CN100525820C - Medicine for treating prostate disease - Google Patents
Medicine for treating prostate disease Download PDFInfo
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- CN100525820C CN100525820C CNB2006100696136A CN200610069613A CN100525820C CN 100525820 C CN100525820 C CN 100525820C CN B2006100696136 A CNB2006100696136 A CN B2006100696136A CN 200610069613 A CN200610069613 A CN 200610069613A CN 100525820 C CN100525820 C CN 100525820C
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Abstract
The present invention pertains to the field of pharmaceutical technology, which discloses a drug for treating prostate disease and the preparation method. The drug is mainly composed of pangolin scales, sharpleaf galangal fruit, combined spicebush root and Chinese eaglewood, or pangolin scales, sharpleaf galangal fruit, combined spicebush root, Chinese eaglewood and cowherb seed; the mix ratio by weight is: 5 to 25 parts of pangolin scales, 5 to 25 parts of sharpleaf galangal fruit, 15 to 90 parts of combined spicebush root and 1 to 20 parts of Chinese eaglewood; and the drug can further contains 10 to 30 parts of cowherb seed. The drug can be made into any formulation which is acceptable clinically or on the pharmacy, while the oral preparation is preferential. The drug has the effects of inducing resuscitation, removing blood stasis, warming kidney and regulating qi, which can be used for the treatment of chronic prostatic hyperplasia.
Description
1, technical field
The present invention relates to a kind of medicine that is used for prostatosis and preparation method thereof, belong to medical technical field.
2, background technology
Prostatic hyperplasia claims prostate hyperplasia again, is mainly in middle-older patient, and is on the books to it on the Ancient Times in China medical book before 2000, is called " infirmity ".On pathology, prostate is loose because of hypertrophy changes, hypertrophy itself is optimum change, but the body of gland that increases compressing back urethra causes bladder neck to block, freely do not cause the severe complication that blocks with the upper part urinary tract because of urinating for a long time, as in the outgrowth case of prostate, there is 10%-25% that canceration can take place approximately, directly threaten patient's health and lives.At present still do not have the specially good effect Western medicine and can under the prerequisite of anti-recurrence that has no side effect, thoroughly cure its disease; As for operative treatment, no matter be open surgery or endoscope's operation down, certain risk is all arranged, and very easily cause other complication.At present, the traditional Chinese medical herbal treatment prostatic hyperplasia has good curative effect.Motherland's Chinese medicine extensive knowledge and profound scholarship, be particularly good at treatment chronic disease, difficult disease in the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs process, can be got hold of integral body and combine with partial, correctly handle disease to reach the purpose of healing.
Squama Manis is the scute of Manidae animal Squama Manis Manis pentadactyla Linnaeus.Salty in the mouth, cold nature.Return liver, stomach warp.The stimulating milk secretion of stimulating the menstrual flow, detumescence and apocenosis, expel wind to dredge collateral.Be used for amenorrhea and mass in the abdomen, galactostasis, carbuncle sore tumefacting virus, arthralgia, numbness contracture." Records of Tradition Chinese and Western Medicine in Combination " medium cloud: " Squama Manis, gas raw meat and scurrying, the property that it walks to scurry, very careful, so can declare logical internal organs, implement passages through which vital energy circulates, reach the pass key thoroughly, all blood clotting blood is poly-for sick, all can open it." the boiling hot processed product of making of Squama Manis commonly used clinically.
Fructus Alpiniae Oxyphyllae is the dry mature fruit of zingiberaceous plant Fructus Alpiniae Oxyphyllae Alpinia oxyphylla Miq..Acrid in the mouth, warm in nature.Return spleen, kidney channel.Warming spleen and stopping diarrha, take the photograph saliva, warming the kidney, controlling nocturnal emission with astringent drugs reducing urination.Be used for spleen-cold syndrome and have loose bowels, cold type of pain in the abdomen, mouthful many salivas, enuresis due to deficiency of the kidney, frequent micturition, seminal emission nebulousurine.Can reinforcing the kidney and supporting YANG, and property takes in concurrently puckeryly, is good at the controlling nocturnal emission with astringent drugs reducing urination.
The Radix Linderae is the dried root of canella Radix Linderae Lindera aggregata (Sims) Kosterm..Acrid in the mouth, warm in nature.Return lung, spleen, kidney, urinary bladder channel.Promoting the circulation of QI to relieve pain, warming kidney for dispelling cold, reducing urination for preventing enuresis.Be used for chest and abdomen swelling and pain, QI rising in reverse order dyspnea with rapid respiration, deficiency-cold in the urinary bladder, enuresis frequent micturition, hernia, dysmenorrhea.
Lignum Aquilariae Resinatum is the timber that thymelaeceae plant Lignum Aquilariae Resinatum Aquilaria sinensis (Lour.) Gilg contains resin.Acrid in the mouth, hardship, slightly warm in nature.Return spleen, stomach, kidney channel.Promoting the circulation of QI to relieve pain, warming middle-JIAO to arrest vomiting, helping inspiration to relieve asthma.Be used for the vexed pain of breast abdominal distention, gastrofrigid vomiting singultus, the QI rising in reverse order of suffering from a deficiency of the kidney dyspnea with rapid respiration.
Semen Vaccariae is the dry mature seed of pinkwort Vaccaria segetalis Vaccaria segetalis (Neck.) Garcke.Bitter in the mouth, property is flat.Return liver, stomach warp.Promoting blood circulation to restore menstrual flow, stimulating milk secretion eliminating carbuncle, inducing diuresis for treating stranguria syndrome.Be used for lack of lactation after delivery, amenorrhea, dysmenorrhea, acute mastitis swells and ache, pyretic stranguria, stranguria with blood, stranguria caused by urinary stone etc.Use the processed product of Semen Vaccariae parch clinically always.
At present, utilize Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae and Lignum Aquilariae Resinatum, or Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum and Semen Vaccariae composition of prescription, be used to prepare the medicine for the treatment of prostatosis, do not appear in the newspapers as yet.
3, summary of the invention
In order to meet clinical needs, improve curative effect, enlarge medicine variety, the invention provides that a kind of prescription science, preparation are simple, determined curative effect be used for the treatment of medicine of prostatosis and preparation method thereof.
Gerontal patient's asthenia of renal qi, insufficiency of kidney-YANG, disturbance in functioning of QI, hematogenous blockage are so cause the cloudy blood clotting of prostate to gather and the hypertrophy hypertrophy.The chronic prostate hyperplasia obstinate belongs to the reason that prolonged illness must the stasis of blood, and the stasis of blood is then obstructed, stagnation of QI and blood may bring about pain.The prostatic hyperplasia person whenever has blood stasis to be stranded the resistance lower orifices, so the urine sound of rain pattering is not to the utmost, or puckery pain during urine, or lower abdominal distention pain, blood stasis dispelling softening the hard mass method is also very commonly used.Wherein search the product that pick with being key medicine with insects especially.Mountain, Squama Manis cave and occupying, residence water and eating the moon and goes into sun, and its property is walked to scurry, and is very careful, and all blood clotting blood is poly-for sick, all can open it.Its salty in the mouth, salty energy hard masses softening and resolving is used for prostate hyperplasia, and hypertrophy is improved, and is our monarch drug.Prostatic hyperplasia is often smooth with urine, frequent micturition, and through cloud: " here body fluid is hidden for bladder person, the viscus likened to a pond, and gasification then can go out." bladder and kidney the exterior and the interior each other, be located on the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, most important in gasification function.If yang-energy is humble in the kidney, water must be unfavorable, only warming the kidney to activate YANG freeze then that the river gets the sun and water from logical.We are aided with Fructus Alpiniae Oxyphyllae supplementing the kidney to control the nocturnal reducing urination, the circulation of qi promoting of Radix Linderae warming kidney for dispelling cold; The Lignum Aquilariae Resinatum circulation of qi promoting, but that warming middle-JIAO is held concurrently is logical, makes gas capable and water is capable.
Drug main of the present invention will be made by following bulk drugs, and wherein Squama Manis preferably adopts it to scald the processed product of system:
5～25 parts of Squama Maniss, 5～25 parts of Fructus Alpiniae Oxyphyllae, 15～90 parts of the Radixs Linderae, 1～20 part of Lignum Aquilariae Resinatum.
The weight portion of each crude drug of medicine of the present invention is preferably:
15 parts of Squama Maniss, 15 parts of Fructus Alpiniae Oxyphyllae, 45 parts of the Radixs Linderae, 9 parts of Lignum Aquilariae Resinatum.
Manufacturing method for above mentioned medicine comprises the steps:
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, standby;
3) Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weigh up are extracted volatile oil with steam distillation, with the beta-cyclodextrin inclusion compound oven dry, standby; Collect water liquid, medicinal residues decoct with water, and merge extractive liquid, filters, and filtrate is concentrated into finite concentration, precipitate with ethanol, and cold preservation is left standstill, and filters, and decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis powder mix, and get active constituents of medicine of the present invention.
Manufacturing method for above mentioned medicine, concrete steps are:
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, crosses 60 mesh sieves, standby;
3) water that Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weighs up is added 6 times of amounts extracted 8 hours with steam distillation, collect volatile oil, (getting beta-schardinger dextrin-is dissolved in and makes into saturated solution in the suitable quantity of water with beta-cyclodextrin inclusion compound, inject volatile oil, high-speed stirred 2 hours, cold preservation left standstill 24 hours, filtered), 60 ℃ of dry inclusion complexes, standby; Collect water liquid, medicinal residues decoct with water secondary, all add 4 times of amounts of water at every turn, decoct 3 hours, collecting decoction filters, and it is 1.10～1.13 that filtrate is concentrated into relative density, and adding ethanol is 70% precipitate with ethanol to containing the alcohol amount, cold preservation was left standstill 24 hours, filtered, and decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis fine powder mix, and get active constituents of medicine of the present invention.
Also can add Semen Vaccariae in the drug prescription of the present invention, but Semen Vaccariae promoting blood circulation to restore menstrual flow, inducing diuresis for treating stranguria syndrome strengthens the power of the blood stasis dispelling of Squama Manis.Share with Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, all medicines of Lignum Aquilariae Resinatum, play the effect of sensible blood stasis expelling, the kidney warming regulating QI altogether, chronic prostate hyperplasia and the frequent micturition that causes thereof, urine are not freely had good curative effect.
Medicine of the present invention can also be made by following bulk drugs, and wherein Semen Vaccariae preferably adopts the processed product of frying:
5～25 parts of Squama Maniss, 5～25 parts of Fructus Alpiniae Oxyphyllae, 15～90 parts of the Radixs Linderae, 1～20 part of Lignum Aquilariae Resinatum, 10～30 parts of Semen Vaccariae.
The weight portion of each crude drug is preferably:
15 parts of Squama Maniss, 15 parts of Fructus Alpiniae Oxyphyllae, 45 parts of the Radixs Linderae, 9 parts of Lignum Aquilariae Resinatum, 20 parts of Semen Vaccariae.
Manufacturing method for above mentioned medicine may further comprise the steps:
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum, the Semen Vaccariae of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, standby;
3) Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weigh up are extracted volatile oil with steam distillation, with the beta-cyclodextrin inclusion compound oven dry, standby; Collect water liquid, medicinal residues decoct with water with Semen Vaccariae, and merge extractive liquid, filters, and filtrate is concentrated into finite concentration, precipitate with ethanol, and cold preservation is left standstill, and filters, and decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis powder mix, and get active constituents of medicine of the present invention.
Manufacturing method for above mentioned medicine, concrete steps are:
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum, the Semen Vaccariae of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, crosses 60 mesh sieves, standby;
3) water that Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weighs up is added 6 times of amounts extracted 8 hours with steam distillation, collect volatile oil, (getting beta-schardinger dextrin-is dissolved in and makes into saturated solution in the suitable quantity of water with beta-cyclodextrin inclusion compound, inject volatile oil, high-speed stirred 2 hours, cold preservation left standstill 24 hours, filtered), 60 ℃ of dry inclusion complexes, standby; Collect water liquid, medicinal residues and Semen Vaccariae decoct with water secondary, all add 4 times of amounts of water at every turn, decocted collecting decoction 3 hours, filter, it is 1.10～1.13 that filtrate is concentrated into relative density, and adding ethanol is 70% precipitate with ethanol to containing the alcohol amount, and cold preservation was left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis powder mix, and get active constituents of medicine of the present invention.
The crude drug of medicine of the present invention is by weight as proportioning, can increase or reduce according to corresponding proportion when producing, and can kilogram be unit as large-scale production, or be unit with the ton that small-scale production also can restrain and be unit, and weight can increase or reduce.The weight proportion of medicine material medicine of the present invention obtains through science screening, and for especial patient, the ratio of can corresponding adjustment forming increases or reduce being no more than 100%.
Medicine of the present invention has the effect of sensible clots absorbing, the kidney warming regulating QI, is used for the chronic prostate hyperplasia hypertrophy.
Medicine of the present invention can be mixed and made into clinically any or pharmaceutically acceptable dosage form, preferred oral preparation with one or more pharmaceutically acceptable carriers.When being applied to the patient who needs this treatment in the mode of oral administration, can be made into conventional solid preparation, as tablet, capsule, pill, soft capsule, dispersible tablet, chewable tablet, oral cavity disintegration tablet, oral liquid, granule, drop pill, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule etc.
When medicine of the present invention is made preparation, the conventional method production in the existing pharmaceutical field can be adopted, various pharmaceutically acceptable carriers can be added when needing.Described carrier comprises diluent, excipient, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier, lubricant of pharmaceutical field routine etc.
Medicine of the present invention is when making oral formulations, and selectable filler has: starch, Icing Sugar, calcium phosphate, calcium sulfate two water things, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.; Selectable binding agent has: sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hypromellose, gelling starch etc.; Selectable disintegrating agent has: dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.; Selectable lubricant has: magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc.
The advantage of medicine of the present invention is:
(1) provides the medicine of little, the cheap pure treatment by Chinese herbs prostatic hyperplasia of a kind of determined curative effect, safe ready, side effect, increased the clinical application kind, satisfied clinical needs.
(2) pharmacological evaluation shows, medicine of the present invention can suppress the hypertrophy of prostatic hyperplasia model rat prostate smooth muscle cell and basal cell, dwindles the prostate volume of prostatic hyperplasia model rat, reduces weight of prostate; Can suppress the synthetic and secretion of castrated rats prostate specific acid phosphatase, thereby restrain the growth of prostata tissue; Water load rat there is tangible diuresis.Show that medicine of the present invention has the outgrowth effect of good supression to prostatic hyperplasia, and diuresis is arranged.
(3) pharmaceutical preparation of the present invention is simple, and mass discrepancy is little between the different batches medicine, and drug quality is uniform and stable.
Below example is further set forth by Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum (to call the A that writes out a prescription in the following text) by experiment, or the beneficial effect of the medicine made of Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum and Semen Vaccariae (to call the B that writes out a prescription in the following text).
Experimental example 1: medicine of the present invention is to the influence of rat prostate smooth muscle tissue
Animal subject: the Wistar rat, male, body weight 280～320g, is divided into 6 groups, 8 every group at random by 48.
Test sample: proscar, every contains 4-nitrogen steroid hormone chemical compound 5mg, is produced by U.S. MSD Corp.;
The testosterone propionate injection, 50mg/mL is produced by Shanghai the 9th pharmaceutical factory.
Drug prescription A active component of the present invention, self-control.
Instrument MIAS-2000 type graph image analytical system; Ordinary optical microscope, Japanese Olympus.Electronic balance (Sai Duolisi BP-61, sensibility reciprocal 0.1mg/kg).
Reagent a-SMA antibody kit is available from Beijing Zhong Shan Bioisystech Co., Ltd; Other also have 3 ‰ pentobarbital sodium liquid and PBS (pH7.2) liquid.
Experimental technique:
1.1 rat is divided into 6 groups at random: blank group, model group, basic, normal, high three the dosage groups of drug prescription A of the present invention, positive control proscar group.8 rats are after 3 ‰ pentobarbital sodiums are with 10mL/kg dosage intraperitoneal injection of anesthesia, and aseptic operation cuts hypogastric region, free testis, but do not excise testis, 1 week of postoperative is recovered the back naturally as blank group.40 rats are after 3 ‰ pentobarbital sodiums are with 10mL/kg dosage intraperitoneal injection of anesthesia, and aseptic excision bilateral testes is after 1 week recovered naturally, be divided into 5 groups at random by body weight, 8 every group, all percutaneous is injected testosterone propionate 5mg/kg down, 1 time/d, and irritate stomach simultaneously and give medicine.Wherein, blank group and testosterone model group: give distilled water 10ml/kg through irritating stomach, 1 time/d, all the other respectively organize the gastric infusion relative medicine, and dosage sees Table 1.During successive administration 30d, take by weighing rat body weight, through the femoral artery sacrificed by exsanguination, extract each leaf of prostate, claim rat prostate weight, the water method of substitution is measured prostate volume, and calculates prostate index (weight of prostate/rat body weight * 100), get the same area prostata tissue, with 10% dipped into formalin 3d.The routine paraffin wax embedding, serial section, wherein the 1st conventional H E dyeing is observed the prostata tissue cellularity and is changed.
1.2 the operation of test kit description is pressed in the dyeing of immunohistochemical staining SP method, with the positive contrast of positive sheet that provides in the test kit, substitutes an anti-negative contrast with PBS liquid.20 times of mirrors are observed down, and 10 visuals field are got in every section, and occurring brown yellow granule in the cell cytosol is the a-SMA positive cell, analyzes with MIAS-2000 type graph image analytical system.
Experimental result
1.1 each dosage group of weight of prostate and prostate index drug prescription A of the present invention and proscar group all can be dwindled prostate volume, reduce weight of prostate, reduce prostate index (PI).As shown in table 1.
Table 1 medicine of the present invention is to rat prostate weight, volume, exponential influence (X ± SD)
Annotate: compare with the blank group
*P＜0.01; Compare with the testosterone model group,
△ △P＜0.01.
1.2HE dyeing testosterone group body of gland dense arrangement, the expansion of part body of gland, part is mamillary, and prominent the luminal sectetion thing increases to intracavity, and epithelial cell is multiple layer or column, nucleus circle or be oval type, visible kernel.Between the little vasodilation hyperemia of matter, a matter smooth muscle increases.Each dosage group of drug prescription A of the present invention and the visible lumen diameter of proscar group and wall of the lumen thickness are all little than the testosterone group, and the luminal sectetion thing reduces, and the stroma smooth muscle is more loose.
Table 2 medicine of the present invention is organized the influence (X ± SD) of a-SMA to rat prostate
Annotate: compare with the blank group
*P＜0.05; Compare with the testosterone model group,
△P＜0.05,
△ △P＜0.01.
1.3a-SMA the dyeing a-SMA positive is colored as cytoplasm and pale brown color.The a-SMA protein positive is painted in a matter smooth muscle cell in the normal rat prostata tissue; A-SMA is positive painted in a matter smooth muscle cell and glandular epithelium basal cell in model group rat prostate tissue, and it is darker to dye; Positive main painted in each dosage group of drug prescription A of the present invention and proscar group a-SMA in a matter smooth muscle cell and glandular epithelium basal cell, but dyeing is more shallow, is starkly lower than model group.It is as shown in table 2 that each organizes in the prostata tissue a-SMA expression.
Conclusion: the pathophysiological change that causes prostatic hyperplasia mainly contains two factors: dynamic property factor (the level and smooth muscular hypertonia of prostate) and firm static factor (prostate volume increase).Prostata tissue is made up of a matter and body of gland, and the ratio of matter and body of gland is higher than the ratio of matter and body of gland between normal prostate tissue in the middle of the hypertrophy prostata tissue.Between in the matter smooth muscle composition proportion bigger, a-SMA (a-smooth muscle actin) is the myocyte's microfilament with contractile function, mainly be present in smooth muscle cell, myoepithelial cell and myofibroblast also have expression, anti-a-SMA monoclonal antibody can with above-mentioned cell effect, and become the label of smooth muscle cell.Matter smooth muscle cell a-SMA positive expression is higher than normal group between the model group prostate, and the obvious hypertrophy of model group prostate smooth muscle tissue is described, and is similar with the pathological change of people BPH (prostatic hyperplasia).Matter smooth muscle cell a-SMA positive expression obviously reduces between each dosage group of drug prescription A of the present invention, illustrates that drug prescription A of the present invention can suppress the hypertrophy of BPH rat model prostate smooth muscle cell, and then alleviates firm static factor and the dynamic property factor of BPH.In addition, each dosage group glandular epithelium basal cell a-SMA positive expression of drug prescription A of the present invention weakens, and illustrates that drug prescription A of the present invention also can suppress the hypertrophy of basal cell.
Experimental example 2: medicine of the present invention is to prostatic hyperplasia rat blood serum acid phosphatase (ACP), serum testosterone (T) and estrogen (E
2
)
Influence
Animal subject: the Wistar rat, male, body weight 280～320g, is divided into 5 groups, 8 every group at random by 40.
Test sample: the testosterone propionate injection, 50mg/mL is produced by Shanghai the 9th pharmaceutical factory;
Acid phosphatase enzyme reagent kit, Nanjing build up bio-engineering research institute;
The total protein test kit, Beijing Bai Ding biological engineering company limited;
The gonadal hormone radioimmunological kit, German Bayer company;
Refined caster oil;
Drug prescription B active component of the present invention, self-control.
Experimental technique: 40 rats are divided into 5 groups at random by body weight: normal control group, model group, the basic, normal, high dosage group of drug prescription B of the present invention.Except that the normal control group, (testosterone is dissolved in Oleum Ricini to 4 groups of rat abdominal part hypodermic every day testosterone propionate 4ml/kg, and 2mg/ml), the normal control group is injected refined caster oil, 7d modeling continuously in addition.Basic, normal, high dosage group difference gastric infusion behind the 7d, normal control group and model group are irritated stomach with normal saline.5 weeks of successive administration.Win prostate after 5 weeks, because sex hormones secretion has the pulsed characteristics, so successively get blood from eye socket and the femoral artery of rat, the interval of twice blood sample collection is 3h, each blood sample of gathering adds the heparin sodium anticoagulant, and with the centrifugal 10min of refrigerated centrifuge (3000r/min), separated plasma is put in-20 ℃ of refrigerators and preserved behind the 15min, respectively organize the rat plasma sex hormone level with measured by radioimmunoassay, and calculate blood plasma gonadal hormone average twice.With alpha-Naphthol phosphate method colorimetric determination blood plasma TAP (ACP), with the L-Tartaric acid non-prostate specific acid phosphatase of method colorimetric determination (NPAP), prostate specific acid phosphatase (PAP)=ACP-NPAP.
Experimental result
2.1 the variation model group rat of each dosage group rat plasma T and E2 behind the subcutaneous injection testosterone propionate, can make the rat blood serum testosterone levels raise, with normal control group comparing difference remarkable (p＜0.01).The medicament composing prescription B of the present invention of various dose raises to the rat blood serum testosterone antagonism, remarkable with the model group comparing difference, wherein the antagonism that causes of low dosage does not have significant difference (p〉0.05), and middle dosage and heavy dose of antagonism serum testosterone rising effect that causes have significant difference (p＜0.01).Each organizes the serum estradiol level does not have significant change.The results are shown in Table 3.
Table 3 medicine of the present invention is to prostatic hyperplasia rat plasma T and E
2Influence (X ± SD)
Annotate: compare with normal control group group
*P＜0.01; Compare with the testosterone model group,
△ △P＜0.01.
2.2 variation model group rat blood serum ACP, the PAP level of each dosage group rat blood serum activity of acid phosphatase level significantly raise, relatively there were significant differences (p＜0.01) with the normal control group.The administration group increases with the dosage of drug prescription B of the present invention, inhibitory action to serum ACP, PAP level strengthens gradually, the variation that low dosage drug prescription B of the present invention causes does not have significant difference (p〉0.05), and middle dosage and heavy dose of inhibitory action to serum ACP, PAP level have significant difference (p＜0.05 and p＜0.01).Each organizes the active no significant change of serum N PAP.The results are shown in Table 4.
Table 4 medicine of the present invention is to the influence of prostatic hyperplasia rat blood serum ACP, NPAP, PAP (X ± SD)
Annotate: compare with the normal control group
*P＜0.01; Compare with the testosterone model group,
△ △P＜0.01.
Conclusion: since serum in PAP mainly from prostata tissue, so the active variation of blood-serum P AP can reflect the prostate state.The prostata tissue hypertrophy is strengthened, and blood-serum P AP raises, and dosage and high dose drug prescription B of the present invention can obviously suppress blood-serum P AP rising during experiment showed, thereby explanation drug prescription B of the present invention is to the inhibitory action of prostata tissue growth.Because the synthetic and secretion of PAP relies on androgenic existence, and the growth of prostata tissue relies on the serum androgen level, estrogen also has an effect to its growth, so drug prescription B antagonism level of serum testosterone of the present invention raises and influenced blood-serum P AP and raises and suppress the gland tissue growth in the experiment.Drug prescription B of the present invention does not have obvious influence to the serum estradiol level in the experiment, but has caused the change of T/E ratio because testosterone concentration changes, so can influence the growth of prostata tissue equally.So can suppress the synthetic and secretion of prostate specific acid phosphatase to drug prescription B of the present invention.
Experimental example 3: medicine of the present invention is to the diuresis of rat
Animal subject: the Wistar rat, male, body weight 280～320g, is divided into 4 groups, 10 every group at random by 40.
Test sample: B active component in medicine side of the present invention.
Experimental technique: 40 rats are divided into 4 groups at random by body weight: matched group, the basic, normal, high dosage group of drug prescription B of the present invention.Fasting is 18 hours before the test, can't help water, and each Mus is irritated stomach by 2ml/100g and gives distilled water (medicine of administration group adds in the entry load), gently presses the rat hypogastric region to make the bladder emptying.Immediately rat is put into metabolic cage, 1 in every cage was collected urine, and was carried out statistical procedures with the urine value in 2,4 hours.
The results are shown in Table 5.
Table 5 medicine of the present invention is to the diuresis of rat (X ± SD)
Annotate: compare with matched group
*P＜0.05,
*P＜0.01.
Conclusion: compare with matched group, 2 hours and 4 hours showed increased after low, the middle dosage group administration of medicine of the present invention, significant difference (p＜0.05), 4 hours urine amounts are compared with matched group and utmost point significant difference (p＜0.01) occurred after the high dose group administration.Show that medicine of the present invention has tangible diuresis to water load rat, the high dose group diuresis is the strongest.
4, the specific embodiment
The specific embodiment of form is described in further detail foregoing of the present invention by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Embodiment 1: the preparation of medicinal tablet of the present invention
Squama Manis 150g, Fructus Alpiniae Oxyphyllae 150g, Radix Linderae 450g, Lignum Aquilariae Resinatum 90g
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, crosses 60 mesh sieves, standby;
3) water that Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weighs up is added 6 times of amounts extracted 8 hours with steam distillation, collect volatile oil, (getting beta-schardinger dextrin-is dissolved in and makes into saturated solution in the suitable quantity of water with beta-cyclodextrin inclusion compound, inject volatile oil, high-speed stirred 2 hours, cold preservation left standstill 24 hours, filtered), 60 ℃ of dry inclusion complexes, standby; Collect water liquid, medicinal residues decoct with water secondary, all add 4 times of amounts of water at every turn, decoct 3 hours, collecting decoction filters, and it is 1.10～1.13 that filtrate is concentrated into relative density, and adding ethanol is 70% precipitate with ethanol to containing the alcohol amount, cold preservation was left standstill 24 hours, filtered, and decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis fine powder mix, and add binding agent, disintegrating agent and lubricant and make granule, and drying is pressed into 1000.
Embodiment 2: the preparation of medicine capsule of the present invention
Squama Manis 150g, Fructus Alpiniae Oxyphyllae 150g, Radix Linderae 450g, Lignum Aquilariae Resinatum 90g, Semen Vaccariae 200g
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum, the Semen Vaccariae of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, crosses 60 mesh sieves, standby;
3) water that Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weighs up is added 6 times of amounts extracted 8 hours with steam distillation, collect volatile oil, (getting beta-schardinger dextrin-is dissolved in and makes into saturated solution in the suitable quantity of water with beta-cyclodextrin inclusion compound, inject volatile oil, high-speed stirred 2 hours, cold preservation left standstill 24 hours, filtered), 60 ℃ of dry inclusion complexes, standby; Collect water liquid, medicinal residues and Semen Vaccariae decoct with water secondary, all add 4 times of amounts of water at every turn, decocted collecting decoction 3 hours, filter, it is 1.10～1.13 that filtrate is concentrated into relative density, and adding ethanol is 70% precipitate with ethanol to containing the alcohol amount, and cold preservation was left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis powder mix, and add binding agent and make granule, dress up 1000 hard capsules.
Embodiment 3: the preparation of medicinal granule of the present invention
Squama Manis 150g, Fructus Alpiniae Oxyphyllae 150g, Radix Linderae 450g, Lignum Aquilariae Resinatum 90g, Semen Vaccariae 200g
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum, the Semen Vaccariae of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, crosses 60 mesh sieves, standby;
3) water that Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weighs up is added 6 times of amounts extracted 8 hours with steam distillation, collect volatile oil, (getting beta-schardinger dextrin-is dissolved in and makes into saturated solution in the suitable quantity of water with beta-cyclodextrin inclusion compound, inject volatile oil, high-speed stirred 2 hours, cold preservation left standstill 24 hours, filtered), 60 ℃ of dry inclusion complexes, standby; Collect water liquid, medicinal residues and Semen Vaccariae decoct with water secondary, all add 4 times of amounts of water at every turn, decocted collecting decoction 3 hours, filter, it is 1.10～1.13 that filtrate is concentrated into relative density, and adding ethanol is 70% precipitate with ethanol to containing the alcohol amount, and cold preservation was left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis powder mix, and adding Icing Sugar, binding agent are made 1000 bag granules.
Embodiment 4: the preparation of medicinal soft capsule of the present invention
Squama Manis 150g, Fructus Alpiniae Oxyphyllae 150g, Radix Linderae 450g, Lignum Aquilariae Resinatum 90g, Semen Vaccariae 200g
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum, the Semen Vaccariae of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, crosses 60 mesh sieves, standby;
3) water that Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weighs up is added 6 times of amounts extracted 8 hours with steam distillation, collect volatile oil, (getting beta-schardinger dextrin-is dissolved in and makes into saturated solution in the suitable quantity of water with beta-cyclodextrin inclusion compound, inject volatile oil, high-speed stirred 2 hours, cold preservation left standstill 24 hours, filtered), 60 ℃ of dry inclusion complexes, standby; Collect water liquid, medicinal residues and Semen Vaccariae decoct with water secondary, all add 4 times of amounts of water at every turn, decocted collecting decoction 3 hours, filter, it is 1.10～1.13 that filtrate is concentrated into relative density, and adding ethanol is 70% precipitate with ethanol to containing the alcohol amount, and cold preservation was left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with thick paste oven dry, pulverize and the Benexate Hydrochloride and the Squama Manis powder of volatile oil mix, active constituents of medicine of the present invention, with soybean oil and soybean phospholipid, Cera Flava heating and melting, mixing is put coldly, adds the gained active component, is pressed into 1000 soft capsules.
Claims (8)
1. a medicine that is used for prostatosis is characterized in that, this medicine is made by following bulk drugs:
5～25 parts of Squama Maniss, 5～25 parts of Fructus Alpiniae Oxyphyllae, 15～90 parts of the Radixs Linderae, 1～20 part of Lignum Aquilariae Resinatum.
2. medicine according to claim 1 is characterized in that, the parts by weight of this each crude drug of medicine are:
15 parts of Squama Maniss, 15 parts of Fructus Alpiniae Oxyphyllae, 45 parts of the Radixs Linderae, 9 parts of Lignum Aquilariae Resinatum.
3. the preparation method of arbitrary medicine according to claim 1 and 2 comprises the following steps:
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, standby;
3) Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weigh up are extracted volatile oil with steam distillation, with the beta-cyclodextrin inclusion compound oven dry, standby; Collect water liquid, medicinal residues decoct with water, and merge extractive liquid, filters, and filtrate is concentrated into finite concentration, precipitate with ethanol, and cold preservation is left standstill, and filters, and decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis powder mix, and get active constituents of medicine of the present invention.
4. medicine according to claim 1 is characterized in that, crude drug wherein also has: 10～30 parts of Semen Vaccariae.
5. medicine according to claim 4 is characterized in that, the parts by weight of this each crude drug of medicine are:
15 parts of Squama Maniss, 15 parts of Fructus Alpiniae Oxyphyllae, 45 parts of the Radixs Linderae, 9 parts of Lignum Aquilariae Resinatum, 20 parts of Semen Vaccariae.
6. according to the preparation method of claim 4 or 5 described arbitrary medicines, comprise the following steps:
1) take by weighing Squama Manis, Fructus Alpiniae Oxyphyllae, the Radix Linderae, Lignum Aquilariae Resinatum, the Semen Vaccariae of described weight portion, standby;
2) Squama Manis that weighs up is ground into fine powder, standby;
3) Fructus Alpiniae Oxyphyllae, the Radix Linderae, the Lignum Aquilariae Resinatum that weigh up are extracted volatile oil with steam distillation, with the beta-cyclodextrin inclusion compound oven dry, standby; Collect water liquid, medicinal residues decoct with water with Semen Vaccariae, and merge extractive liquid, filters, and filtrate is concentrated into finite concentration, precipitate with ethanol, and cold preservation is left standstill, and filters, and decompression filtrate recycling ethanol also is concentrated into thick paste;
4) with the thick paste oven dry, the Benexate Hydrochloride of pulverizing and volatile oil and Squama Manis powder mix, and get active constituents of medicine of the present invention.
7. according to claim 1,2,4,5 described arbitrary medicines, it is characterized in that this medicine and mixing acceptable accessories are made arbitrary preparation.
8. medicine according to claim 7 is characterized in that this medicine and mixing acceptable accessories are made oral formulations.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100696136A CN100525820C (en) | 2006-07-28 | 2006-07-28 | Medicine for treating prostate disease |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100696136A CN100525820C (en) | 2006-07-28 | 2006-07-28 | Medicine for treating prostate disease |
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| CN100525820C true CN100525820C (en) | 2009-08-12 |
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| CN103550414A (en) * | 2013-09-30 | 2014-02-05 | 姜席赋 | Traditional Chinese medicine formula for treatment of prostatitis |
| CN117180382B (en) * | 2023-11-08 | 2024-02-06 | 首都医科大学宣武医院 | Traditional Chinese medicine composition for treating urinary incontinence, preparation method and application |
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Non-Patent Citations (2)
| Title |
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| 名中医诊治慢性前列腺炎的经验及思路探析. 王益平等.中国中医基础医学杂志，第11卷第7期. 2005 |
| 名中医诊治慢性前列腺炎的经验及思路探析. 王益平等.中国中医基础医学杂志，第11卷第7期. 2005 * |
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