CN100363031C - Kuntai tablet preparation and preparation thereof - Google Patents
Kuntai tablet preparation and preparation thereof Download PDFInfo
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- CN100363031C CN100363031C CNB2005101032602A CN200510103260A CN100363031C CN 100363031 C CN100363031 C CN 100363031C CN B2005101032602 A CNB2005101032602 A CN B2005101032602A CN 200510103260 A CN200510103260 A CN 200510103260A CN 100363031 C CN100363031 C CN 100363031C
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Abstract
The present invention relates to a kuntai tablet preparation and preparation thereof, wherein the tablet preparation is Chinese medicine for curing premenopausal and postmenopausal diseases and is prepared from cooked rehmannia root, coptis root, white peony root, scutellaria root, ass hide glue and poria.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation, particularly a kind of Chinese medicinal tablet for the treatment of all cards before and after menopause and preparation method thereof, this tablet be by Radix Rehmanniae Preparata, Rhizoma Coptidis, and the Radix Paeoniae Alba, Radix Scutellariae, Colla Corii Asini, Poria is made.
Background technology:
Female safe capsule is the new Chinese medicine prescribed preparation that country's " drug standard " records, and is made by Radix Rehmanniae Preparata, Rhizoma Coptidis, the Radix Paeoniae Alba, Radix Scutellariae, Colla Corii Asini, Poria Six-element Chinese medicine, and function is a nourishing YIN and clearing away heat, the relieving restlessness of calming the nerves.Be used for all cards in front and back in menopause: the hyperactivity of fire caused by deficiency of YIN person, disease sees that gradually hot side is red, spontaneous sweating is vexed not peaceful, insomnia and dreamful sleep, dizziness and tinnitus, soreness of the waist and knees, feverish sensation in the palms and soles etc.; Woman woman ovarian function decline climacteric syndrome is seen above-mentioned shower.This pharmaceutically dosage form is a capsule, and capsule 's content 0.25g once takes the 4-8 grain.
Because the easy moisture absorption of hard capsule softgel shell becomes fragile, influence the stability of product, because existing technology and quality standard fall behind, cause its content to be loose shape, volume is big, and adding capsule shells has more increased volume and unfavorable swallowing, for overcoming above defective, select Tabules to carry out technological transformation, and its curative effect and quality have been studied, obtained beyond thought effect.Tablet quality of the present invention is stable, dosage is accurate, the medicine content difference is little in the sheet, takes, carries, transports, storage etc. is all more convenient, easily implements the big production of mechanization, and output is big, and cost is low.Owing to make into to have increased in the sheet behind the tablet, once take the sheet number and reduce, reduce injection volume simultaneously and be convenient to swallow, in addition, tablet stability is better, is difficult for the moisture absorption after adopting film coating, easily preserves.
Summary of the invention:
The invention provides a kind of Chinese medicinal tablet for the treatment of all cards before and after menopause and preparation method thereof, this tablet is by Radix Rehmanniae Preparata, Rhizoma Coptidis, and the Radix Paeoniae Alba, Radix Scutellariae, Colla Corii Asini, Poria is made.
The present invention is with Radix Rehmanniae Preparata, Rhizoma Coptidis, the Radix Paeoniae Alba, Radix Scutellariae, Colla Corii Asini, the Poria raw material is processed through extraction or other modes, makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.Since Radix Rehmanniae Preparata, Rhizoma Coptidis, the Radix Paeoniae Alba, Radix Scutellariae, the active substance that Colla Corii Asini, Poria are made has the easy moisture absorption, loose, instability, characteristics such as bitter in the mouth, therefore it is very important to select suitable medicine acceptable carrier to prepare tablet of the present invention, the present invention has selected pregelatinized Starch especially, magnesium stearate, and low-substituted hydroxypropyl cellulose is as the carrier of tablet of the present invention, it is that adjuvants such as different diluent, binding agent, lubricant and fluidizer have been carried out the result who draws after the screening, preferably comes out.The pharmaceutically active substance of tablet of the present invention is made by following Chinese medicinal raw materials,
Radix Rehmanniae Preparata 600g Rhizoma Coptidis 600g Radix Paeoniae Alba 300g
Radix Scutellariae 300g Colla Corii Asini 100g Poria 100g
Method for making is as follows:
Above Six-element, Poria, Colla Corii Asini mixed powder are broken into fine powder; Radix Scutellariae adds 100 ℃ of decoctings of 5 times of amounts and boils secondary, each 1.5 hours, filters merging filtrate; All the other Radix Rehmanniae Preparata etc. three flavor, add 5 times of water gaging soaked overnight after, decoct secondary, each, 1.5 hour, filtering, filtrate and above-mentioned filtrate merge, and are concentrated into the clear paste of relative density 1.10 (70 ℃), spray drying, the powder that gets dry extract promptly gets pharmaceutically active substance of the present invention with above-mentioned fine powder mixing.
The carrier pregelatinized Starch that pharmaceutically active substance of the present invention and the present invention select as tablet of the present invention, low-substituted hydroxypropyl cellulose, hybrid process is granulated, drying, it is an amount of to add magnesium stearate, and mixing is pressed into 1000, the bag film-coat, promptly.
Wherein pregelatinized Starch addition is 30g, and the low-substituted hydroxypropyl cellulose addition is 30g, and the magnesium stearate addition is 1.65g.Screening obtains the ratio of above weight proportion through science, is that adjuvants such as different diluent, binding agent, lubricant and fluidizer are screened, and by result of the test, preferably comes out.Its screening process is as follows:
Select for use pregelatinized Starch, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium as filler and disintegrating agent, we cooperate this extract powder to above-mentioned adjuvant, respectively with 70%, 80%, 90% alcohol granulation, tabletting, and be index with the hardness and the disintegration of particulate flowability (angle of repose-funnel method), tablet respectively, investigate the quality of prescription, the results are shown in Table 1.
Table 1 tabletting prescription screening result
| Prescription one | Prescription two | Prescription three | Prescription four | Prescription five | Prescription six | |
| Extract powder starch pregelatinized Starch low-substituted hydroxypropyl cellulose | 490g 60g - | 490g - 60g | 490g - 30g 30g | 490g 30g - 30g | 490g 30g - - | 490g - 30g - |
| Carboxymethyl starch sodium magnesium stearate hardness angle of repose disintegration sheet is heavy | -1.65g＜40 °＞45 minutes 0.55g of 3.5kg | -1.65g＜35 °＞38 minutes 0.55g of 4.0kg | -1.65g＜35 °＞17 minutes 0.55g of 4.0kg | -1.65g＜40 °＞30 minutes 0.55g of 4.0kg | 30g 1.65g＜35 °＞27 minutes 0.55g of 4.0kg | 30g 1.65g＜40 °＞15 minutes 0.55g of 4.5kg |
Above-mentioned experimental result shows, with write out a prescription three, the tabletting effect of prescription six is preferable, but low-substituted hydroxypropyl cellulose is inexpensive than carboxymethyl starch sodium, so choosing prescription three, i.e. dried cream powder and pregelatinized Starch mixing are with 80% alcohol granulation, drying, it is big to be lower than 80% alcohol granulation viscosity, 80% above alcohol granulation be should use, low-substituted hydroxypropyl cellulose and magnesium stearate mixing added, tabletting.
The extraction process of pharmaceutically active substance of the present invention also obtains through screening, and this technology has substantive progressive than existing technology, and this technology detailed step is as follows:
1, pulverizes: get Poria, the Colla Corii Asini mixed powder is broken into fine powder, crosses in the rearmounted stainless steel cask of 80 mesh sieves standby.
2, Radix Scutellariae decocts: get Radix Scutellariae and add 100 ℃ of decoctings of 5 times of amounts and boil secondary, and each 1.5 hours,, standby with the filtration of 200 mesh sieves, merging filtrate.
3, decoction such as Radix Rehmanniae Preparata: get Radix Rehmanniae Preparata, the Radix Paeoniae Alba, Rhizoma Coptidis, add 5 times of water gaging soaked overnight after, decoct secondary, each 1.5 hours,, standby with the filtration of 200 mesh sieves, merging filtrate.
4, concentrate: get above-mentioned two extracting solution and merge, be evaporated to the clear paste of relative density 1.10 (70 ℃), standby.
5, spray drying: get above-mentioned concentrated solution, carry out spray drying by following condition, intake air temperature is 1500-170 ℃, 90-120 ℃ of air outlet temperature, and 4000 rev/mins of high speed centrifugation nebulizer rotating speeds,
Charging rate 40-60ml/ minute, powder outlet quantity 0.3-0.5kg per hour.
6, tabletting: with spray drying extract powder and Poria, donkey-hide gelatin fine powder and an amount of pregelatinized Starch, mixing, with 80% alcohol granulation, drying, granulate adds 0.3% magnesium stearate, 5% low-substituted hydroxypropyl cellulose, puts in the mixer and mixes 20 minutes.B measures the moisture of mixed powder, should be controlled at about 2.5%; The special-shaped stamping of C, control hardness＞4Kg.
7, coating: a: it is an amount of to get " prompt color " HGY type gastric solubleness film coating pre-mix dose, with 85% ethanol by the preparation of 8% concentration, progressively adding in the mixer of a belt stirrer, it is stand-by to be mixed with the coating suspension.B: put into plain sheet in bag and pot, begin to rotate coating pan, rotational speed regulation is to 5-15rpm, feeds hot blast, and control tablet temperature is carried out the coating operation under 35-38 ℃ of condition, spray all coating solutions, and continuation drying 10 minutes promptly obtains the finished product behind the coating.
8, packing: be distributed into 12 of every plates with tablet packing machine.
The present invention also provides the method for quality control of tablet of the present invention, comprises, character is differentiated, checks steps such as assay.
The present invention has made tablet through technological transformation with capsule, has selected optimization formula simultaneously, has solved stability and hygroscopicity problem, has improved mouthfeel, the tablet good effect of making, and side effect is little, and taking convenience has been obtained beyond thought effect.
The specific embodiment:
Further specify the present invention by the following examples.
Embodiment 1
Radix Rehmanniae Preparata 600g Rhizoma Coptidis 600g Radix Paeoniae Alba 300g
Radix Scutellariae 300g Colla Corii Asini 100g Poria 100g
Method for making is as follows:
Above Six-element, Poria, Colla Corii Asini mixed powder are broken into fine powder; Radix Scutellariae adds 100 ℃ of decoctings of 5 times of amounts and boils secondary, each 1.5 hours, filters merging filtrate; All the other Radix Rehmanniae Preparata etc. three flavor, add 5 times of water gaging soaked overnight after, decoct secondary, each, 1.5 hour, filtering, filtrate and above-mentioned filtrate merge, and are concentrated into the clear paste of relative density 1.10 (70 ℃), spray drying, the powder that gets dry extract promptly gets pharmaceutically active substance of the present invention with above-mentioned fine powder mixing.
The carrier pregelatinized Starch that pharmaceutically active substance of the present invention and the present invention select as tablet of the present invention, low-substituted hydroxypropyl cellulose, hybrid process is granulated, drying, it is an amount of to add magnesium stearate, and mixing is pressed into 1000, the bag film-coat, promptly.
Wherein pregelatinized Starch addition is 30g, and the low-substituted hydroxypropyl cellulose addition is 30g, and the magnesium stearate addition is 1.65g.
Claims (4)
1. Chinese medicinal tablet for the treatment of all cards before and after menopause, this tablet is by Radix Rehmanniae Preparata 600g, Rhizoma Coptidis 600g Radix Paeoniae Alba 300g, Radix Scutellariae 300g, Colla Corii Asini 100g, Poria 100g makes, and wherein contains to make the needed carrier of tablet, and described carrier is pregelatinized Starch, low-substituted hydroxypropyl cellulose, magnesium stearate, the amount of each component is a Radix Rehmanniae Preparata, Rhizoma Coptidis, the Radix Paeoniae Alba, the active constituents of medicine 490g that Radix Scutellariae, Colla Corii Asini, Poria are made, pregelatinized Starch 30g, low-substituted hydroxypropyl cellulose 30g, magnesium stearate 1.65g, wherein said pharmaceutically active substance prepares in order to the below method: Poria, the Colla Corii Asini mixed powder is broken into fine powder; Radix Scutellariae adds 100 ℃ of decoctings of 5 times of amounts and boils secondary, each 1.5 hours, filters merging filtrate; All the other Radix Rehmanniae Preparata etc. three flavor, add 5 times of water gaging soaked overnight after, decoct secondary, each, 1.5 hours, filter, filtrate and the merging of above-mentioned filtrate are concentrated into the clear paste of relative density 1.10, spray drying, the powder that gets dry extract promptly gets pharmaceutically active substance with above-mentioned fine powder mixing.
2. the preparation method of the Chinese medicinal tablet of claim 1 is characterized in that, step is as follows: pharmaceutically active substance and pregelatinized Starch, low-substituted hydroxypropyl cellulose, mix, granulate, drying, it is an amount of to add magnesium stearate, mixing is pressed into 1000, the bag film-coat, promptly.
3. the preparation method of claim 2 is characterized in that, wherein granulation step adopts the 80-100% alcohol granulation.
4. the method for quality control of the tablet of claim 1 is characterized in that, comprises character, differentiates, checks the assay step.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101032602A CN100363031C (en) | 2005-09-21 | 2005-09-21 | Kuntai tablet preparation and preparation thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101032602A CN100363031C (en) | 2005-09-21 | 2005-09-21 | Kuntai tablet preparation and preparation thereof |
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| Publication Number | Publication Date |
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| CN1742870A CN1742870A (en) | 2006-03-08 |
| CN100363031C true CN100363031C (en) | 2008-01-23 |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102091182B (en) * | 2011-03-15 | 2012-05-09 | 程卫东 | Medicament for treating perimenopausal syndrome |
| CN102309414B (en) * | 2011-09-22 | 2014-02-26 | 贵阳新天药业股份有限公司 | Dry-process granulation method of kuntai capsule |
| CN103432275B (en) * | 2013-08-30 | 2015-07-22 | 贵阳新天药业股份有限公司 | Sustained-release nano-capsules for improving endometrial receptivity and application thereof |
| CN103566020B (en) * | 2013-08-30 | 2015-12-09 | 贵阳新天药业股份有限公司 | A kind of Chinese medicine composition preventing and treating female dimacteric syndrome |
| CN103690672B (en) * | 2013-12-31 | 2016-08-31 | 贵阳新天药业股份有限公司 | For treating controlled release preparation of anovulatory dysfunctional uterine hemorrhage that women's ovary dysfunction causes and preparation method thereof |
| CN106806642A (en) * | 2016-11-28 | 2017-06-09 | 李元英 | A kind of Chinese medicine preparation for treating insomnia |
| CN111514209A (en) * | 2019-08-28 | 2020-08-11 | 贵阳新天药业股份有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for preventing and/or treating myocardial ischemia-reperfusion injury |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733135A (en) * | 2005-08-19 | 2006-02-15 | 郭凌云 | Oral liquid for curing women's climacteric melancholia and process for preparing the same |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733135A (en) * | 2005-08-19 | 2006-02-15 | 郭凌云 | Oral liquid for curing women's climacteric melancholia and process for preparing the same |
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Owner name: JIANGXI XINZHENGPHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: HUANG RUPING; APPLICANT Effective date: 20070914 |
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Effective date of registration: 20070914 Address after: 337000 Eastern District of Pingxiang hi tech Industrial Park, Jiangxi Applicant after: Jiangxi Xinzheng Pharmaceutical Co. Ltd. Address before: 330000 Jiangxi city of Nanchang Province Ding Road No. 88 Athens Hengmao international room 2302 Applicant before: Huang Ruping Co-applicant before: Li Ziqiang |
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