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 preparation method of Chinese medicine preparation, particularly a kind of enriching yin and nourishing kidney, spermatogenesis are filled out the preparation method of 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 for the treatment of 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 to develop on motherland theory of medicine basis, not only treats all diseases of suffering from a deficiency of the kidney, 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, take the cattle and sheep internal organs as primary raw material, is equipped with multiple rare Chinese medicine, plays altogether enriching yin and nourishing kidney, 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 tepors of nutritional labeling such as several amino acids (aspartic acid, threonine etc.), steroidal composition (cholesterol, testosterone, estradiol, two red testosterones), Testosterone (testosterone), calcium, phosphorus, ferrum, sweet in the mouth has the effect of strengthening yang and invigorating kidney; The bull testis powder is sweet in flavor and warm in property, enters 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 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 energy nourishing lung and kidney, astringent or styptic treatment for spontaneous sweating kidney essense; Os Draconis sweet in the mouth, slightly warm in nature enter 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.Poria etc. 3 flavor is altogether for making medicine, 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, having to mend has logically, resides and leads in invigorating middle warmer, plays altogether kidney tonifying, essence replenishing, 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 as follows:
[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 makes 1000,
[method for making] above nine flavor medical materials are got bull testis and are ground into fine powder, and are for 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 ℃); The seven flavor medicine materials such as all the other Radix Rehmanniae Preparata decoct with water secondary, and 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate 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 make syrup, with above-mentioned fine powder mixing, granulation, drying, tabletting, sugar coating, and get final product.
[character] this product is coated tablet, removes the aobvious brown color of sugar-coat; The gas raw meat, the flavor sweet.
This product is got in [discriminating] (1), and put microscopically and observe: egg yolk sample 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 this product, remove sugar-coat, porphyrize adds methanol 20ml, and supersound process 20 minutes filters, and filtrate evaporate to dryness, residue add methanol 5ml makes dissolving, as need testing solution.Other gets Rhizoma Dioscoreae control medicinal material 2g, adds ethanol 10ml, is made in the same way of control medicinal material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, take chloroform-methanol-water (14: 5: 1) as 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, the speckle of aobvious same color.
[inspection] should meet every regulation relevant under the tablet item (appendix ID of Chinese Pharmacopoeia version in 2010).
[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 the difficult problem because of easy generations of most Chinese medicine preparation such as containing traditional Chinese medicinal extract powder in this prescription, the former powder of Chinese medicine reaches more than 30%, granulates with syrup simultaneously, causes the preparation process viscosity to occur large, in conjunction with bad, makes pellet hardness large, and the disintegration of tablet time is long.Adopt the sugar-coat coating method.Coating is long cycle time, the factor that affects coating quality is many, and operation is difficult the grasp, and the product appearance quality is wayward, deposit after a period of time because oxidation occurs 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 existing 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 made by former, the adjuvant of following weight proportion:
The extract powder 30-40% that contains Effective Component of Chinese Medicine
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% that contains Effective Component of Chinese Medicine
Microcrystalline Cellulose 47.76%,
Lactose monohydrate 11.94%,
Polyvinylpolypyrrolidone 0.83%,
Silicon dioxide 4.98%,
Magnesium stearate 0.66%.
Wherein, contain the extract powder of Effective Component of Chinese Medicine, preparation method is as follows:
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, for subsequent use;
B: after the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean with clear water, thinly slice, 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: the seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate 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, preparation method is as follows:
Measure by prescription and to mix 30 minutes with polyvinylpolypyrrolidone, silicon dioxide, the extract powder that contains Effective Component of Chinese Medicine after microcrystalline Cellulose mixes with lactose monohydrate, after mixing is crossed 60 mesh sieves, the adding magnesium stearate lubricant always mixes after 15 minutes, tabletting, and get final product, in case of necessity can sugar coating or film-coat.
The present invention carries out process modification to existing tablet technique 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 cheap water for extracting solvent.The present invention extracts dried cream amount as the experiment selection indicators take raw medicinal herbs, thinks by analysis to decoct the principal element that number of times and these three factors of amount of water are impact decoctions by decocting time.As three factors, with reference to traditional decoction technique, choose three varying levels and carry out orthogonal test, obtain optimum extraction condition.Former preparation method D step is made syrup for getting sucrose 220~230g, with above-mentioned fine powder mixing, granulation, drying, tabletting, and sugar coating and get final product.Difficult problem because of easy generations of most Chinese medicine preparation such as containing traditional Chinese medicinal extract powder in this prescription, the former powder of Chinese medicine reaches more than 30%, after causing adding syrup in the preparation process, viscosity occurs large, in conjunction with bad, makes pellet hardness large, 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 affects coating quality is many, and operation is difficult the grasp, and the product appearance quality is wayward, deposit after a period of time because oxidation occurs 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 microcrystalline Cellulose and lactose monohydrate obtain after 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 large, viscosity large, be difficult for the shortcoming such as preparation.To strengthen after the kidney mind tranquilizing tablet changes film coating technique into by original sugar coating technique, and avoid medicine directly to contact with air, phenomenon occurs to have solved in storage process the moisture absorption, soften, go mouldy etc.Through the flat appearance of contrast sheet, color and luster homogeneous, steady quality.Whole coating process operation is simplified, and the factor that affects coating quality greatly reduces also controlled.Coating adhesive force is stronger behind the film coating, and the 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 of the present invention forms through the screening acquisition, and screening process is as follows:
Compound basis and Formulation thinking
1. Formulation thinking
Viscosity increases after inventing contained traditional Chinese medicinal extract powder and meet wetting agent according to this, be difficult for the 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 a large amount of Experimental Comparisons, determine prescription basic composition of the present invention.Tablet is generally take outward appearance, hardness, disintegration and stability thereof as main investigation index, the research of writing out a prescription.Several prescriptions of listing the examination development are as follows:
Table 1 Core formulation screening table
Supplementary material (g)/every
Above result of the test shows: the content no significant difference of six prescriptions.Prescription 2 and prescription 5 powder flowbilitys are bad, have 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 at indices such as outward appearance, hardness, disintegration, content, so select prescription 4 as the further research of basic prescription.By 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 technique with technique change, and is progressive to some extent, and relevant contrast test is as follows:
New and old preparation technology's contrast
The stability test investigation and comparison
The specific embodiment
Further specify the present invention below by embodiment, 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% that contains Effective Component of Chinese Medicine in the tablet
Microcrystalline Cellulose 47.76%,
Lactose monohydrate 11.94%,
Polyvinylpolypyrrolidone 0.83%,
Silicon dioxide 4.98%,
Magnesium stearate 0.66%.
Preparation method:
A: get bull testis and be ground into fine powder, for subsequent use;
B: after the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean with clear water, thinly slice, 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: the seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate 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 preparation method of tablet is as follows:
Measure by prescription and to mix 30 minutes with polyvinylpolypyrrolidone, silicon dioxide, the extract powder that contains Effective Component of Chinese Medicine after microcrystalline Cellulose mixes with lactose monohydrate, after mixing was crossed 60 mesh sieves, the adding magnesium stearate lubricant always mixed after 15 minutes, tabletting, and get final product.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% that contains Effective Component of Chinese Medicine
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, for subsequent use;
B: after the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean with clear water, thinly slice, 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: the seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate 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 preparation method of tablet is as follows:
Measure by prescription and to mix 30 minutes with polyvinylpolypyrrolidone, silicon dioxide, the extract powder that contains Effective Component of Chinese Medicine after microcrystalline Cellulose mixes with lactose monohydrate, after mixing was crossed 60 mesh sieves, the adding magnesium stearate lubricant always mixed after 15 minutes, tabletting, and get final product.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% that contains Effective Component of Chinese Medicine
Microcrystalline Cellulose 40%,
Lactose monohydrate 14%,
Polyvinylpolypyrrolidone 1%,
Silicon dioxide 4%,
Magnesium stearate 1%.
A: get bull testis and be ground into fine powder, for subsequent use;
B: after the Testis Et penis Bovis seu Bubali washing, reject connective tissue, muscle etc., clean with clear water, thinly slice, 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: the seven flavor medicine materials such as all the other Radix Rehmanniae Preparata, decoct with water secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate 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 preparation method of tablet is as follows:
Measure by prescription and to mix 30 minutes with polyvinylpolypyrrolidone, silicon dioxide, the extract powder that contains Effective Component of Chinese Medicine after microcrystalline Cellulose mixes with lactose monohydrate, after mixing was crossed 60 mesh sieves, the adding magnesium stearate lubricant always mixed after 15 minutes, tabletting, and get final product.In case of necessity can sugar coating or film-coat.