A kind of enriching yin and nourishing kidney, spermatogenesis are filled out Chinese medicine of marrow and preparation method thereof
Technical field
The present invention relates to a kind of method for preparing of Chinese medicine preparation, the method for preparing that particularly a kind of enriching yin and nourishing kidney, spermatogenesis are filled out the Chinese medicine preparation of marrow.
Technical background
Strong kidney mind tranquilizing tablet has enriching yin and nourishing kidney, spermatogenesis is filled out the marrow effect; By Testis Et penis Bovis seu Bubali, bull testis, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Radix Bupleuri, Os Draconis, Herba Epimedii, Poria, Rhizoma Alismatis, Fructus Broussonetiae nine flavor medical material prescriptions, clinically be used to treat deficiency of kidney-essence, have a dizzy spell, cardiopalmus tinnitus, mind are peaceful, soreness of the waist and knees, impotence and seminal emission etc.
Strong kidney mind tranquilizing tablet is on motherland theory of medicine basis, to develop, and not only treatment is suffered from a deficiency of the kidney at disease, but also starts with Zhi Qigen, Zhi Qiben from this cause of disease of suffering from a deficiency of the kidney.Prescription is superior, and compatibility is proper, is primary raw material with the cattle and sheep internal organs, is equipped with multiple rare Chinese medicine, plays enriching yin and nourishing kidney altogether, and spermatogenesis is filled out the effect of marrow.Testis Et penis Bovis seu Bubali, bull testis powder are monarch drug in the prescription.Testis Et penis Bovis seu Bubali contains the flat tepor of nutritional labeling property such as several amino acids (aspartic acid, threonine etc.), steroidal composition (cholesterol, testosterone, estradiol, two red testosterones), Testosterone (testosterone), calcium, phosphorus, ferrum, and sweet in the mouth has the effect of strengthening yang and invigorating kidney; Bull testis mealiness sweet in the mouth temperature is gone into kidney channel, has reinforcing the kidney and supporting YANG, controlling nocturnal emission with astringent drugs, and the effect of band, the two accounts for more than 80% of prescription composition.Radix Rehmanniae Preparata is a ministerial drug, nourishing YIN and supplementing blood, and beneficial essence is filled out marrow.Be used for the hepatic and renal YIN deficiency, soreness of the waist and knees, osteopyrexia and fever, the night sweat seminal emission, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, severe palpitation, menoxenia, metrostaxis, dizzy, tinnitus, early whitening of beard and hair.Rhizoma Dioscoreae, Os Draconis, Fructus Broussonetiae are all adjuvant drug.The moon of Rhizoma Dioscoreae ability nourishing lung and kidney, astringent or styptic treatment for spontaneous sweating kidney essense; Os Draconis sweet in the mouth, slightly warm in nature are gone into kidney channel; Nourishing kidney yin is filled up marrow; Be used for tinnitus due to deficiency of the kidney, soreness of the waist and knees, sexual impotence, seminal emission, dysphoria with smothery sensation, anemia etc.The sub-the kidney invigorating liver heat removing of Fructus Broussonetiae makes eye bright diuresis.Be used for soreness of the waist and knees, the asthenia hectic fever due to YIN-deficiency, dizzy blurred vision, order is given birth to nebula film, edema distension.3 flavors such as Poria are messenger drug altogether, the Poria eliminating dampness and diuresis, and mind tranquilizing and the heart calming, all medicines are collaborative, and QI and blood is taken into account, through dirty homology, Yin Yang balancing, there have benefit to have to be logical, and residence leads in invigorating middle warmer, plays kidney tonifying, essence replenishing altogether, the merit in YIN nourishing Yiyang.Through the hospital clinical checking, total effective rate is 86.1%.
The national standard of strong kidney mind tranquilizing tablet is following:
[prescription] Testis Et penis Bovis seu Bubali 200g, bull testis 100g, Radix Rehmanniae Preparata 20g, Rhizoma Dioscoreae 10g, Os Draconis 10g, Herba Epimedii 6g, Poria 6g, Rhizoma Alismatis 6g, Fructus Broussonetiae 10g, sucrose 130g processes 1000,
[method for making] above nine flavor medical materials are got bull testis and are ground into fine powder, and are subsequent use; After the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean with clear water, thinly slice, add the water decompression and extract 2 times, each 1.5 hours, gradation filtered, and merging filtrate also is evaporated to the clear paste that relative density is 1.15~1.25 (80 ℃); Seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decocte with water secondary, 2 hours for the first time, 1 hour for the second time; Collecting decoction filters, and filtrating is concentrated into the thick paste that relative density is 1.25~1.35 (80 ℃), merges with above-mentioned clear paste; Add above-mentioned fine powder, mixing, drying is ground into fine powder.Get sucrose and process syrup,, process granule with above-mentioned fine powder mixing, drying, tabletting, sugar coating promptly gets.
[character] these article are coated tablet, remove sugar-coat and show pale brown color; The gas raw meat, the flavor sweet.
These article are got in [discriminating] (1), and put microscopically and observe: egg yolk appearance agglomerate is faint yellow or yellow, is full of granule; Muscle fiber is irregular to be torn, colourless or faint yellow.
(2) get 10 of these article, remove sugar-coat, porphyrize adds methanol 20ml, and supersound process 20 minutes filters, the filtrating evaporate to dryness, and residue adds methanol 5ml makes dissolving, as need testing solution.Other gets Rhizoma Dioscoreae control medicinal material 2g, adds ethanol 10ml, shines medical material solution in pairs with legal system.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; With chloroform-methanol-water (14: 5: 1) is developing solvent; Launch, take out, dry; Spray is with 10% phosphomolybdic acid ethanol solution, and it is clear that hot blast blows to the speckle colour developing.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
[inspection] should meet each item regulation (appendix ID of Chinese Pharmacopoeia version in 2010) relevant under the tablet item.
[function cures mainly] enriching yin and nourishing kidney, spermatogenesis is filled out marrow.Be used for deficiency of kidney-essence, have a dizzy spell, cardiopalmus tinnitus, mind is not peaceful, soreness of the waist and knees, impotence and seminal emission.
[usage and dosage] is oral, one time 5,3 times on the one.
But a difficult problem because of easy generations of most Chinese medicine preparation such as containing the Chinese medical concrete powder in this prescription, the former powder of Chinese medicine reaches more than 30%, granulates with syrup simultaneously, and it is big to cause the preparation process viscosity to occur, and in conjunction with bad, it is big to make pellet hardness, and the disintegration of tablet time is long.Adopt the sugar-coat coating method.Coating is long cycle time; The factor that influences coating quality is many, and operation is difficult to be grasped, and the product appearance quality is wayward; Deposit after a period of time because oxidation takes place in air, polyreaction generates coloring matter makes tablet surface the film color phenomenon occur, causes poor stability.Therefore this Chinese medicine has certain limitation in clinical practice, and existence needs improvements.
Summary of the invention
The purpose of this invention is to provide a kind of new strong kidney mind tranquilizing tablet and preparation method thereof.
Strong kidney mind tranquilizing tablet of the present invention is processed by former, the adjuvant of following weight proportion:
The extract powder 30-40% of pharmaceutically active ingredient in containing
Microcrystalline Cellulose 40-50%,
Lactose monohydrate 10-15%,
Polyvinylpolypyrrolidone 0.5-1%,
Silicon dioxide 4-6%,
Magnesium stearate 0.5-1%.
Preferably:
The extract powder 33.83% of pharmaceutically active ingredient in containing
Microcrystalline Cellulose 47.76%,
Lactose monohydrate 11.94%,
Polyvinylpolypyrrolidone 0.83%,
Silicon dioxide 4.98%,
Magnesium stearate 0.66%.
Wherein, the extract powder of pharmaceutically active ingredient in containing, method for preparing is following:
Testis Et penis Bovis seu Bubali 200g, bull testis 100g, Radix Rehmanniae Preparata 20g, Rhizoma Dioscoreae 10g, Os Draconis 10g, Herba Epimedii 6g, Poria 6g, Rhizoma Alismatis 6g, Fructus Broussonetiae 10g, the Chinese medicine of this proportioning can prepare 1000 in tablet.
A: get bull testis and be ground into fine powder, subsequent use;
B: after the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean, thinly slice with clear water, extracting in water 2 times, each 1.5 hours, gradation filtered, and merging filtrate also is evaporated to the clear paste that relative density is 1.15~1.25 (80 ℃);
C: seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decocte with water secondary, 2 hours for the first time, 1 hour for the second time; Collecting decoction filters, and filtrating is concentrated into the thick paste that relative density is 1.25~1.35 (80 ℃), merges with above-mentioned clear paste; Add above-mentioned fine powder, mixing, drying is ground into fine powder.
Tablet of the present invention, method for preparing is following:
Measure by prescription that microcrystalline Cellulose mixes back and polyvinylpolypyrrolidone, silicon dioxide with lactose monohydrate, the extract powder that contains middle pharmaceutically active ingredient mixed 30 minutes; After mixing is crossed 60 mesh sieves; The adding magnesium stearate lubricant carries out always mixing after 15 minutes, tabletting; Promptly get, in case of necessity can sugar coating or film-coat.
The present invention carries out process modification to existing tablet technology and obtains; Improved foundation mainly contains: Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Os Draconis, Herba Epimedii, Poria, Rhizoma Alismatis, Fructus Broussonetiae main component are flavonoid, glycoside; Amino acids, trace element, these compositions are all water-soluble; Consider suitability for industrialized production and production cost problem, select for use cheap water for extracting solvent.It is the experiment selection indicators that the present invention extracts dried cream amount with raw medicinal herbs, and through thinking decocting time, decocting number of times and these three factors of amount of water is principal elements that influence decocts.As three factors, with reference to traditional decoction technology, choose three varying levels and carry out orthogonal test, obtain optimum extraction condition.Former method for preparing D step is processed syrup for getting sucrose 220~230g, with above-mentioned fine powder mixing, processes granule, drying, and tabletting, sugar coating promptly gets.Because of contain the Chinese medical concrete powder in this prescription, the former powder of Chinese medicine reaches more than 30%, after causing in the preparation process adding syrup, the difficult problem of most Chinese medicine preparation are prone to generation such as it is big viscosity to occur, and ins conjunction with bad, it is big to make pellet hardness, and the disintegration of tablet time is long.This kind has been taked the method for making of wet granule compression tablet, sugar coating always since going into operation.Coating is long cycle time; The factor that influences coating quality is many, and operation is difficult to be grasped, and the product appearance quality is wayward; Deposit after a period of time because oxidation takes place in air, polyreaction generates coloring matter makes tablet surface the film color phenomenon occur, causes poor stability.The present invention has selected comparatively advanced microcrystalline Cellulose, lactose monohydrate, polyvinylpolypyrrolidone, silicon dioxide, magnesium stearate as pharmaceutical adjunct, and the mixture that obtains after microcrystalline Cellulose and the lactose monohydrate mixing can improve flowability, the compressibility of powder.Adopt direct powder compression, need not to granulate, do not add any wetting agent, increased medicine stability, overcome that the Chinese medicine dose is big, viscosity big, be difficult for shortcoming such as preparation.To strengthen after the kidney mind tranquilizing tablet changes bag film-coat technology into by original sugar coating technology, and avoid medicine directly to contact, phenomenon generation such as solved in storage process the moisture absorption, soften, go mouldy with air.Through the flat appearance of contrast sheet, color and luster homogeneous, steady quality.Whole coating process operation is simplified, and the factor that influences coating quality significantly reduces also controlled.Coating adhesive force is stronger behind the film coating, and indexs such as disintegration, moisture meet the target level of product quality requirement, and medicine stability is higher, humidity resistance is better, dissolution rate is higher, surface color is more gorgeous, and the scope of application is wider.
Prescription composition of the present invention is to obtain through screening, and screening process is following:
Compound basis and prescription mentality of designing
1. prescription mentality of designing
Viscosity increases after inventing contained Chinese medical concrete powder and meet wetting agent according to this; Be difficult for characteristics such as granulation, consider that conventional wet granulation adjuvant can't adapt to dry granulation, in conjunction with domestic and international pertinent literature; Through lots of expriments contrasting, confirm prescription basic composition of the present invention.Tablet serves as main investigate index, the research of writing out a prescription with outward appearance, hardness, disintegration and stability thereof generally.Several prescriptions of listing the examination development are following:
Table 1 label prescription screening table
Supplementary material (g)/every
Above result of the test shows: the content no significant difference of six prescriptions.Prescription 2 is bad with prescription 5 powder flowbilitys, has certain aberration, and hardness is bad; The 1 label hardness of writing out a prescription is less than normal, is difficult for coating; Produce to hang in the 3 dry powder sheeting processes of writing out a prescription and cover phenomenon; The not first mixing of 6 microcrystalline Cellulose and lactose monohydrate of writing out a prescription, flowability is not fine; Prescription 4 is all better in each item indexs such as outward appearance, hardness, disintegration, content, so select prescription 4 as the further research of basic prescription.Through the trial-production of a large amount of lab scales, pilot scale, amplification sample, the proportioning of prescription 4 is best proportioning.
Prescription composition of the present invention causes the present invention to compare with existing technology with technique change, and is progressive to some extent, and relevant contrast test is following:
New and old preparation technology's contrast
Stability test research contrast
The specific embodiment
Further specify the present invention through embodiment below, but not as limitation of the present invention.
Embodiment 1
Testis Et penis Bovis seu Bubali 200g, bull testis 100g, Radix Rehmanniae Preparata 20g, Rhizoma Dioscoreae 10g, Os Draconis 10g, Herba Epimedii 6g, Poria 6g, Rhizoma Alismatis 6g, Fructus Broussonetiae 10g, the Chinese medicine of this proportioning can prepare 1000 in tablet.
The extract powder 33.83% of pharmaceutically active ingredient in containing in the tablet
Microcrystalline Cellulose 47.76%,
Lactose monohydrate 11.94%,
Polyvinylpolypyrrolidone 0.83%,
Silicon dioxide 4.98%,
Magnesium stearate 0.66%.
Method for preparing:
A: get bull testis and be ground into fine powder, subsequent use;
B: after the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean, thinly slice with clear water, extracting in water 2 times, each 1.5 hours, gradation filtered, and merging filtrate also is evaporated to the clear paste that relative density is 1.15~1.25 (80 ℃);
C: seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decocte with water secondary, 2 hours for the first time, 1 hour for the second time; Collecting decoction filters, and filtrating is concentrated into the thick paste that relative density is 1.25~1.35 (80 ℃), merges with above-mentioned clear paste; Add above-mentioned fine powder, mixing, drying is ground into fine powder.
The method for preparing of tablet is following:
By prescription measure microcrystalline Cellulose mix with lactose monohydrate the back with polyvinylpolypyrrolidone, silicon dioxide, contain in the extract powder of pharmaceutically active ingredient mixed 30 minutes, after mixing was crossed 60 mesh sieves, the adding magnesium stearate lubricant carries out always mixed after 15 minutes, tabletting promptly got.In case of necessity can sugar coating or film-coat.
Embodiment 2
Testis Et penis Bovis seu Bubali 200g, bull testis 100g, Radix Rehmanniae Preparata 20g, Rhizoma Dioscoreae 10g, Os Draconis 10g, Herba Epimedii 6g, Poria 6g, Rhizoma Alismatis 6g, Fructus Broussonetiae 10g, the Chinese medicine of this proportioning can prepare 1000 in tablet.
The extract powder 30% of pharmaceutically active ingredient in containing
Microcrystalline Cellulose 50%,
Lactose monohydrate 15%,
Polyvinylpolypyrrolidone 0.5%,
Silicon dioxide 4%,
Magnesium stearate 0.5%.
A: get bull testis and be ground into fine powder, subsequent use;
B: after the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean, thinly slice with clear water, extracting in water 2 times, each 1.5 hours, gradation filtered, and merging filtrate also is evaporated to the clear paste that relative density is 1.15~1.25 (80 ℃);
C: seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decocte with water secondary, 2 hours for the first time, 1 hour for the second time; Collecting decoction filters, and filtrating is concentrated into the thick paste that relative density is 1.25~1.35 (80 ℃), merges with above-mentioned clear paste; Add above-mentioned fine powder, mixing, drying is ground into fine powder.
The method for preparing of tablet is following:
By prescription measure microcrystalline Cellulose mix with lactose monohydrate the back with polyvinylpolypyrrolidone, silicon dioxide, contain in the extract powder of pharmaceutically active ingredient mixed 30 minutes, after mixing was crossed 60 mesh sieves, the adding magnesium stearate lubricant carries out always mixed after 15 minutes, tabletting promptly got.In case of necessity can sugar coating or film-coat.
Embodiment 3
Testis Et penis Bovis seu Bubali 200g, bull testis 100g, Radix Rehmanniae Preparata 20g, Rhizoma Dioscoreae 10g, Os Draconis 10g, Herba Epimedii 6g, Poria 6g, Rhizoma Alismatis 6g, Fructus Broussonetiae 10g, the Chinese medicine of this proportioning can prepare 1000 in tablet.
The extract powder 40% of pharmaceutically active ingredient in containing
Microcrystalline Cellulose 40%,
Lactose monohydrate 14%,
Polyvinylpolypyrrolidone 1%,
Silicon dioxide 4%,
Magnesium stearate 1%.
A: get bull testis and be ground into fine powder, subsequent use;
B: after the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean, thinly slice with clear water, extracting in water 2 times, each 1.5 hours, gradation filtered, and merging filtrate also is evaporated to the clear paste that relative density is 1.15~1.25 (80 ℃);
C: seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decocte with water secondary, 2 hours for the first time, 1 hour for the second time; Collecting decoction filters, and filtrating is concentrated into the thick paste that relative density is 1.25~1.35 (80 ℃), merges with above-mentioned clear paste; Add above-mentioned fine powder, mixing, drying is ground into fine powder.
The method for preparing of tablet is following:
By prescription measure microcrystalline Cellulose mix with lactose monohydrate the back with polyvinylpolypyrrolidone, silicon dioxide, contain in the extract powder of pharmaceutically active ingredient mixed 30 minutes, after mixing was crossed 60 mesh sieves, the adding magnesium stearate lubricant carries out always mixed after 15 minutes, tabletting promptly got.In case of necessity can sugar coating or film-coat.