CN1218714C - Kidney asthenia treating medicine and its prepn process - Google Patents

Kidney asthenia treating medicine and its prepn process Download PDF

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CN1218714C
CN1218714C CN 02100342 CN02100342A CN1218714C CN 1218714 C CN1218714 C CN 1218714C CN 02100342 CN02100342 CN 02100342 CN 02100342 A CN02100342 A CN 02100342A CN 1218714 C CN1218714 C CN 1218714C
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kidney
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郭海
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Abstract

The present invention discloses medicine for treating renal deficiency. The medicine uses saline cistanche mainly, raw medicinal materials with the certain weight ratio, such as saline cistanche, dodder, epimedium herb, milkvetch root and pulp of dogwood fruit as raw materials, after the raw materials are cleaned, purified, pulverized and are extracted with a solvent, concentrated liquid is obtained by concentrating at low temperature after leach and extract are mixed and filtered, and the concentrated liquid is prepared into the dosage form of any kind of pharmacy according to a conventional method. The medicine of the present invention greatly protects biological active substances in Chinese herbal medicine with the formula principle that regulation, reinforcement and treatment are combined into a whole, the unique formula and a low temperature crude medicine extract engineering technology of applied science in preparation methods, and effective components in Chinese herbal medicine are sufficiently extracted. The stability of quality is ensured with a quantitative analysis and identification method, and the present invention has obvious therapeutic effect.

Description

Be used for the treatment of medicine of suffering from a deficiency of the kidney and preparation method thereof
Technical field:
The present invention relates to the medicine that a kind of treatment is suffered from a deficiency of the kidney, is the Chinese patent medicine of feedstock production with the Chinese herbal medicine specifically, the invention still further relates to the preparation method of this medicine.
Background technology:
Along with social high speed development, the quickening of work, rhythm of life, for the development of cause, people often ignore healthy among striving, and What is more, exchanges benefit for healthy over loading.The overdraw of many middle-aged and elderly people energy causes the chronic diseases of suffering from a deficiency of the kidney, and is in sub-health state, as: smart tired power is weary, soreness of waist and ache in legs, forgetful, insomnia, sexual disorder, alopecia, lustreless complexion, sterility and infertility or the like.Theory of Chinese medical science is thought: " which kind of cause finally all can cause suffering from a deficiency of the kidney for some chronic deficient property diseases, which kind of type no matter ", " must reach kidney thoroughly ".
The Huangdi's Internal Classics speech: " woman five or seven (35 years old), man five or eight (40 years old), the kidney qi degradation, vital organs of the human body elite is day damage thereupon ", show that with advancing age people's renal function day by day weakens.As seen, kidney deficiency is a kind of commonly encountered diseases, frequently-occurring disease, and custom has saying of " ten people nine suffering from a deficiency of the kidney ".
At present, the medicine that the treatment of selling on the market is suffered from a deficiency of the kidney is very different, and main weak point shows in the following areas:
1, many Chinese medicines are through proved recipe, and treatment mechanism and effect that shortage and modern life science research combine and verifies and analyze this medicine belong to the experience category more.
2, most tcm products lack the quantitative target of finger printing, are difficult to control drug quality.
3. some Chinese medicine is acute complementary class strengthening yang and invigorating kidney medicine, contains Radix Ginseng, Cornu Cervi Pantotrichum etc., as oral liquid of spring, contains Radix Ginseng, Cornu Cervi Pantotrichum, Gallus Domesticus, Herba Epimedii, Actinolitum.Many Chinese medicines that contain animal class raw material as the black three kidney balls in sea, contain Penis et testis cervi, Testis et penis callorhini, sea crow, Radix Ginseng etc., and its part material derives from state guarantee animal such as fur seal, thereby raw material are limited.These the kidney invigorating medicine tonifying YANGs simply may cause negative and positive further to be lacked of proper care, and are harmful to health on the contrary.
In addition, method such as existing Chinese medicine relates to steaming in concocting process, process, boil makes that some active substance is destroyed owing to temperature is too high in the Chinese medicine, and effective ingredient incurs loss.
The Western medicine that is used for the treatment of because of the associated diseases of suffering from a deficiency of the kidney of public use at present mostly is hormone medicine, and side effect is big and many.Can only play the expansion blood vessel function as viagra (viagra), can separate needing of a period of time, cure the symptoms, not the disease, long-time use also can cause dependency.
Summary of the invention:
Theory of Chinese medical science is thought: " kidney controlling essence storage is the source of people's bulk-growth, growth, reproduction, is the root of vital movement, so be called the congenital foundation.”
Purpose of the present invention provides a kind of fully natural green Chinese herbal medicine that is used for the treatment of the disease of suffering from a deficiency of the kidney just with this root be object originally, does not contain animal class, hormones, chemosynthesis class medicine, has no side effect.
Another object of the present invention provides a kind of method for preparing described medicine under cryogenic conditions, makes that the active substance in the Chinese medicine can not go to pot owing to temperature is too high, reduces loss of effective components as far as possible.
Technical scheme of the present invention is as follows:
Medicine of the present invention is made by following component: (consumption is a weight portion)
Herba Cistanches 25-60 Semen Cuscutae 4-25
Herba Epimedii 4-25 Radix Astragali 3-20
Fructus Corni 5-20
The preparation method of medicine of the present invention may further comprise the steps successively:
1. Herba Cistanches, Herba Epimedii, Semen Cuscutae, the Radix Astragali, Fructus Corni crude drug are cleaned, removed slag, be ground into the granule that diameter is 3-5mm;
2. the granule after will pulverizing mixes, and adding concentration is the alcoholic acid aqueous solution of 60-70%, room temperature lixiviate 24-36 hour;
3. lixiviating solution is filtered stand-byly, the solid drugs that leaches is added in the extraction pot, the alcoholic acid aqueous solution that adds concentration simultaneously and be 60-70% extracts again, obtains extracting solution;
4, extracting solution is mixed with lixiviating solution, filter the back and add the concentration tank concentrating under reduced pressure, temperature is no more than 60 ℃, obtains concentrated solution;
5, be prepared into any pharmaceutics on said to such an extent that dosage form get final product according to conventional method concentrated solution.
The method that wherein is prepared into oral liquid can be: adding an amount of distilled water and go into concentrated solution, is to precipitate more than 24 hours under the 3-7 ℃ of condition or add clarifier to clarify in temperature; Behind supernatant liquid filtering, add the Mel that boils that is equivalent to the former medicine weight of Herba Cistanches 15-30% and obtain medicinal liquid, add the sorbic acid that is equivalent to medicinal liquid cumulative volume 0.1%-0.3% again; Filtrate filtered is bottled after quality inspection, and 110 ℃-120 ℃ sterilizations got final product in 30-50 minute.
Wherein being prepared into granule with the method for using as electuary can be: concentrated solution is heated to 55 ℃-60 ℃, adds the white dextrin that is equivalent to concentrated solution weight 6%-10%, add water mix well to proportion be 1-1.40; Carry out spray drying and obtain dry powder; Add light white sugar again in dry powder, powder shape requires outward appearance neat, and the 13-50 order that sieves contains moisture≤5%; Utilizing ultraviolet spectroscopy content to carry out sanitary inspection again gets final product.
The prescription analysis of medicine of the present invention:
Herba Cistanches, sweet in the mouth, warm in nature, go into kidney, large intestine channel, the Shennong's Herbal cloud: " main reinforcing YIN-essence, beneficial vital essence, how sub." " property of medicine opinion " cloud: " beneficial marrow, improving healthy complexion is prolonged life, and mends tonifying YANG greatly." this product both mended marrow, invigorating kidney-YANG again, for controlling the infertile good medicine of sexual impotence, holding concurrently can loosening bowel to relieve constipation, can control the dryness of the intestine constipation, is the monarch drug in the medicament composing prescription of the present invention.
Herba Epimedii, acrid in the mouth, sweet, warm in nature, go into liver, kidney channel, Shennong's Herbal cloud: " main impotence, the exhausted wound." " Mingyi Bielu " meaning: " the hard muscles and bones of energy ", be the product of kidney invigorating and YANG supporting, can assist monarch drug to strengthen the merit of invigorating kidney-YANG, be the ministerial drug in the medicament composing prescription of the present invention.
Fructus Corni, " book on Chinese herbal medicine newly organized " carries: " medicine of nourishing YIN does not have not inclined to one side, and the victor is the only big invigorating the liver and kidney of mountain cornel and not dying also, and it is partially both not had cold and heat, does not have the back of the body of negative and positive again, is the hat of nourishing YIN in fact." be the ministerial drug in the medicament composing prescription of the present invention.
Semen Cuscutae, acrid in the mouth, sweet, property is flat, goes into liver, and kidney channel can nourishing YIN, again can YANG invigorating, be the product of strengthening both YIN and YANG, " property of medicine opinion " cloud: " can control men and women's cold caused by deficiency, sperm adding and marrow healthing goes the pain in the lumbar region knee joint cold, and clothes are prolonged life improving healthy complexion for a long time." and have controlling nocturnal emission with astringent drugs concurrently, reducing urination makes eye bright, the effect of antidiarrheal; The Radix Astragali, sweet in the mouth, slightly warm in nature is gone into lung, and spleen channel is the key medicine of QI invigorating, can control the disease of all deficient qi and bloods, and gas has impetus, can strengthen supporing yang merit; The two is the adjuvant drug in the medicament composing prescription of the present invention altogether.(Beijing University of Chinese Medicine, professor Yan Zhenghua separates extracts by the medicine of the present invention side of being write)
The Chinese medical theory of medicine of the present invention institute foundation:
The Compendium of Material Medica record, Herba Cistanches cure mainly " five kinds of strain and seven kinds of impairment, invigorating middle warmer, remove stem invasion by pathogenic cold burning pain, support the five internal organs, reinforcing YIN-essence benefit vital essence, many sons, gynecological mass in abdomen, for a long time clothes make light of one's life by commiting suicide, remove bladder pathogen, lumbago, dysentery relieving, beneficial marrow, improving healthy complexion, prolong life, mend greatly, tonifying YANG ... ".
" Bencao Jingshu " record, Herba Cistanches " key medicine of nourishing kidney replenishing vital essence and blood ".
" book on Chinese herbal medicine is looked for the truth " record, " it is out of fashion that square book claims that it mends essence, beneficial marrow, the exhausted sun of man is prolonged life, managed to happy color, and the woman is exhausted, and the moon does not produce non-praising for Herba Cistanches.”
The existing at home and abroad report of the chemical structural formula of the Main Ingredients and Appearance in the Herba Cistanches.(referring to " Chinese herbal medicine " magazine " research of Herba Cistanches chemical analysis " literary composition in 1994);
Though also useful Herba Cistanches gets in some herbal mixture, seldom occurs with principal agent.In the medicament composing prescription of the present invention, be principal agent with the Herba Cistanches, the property of medicine that emphasis excavates the Chinese medicine Herba Cistanches is main, is aided with Herba Epimedii, Semen Cuscutae, the Radix Astragali, Fructus Corni etc. to help the property of medicine performance of Herba Cistanches.
Efficacy of drugs of the present invention is: kidney-tonifying sperm-generating, QI invigorating tonifying YANG, strengthening the body resistance, slow down aging.Cure mainly: the waist knee joint weakness that deficiency of kidney essence, insufficiency of kidney-YANG cause, aversion to cold and preference for warmth, sexual impotence or sexual function lower, and women's cold womb is infertile, the dryness of the intestine constipation, Mental fatigue power is weary, frequent micturition, luxated tooth alopecia, hypomnesis, Hiccough and deaf etc.
In the present invention's prescription, Herba Cistanches, Semen Cuscutae etc. is not only warming and recuperating the kidney-YANG but also the smart raw material of Chinese medicine of YIN nourishing benefit, treating YANG within YIN, treating YIN within YANG, coordinating YIN and YANG balance; Prescription does not contain acute complementary class raw materials such as Radix Ginseng, Trionyx sinensis Wiegmann, Cornu Cervi Pantotrichum, whip, and has and mend and not high, temperature and not hot characteristics.
Medicine of the present invention shows that through Beijing Medical University's assay determination it contains 16 seed amino acids (seeing Table 1), to replenish the aminoacid of needed by human, strengthens autoimmune function.
Table 1
The aminoacid title Content (μ g/ml) The aminoacid title Content (μ g/ml)
Aspartic acid ASP 202.200 Isoleucine ILE 40.818
Threonine THR 34.641 Leucine LEU 41.298
Serine SER 32.953 Tyrosine TYR 155.027
Glutamic acid GLU 585.736 Phenylalanine PHE 174.564
Glycine GLY 114.842 The r-aminobutyric acid A-ABA 131.52
Alanine ALA 210.761 Histidine HIS 14.360
Valine VAL 94.234 Arginine ARG 43.853
Methionine MET 79.375 Proline PRO 95.983
Medicine of the present invention adopts accurate plasmatron spectrographic analysis to measure through Institute of Analysis of Peking University, show its contain 10 surplus the trace element (seeing Table 2) of kind of needed by human, replenish the needs of human body, enhancing body vigor.The data unit of getting is μ g/10ml in the table.
Table 2
Element The content of sample 1 The content of sample 2 Element The content of sample 1 The content of sample 2
Fe 66.5 66.1 Mg 3350 3194
Zn 65.5 182 B 17.4 17.4
Cu 1.5 1.7 Cd 0.4 /
Mn 29.5 28.1 Cr 4.8 4.7
Al 17.2 20.4 Pb / /
Sr 8.0 8.4 Si 53.8 83.3
P 1775 1717 K 32.5×10 3 32.5×10 2
Ca 2365 2806
Medicine of the present invention has been obtained a series of very significant reliable results in pharmacology, the experiment of pharmacodynamics zooscopy:
One, to Immune Effects:
Experiment shows that medicine of the present invention can obviously improve the phagocytic function of mouse monokaryon macrophage through Shandong Medical University, promotes the formation and the delayed hypersensitivity of hemolysin, and can significantly increase the lymphocytic propagation of spleen T.The result takes passages as follows:
1. medicine of the present invention the results are shown in Table 3 to the influence of immunocompromised mouse monokaryon macrophage.The exponential sum phagocytic index of cleaning up of CA group is starkly lower than normal control group (P<0.001).4.6g/kg of the present invention, 9.2g/kg group and renal aid syrup group have been significantly increased and have cleaned up exponential sum Wu and bite index, have compared significant difference with the CA group.
Table 3: medicine of the present invention is to the influence of mouse monokaryon macrophage (n=11, x ± s)
Group Dosage (g/kg) K α
The normal control group - 0.0713±0.0163 7.580±0.557
The CA group 0.05 0.0248±0.0072 +++ 4.552±0.882 +++
Administration group of the present invention 2.3 0.0273.±0.0069 5.211±0.526
4.6 0.0335±0.0096 * 5.677±0.602 **
9.2 0.0338±0.0071 * 5.855±0.690 **
The renal aid syrup 25ml/kg 0.0325±0.0085 * 5.578±0.382 **
Compare with the normal control group +++P<0.001; Compare with the CA group *P<0.05, *P<0.01
2. medicine of the present invention forms the influence of testing to immunocompromised mice hemolysin, the results are shown in Table 4.CA group mice serum HC 50Be starkly lower than normal control group (P<0.001).4.6g/kg of the present invention, 9.2g/kg group and renal aid syrup group have all significantly increased hemospermia HC 50Be worth, comparing with the CA group all has significant difference.
Table 4: medicine of the present invention is to mice serum HC 50Influence (n=12, x ± s)
Group Dosage (g/kg) HC 50
The normal control group - 18.90±1.76
The CA group 0.05 9.12±1.05 +++
Administration group of the present invention 2.3 9.60±1.00
4.6 10.43±0.91 **
9.2 11.30±0.87 ***
Renal aid syrup group 25ml/kg 11.16±0.90 ***
Compare with the normal control group +++P<0.001; Compare with the CA group *P<0.05, * *P<0.001
3, medicine of the present invention the results are shown in Table 5 to the influence of immunocompromised mice delayed hypersensitivity.CA group mice foot swelling rate, thymus index and spleen index all are starkly lower than normal control group (P<0.001).The present invention obeys liquid 4.6g/kg, 9.2g/kg group and renal aid syrup group be significantly increased foot swelling rate, thymus index and spleen index.
Table 5: medicine of the present invention is to the influence of mice delayed hypersensitivity (n=12, x ± s)
Group Dosage (g/kg) Foot swelling rate (%) Thymus index (mg/g) Spleen index (mg/g)
The normal control group - 15.88 5.26 2.55±1.18 5.21±1.21
The CA group 0.05 3.77±1.8 +++ 0.61±0.17 +++ 1.54±0.19 +++
Oral liquid of the present invention 2.3 5.51±3.50 0.82±0.12 ** 2.09±0.49 **
4.6 7.32±2.50 ** 0.84±0.21 * 2.10±0.38 ***
9.2 8.67±2.40 *** 0.92±0.24 ** 2.20±0.51 ***
Renal aid bran slurry group 25ml/kg 7.83±2.30 ** 0.74±0.098 * 2.06±0.48 **
Compare with the normal control group +++P<0.001; Compare with the CA group *P<0.05, *P<0.01, * *P<0.001.
4, give medicine of the present invention in the body to the lymphopoietic influence of spleen T, the results are shown in Table 6.CA group OD value is starkly lower than normal control group (P<0.01), and oral liquid 9.2g/kg group of the present invention significantly increases the OD value, has compared significant difference (P<0.05) with the CA group.Point out medicine vivo medicine-feeding of the present invention that the lymphocytic propagation of T is had obvious facilitation.
Table 6: medicine of the present invention to the lymphopoietic influence of spleen T (in the body, n=6, x ± s)
Group Dosage (g/kg) The OD value
The normal control group - 0.722±0.044
The CA group 0.05 0.615±0.035 ++
Administration group of the present invention 2.3 0.619±0.038
4.6 0.632±0.033
9.2 0.667±0.031 *
Renal aid syrup group 25ml/kg 0.658±0.036
Compare with the normal control group ++P<0.01; Compare with the Cy group *P<0.05.
More than studies have shown that: medicine of the present invention can obviously improve the phagocytic function of mouse monokaryon macrophage, promotes the formation and the delayed hypersensitivity of hemolysin, and can significantly increase the lymphocytic propagation of spleen T.
Two, antifatigue effect research
Carry out the experimentation of antifatigue effect through Shandong Medical University, the result shows that medicine of the present invention obviously prolongs the mice swimming time.Laboratory report is as follows:
Summary: experiment is studied antifatigue effect of the present invention by observing the present invention to mice room temperature swimming time, high temperature swimming time and the influence of cold-resistant time.The result shows: gastric infusion can obviously prolong mice room temperature and high temperature swimming time, and not have tangible cold-resistant function after 14 days.
Material: medicine of the present invention, 0.4g crude drug/ml, lot number 990704, Beijing Yadong Biology Pharmacy Co., Ltd.Be made into 0.368g/ml with normal saline before the experiment; 0.184g/ml, 0.092g/ml; Renal aid syrup 10ml/ props up, and No. (1996) 096041, the accurate word of medicine are defended in lot number Jiangxi, and the Nanchang Ji is given birth to pharmaceutical factory.
Kunming mouse, body weight 20-23g male and female half and half, Shandong University's Experimental Animal Center provides.The quality certification number: No. 970102, Shandong kinoplaszm word.
Wherein, medicine of the present invention to influencing of mice room temperature swimming time experimental technique and result are as follows:
Get 60 of healthy mices, be divided into normal saline group (0.25ml/10g), medicine high dose group of the present invention (9.2g/kg) at random, middle agent group (4.6g/kg) and low agent group (2.3g/kg) and renal aid group (0.25ml/10g).Press above-mentioned dosage gastric infusion every day 1 time, logotype 14 days, fasting is 12 hours before the last medicine.Bear a heavy burden mouse tail (body weight 8%) half an hour behind the medicine, puts into long 73cm, wide 33cm, high 25cm and depth of water 17cm pond, 25 ℃ of water temperatures, and built-in motor stirrer stirs to produce wave.Observe also record mice swimming time, promptly put into pond to Mus head and immerse the water required time that do not surface in 10 seconds from mice.The result shows that the high, medium and low dosage group of the present invention swimming time prolongs than normal saline group approximately, and the P value is respectively less than 0.001,0.01 and 0.05.
Table 7: medicine of the present invention is to the influence of room temperature swimming time (n=12, x ± s)
Group Dosage (crude drug g/kg) Swimming time (min)
The normal saline group - 4.67±1.18
Administration group of the present invention 2.3 6.61±2.08 *
4.6 6.72±1.67 **
9.2 6.92±1.26 ***
Renal aid syrup group 25ml/kg 6.14±1.52 *
Compare with the normal saline group *P<0.05 *P<0.01 * *P<0.001
Brief summary: the present invention can obviously prolong mice room temperature swimming time.
Three, kidney invigorating and YANG supporting effect experiment
Through Shandong Medical University medicine of the present invention is carried out kidney invigorating and YANG supporting effect experimental study, result of the test shows: effects such as this medicine has tonifying YANG, improves the rat mating ability, antagonism insufficiency of kidney-YANG, deficiency of the kidney yin, enhancing fertility.These results suggest medicine of the present invention has stronger kidney invigorating and YANG supporting effect.Test report is as follows:
1, yang invigorating functions test
Summary: castrated rats gastric infusion 20 days.The present invention gets medicine 2g/kg, 4g/kg, three dosage groups of 8g/kg and castration group relatively, all can shorten the incubation period of castrated rats erection, prolongs the persistent period, obviously increases the prostate+seminal fluid capsule of castrated rats, the weight of levator ani.The present invention gets medicine 4g/kg group preputial glands weight significantly to be increased, and prompting the present invention has yang invigorating functions to castrated rats.
Test objective: observe the yang invigorating functions of medicine of the present invention to castrated rats.
Medicine: medicine 0.4g crude drug/ml of the present invention, lot number: 990704, the Beijing Yadong Biology Pharmacy Co., Ltd, renal aid 10ml/, No. (1996) 096041, lot number, the Nanchang Ji is given birth to pharmaceutical factory.
Animal: the wistar rat, male, body weight 110-130g is provided by Shandong Medical University experimental animal center, the quality certification number: No. 970101, Shandong kinoplaszm word.
Dosage: medicine 2g/kg of the present invention, 4g/kg, 8g/kg; Renal aid syrup 25ml/kg.
Method: get 84 of healthy rats, with 1.8% sodium pentobarbital (36mg/kg) ip anesthesia, the routine disinfection skin of scrotum is extractd bilateral testes (a sham operated rats otch is not plucked testis), postoperative im benzylpenicillin-Na salt 20,000 μ/kg, for three days on end.All the other rat castration operation back d4 are divided into 6 groups at random except that sham operated rats: (1) castration model group: distilled water 2ml/100g; (2) androlin group: 0.2mg/ only; (3) renal aid group: 25ml/kg; (4)-(6) medicine 2g/kg of the present invention, 4g/kg and 8g/kg, the administration volume is 2ml/100g; (7) sham operated rats: distilled water 2ml/100g.Except that (2) group was subcutaneous injection, all the other each groups were gastric infusion, once a day, continuous 20 days, d21 places rat penis position with the electrical stimulation electrode behind the medicine, gives the 4mA electric current and irritates, and record begins to erect the time (erecing incubation period) and persistent period to penis from irritating.D22 puts to death rat and takes out preputial glands, prostate+seminal fluid capsule, levator ani, cavernous body of penis flesh, adrenal gland rapidly, weighs, and calculates organ coefficient, represents with internal organs weight in wet base mg/100g body weight.
The result: (1) is to the influence of erection, three dosage groups of medicine of the present invention and castration model group are relatively, all can significantly improve the irritability that the castrated rats penis irritates the outside, under the micro-electrical stimulation effect in part, obviously shorten rat erection incubation period (P<0.001), prolong the persistent period (P<0.01), the results are shown in Table 8.
Table 8: medicine of the present invention is to the influence of erection and persistent period (x ± s)
Tissue Dosage Number of animals (only) Erect incubation period (S) Persistent period (S)
Sham operated rats - 10 3.1±2.3 5.9±3.1
The androlin group 0.2mg/ only 10 7.3±7.3 *** 4.6±2.4 ***
Model control group - 10 56.2±7.1 +++ 0.3±0.5 +++
Of the present invention group 2g/kg 10 24.6±13.3 *** 1.4±0.8 **
4g/kg 10 12.3±6.9 *** 4.7±2.3 **
8g/kg 9 12.3±6.7 *** 1.9±1.2 **
The renal aid group 20ml/kg 10 13.1±6.7 *** 1.9±1.3 **
Compare with model control group *P<0.01 * *P<0.001; Compare with sham operated rats +++P<0.001
2. to the influence research of the sperm quantity of animal:
Research report is as follows:
To the influence of mouse sperm quantity and sperm relative populations, dissect and get the bilateral epididymis, get its most of afterbody, weigh, put into the plate that fills 5mlPBS, shred the back and placed 20 minutes, sperm is freely swum out of, get suspension.Evenly mixed with suction pipe piping and druming, carry out sperm count and draw sperm quantity, and press the sub-relative populations of following formula refinement (individual/g epididymis cabrage): sperm relative populations=sperm quantity (individual)/tail of epididymis weight (g).
The result shows that the high, medium and low dosage of medicine of the present invention all is significantly increased effect to the male mice sperm quantity, with the normal control group significant difference (p value respectively less than 0.01,0.01,0.05) is arranged relatively.Height of the present invention, middle dosage also are significantly increased effect to male mice sperm relative populations, with the normal control group significant difference (p<0.05) is arranged relatively, renal aid syrup group can obviously increase sperm quantity and sperm relative populations (p is respectively less than 0.01 and 0.05).See Table 9.
Table 9: medicine of the present invention is to the influence of sperm quantity and relative populations (n=11x ± s)
Group Dosage Sperm quantity (* 10 6Individual) Sperm relative populations (* 10 8Individual/g epididymis cabrage)
The normal control group - 1.51±0.46 1.33±0.34
Of the present invention group 2.3g/kg 1.97±0.47 * 1.35±0.40
4.6g/kg 2.24±0.58 ** 1.68±0.53 *
9.2g/kg 2.61±0.84 ** 1.76±0.56 *
Renal aid syrup group 25ml/kg 3.10±0.85 ** 1.66±0.26 *
Compare with the normal control group *P<0.05 *P<0.01
Medicine of the present invention is to the influence of male mice fertility: by experimental observation to the dynamic effect of male mice sperm and reflect its influence indirectly to fertility, the result shows: gastric infusion is after 15 days, and this medicine does not have obvious influence to mouse testis weight and testis index; Can obviously increase mouse sperm quantity and relative populations; Significantly improve mouse sperm and have motility rate and Maturity; And the mouse sperm energy is not had obvious effect.The quantity of pointing out this medicine not only can increase sperm, and can improve the quality of sperm.
An important feature of the present invention also shows the application modern life science, molecular biology, and the high-tech approach of cytology and modern medicine is studied and has been verified that the present invention treats the mechanism of disease and to the effect of human body.
One, the medicine of the present invention cytology and biochemical studies have shown that of carrying out through Chinese-Japanese Friendship Clinic Medical Inst, it improves self DNA (DNA (deoxyribonucleic acid)) synthetic ratio and must act on significantly, can strengthen the regeneration of cell, excites the vigor of nephrocyte.
Two, since mid-term in 20th century, world medical circle studies have shown that free radical superfluous in the human body is one of morbific important root, it makes body senilism, induce an illness, destroy cell tissue, become morbific chief-criminal and bring disaster upon medicine, the performance of suffering from a deficiency of the kidney of clinical card shape that radical reaction produced and Chinese medicine is very similar.
Medicine of the present invention is through Beijing Medical University's natural drug and paramagnetic resonance seminar of bionical medicine National Key Laboratory applied molecular biology method, adopt accurate EPR spectrometer to measure, show that medicine of the present invention can effectively remove superfluous free radical and reach more than 95%.Research process is as follows:
1. experimental technique:
(1) the Fenton reaction produces hydroxyl radical free radical, that is:
(2) electron paramagnetic resonance ESR detection is caught in spin OH, that is:
(3) calculating of suppression ratio I: I=(ho-hx)/ho%, wherein, ho, hx are respectively the ESR wave spectrum test height that adduct is caught in the spin of contrast and sample.
(4) ESR test condition: used instrument is the X-band ESP300 of a Bruker company type electronic paramagnetic resonance spectrometer, condition is as follows: microwave power 20mW, 100KHz adjusts frequency, modulation amplitude 2Gauss, central magnetic field 3490Gauss, sweep length 200Gauss, sweep time 320S, time constant 640mS, room temperature detects.
2. experimental result: medicine of the present invention suppresses OH the results are shown in table 10.The concentration of stock solution is represented with C, dilutes 0.5,0.25,0.125,0.062 of original content then respectively, and 0.031 times is control sample with water.
Table 10: variable concentrations of the present invention for The suppression ratio of OH
Sample concentration C 0 0.031 0.062 0.125 0.250 0.500 1
Inhibition degree (%) 0 75 80 85 90 92.5 95
3. experiment impression:
Under this experiment condition, drug sample result of experiment of the present invention is shown: this medicine has stronger right The inhibition ability of OH, and it is relevant to be concentration.
Medicine of the present invention adopts accurate EPR spectrometer to measure through Beijing Medical University's natural drug and paramagnetic resonance seminar of bionical medicine National Key Laboratory applied molecular biology method, and it is stronger to O to show that medicine of the present invention has 2 -The inhibition ability, and it is relevant to be concentration, to O 2 -The inhibition ability, as if comparison The inhibition ability of OH is stronger.Research process is as follows:
1. experimental technique:
(1) xanthine (X) produces O under xanthine oxidase (XOD) catalysis 2 -, promptly
(2) spin is caught electron paramagnetic resonance ESR and is detected O - 2, promptly
(3) calculating of suppression ratio I: I=(ho-hx)/ho%, wherein, ho, hx are respectively the ESR wave spectrum test height that adduct is caught in contrast and sample spin.
(4) ESR test condition: used instrument is the X-band ESP300 of a Bruker company type electronic paramagnetic resonance spectrometer, condition is as follows: microwave power 20mW, modulating frequency 100KHz, modulation amplitude 1.5Gauss, central magnetic field 3490Gauss, sweep length 200Gaus, sweep time 320S, time constant 640mS, room temperature detects.
2. experimental result: medicine of the present invention suppresses the X/XOD system and produces O 2 -Ability list in table 11, the concentration of stock solution is represented with C, dilutes 0.5,0.25,0.125,0.062 then respectively, 0.031 times is control sample with water.
Table 11: the medicine of the present invention of variable concentrations is for O 2 -Suppression ratio
Sample concentration C 0 0.031 0.062 0.125 0.250 0.500 1
Suppression ratio (%) 0 66 78 86 93 97 ≈100
3. experiment impression: medicine of the present invention has stronger to O 2 -The inhibition ability, and it is relevant to be concentration; To O 2 -The inhibition ability, as if the inhibition ability of comparing OH stronger.
Medicine of the present invention shows that by the experimentation of Beijing Medical University institute of materia medica it has tangible immunologic function.Research process is as follows:
1. experimental technique:
(1) method of employing " clearance test of mice carbon ", the india ink 0.1ml/10g of mouse tail vein injection dilution, the mensuration mice (KM, 30 ± 5g, the Beijing Medical University Animal House, lot number: the phagocytic index a moving word 01-3049 of doctor), the computational methods of a are as follows:
A=[body weight/(liver weight+spleen is heavy)] * K 1/3
K=(lgOD 1-lgOD 2)/(t 2-t 1)
Wherein, t 1And t 2After injecting india ink respectively, the time of getting blood in the mouse orbit, lgOD 1And lgOD 2Being respectively above-mentioned adopts to such an extent that blood sample 20ul adds 2ml Na 2CO 3In the solution, the optical density value that records at the 600nm place.With Na 2CO 3Solution is made blank.
(2) put to death mice, get liver, spleen, thymus, blot organ surface blood with filter paper respectively and weigh.
(3) laboratory animal is divided two groups: one group is contrast, and another group is irritated stomach medicine 0.024ml/10mg of the present invention, 1 day twice, totally 7 days.
2. experimental result: medicine of the present invention sees Table 12 to the influence of mice phagocytic index and spleen and thymic weight.
Table 12: the present invention is to mice phagocytic index and spleen and the heavy influence of thymus
Matched group The medication group Variation after the medication
Phagocytic index (a) 3.36±0.68 4.71±0.72 ↑40.2%
Spleen heavy (mg/g) 4.73±0.59 6.12±0.33 ↑29.4%
Thymus (mg/g) 2.06±0.29 2.78±0.17 ↑34.9%
3. experiment impression: the mice of irritating stomach medicine of the present invention can obviously increase the phagocytic index of cell, and the weight of immune organ spleen and thymus also obviously increases.
Another characteristics of the present invention are the methods with scientific quantitative, identify on molecular level in the finger printing mode quality of product to guarantee drug manufacture quality of stability of the present invention and reliability.Medicine of the present invention has exclusive characteristic peak in the 370-372nm place in ultraviolet (UV) spectrogram, can calculate the content of product with this peak area, thereby control of product quality is quantized, and constant product quality is guaranteed.
Advantage of the present invention and good effect:
No acute complementary class medicine and Radix Ginseng, Cornu Cervi Pantotrichum etc. also do not have animal kind medicine thing such as whip class, Trionyx sinensis Wiegmann class, fur seal etc. in the composition of medicine of the present invention, do not contain hormone and chemosynthesis class medicine, therefore have no side effect.
The present invention is guidance with whole sight of theory of Chinese medical science core, whole factor with the people is a basis, develop medicine with coordinating YIN and YANG balance, extra-nutrition, treatment and prophylactic innovative idea, the three is integrated, YIN nourishing benefit is smart again to make medicine warming and recuperating the kidney-YANG of the present invention, the coordinating YIN and YANG balance, and belong to the temperature compensation type, promptly mend and not high temperature and not dry.This and Western medicine single therapy, or some Chinese medicine to be partial to a kind of disease far different.
Pharmaceutical formulation medical material of the present invention is raw medicinal herbs, without high-temperature process, the effective ingredient that has kept medical material, method of the present invention adopts extract at low temperature, make the bioactive substance that contains in the Chinese crude drug, unlikely destroyed as bioactie agent of some activated oligonucleotide reductase etc., make that effective ingredient is fully extracted in the Chinese medicine.Use the specific finger printing of ultraviolet spectroscopy, the active ingredient of Preliminary Identification medicine, content quantitatively, at visible features peak, 370-372nm place, this is one of quantitative control criterion of quality of medicine of the present invention as medicine of the present invention, has guaranteed the stability of drug quality.
Embodiment:
Take by weighing raw material raw medicinal herbs (kilogram) by following proportioning:
Herba Cistanches 30 Herba Epimedii 12 Semen Cuscutae 10
Fructus Corni 11 Radixs Astragali 8
Production method is as follows:
1. Herba Cistanches, Herba Epimedii, Semen Cuscutae, the Radix Astragali, Fructus Corni crude drug are cleaned, removed slag, be ground into the granule that diameter is 4mm;
2. the granule after will pulverizing mixes, and adding concentration is the alcoholic acid aqueous solution of 60-70%, room temperature lixiviate 24 hours;
3. lixiviating solution is filtered stand-byly, the solid drugs that leaches is added in the extraction pot, add concentration simultaneously and be 65% alcoholic acid aqueous solution and extract again, obtain extracting solution;
4, extracting solution is mixed with lixiviating solution, filter the back and add the concentration tank concentrating under reduced pressure, temperature is 55 ℃, obtains concentrated solution;
5. adding an amount of distilled water and go into concentrated solution, is to precipitate 24 hours under 5 ℃ of conditions in temperature;
6. with behind the supernatant liquid filtering, add the Mel that boils that is equivalent to the former medicine weight 20% of Herba Cistanches and obtain medicinal liquid, add the sorbic acid that is equivalent to medicinal liquid cumulative volume 0.2% again; Filtrate filtered is bottled after quality inspection, sterilizes 40 minutes, and makes oral liquid for 110 ℃-120 ℃.

Claims (6)

1. be used for the treatment of the medicine of suffering from a deficiency of the kidney, it is characterized in that it is the medicament of being made by the following weight proportion raw material:
Herba Cistanches 25-60 Semen Cuscutae 4-25 Herba Epimedii 4-25
Radix Astragali 3-20 Fructus Corni 5-20.
2. the medicine of suffering from a deficiency of the kidney that is used for the treatment of as claimed in claim 1 is characterized in that described medicament is an oral liquid.
3. the medicine of suffering from a deficiency of the kidney that is used for the treatment of as claimed in claim 1 is characterized in that described medicament is a dissolved granule.
4. the described preparation method that is used for the treatment of the medicine of suffering from a deficiency of the kidney of claim 1, carry out according to the following steps successively:
(1) Herba Cistanches, Herba Epimedii, Semen Cuscutae, the Radix Astragali, Fructus Corni crude drug are cleaned, removed slag, be ground into the granule that diameter is 3-5mm;
(2) granule after will pulverizing mixes, and adding concentration is the alcoholic acid aqueous solution of 60-70%, room temperature lixiviate 24-36 hour;
(3) lixiviating solution is filtered stand-by, the solid drugs that leaches is added in the extraction pot, the alcoholic acid aqueous solution that adds concentration simultaneously and be 60-70% extracts again, obtains extracting solution;
(4) extracting solution is mixed with lixiviating solution, filter the back and add the concentration tank concentrating under reduced pressure, temperature is no more than 60 ℃, obtains concentrated solution;
(5) concentrated solution is prepared into said dosage form on any pharmaceutics according to conventional method.
5. the preparation method that is used for the treatment of the medicine of suffering from a deficiency of the kidney as claimed in claim 4 is characterized in that, described step (5) is to be prepared as follows into oral liquid:
(a) adding an amount of distilled water and go into concentrated solution, is to precipitate more than 24 hours under the 3-7 ℃ of condition or add clarifier to clarify in temperature;
(b) with behind the supernatant liquid filtering, add the Mel that boils that is equivalent to the former medicine weight of Herba Cistanches 15-30% and obtain medicinal liquid, add the sorbic acid that is equivalent to medicinal liquid cumulative volume 0.1%-0.3% again; Filtrate filtered is bottled after quality inspection, and 110 ℃-120 ℃ sterilizations got final product in 30-50 minute.
6. the preparation method that is used for the treatment of the medicine of suffering from a deficiency of the kidney as claimed in claim 4 is characterized in that, described step (5) is to be prepared as follows into dissolved granule:
(a) concentrated solution is heated to 55 ℃-60 ℃, adds the white dextrin be equivalent to concentrated solution weight 6%-10%, add water mix well to proportion be 1-1.40;
(b) carry out spray drying and obtain dry powder; Add light white sugar again in dry powder, powder shape requires outward appearance neat, and the 13-50 order that sieves contains moisture≤5%;
(c) utilizing ultraviolet spectroscopy content to carry out sanitary inspection again gets final product.
CN 02100342 2002-01-11 2002-01-11 Kidney asthenia treating medicine and its prepn process Expired - Fee Related CN1218714C (en)

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CN1762410B (en) * 2005-06-30 2010-11-17 苏州长征-欣凯制药有限公司 Chinese dodder seed extract, its preparation method, Chinese proprietary medicine containing extracts thereof and use thereof
CN103768214B (en) * 2014-02-12 2015-11-25 宁波超越新材料科技有限公司 A kind of Chinese medicine composition for the treatment of kidney yang deficiency syndrome rhinitis
CN104027493A (en) * 2014-05-26 2014-09-10 陆华 Pharmaceutical composition for preventing or treating yang deficiency syndrome and preparation method and application of pharmaceutical composition
CN106581176A (en) * 2017-01-23 2017-04-26 新疆沃霖生态科技有限公司 Traditional Chinese medicine composition for treating infertility and preparation method and application thereof
CN112043795A (en) * 2020-09-09 2020-12-08 刘宝顺 Composition for treating impotence and application thereof

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