective ingredient is all 0.3, every kind of effective ingredient percentage composition scoring=(this this effective ingredient percentage composition of effective ingredient percentage composition/maximum) * these composition weight coefficient * 100; Comprehensive grading=three kind of effective ingredient scoring sum.
Table 3 kidney invigorating and YANG supporting Chinese medicine decocting extracts orthogonal experiments
Figure BDA0000139491850000081
Extreme difference R value size shows that it is A>C>B that each factor influences size order to extraction effect from table 3; From each factor level (analysis of K value), factor A is K again 2>K 3>K 1, factor B is K 3>K 2>K 1, factor C is K 2>K 3>K 1From table 3 intuitive analysis, best decocting extraction conditions is A 2B 1C 2Consider big production practical situation, be necessary the lower horizontal significance of each factor is carried out variance analysis that the result sees the following form.
The variance analysis of table 4 decocting extraction effect
Figure BDA0000139491850000082
Annotate: the variance analysis computing formula
s 2 = 1 n Σ i = 1 n ( x i - x ‾ ) 2 (quadratic sum)
M = S 2 n - 1 (mean square)
Figure BDA0000139491850000085
M Mistake=M D(F value)
Look into the F-distribution tables of critical values, get F 0.05(2,2)=19.00, F 0.01(2,2)=99.00
Show that from table 4 The results of analysis of variance factor A has tangible significance meaning (P<0.01) to extraction effect, factor B does not have significance meaning (P>0.05) to extraction effect; Factor C has significance meaning (P<0.05) to extraction effect.
The present invention is optimized the amount of water that decocts for the first time, and the weight coefficient of its setting and comprehensive grading computational methods are the same.Experimental technique: take by weighing Fructus Rosae Laevigatae 200g, Gecko 7.5g, Herba Epimedii 555g, Semen Allii Tuberosi 7.5g, Fructus Corni 250g, add the water of different multiples the first time, soaks after 2 hours to decoct 2 hours; Adding for the second time needs the decocting of 10 times of amounts of decocting herbs gross weight to boil 2 hours, filters merging filtrate; Being concentrated into relative density is the thick paste of 1.30~1.35 (60 ℃), dries, pulverized 100 mesh sieves, and fine powder gets dry extract; The accurate title, decided dried cream fine powder total amount, measures three kinds of content of effective respectively, calculates three kinds of effective ingredient quality percentage composition in this medical material respectively; And optimizing the best amount of water that decocts for the first time with the comprehensive grading method, result of the test is seen table 5.
Table 5 is the amount of water preferred result for the first time
Can find out that from table 5 the best amount of water that decocts for the first time is 20 times of need decocting herbs gross weight.
The analysis of associative list 1, table 2, table 3, table 4 and table 5; Best decocting extraction conditions is: decoct amount of water 20 times for need decocting herbs gross weight for the first time; Decoct for the second time amount of water 10 times for need decocting herbs gross weight; Twice decocting time is 2 hours, soaks 2 hours earlier before decocting for the first time; Medical material to decocting after twice filters; Merging filtrate, it is the thick paste of 1.30~1.35 (60 ℃) that 60 ℃ of concentrating under reduced pressure become relative density, drying; Pulverize; The accurate title, decide, and adopts each component content of high effective liquid chromatography for measuring respectively, is converted into the percentage composition of effective ingredient in this medical material of respectively frying in shallow oil proposition.According to above-mentioned best decocting extraction conditions, verify three batches, the result sees table 6.
Table 6 decocting extraction conditions demonstration test result
Tested number Icariin (%) Fructus Rosae Laevigatae polysaccharides (%) Loganin (%)
1 0.57 41.88 0.80
2 0.58 41.90 0.81
3 0.59 41.92 0.82
Meansigma methods 0.58 41.90 0.81
The rate of transform 96.7% 98.6% 95.8%
As shown in table 6, demonstration test result is consistent with the best decocting extraction of quadrature result.Prove that the preferred best decocting extraction conditions of above-mentioned orthogonal experiment is practicable, the rate of transform of active constituents of medicine Fructus Rosae Laevigatae polysaccharides reaches 98.6%, and the rate of transform of icariin reaches 96.7%, and the rate of transform of loganin reaches 95.8%.
The present invention compared with prior art has the following advantages:
1, adopt the kidney invigorating and YANG supporting Chinese medicinal tablet and the capsule of method preparation of the present invention to can be used for treating hyposexuality, sexual impotence, seminal emission, premature ejaculation, nocturia, dribbling urination, leukorrhagia, soreness of the waist and knees; For hyposexuality patient obvious effective rate is 81.54%, and effective percentage is 96.92%; For the impotence patient obvious effective rate is 82.78%, and effective percentage is 97.02%; For night nocturnal emission patient obvious effective rate be 78.43%, effective percentage is 97.39%; For premature ejaculation, nocturia number of times too much, dribbling urination patient obvious effective rate is 84.26%, effective percentage is 97.87%, does not all find obvious adverse reaction.
2, the present invention is through carrying out preferably each decoction amount of water and decocting time; Kept to greatest extent in the medical material effective each effective ingredient of indication, made the rate of transform of active constituents of medicine Fructus Rosae Laevigatae polysaccharides reach 98.6%, the rate of transform of icariin reaches 96.7%; The rate of transform of loganin reaches 95.8%; Reduce the leaching of invalid components simultaneously, strengthened medication effect, reduced production cost.
3, the kidney invigorating and YANG supporting Chinese medicinal capsule agent of adopting method of the present invention to prepare can be covered adverse drug and smell flavor, improves medicine stability; Avoided the influence of moisture, air, light; Prevent that medicine from making moist, oxidation, photolysis, bad flavor or the unsettled ingredient of smelling of tool had covering to a certain extent, protection and Stabilization; This capsule is directly to be loaded in the capsule shells with pulverulence, and the influence of factor such as be not stressed is so dispersion rapidly, stripping and absorption in gastrointestinal tract improved bioavailability of medicament.
The specific embodiment
Embodiment 1
Step 1, get Fructus Rosae Laevigatae 200g, Gecko 60g, Herba Epimedii 555g, Semen Allii Tuberosi 60g, Fructus Corni 250g;
Step 2, get Gecko described in the step 1 and each 52.5g of Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use;
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is 20 times of need decocting herbs gross weight; Earlier medical material is soaked before decocting for the first time and decocted in 2 hours again, the amount of water that decocts for the second time is for needing 10 times of decocting herbs gross weight, and the time of twice decoction is 2 hours; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.30 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and granulates; Drying adds 0.5% starch of dry back granular mass, and mixing, tabletting are processed 1000; Sugar coating obtains the kidney invigorating and YANG supporting Chinese medicinal tablet, the heavy 0.3g of every plain sheet.
Embodiment 2
Present embodiment is identical with embodiment 1; Wherein difference is: used adjuvant is Pulvis Talci, magnesium stearate, dextrin, sucrose, cyclodextrin or sodium benzoate, perhaps is at least two kinds in Pulvis Talci, starch, magnesium stearate, dextrin, sucrose, cyclodextrin and the sodium benzoate.
Embodiment 3
Step 1, get Fructus Rosae Laevigatae 250g, Gecko 100g, Herba Epimedii 600g, Semen Allii Tuberosi 100g, Fructus Corni 300g;
Step 2, get Gecko described in the step 1 and each 52.5g of Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use;
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is needs 25 times of decocting herbs gross weight; The amount of water that decocts for the second time is needs 8 times of decocting herbs gross weight, and decocting time is 4 hours for the first time, and decocting time is 3 hours for the second time; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.32 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and granulates; Drying adds 0.5% starch and sucrose of dry back granular mass, mixing, tabletting; Sugar coating obtains the kidney invigorating and YANG supporting Chinese medicinal tablet, the heavy 0.3g of every plain sheet.
Embodiment 4
Present embodiment is identical with embodiment 3; Wherein difference is: used adjuvant is a kind of in Pulvis Talci, starch, magnesium stearate, dextrin, sucrose, cyclodextrin and the sodium benzoate or more than three kinds; Perhaps being two kinds in Pulvis Talci, magnesium stearate, dextrin, sucrose, cyclodextrin and the sodium benzoate, perhaps is the mixture of a kind of and starch in Pulvis Talci, magnesium stearate, dextrin, cyclodextrin and the sodium benzoate.
Embodiment 5
Step 1, get Fructus Rosae Laevigatae 150kg, Gecko 30kg, Herba Epimedii 500kg, Semen Allii Tuberosi 30kg, Fructus Corni 200kg;
Step 2, get Gecko described in the step 1 and each 52.5kg of Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use;
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is needs 15 times of decocting herbs gross weight; Earlier medical material is soaked before decocting for the first time and decocted again in 2 hours; The amount of water that decocts for the second time is needs 12 times of decocting herbs gross weight, and decocting time is 3 hours for the first time, and decocting time is 1 hour for the second time; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.35 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and granulates; Drying adds 0.5% Pulvis Talci, starch and magnesium stearate of dry back granular mass, mixing, tabletting; Sugar coating obtains the kidney invigorating and YANG supporting Chinese medicinal tablet, the heavy 0.3g of every plain sheet.
Embodiment 6
Present embodiment is identical with embodiment 5; Wherein difference is: used adjuvant be in Pulvis Talci, starch, magnesium stearate, dextrin, sucrose, cyclodextrin and the sodium benzoate a kind of, more than two kinds or four kinds; Perhaps be three kinds in Pulvis Talci, magnesium stearate, dextrin, sucrose, cyclodextrin and the sodium benzoate; Perhaps being in Pulvis Talci, dextrin, sucrose, cyclodextrin and the sodium benzoate the two kinds mixture with starch, perhaps is a kind of and starch and the mixture of magnesium stearate in dextrin, sucrose, cyclodextrin and the sodium benzoate.
Embodiment 7
Step 1, get Fructus Rosae Laevigatae 200g by weight, Gecko 60g, Herba Epimedii 555g, Semen Allii Tuberosi 60g, Fructus Corni 250g;
Step 2, get Gecko described in the step 1 and each 52.5g of Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use;
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is 20 times of need decocting herbs gross weight; Earlier medical material is soaked before decocting for the first time and decocted in 2 hours again, the amount of water that decocts for the second time is for needing 10 times of decocting herbs gross weight, and the time of twice decoction is 2 hours; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.33 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and crosses 65 mesh sieves, encapsulatedly processes 1000, and every dress 0.3g obtains the agent of kidney invigorating and YANG supporting Chinese medicinal capsule.
Embodiment 8
Step 1, get Fructus Rosae Laevigatae 150g by weight, Gecko 100g, Herba Epimedii 500g, Semen Allii Tuberosi 30g, Fructus Corni 200g;
Step 2, get Gecko described in the step 1 and each 52.5g of Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use;
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is 15 times of need decocting herbs gross weight; Earlier medical material is soaked before decocting for the first time and decocted again in 2 hours; The amount of water that decocts for the second time is for needing 12 times of decocting herbs gross weight, and decocting time is 4 hours for the first time, and decocting time is 1 hour for the second time; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.30 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and crosses 65 mesh sieves, and is encapsulated, and every dress 0.3g obtains the agent of kidney invigorating and YANG supporting Chinese medicinal capsule.
Embodiment 9
Step 1, get Fructus Rosae Laevigatae 250kg by weight, Gecko 30kg, Herba Epimedii 600kg, Semen Allii Tuberosi 100kg, Fructus Corni 300kg;
Step 2, get Gecko described in the step 1 and each 52.5kg of Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use;
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is 25 times of need decocting herbs gross weight; Earlier medical material is soaked before decocting for the first time and decocted in 2 hours again, the amount of water that decocts for the second time is for needing 8 times of decocting herbs gross weight, and twice decocting time is 3 hours; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.35 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and crosses 65 mesh sieves, and is encapsulated, and every dress 0.3g obtains the agent of kidney invigorating and YANG supporting Chinese medicinal capsule.
Content to effective ingredient icariin, Fructus Rosae Laevigatae polysaccharides and loganin in the kidney invigorating and YANG supporting Chinese medicinal capsule agent of the kidney invigorating and YANG supporting Chinese medicinal tablet of embodiment 1 preparation and embodiment 7 preparations detects, and the rate of transform of calculating effective ingredient, and the result sees the following form:
The content of effective and the rate of transform in table 7 kidney invigorating and YANG supporting Chinese medicinal tablet/capsule
Figure BDA0000139491850000141
Can find out from table 7, adopt method of the present invention to prepare kidney invigorating and YANG supporting Chinese medicinal tablet and capsule, the rate of transform of each effective ingredient is all more than 95%, and present domestic Chinese patent medicine is lower to the extraction rate of transform of above three kinds of effective ingredient, all about 20%~30%.This shows that the effective ingredient rate of transform of the present invention is significantly higher than the present method for distilling effective ingredient rate of transform, has improved drug effect, has reduced cost.
The usage and dosage of kidney invigorating and YANG supporting Chinese medicinal tablet of the present invention: oral, one time 4~6,2~3 times on the one.
The usage and dosage of kidney invigorating and YANG supporting Chinese medicinal capsule of the present invention agent: oral, one time 4~6,2~3 times on the one.
Efficacy assessment standard: efficacy assessment standard is with reference to " new Chinese medicine clinical research indication principle ", Chinese Medicine science and technology publishing house, version execution in 2002.
Long-term clinical test results shows: according to the long-term clinical 325 routine hyposexuality patients that are used for of kidney invigorating and YANG supporting Chinese medicinal tablet warp that method for preparing provided by the invention is processed, obvious effective rate is 81.54%, and effective percentage is 96.92%; For 302 routine impotence patients, obvious effective rate is 82.78%, and effective percentage is 97.02%; For 153 example nocturnal emission patients at night, obvious effective rate is 78.43%, and effective percentage is 97.39%; For 235 routine premature ejaculation, the nocturia number of times is too much, the dribbling urination patient, and obvious effective rate is 84.26%, and effective percentage is 97.87%, does not all find obvious adverse reaction.This tablet is storage requirement held 24 months in the room temperature storehouse, and each item detects index and all meets statutory standards, steady quality.
According to the long-term clinical 235 routine hyposexuality patients that are used for of kidney invigorating and YANG supporting Chinese medicinal capsule agent warp that method for preparing provided by the invention is processed, obvious effective rate is 82.30%, and effective percentage is 96.17%; For 282 routine impotence patients, obvious effective rate is 82.98%, and effective percentage is 97.52%; For 187 example nocturnal emission patients at night, obvious effective rate is 79.14%, and effective percentage is 97.86%; Too much for 385 routine premature ejaculation, nocturia number of times, the dribbling urination patient, obvious effective rate is 84.94%, effective percentage is 98.18%, does not all find obvious adverse reaction.This capsule is storage requirement held 24 months in the room temperature storehouse, and each item detects index and all meets statutory standards, steady quality.
The present invention has carried out acute toxicity test: get mice; Also do not cause death with the heavy dose of clothes of irritating of the kidney invigorating and YANG supporting Chinese medicine of the present invention's preparation; To the day maximum tolerated dose of mouse stomach administration be equivalent to be grown up 582 times of clinical consumption per day, under this dosage, do not observe toxic reaction.
The present invention has also carried out chronic toxicity test: get four groups of rats; It is the blank group; Heavy dose of group, middle dose groups and small dose group, the blank group is irritated the stomach ordinary water, and heavy dose of group, middle dose groups and small dose group are irritated stomach kidney invigorating and YANG supporting Chinese medicine of the present invention every day; Irritate stomach dosage be equivalent to respectively to be grown up 100 times, 50 times and 25 times of clinical day dose; Once a day, successive administration was observed each group rat after six months, and the observation project is General observation and the complete detection that comprises 29 of hematological examinations.The result shows that obvious adverse reaction does not all appear in three dosages, shows that the kidney invigorating and YANG supporting Chinese medicine that becomes according to method for preparing provided by the invention is safe.
Long-term stable experiment shows that the kidney invigorating and YANG supporting Chinese medicine of the present invention's preparation is pressed commercially available back; Under normal temperature condition, stored 24 months; Each item test rating and the preceding more equal no significant difference of test, each item index all meets national statutory standards, explains that these article have good stability.
The above; It only is preferred embodiment of the present invention; Be not that the present invention is done any restriction, every according to inventing technical spirit to any simple modification, change and equivalent structure variation that above embodiment did, all still belong in the protection domain of technical scheme of the present invention.

Claims (10)

1. the method for preparing of a kidney invigorating and YANG supporting Chinese medicinal tablet is characterized in that, this method may further comprise the steps:
Step 1, get Fructus Rosae Laevigatae 150-250 part by weight, Gecko 30-100 part, Herba Epimedii 500-600 part, Semen Allii Tuberosi 30-100 part, Fructus Corni 200-300 part;
Step 2, get each 52.5 parts of Gecko described in the step 1 and Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use;
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is 15~25 times of need decocting herbs gross weight; The amount of water that decocts for the second time is for needing 8~12 times of decocting herbs gross weight, and decocting time is 2~4 hours for the first time, and decocting time is 1~3 hour for the second time; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.30~1.35 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and granulates, and drying adds adjuvant, mixing, and tabletting, sugar coating obtains the kidney invigorating and YANG supporting Chinese medicinal tablet.
2. the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal tablet according to claim 1 is characterized in that, the medical material of respectively distinguishing the flavor of described in the step 1 is counted by weight: 200 parts of Fructus Rosae Laevigatae, 60 parts of Geckos, 555 parts of Herba Epimedii, 60 parts of Semen Allii Tuberosi, 250 parts of Fructus Corni.
3. the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal tablet according to claim 1; It is characterized in that; The amount of water that decocts for the first time described in the step 3 is for needing 20 times of decocting herbs gross weight, and the amount of water that decocts for the second time is for needing 10 times of decocting herbs gross weight.
4. the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal tablet according to claim 1; It is characterized in that; The medical material that will decoct earlier before decocting for the first time described in the step 3 soaked 2 hours, said first time decocting time and the second time decocting time be 2 hours.
5. the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal tablet according to claim 1 is characterized in that, adjuvant described in the step 4 is one or more in Pulvis Talci, starch, magnesium stearate, dextrin, sucrose, cyclodextrin and the sodium benzoate.
6. the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal tablet according to claim 1 is characterized in that, the addition of adjuvant described in the step 4 is 0.5% of a dry back granular mass.
7. the method for preparing of kidney invigorating and YANG supporting Chinese medicinal capsule agent is characterized in that, this method may further comprise the steps:
Step 1, get Fructus Rosae Laevigatae 150-250 part by weight, Gecko 30-100 part, Herba Epimedii 500-600 part, Semen Allii Tuberosi 30-100 part, Fructus Corni 200-300 part;
Step 2, get each 52.5 parts of Gecko described in the step 1 and Semen Allii Tuberosi, mix after being ground into fine powder, subsequent use; Remaining Gecko and Semen Allii Tuberosi powder are broken into coarse powder, subsequent use;
Step 3, with together twice of the decocte with water of the Fructus Rosae Laevigatae that takes by weighing in coarse powder described in the step 2 and the step 1, Herba Epimedii and Fructus Corni; The amount of water that decocts for the first time is 15~25 times of need decocting herbs gross weight; The amount of water that decocts for the second time is for needing 8~12 times of decocting herbs gross weight, and decocting time is 2~4 hours for the first time, and decocting time is 1~3 hour for the second time; Filter the back merging filtrate, being concentrated into 60 ℃, to record relative density be 1.30~1.35 thick paste;
Step 4, fine powder described in the step 2 is added described in the step 3 in the thick paste, the after drying that stirs is pulverized, and crosses 65 mesh sieves, and is encapsulated, obtains the agent of kidney invigorating and YANG supporting Chinese medicinal capsule.
8. the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal capsule according to claim 7 agent is characterized in that, the medical material of respectively distinguishing the flavor of described in the step 1 is counted by weight: 200 parts of Fructus Rosae Laevigatae, 60 parts of Geckos, 555 parts of Herba Epimedii, 60 parts of Semen Allii Tuberosi, 250 parts of Fructus Corni.
9. the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal capsule according to claim 7 agent; It is characterized in that; The amount of water that decocts for the first time described in the step 3 is for needing 20 times of decocting herbs gross weight, and the amount of water that decocts for the second time is for needing 10 times of decocting herbs gross weight.
10. the method for preparing of a kind of kidney invigorating and YANG supporting Chinese medicinal capsule according to claim 7 agent; It is characterized in that; The medical material that will decoct earlier before decocting for the first time described in the step 3 soaked 2 hours, said first time decocting time and the second time decocting time be 2 hours.
CN2012100491447A 2012-02-29 2012-02-29 Preparation method of Chinese medicinal tablets and capsules for tonifying kidney and strengthening yang Pending CN102579773A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104547963A (en) * 2015-02-13 2015-04-29 王学兵 Medicine for treating male kidney-deficiency waist-knee cold pain and frequent urination and preparation method thereof
CN104622905A (en) * 2015-03-05 2015-05-20 济南康众医药科技开发有限公司 Medicinal composition without gecko smell
CN105770392A (en) * 2016-02-18 2016-07-20 西安圣威制药有限公司 Traditional Chinese medicine composition for invigorating kidney and strengthening Yang and enriching essence and supplementing marrow and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
高华: "《最新国家药品标准实施手册》", 31 March 2004, 社会科学文献出版社 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104547963A (en) * 2015-02-13 2015-04-29 王学兵 Medicine for treating male kidney-deficiency waist-knee cold pain and frequent urination and preparation method thereof
CN104622905A (en) * 2015-03-05 2015-05-20 济南康众医药科技开发有限公司 Medicinal composition without gecko smell
CN105770392A (en) * 2016-02-18 2016-07-20 西安圣威制药有限公司 Traditional Chinese medicine composition for invigorating kidney and strengthening Yang and enriching essence and supplementing marrow and preparation method thereof
CN105770392B (en) * 2016-02-18 2020-06-09 西安圣威制药有限公司 A Chinese medicinal composition for invigorating kidney, supporting yang, replenishing essence and replenishing marrow, and its preparation method

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