CN1857478A - Xietingfeng medicine preparation and its preparing process - Google Patents
Xietingfeng medicine preparation and its preparing process Download PDFInfo
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- CN1857478A CN1857478A CN 200510003159 CN200510003159A CN1857478A CN 1857478 A CN1857478 A CN 1857478A CN 200510003159 CN200510003159 CN 200510003159 CN 200510003159 A CN200510003159 A CN 200510003159A CN 1857478 A CN1857478 A CN 1857478A
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Abstract
The present invention discloses new Xietingfeng medicine preparation for treating intestinal tract diseases and its preparation process. The Xietingfeng medicine preparation is prepared with root of hairysalk tinospora, flavescent sophora root, garden burnet and leatherleaf mahonia in certain weight proportion, and may be syrup, granule, tablet or soft capsule. The Xietingfeng medicine preparation is developed on the basis of Xietingfeng capsule, and has high medicine component leaching out rate, high bioavailability, small dosage, stable medicine property and raised curative effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine pharmaceutical preparation for the treatment of intestinal tract disease, belong to the field of traditional Chinese medicine technology.
Technical background
Intestinal tract disease is a frequently-occurring disease, commonly encountered diseases.Its curative is the standing medicine of family, rushes down that to stop the sealing capsule be exactly a kind of reasonable Chinese patent medicine of treatment intestinal tract disease effect commonly used.But find in actual use,, also come with some shortcomings though their therapeutic effect is good.Rush down and stop sealing capsular deficiency and be: content uniformity easily transfinites, and causes taking dose inaccurate; Moisture-sensitive, deliquescing, caking, even go mouldy, light, air, moisture etc. are bigger to its influence.In addition, different patients has different preferences to the dosage form of taking, and only the also inconvenient patient of this a kind of dosage form is to the selection of pharmaceutical dosage form.
Summary of the invention
The object of the invention is, provides the medicine of treatment intestinal tract disease to rush down novel formulation of stopping sealing and preparation method thereof, solves the problem that prior art exists.
Technical scheme of the present invention.Rush down and stop sealing pharmaceutical preparation, it is characterized in that: it is with following materials of weight proportions,
Radix Tinosporae 20-50 part, Radix Sophorae Flavescentis 20-50 part,
Radix Sanguisorbae 10-30 part, Caulis Mahoniae 15-35 part;
Be prepared into syrup, tablet, granule, soft capsule.
The above-mentioned preparation method of stopping sealing pharmaceutical preparation of rushing down is on the waiting list raw material by given components by weight percent, by following step preparation;
A, Radix Tinosporae is cut into the sheet of 2-6mm, as the A product;
B, with Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae cut into 10-15mm the section, as the B product;
C, the A product of 90% amount are dried, be ground into 80-120 purpose fine powder, as the C product;
D, with A product and B product mixing, decoct with water twice, for the first time amount of water be medical material 3-6 doubly, decocting time is 2-6 hour; For the second time amount of water be medical material 2-4 doubly, decocting time is 1-3 hour; Merge twice medicinal liquid, left standstill 20-28 hour, get the 65-75% of supernatant concentration, get medicinal liquid D1 product to total amount; Maybe will remain A product and the B product mixing of 10% amount, and decoct with water twice, the first time, amount of water was the 3-6 times of medical material, and decocting time is 2-6 hour; For the second time amount of water be medical material 2-4 doubly, decocting time is 1-3 hour; Merge twice medicinal liquid, filter; It is the extractum of 1.2-1.3 that concentrating under reduced pressure becomes relative density, measures 80 ℃ of temperature, becomes dried cream with microwave at 60-80 ℃ of following drying under reduced pressure, is ground into the 80-120 order, gets the D2 product; Or with A product and B product mixing, decoct with water twice, for the first time amount of water be medical material 3-6 doubly, decocting time is 2-4 hour; For the second time amount of water be medical material 2-4 doubly, decocting time is 1-3 hour; Merge twice medicinal liquid, filter; It is the extractum of 1.2-1.3 that concentrating under reduced pressure becomes relative density, and measuring temperature is 80 ℃, becomes dried cream with microwave at 60-80 ℃ of following drying under reduced pressure, is ground into 80-140 order fine powder, gets the D3 product;
D, the D1 product are made syrup, D2 product and C product mixing are made tablet, the D3 product are made granule and soft capsule.
Aforementioned rushing down stops sealing in the preparation method of pharmaceutical preparation, and described step a is preferably: Radix Tinosporae is cut into the sheet of 4mm, as the A product.
Aforementioned rushing down stops sealing in the preparation method of pharmaceutical preparation, and described step b is preferably: with Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae cut into 10mm the section, as the B product.
Aforementioned rushing down stops sealing in the preparation method of pharmaceutical preparation, and described step c is preferably: with A product and B product mixing, decoct with water twice, for the first time amount of water is 4 times of medical material, and decocting time is 3 hours; For the second time amount of water is 2 times of medical material, and decocting time is 1.5 hours; Merge twice medicinal liquid, left standstill 24 hours, get supernatant concentration, get medicinal liquid D1 product to 70% of total amount; Or, decoct with water twice with 10%A product and B product mixing, and for the first time amount of water is 4 times of medical material, decocting time is 3 hours; For the second time amount of water is 2 times of medical material, and decocting time is 1.5 hours; Merge twice medicinal liquid, filter; It is 1.25 extractum that concentrating under reduced pressure becomes relative density, measures 80 ℃ of temperature, becomes dried cream with microwave at 70 ℃ of following drying under reduced pressure, is ground into 80-100 order fine powder, must the D2 product; Or with A product and B product mixing, decoct with water twice, for the first time amount of water be medical material 3-6 doubly, decocting time is 2-4 hour; For the second time amount of water be medical material 2-4 doubly, decocting time is 1-3 hour; Merge twice medicinal liquid, filter; It is the extractum of 1.2-1.3 that concentrating under reduced pressure becomes relative density, and measuring temperature is 80 ℃, becomes dried cream with microwave at 60-80 ℃ of following drying under reduced pressure, is ground into 80-140 order fine powder, gets the D3 product.
Aforementioned rushing down stops sealing in the preparation method of pharmaceutical preparation, and syrup prepares like this: get sucrose 300-400 part and add water and make simple syrup, taking liquid D1 product and adjuvant three mixing are prepared into to rush down and stop sealing syrup; Adjuvant adopts that the benzoic acid of D1 product weight 0.3-0.5% is received, the ethyl hydroxybenzoate of 0.03-0.05%, the citric acid of 0.37-0.62%, the Fructus Myricae rubrae essence of 0.37-0.62%; With the above-mentioned mixing bottling of getting the raw materials ready, packing.
Aforementioned rushing down stopped sealing in the preparation method of pharmaceutical preparation, tablet prepares like this: get D2 product and C product mix homogeneously, it is an amount of to add concentration and be 5% starch slurry, granulate, cut into 16~20 purpose granules, airpillow-dry with cutter, with 14~16 eye mesh screen granulate, the carboxymethyl starch sodium that adds total amount 3%, tabletting, promptly.
Aforementioned rushing down stops sealing in the preparation method of pharmaceutical preparation, and granule prepares like this: get 550~700 parts of sucrose, be ground into 80~100 purpose cane sugar powders; An amount of with D3 product and soluble starch, mix homogeneously with purified water or 50-70% alcohol granulation, cuts into 14~20 order granules with cutter, airpillow-dry, and with 12~18 mesh sieve granulate, packing.
Aforementioned rushing down stops sealing in the preparation method of pharmaceutical preparation, and soft capsule prepares like this: get the D3 product and add vegetable oil and an amount of suspending agent, and be flow-like through the emulsifying of colloid mill mixing, send into soft capsule pellet press fluid reservoir; Take by weighing a certain amount of gelatin simultaneously and put into the vacuum glue pot, add an amount of cold distilled water and be dipped to the gelatin expansion through 5-15 minute, dissolve with the hot bath method heated and stirred, filter, filtrate under agitation adds glycerol, arabic gum and small amount of coloring matter, mixing reaches the viscosity of defined, puts into capsule filler capsule liquid chamber; Make soft capsule.
Compared with the prior art, the present invention stops on the sealing capsule formula basis former rushing down, through testing, contrast, conclude, screen, sum up novel formulation of acquisition and preparation method thereof repeatedly.In the present invention: the order number that Radix Tinosporae is ground into fine powder and pulverizing; Radix Tinosporae is cut into the sheet of certain specification; Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae are cut into the section of certain specification; Part or all of decocting; Be condensed into the relative density of extractum after the decoction and adopt microwave under suitable temperature, to carry out drying under reduced pressure; All be the result that the inventor obtains on a large amount of experiment basis.Preparation medicine composition dissolution height of the present invention, bioavailability height, dose is little, the property of medicine is stable, and therapeutic effect all is better than existing preparation.The present invention still to existing dosage form do not carried out replenishing, perfect, and enriched the kind of dosage form, can make things convenient for different patients according to preference to the dosage form of taking, pharmaceutical dosage form is selected to take.
The applicant carries out a series of experiments, and can confirm that method provided by the invention is effectively controlled, the preparation good effect.
Experimental example:
Medicinal material processing length is tested the influence of the water extracted immersing paste yield:
Test method: adopt respectively same batch cut into the length difference, the different medical material (Radix Tinosporae, Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae) of thickness carries out decocting in water.Soon Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae three flavor medical materials cut into 10mm section, 12mm section, 14mm section respectively, and Radix Tinosporae is cut into 2mm sheet, 4mm sheet, 6mm sheet, after the mixing, decoct.It is 1.25 extractum that the water decoction concentrating under reduced pressure becomes relative density, measures 80 ℃ of temperature; Add up extractum yield (1.25/80 ℃) respectively.
Extractum yield catalog:
12mm section and 2mm sheet | 34.3 | 34.0 | 34.2 | 34.5 | 34.7 | 34.1 | 34.3 |
14mm section and 2mm sheet | 33.3 | 33.1 | 33.5 | 33.4 | 33.8 | 33.2 | 33.4 |
10mm section and 4mm sheet | 38.5 | 38.6 | 38.4 | 38.7 | 38.3 | 38.2 | 38.5 |
12mm section and 4mm sheet | 36.7 | 36.6 | 36.4 | 36.1 | 36.2 | 36.8 | 36.5 |
14mm section and 4mm sheet | 35.4 | 35.0 | 35.5 | 35.2 | 35.1 | 35.3 | 35.3 |
10mm section and 6mm sheet | 36.2 | 36.0 | 36.6 | 36.5 | 36.1 | 36.3 | 36.3 |
12mm section and 6mm sheet | 32.2 | 31.9 | 31.8 | 32.0 | 32.6 | 32.4 | 32.2 |
14mm section and 6mm sheet | 31.0 | 30.6 | 30.4 | 31.2 | 31.1 | 30.9 | 30.9 |
Above experimental data shows, Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae three flavor medical materials are cut into 10mm section, 12mm section, 14mm section respectively, Radix Tinosporae is cut into 2mm sheet, 4mm sheet, 6mm sheet, after the mixing, in the various combination that decocts.What the yield of its extractum was the highest is that Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae three flavor medical materials are cut into the 10mm section respectively, and Rhizoma Polygonati is cut into the 4mm sheet, decocts after the mixing.So select for use Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae three flavor medical materials are cut into the 10mm section respectively, Radix Tinosporae is cut into 4mm sheet the best.
The specific embodiment
Embodiment 1.Rush down the syrup that stops sealing medicine.It is with following materials of weight proportions,
Radix Tinosporae 160g, Radix Sophorae Flavescentis 160g,
Radix Sanguisorbae 100g, Caulis Mahoniae 100g;
Be prepared into syrup 1000ml.
Be on the waiting list raw material by given components by weight percent, by following step preparation;
A, Radix Tinosporae is cut into the sheet of 4mm, as the A product;
B, with Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae cut into 10mm the section, as the B product;
C, with A product and B product mixing, decoct with water twice, for the first time amount of water is 4 times of medical material, decocting time is 2 hours; For the second time amount of water is 2 times of medical material, and decocting time is 1 hour; Merge twice medicinal liquid, left standstill 24 hours, get supernatant concentration, get medicinal liquid D1 product to 70% of total amount;
D, get sucrose and add water and make simple syrup, taking liquid D1 product and adjuvant three mixing are prepared into to rush down and stop sealing syrup; Adjuvant adopts that the benzoic acid of D1 product total amount 0.4% is received, 0.04% ethyl hydroxybenzoate, 0.5% citric acid, 0.5% Fructus Myricae rubrae essence; With the above-mentioned mixing bottling of getting the raw materials ready, packing.Oral, a 10ml, 3 times on the one.
Embodiment 2.Rush down the granule that stops sealing medicine.It is with following materials of weight proportions,
Radix Tinosporae 400g, Radix Sophorae Flavescentis 400g,
Radix Sanguisorbae 250g, Caulis Mahoniae 250g;
Be prepared into granule 1000g.
Be on the waiting list raw material by given components by weight percent, by following step preparation;
A, Radix Tinosporae is cut into the sheet of 4mm, as the A product;
B, with Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae cut into 10mm the section, as the B product;
C, with A product and B product mixing, decoct with water twice, for the first time amount of water is 4 times of medical material, decocting time is 3 hours; For the second time amount of water is 2 times of medical material, and decocting time is 1.5 hours; Merge twice medicinal liquid, filter; It is the extractum of 1.25 (80 ℃) that concentrating under reduced pressure becomes relative density, is dried to dried cream with microwave (70 ℃), is ground into 80-120 purpose fine powder, gets the C product;
D, get 600 parts of cane sugar powders, be ground into 80-100 order cane sugar powder, an amount of with C product and soluble starch, mix homogeneously, add an amount of purified water or 50~70% alcohol granulations, cut into 14~20 order granules, airpillow-dry with cutter, with 12~18 mesh sieve granulate, make granule, packing.Oral, a 5g (1 bag), 3 times on the one.
Embodiment 3.Rush down the tablet that stops sealing medicine.It is with following materials of weight proportions,
Radix Tinosporae 200g, Radix Sophorae Flavescentis 200g,
Radix Sanguisorbae 125g, Caulis Mahoniae 125g;
Be prepared into 1000 in tablet.
Be on the waiting list raw material by given components by weight percent, by following step preparation;
A, Radix Tinosporae is cut into the sheet of 4mm, as the A product;
B, with Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae cut into 10mm the section, as the B product;
C, with the Radix Tinosporae oven dry of 90% amount in the A product, be ground into 80-120 purpose fine powder, as the C product;
The Radix Tinosporae and the B product mixing of residue 10% amount decoct with water twice in d, the A product, and the first time, amount of water was 4 times of medical material, and decocting time is 3 hours; For the second time amount of water is 2 times of medical material, and decocting time is 1.5 hours; Merge twice medicinal liquid, filter; It is the extractum of 1.25 (80 ℃) that concentrating under reduced pressure becomes relative density, is dried to dried cream with microwave (70 ℃), is ground into 80-100 purpose fine powder, gets the D product;
E, with D product and C product mix homogeneously, it is an amount of to add concentration and be 5% starch slurry, mixing is granulated, and cuts into 16~20 purpose granules with cutter, airpillow-dry, with 14~18 eye mesh screen granulate, add 3% carboxymethyl starch sodium, tabletting, adopt stomach dissolution type film-coat pre-mixing agent (Opadry) coating, promptly.Oral, one time 4~6,3 times on the one.
Embodiment 4.Rush down the soft capsule that stops sealing medicine.It is with following materials of weight proportions,
Radix Tinosporae 200g, Radix Sophorae Flavescentis 200g,
Radix Sanguisorbae 125g, Caulis Mahoniae 125g;
Be prepared into 1000 of soft capsules.
Be on the waiting list raw material by given components by weight percent, by following step preparation;
A, Radix Tinosporae is cut into the sheet of 4mm, as the A product;
B, with Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae cut into 10-15mm the section, as the B product;
C, A product and B product mixing decoct with water twice, and for the first time amount of water is 4 times of medical material, and decocting time is 3 hours; For the second time amount of water is 2 times of medical material, and decocting time is 1.5 hours; Merge twice medicinal liquid, filter; It is the extractum of 1.25 (80 ℃) that concentrating under reduced pressure becomes relative density, is dried to dried cream with microwave (70 ℃), is ground into 120 purpose fine powders, gets the C product;
D, get the C product and add vegetable oil and an amount of suspending agent, and be flow-like, send into capsule pellet press fluid reservoir through the emulsifying of colloid mill mixing; Take by weighing a certain amount of gelatin simultaneously and put into the vacuum glue pot, add an amount of cold distilled water and be dipped to the gelatin expansion through 5-15 minute, dissolve with the hot bath method heated and stirred, filter, filtrate under agitation adds glycerol, arabic gum and small amount of coloring matter, mixing reaches the viscosity of defined, puts into capsule pellet press capsule liquid chamber; Make soft capsule.Oral, a 2-4 grain, 3 times on the one.
Claims (9)
1, rush down and stop sealing pharmaceutical preparation, it is characterized in that: it is with following materials of weight proportions,
Radix Tinosporae 20-50 part, Radix Sophorae Flavescentis 20-50 part,
Radix Sanguisorbae 10-30 part, Caulis Mahoniae 15-35 part;
Be prepared into syrup, tablet, granule, soft capsule.
2, the preparation method of stopping sealing pharmaceutical preparation of rushing down as claimed in claim 1 is characterized in that: be on the waiting list raw material by given components by weight percent, by following step preparation;
A, Radix Tinosporae is cut into the sheet of 2-6mm, as the A product;
B, with Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae cut into 10-15mm the section, as the B product;
C, the A product of 90% amount are dried, be ground into 80-120 purpose fine powder, as the C product;
D, with A product and B product mixing, decoct with water twice, for the first time amount of water be medical material 3-6 doubly, decocting time is 2-6 hour; For the second time amount of water be medical material 2-4 doubly, decocting time is 1-3 hour; Merge twice medicinal liquid, left standstill 20-28 hour, get the 65-75% of supernatant concentration, get medicinal liquid D1 product to total amount; Maybe will remain A product and the B product mixing of 10% amount, and decoct with water twice, the first time, amount of water was the 3-6 times of medical material, and decocting time is 2-6 hour; For the second time amount of water be medical material 2-4 doubly, decocting time is 1-3 hour; Merge twice medicinal liquid, filter; It is the extractum of 1.2-1.3 that concentrating under reduced pressure becomes relative density, measures 80 ℃ of temperature, becomes dried cream with microwave at 60-80 ℃ of following drying under reduced pressure, is ground into the 80-120 order, gets the D2 product; Or with A product and B product mixing, decoct with water twice, for the first time amount of water be medical material 3-6 doubly, decocting time is 2-4 hour; For the second time amount of water be medical material 2-4 doubly, decocting time is 1-3 hour; Merge twice medicinal liquid, filter; It is the extractum of 1.2-1.3 that concentrating under reduced pressure becomes relative density, and measuring temperature is 80 ℃, becomes dried cream with microwave at 60-80 ℃ of following drying under reduced pressure, is ground into 80-140 order fine powder, gets the D3 product;
D, the D1 product are made syrup, D2 product and C product mixing are made tablet, the D3 product are made granule and soft capsule.
3, the preparation method of stopping sealing pharmaceutical preparation of rushing down according to claim 2 is characterized in that: described step a is, Radix Tinosporae cut into the sheet of 4mm, as the A product.
4, according to claim 3 rush down stop sealing pharmaceutical preparation preparation method, it is characterized in that: described step b is, Radix Sophorae Flavescentis, Radix Sanguisorbae, Caulis Mahoniae cut into the section of 10mm, as the B product.
5, the preparation method of stopping sealing pharmaceutical preparation of rushing down according to claim 3 is characterized in that: described step c is, with A product and B product mixing, decocts with water twice, and amount of water is 4 times of medical material for the first time, and decocting time is 3 hours; For the second time amount of water is 2 times of medical material, and decocting time is 1.5 hours; Merge twice medicinal liquid, left standstill 24 hours, get supernatant concentration, get medicinal liquid D1 product to 70% of total amount; Or, decoct with water twice with 10%A product and B product mixing, and for the first time amount of water is 4 times of medical material, decocting time is 3 hours; For the second time amount of water is 2 times of medical material, and decocting time is 1.5 hours; Merge twice medicinal liquid, filter; It is 1.25 extractum that concentrating under reduced pressure becomes relative density, measures 80 ℃ of temperature, becomes dried cream with microwave at 70 ℃ of following drying under reduced pressure, is ground into 80-120 order fine powder, must the D2 product; Or with A product and B product mixing, decoct with water twice, for the first time amount of water be medical material 3-6 doubly, decocting time is 2-4 hour; For the second time amount of water be medical material 2-4 doubly, decocting time is 1-3 hour; Merge twice medicinal liquid, filter; It is the extractum of 1.2-1.3 that concentrating under reduced pressure becomes relative density, and measuring temperature is 80 ℃, becomes dried cream with microwave at 60-80 ℃ of following drying under reduced pressure, is ground into 80-140 order fine powder, gets the D3 product.
6, according to the described preparation method of stopping sealing pharmaceutical preparation of rushing down of arbitrary claim in the claim 2 to 4, it is characterized in that: syrup prepares like this, get sucrose 300-400 part and add water and make simple syrup, taking liquid D1 product and adjuvant three mixing are prepared into to rush down and stop sealing syrup; Adjuvant adopts that the benzoic acid of D1 product weight 0.3-0.5% is received, the ethyl hydroxybenzoate of 0.03-0.05%, the citric acid of 0.37-0.62%, the Fructus Myricae rubrae essence of 0.37-0.62%; With the above-mentioned mixing bottling of getting the raw materials ready, packing.
7, according to the described preparation method of stopping sealing pharmaceutical preparation of rushing down of arbitrary claim in the claim 2 to 4, it is characterized in that: tablet prepares like this; Get D2 product and C product mix homogeneously, it is an amount of to add concentration and be 5% starch slurry, granulates, and cuts into 16~20 purpose granules with cutter, airpillow-dry, and with 14~16 eye mesh screen granulate, the carboxymethyl starch sodium of adding total amount 3%, tabletting, promptly.
8, according to the described preparation method of stopping sealing pharmaceutical preparation of rushing down of arbitrary claim in the claim 2 to 4, it is characterized in that: granule prepares like this; Get 550~700 parts of sucrose, be ground into 80~100 purpose cane sugar powders; An amount of with D3 product and soluble starch, mix homogeneously with purified water or 50-70% alcohol granulation, cuts into 14~20 order granules with cutter, airpillow-dry, and with 12~18 mesh sieve granulate, packing.
9, according to the described preparation method of stopping sealing pharmaceutical preparation of rushing down of arbitrary claim in the claim 2 to 4, it is characterized in that: soft capsule prepares like this; Get the D3 product and add vegetable oil and an amount of suspending agent, and be flow-like, send into soft capsule pellet press fluid reservoir through the emulsifying of colloid mill mixing; Take by weighing a certain amount of gelatin simultaneously and put into the vacuum glue pot, add an amount of cold distilled water and be dipped to the gelatin expansion through 5-15 minute, dissolve with the hot bath method heated and stirred, filter, filtrate under agitation adds glycerol, arabic gum and small amount of coloring matter, mixing reaches the viscosity of defined, puts into capsule filler capsule liquid chamber; Make soft capsule.
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Cited By (1)
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CN101780161B (en) * | 2009-09-02 | 2011-09-21 | 贵州百灵企业集团制药股份有限公司 | Capsule quality detection method |
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Cited By (1)
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CN101780161B (en) * | 2009-09-02 | 2011-09-21 | 贵州百灵企业集团制药股份有限公司 | Capsule quality detection method |
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