CN100350939C - Chinese medicine for treating nonbacterial prostatitis and its prepn - Google Patents
Chinese medicine for treating nonbacterial prostatitis and its prepn Download PDFInfo
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- CN100350939C CN100350939C CNB2005100471301A CN200510047130A CN100350939C CN 100350939 C CN100350939 C CN 100350939C CN B2005100471301 A CNB2005100471301 A CN B2005100471301A CN 200510047130 A CN200510047130 A CN 200510047130A CN 100350939 C CN100350939 C CN 100350939C
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Abstract
The present invention relates to a Chinese medicine for treating abacterial prostatitis, which comprises medicinal plants and medicinal animals. The preparation formulations comprise watered pills, honeyed pills, medicinal powder, tablets and capsules. The Chinese medicine for treating abacterial prostatitis is characterized in that the raw materials of the following weight ratio are 50 to 200 portions of bupleurum root, 50 to 200 portions of leech, 100 to 200 portions of motherwort herb, 36 to 80 portions of safflower, 18 to 50 portions of centipede, 100 to 200 portions of dandelion, 0 to 50 portions of powdered yam rhizome, 50 to 100 portions of angelica, 50 to 100 portions of white peony alba, 60 to 80 portions of desertliving cistanche, 50 to 80 portions of largehead atractylodes rhizome, 50 to 80 portions of chicken's gizzard-membrane, 50 to 80 portions of twotoothed achyranthes root and 50 to 80 portions of licorice. The Chinese medicine for treating abacterial prostatitis has two preparation methods: water of which the quantity is 5 to 20 times of the quantity of the raw material medicines which can be extracted in water is added into the raw material medicines which can be extracted in water, such as the motherwort herb, the dandelion, etc., and the mixture is decocted and prepared into extract paste for standby use; the rest components are crumbled into coarse powder, the coarse powder and the extract paste are mixed, and after the mixture is dried into dry products under the temperature of 40 to 80 DEG C, the mixture is crumbled into fine powder; the fine powder is sieved into the powder of 40 to 120 meshes for standby use, and the various preparations are prepared according to the preparation standard.
Description
Technical field
The present invention relates to Chinese medicine for the treatment of prostatosis and preparation method thereof.
Background technology
Prostate diseases is common andropathy, in, account for significant proportion in the senile chronic disease.Also have about the Chinese medicine for the treatment of this disease and the patent of preparation method, have into square, have that single extracts, also pharmaceutical composition is arranged, also have the controlled release micro pill that improves curative effect with method for making.The significant curative effect of Chinese traditional patent formulation is not only by a large amount of clinical trials and is summed up out, especially in excavating motherland's traditional medicine precious deposits, succession older generation skill process, obtains in each link such as the component of prescription, dosage, method for making is constantly explored.
Summary of the invention
The purpose of this invention is to provide prostatitic Chinese medicine of a kind of treatment and preparation method.
The Chinese medicine of treatment nonbacterial prostatitis, comprise medicinal plants and animal, it is characterized in that material component and weight are: Radix Bupleuri 50-200g Hirudo 50-200g Herba Leonuri 100-200g Flos Carthami 36-80g Scolopendra 18-50g Herba Taraxaci 100-200g Hypoglaucous Collett Yam Rhizome 30-50g Radix Angelicae Sinensis 50-100g Radix Paeoniae Alba 50-100g Herba Cistanches 60-80g Rhizoma Atractylodis Macrocephalae 50-80g Endothelium Corneum Gigeriae Galli 50-80g Radix Achyranthis Bidentatae 50-80g Radix Glycyrrhizae 50-80g
Dosage form comprises the watered pill, close ball, powder, tablet, capsule.
Preparation method: one, crude drug Herba Leonuri, Herba Taraxaci are added the water that 5-20 doubly measures, decoct 1-3 time, each 1-3 hour, 100 mesh sieves filtered, collecting decoction, and 80 ℃ of extractum that are evaporated to proportion 1.1-1.4 (40-80 ℃ of heat is surveyed) are standby; All the other components that will be except that Herba Leonuri, Herba Taraxaci are ground into coarse powder, mix with above-mentioned extractum, after being dried to dry product under the 40-80 ℃ of condition, are ground into fine powder, and the 40-120 order that sieves is standby; Press preparation process and pharmaceutical standards that Chinese patent medicine adopts usually, add the adjuvant of above-mentioned each dosage form, make the finished product medicament.
The prostatitic Chinese medicine of treatment of the present invention is in clinical family financial situation for many years on the practical basis, by the new drug approval requirement, and the three class new Chinese medicines that form of test after deliberation.Medicament of the present invention is made up of 14 flavor Chinese medicines such as Radix Bupleuri, Hirudo trematodiasis, has vital energy regualting and blood circulation-promoting, the logical turbid effect of refining, and cures mainly nonbacterial prostatitis, and promptly the traditional Chinese medical science claims " qi stagnation and blood stasis type ".These process conditions of the present invention are through optimization test, and Herba Leonuri and the Herba Taraxaci designed large usage quantity are used as medicine with water extraction and with extract powder, can keep its effective ingredient, have reduced dose again.
The specific embodiment
The former medicine of the Chinese medicine of treatment nonbacterial prostatitis is characterized in that having following four kinds of components and dosage:
1, Radix Bupleuri 120g Hirudo 120g Herba Leonuri 180g Flos Carthami 36g Scolopendra 18g Herba Taraxaci 180g Hypoglaucous Collett Yam Rhizome 30g Radix Angelicae Sinensis 90g Radix Paeoniae Alba 90g Herba Cistanches 60g Rhizoma Atractylodis Macrocephalae 60g Endothelium Corneum Gigeriae Galli 60g Radix Achyranthis Bidentatae 60g Radix Glycyrrhizae 60g.
2, Radix Bupleuri 200g Hirudo 200g Herba Leonuri 150g Flos Carthami 80g Scolopendra 30g Herba Taraxaci 150g Hypoglaucous Collett Yam Rhizome 50g Radix Angelicae Sinensis 100g Radix Paeoniae Alba 100g Herba Cistanches 80g Rhizoma Atractylodis Macrocephalae 80g Endothelium Corneum Gigeriae Galli 80g Radix Achyranthis Bidentatae 80g Radix Glycyrrhizae 80g.
3, Radix Bupleuri 100g Hirudo 100g Herba Leonuri 200g Flos Carthami 50g Scolopendra 20g Herba Taraxaci 200g Hypoglaucous Collett Yam Rhizome 50g Radix Angelicae Sinensis 80g Radix Paeoniae Alba 80g Herba Cistanches 80g Rhizoma Atractylodis Macrocephalae 80g Endothelium Corneum Gigeriae Galli 80g Radix Achyranthis Bidentatae 80g Radix Glycyrrhizae 80g.
4, Radix Bupleuri 50g Hirudo 50g Herba Leonuri 100g Flos Carthami 50g Scolopendra 50g Herba Taraxaci 100g Hypoglaucous Collett Yam Rhizome 50g Radix Angelicae Sinensis 50g Radix Paeoniae Alba 50g Herba Cistanches 50g Rhizoma Atractylodis Macrocephalae 50g Endothelium Corneum Gigeriae Galli 50g Radix Achyranthis Bidentatae 50g Radix Glycyrrhizae 50g
Preparation technology's reference: 1. " pharmaceutics " (whole nation high medical training school teaching material), 2. one one of Chinese Pharmacopoeia nineteen ninety-five version, 3. provisions for new drugs approval and relevant codification (two).Medical material is purchased in Yi Tang pharmacy, sky, Shenyang, all meet Chinese Pharmacopoeia nineteen ninety-five version, its preparation method is characterised in that: one of method: crude drug Herba Leonuri, Herba Taraxaci are added the water that 5-20 doubly measures, decoct 1-3 time, each 1-3 hour, 100 mesh sieves filter, collecting decoction, and 80 ℃ of extractum that are evaporated to proportion 1.1-1.4 (40-80 ℃ of heat is surveyed) are standby; All the other components that will be except that Herba Leonuri, Herba Taraxaci are ground into coarse powder, mix with above-mentioned extractum, after being dried to dry product under the 40-80 ℃ of condition, are ground into fine powder, and the 40-120 order that sieves is standby; Press preparation process and pharmaceutical standards that Chinese patent medicine adopts usually, add the adjuvant of above-mentioned each dosage form, make the finished product medicament.
Two of Chinese medicinal preparation method of the present invention: crude drug Herba Leonuri, Herba Taraxaci, Radix Bupleuri, Flos Carthami, Hypoglaucous Collett Yam Rhizome, the Radix Paeoniae Alba, Herba Cistanches, Radix Achyranthis Bidentatae, Radix Glycyrrhizae are added the water that 5-20 doubly measures, decoct 1-3 time, each 1-3 hour, filter with 100 mesh sieves, collecting decoction, 80 ℃ are evaporated to proportion 1.1-1.4, and (40-80 ℃ of heat is surveyed), it is standby to get extractum; Pulverize all the other components and become coarse powder, mix with above-mentioned extractum, after being dried to dry product under the 40-80 ℃ of condition, be ground into fine powder, the 40-120 order that sieves is standby.
All the other components of pulverizing described in above-mentioned two kinds of methods become in the technology of coarse powder, and described component is divided into three groups:
Pulverize the I Hirudo Endothelium Corneum Gigeriae Galli Rhizoma Atractylodis Macrocephalae Scolopendra Hypoglaucous Collett Yam Rhizome Radix Paeoniae Alba
Pulverize II Radix Bupleuri Radix Angelicae Sinensis Radix Achyranthis Bidentatae Herba Cistanches Radix Glycyrrhizae
Pulverize III Flos Carthami (wherein containing the dried starch that weight is equivalent to Flos Carthami 15%)
Above-mentioned pulverizing expects that Hirudo, Scolopendra, the Endothelium Corneum Gigeriae Galli in first group is animal drugs, and it is many to contain albumen, and viscosity is big, be difficult for pulverizing, and the mealiness of medical materials such as Hypoglaucous Collett Yam Rhizome, the Radix Paeoniae Alba, the Rhizoma Atractylodis Macrocephalae is big, and the mixing that matches like this, pulverizing have simultaneously overcome the difficult greatly shortcoming of pulverizing of animal drugs viscosity.
The 3rd group flos carthami fiber is hard, be difficult for to pulverize, and the starch of earlier to be equivalent to Flos Carthami 15% with weight adds water slurrying, is heated into paste, and Flos Carthami is run through, is ground into powder again after the drying.
Preparation: press preparation process and pharmaceutical standards that Chinese patent medicine adopts usually, add the adjuvant of each dosage form, make the finished product medicament.The fine powder of above-mentioned two kinds of preparation method gained all can be made into various dosage forms.
(1) watered pill: the fine powder that method one is made is made water pill, activated carbon coating, and making ball heavily is the watered pill of 100/5-50g.
(2) honeyed pill: the fine powder that method one is made adds the middle honey of 20-60%, is mixed and made into soft material, makes 5-10g/ grain honeyed pill.
(3) powder: the fine powder direct packaging that method one is made becomes the 5-20g/ bag, powder.
(4) tablet: the fine powder that method two is made is made soft material with ethanol or gelatinized corn starch, and granulation, drying, tabletting, coating contain primary crude drug 1.8 gram/sheets.
(5) capsule: with the fine powder capsule filling machine that method two is made, make 2-0 number hard capsule, contain primary crude drug 1.8 gram/grains.
The optimization test of water extraction process of the present invention is in order to screen the optimum condition of water extraction process, and with reference to the big scope that adopts usually of producing, L is adopted in design
9(3)
4Quadrature is done optimization test, and to extraction time, extraction time, three factors of amount of water, each factor is established three levels and tested respectively.See Table 1.
Table 1
The investigation of dry extract extraction ratio of the present invention
Take by weighing the Herba Leonuri and the Herba Taraxaci of above-mentioned component weight, by preferred extraction conditions test in this method water extraction orthogonal test, making under the condition of the suitable crude drug 4.5-5.0g of the every 1g of dry extract medical material, mix with other medicated powder, is that the overall viscosity or the uniformity all are best.
Press optimum condition and strengthen inventory test three times, extract is drying under reduced pressure under 80 ℃ of conditions, and paste-forming rate sees Table 5.
Table 5
| Tested number | Medical material amount (g) | Receive dried cream amount (g) | Go out dried cream rate (%) | The suitable crude drug amount of every gram extractum (g) |
| 1 2 3 | Press 1,800 ten times of component weight 3600 of 360 5 times of component weight of component weight | 73 359 754 | 20.28 19.94 20.94 | 4.9 5.0 4.8 |
Therefore, the extract of Herba Leonuri and Herba Taraxaci should be controlled at the suitable crude drug 4.5-5.0g of every g extractum aborning.
Process using water of the present invention is excipient, becomes the ball after drying can remove moisture, does not increase the volume of preparation again, also suitable molten loosing, through the check of many batch samples, preparation moisture is controlled at all that watered pill moisture is no more than 9.0% requirement among appendix IA of nineteen ninety-five version, sees Table 6.
Table 6 watered pill moisture quality control table
| Lot number | Sample heavy (g) | Vector heavy (g) | Water content (%) | Meansigma methods (%) conclusion |
| 960301 960302 960303 960318 | 2.0369 1.9103 2.0623 2.0613 | 0.1395 0.1125 0.1635 0.1420 | 6.8 5.9 7.9 6.9 | 6.5 it is up to specification |
| 960406 | 1.9421 | 0.0963 | 5.0 |
Following table is the pilot scale creation data of doing by the inventive method, proves the constant product quality that this method is produced.
The pilot scale creation data
| Lot number | Inventory (Kg) | Powder delivery (cream) amount (Kg) | Mix back total amount (Kg) | Output (Kg) | Yield rate (Kg) |
| 971209 | I 8.1 II 8.4 III 1.2 extract 7.7 and add up to 25.4 | 7.30 7.78 1.11 1.63 17.82 | 17.28 | 14.04 | 81.25 |
| 971216 | I 8.1 II 8.4 III 1.2 extract 7.7 and add up to 25.4 | 7.26 7.74 1.12 1.65 17.77 | 17.29 | 13.96 | 80.74 |
| 971223 | I 8.1 II 8.4 III 1.2 extract 7.7 and add up to 25.4 | 7.40 7.70 1.14 1.60 17.84 | 17.30 | 13.99 | 80.87 |
The Chinese medicine of treatment nonbacterial prostatitis, the usage and dosage of watered pill dosage form:
Oral: early after ante cibum, noon, the supper, 6g/3 next day
The course of treatment: 1-3 month
The animal pharmacology toxicological test:
Clinical efficacy: according to National Drug Administration (1999) ZL-51 Clinical Researches of New Drugs certification, Dongzhimen Hospital, Beijing Univ of Traditional Chinese Medicine organizes each clinical research participant to comprise Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College, Second Hospital Attached To Tianjin Chinese Medicine College, Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine, has formulated " smart turbid pill for curing nonbacterial prostatitis (qi depression to blood stasis disease) III of bavin trematodiasis phase clinical research scheme " jointly.The final report that is selected from Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine is as follows: " so my institute has carried out the research of III clinical trial phase by above-mentioned clinical research scheme to it year July October to 2003 calendar year 2001, observe the clinical efficacy and the safety of the smart turbid pill for curing nonbacterial prostatitis of bavin trematodiasis (qi depression to blood stasis disease).120 examples are included in this test altogether in, and actual clinical is observed 120 examples, wherein treatment group 89 example and matched group 31 examples.This test is taked at random, the method for double blinding dual analog, positive drug parallel control treatment.Result of the test: treatment group clinical cure 8 examples; Produce effects 34 examples; Effective 38 examples; Invalid 9 examples.Showing more, rate is 47.19%.Matched group clinical cure 1 example; Produce effects 7 examples; Effective 14 examples; Invalid 9 examples.Showing more, rate is 25.81%.Treatment group and matched group compare, P=0.008, and difference has the significance meaning.”
Claims (11)
1, a kind of Chinese medicine for the treatment of nonbacterial prostatitis, comprise medicinal plants and animal, it is characterized in that material component and weight are: Radix Bupleuri 50-200g Hirudo 50-200g Herba Leonuri 100-200g Flos Carthami 36-80g Scolopendra 18-50g Herba Taraxaci 100-200g Hypoglaucous Collett Yam Rhizome 30-50g Radix Angelicae Sinensis 50-100g Radix Paeoniae Alba 50-100g Herba Cistanches 60-80g Rhizoma Atractylodis Macrocephalae 50-80g Endothelium Corneum Gigeriae Galli 50-80g Radix Achyranthis Bidentatae 50-80g Radix Glycyrrhizae 50-80g.
2, the Chinese medicine of treatment nonbacterial prostatitis according to claim 1 is characterized in that being selected from four kinds of following compositionss:
(1), Radix Bupleuri 120g Hirudo 120g Herba Leonuri 180g Flos Carthami 36g Scolopendra 18g Herba Taraxaci 180g Hypoglaucous Collett Yam Rhizome 30g Radix Angelicae Sinensis 90g Radix Paeoniae Alba 90g Herba Cistanches 60g Rhizoma Atractylodis Macrocephalae 60g Endothelium Corneum Gigeriae Galli 60g Radix Achyranthis Bidentatae 60g Radix Glycyrrhizae 60g;
(2), Radix Bupleuri 200g Hirudo 200g Herba Leonuri 150g flower 80g Scolopendra 30g Herba Taraxaci 150g Hypoglaucous Collett Yam Rhizome 50g Radix Angelicae Sinensis 100g Radix Paeoniae Alba 100g Herba Cistanches 80g Rhizoma Atractylodis Macrocephalae 80g Endothelium Corneum Gigeriae Galli 80g Radix Achyranthis Bidentatae 80g Radix Glycyrrhizae 80g;
(3), Radix Bupleuri 100g Hirudo 100g Herba Leonuri 200g Flos Carthami 50g Scolopendra 20g Herba Taraxaci 200g Hypoglaucous Collett Yam Rhizome 50g Radix Angelicae Sinensis 80g Radix Paeoniae Alba 80g Herba Cistanches 80g Rhizoma Atractylodis Macrocephalae 80g Endothelium Corneum Gigeriae Galli 80g Radix Achyranthis Bidentatae 80g Radix Glycyrrhizae 80g;
(4), Radix Bupleuri 50g Hirudo 50g Herba Leonuri 100g Flos Carthami 50g Scolopendra 50g Herba Taraxaci 100g Hypoglaucous Collett Yam Rhizome 50g Radix Angelicae Sinensis 50g Radix Paeoniae Alba 50g Herba Cistanches 50g Rhizoma Atractylodis Macrocephalae 50g Endothelium Corneum Gigeriae Galli 50g Radix Achyranthis Bidentatae 50g Radix Glycyrrhizae 50g.
3, prepare a kind of method of Chinese medicine according to claim 1, get the raw materials ready by described component and weight, it is characterized in that: raw medicinal material Herba Leonuri, Herba Taraxaci are added the water that 5-20 doubly measures, decoct 1-3 time, each 1-3 hour, 100 mesh sieves filter, collecting decoction, 80 ℃ are evaporated to proportion 1.1-1.4, and 40-80 ℃ of heat is surveyed, the extract of Herba Leonuri and Herba Taraxaci should be controlled at the suitable primary crude drug 4.5-5.0g of every g extractum, and gained extractum is standby; All the other components that will be except that Herba Leonuri, Herba Taraxaci are ground into coarse powder, mix with above-mentioned extractum, after being dried to dry product under the 40-80 ℃ of condition, are ground into fine powder, and the 40-120 order that sieves is standby.
4, prepare the another kind of method of Chinese medicine according to claim 1, it is characterized in that: crude drug Herba Leonuri, Herba Taraxaci, Radix Bupleuri, Flos Carthami, Hypoglaucous Collett Yam Rhizome, the Radix Paeoniae Alba, Herba Cistanches, Radix Achyranthis Bidentatae, Radix Glycyrrhizae are added the water that 5-20 doubly measures, decoct 1-3 time, each 1-3 hour, filter with 100 mesh sieves, collecting decoction, 80 ℃ are evaporated to proportion 1.1-1.4,40-80 ℃ of heat is surveyed, and it is standby to get extractum; Pulverize all the other components and become coarse powder, mix with aforementioned extractum, after being dried to dry product under the 40-80 ℃ of condition, be ground into fine powder, the 40-120 order that sieves is standby.
5, Chinese medicinal preparation method according to claim 3 is characterized in that: become in the step of coarse powder at all the other components of described pulverizing, all the other components are divided into three groups, pulverize separately:
Pulverize the I Hirudo Endothelium Corneum Gigeriae Galli Rhizoma Atractylodis Macrocephalae Scolopendra Hypoglaucous Collett Yam Rhizome Radix Paeoniae Alba
Pulverize II Radix Bupleuri Radix Angelicae Sinensis Radix Achyranthis Bidentatae Herba Cistanches Radix Glycyrrhizae
Pulverize the III Flos Carthami
The pulverizing of III group: the starch of earlier to be equivalent to Flos Carthami 15% with weight adds water slurrying, is heated into paste, and Flos Carthami is run through, is ground into powder again after the drying.
6, Chinese medicinal preparation method according to claim 4 is characterized in that: become in the step of coarse powder at all the other components of described pulverizing, Hirudo, Endothelium Corneum Gigeriae Galli, the Rhizoma Atractylodis Macrocephalae, Scolopendra are divided into one group of pulverizing, Radix Angelicae Sinensis is pulverized separately.
7, according to claim 3 and 4 described Chinese medicinal preparation method, adopt common preparation process and the pharmaceutical standards of Chinese patent medicine, it is characterized in that further making powder: the described fine powder of direct packaging is finished medicines, 5-20 gram/bag.
8, according to claim 3 and 4 described Chinese medicinal preparation method, adopt common preparation process and the pharmaceutical standards of Chinese patent medicine, it is characterized in that further making the watered pill and get the adjuvant that described fine powder adds the watered pill, make the finished product medicament: ball weighs 100/5-50 gram.
9, according to claim 3 and 4 described Chinese medicinal preparation method, adopt common preparation process and the pharmaceutical standards of Chinese patent medicine, it is characterized in that further making honeyed pill and get the adjuvant that described fine powder adds honeyed pill, make the finished product medicament: honeyed pill 5-10 gram/grain.
10, according to claim 3 and 4 described Chinese medicinal preparation method, adopt common preparation process and the pharmaceutical standards of Chinese patent medicine, it is characterized in that further preparing tablet: add the adjuvant of tablet, make the finished product medicament, tablet contains primary crude drug 1.8 gram/sheets.
11, according to claim 3 and 4 described Chinese medicinal preparation method, adopt common preparation process and the pharmaceutical standards of Chinese patent medicine, it is characterized in that further making the preparation capsule: get the adjuvant that described fine powder adds capsule formulation, make the finished product medicament, capsule contains primary crude drug 1.8 gram/grains.
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| CN101264258B (en) * | 2008-05-04 | 2012-05-23 | 胡春福 | Medicaments for preventing and controlling infectious diseases in genital tract of male and female |
| CN104491625B (en) * | 2015-01-15 | 2017-09-19 | 陈胜利 | One kind treats aseptic prostatitis herbal decoction medicine and preparation method |
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| Title |
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| 中药治疗慢性前列腺炎近况 赵耀东.甘肃中医学院学报，第19卷第3期 2002 * |
| 翟亚春教授治疗慢性前列腺炎经验 肖继来.湖南中医杂志，第20卷第2期 2004 * |
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