CN1628814A - Method for preparing 'Sanjin tablet' - Google Patents
Method for preparing 'Sanjin tablet' Download PDFInfo
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Abstract
The invention discloses a method for preparing 'Sanjin tablet' which comprises, (1) extracting Fructus Rosae Laevigatae, sheep opening, smilax China root, Lygodium japonicum, cat's-foot with water, (2) mixing the extract with pharmaceutically acceptable carrier, spray drying and granulating, (3) tabletting, (4) dressing.
Description
Technical field:
The present invention relates to a kind of preparation method of Chinese medicine preparation, particularly relate to the preparation method of three gold medal preparations such as SANJIN PIAN, this method compared with prior art has lot of advantages.
Background technology:
Three gold medal preparations such as SANJIN PIAN system " kind of including of Chinese pharmacopoeia version in 2000.Be coated tablet or Film coated tablets.Function with cure mainly into: heat-clearing and toxic substances removing, dampness removing is treating stranguria, kidney tonifying.Be used for damp-heat in lower-JIAO, pyretic stranguria, oliguria with reddish urine drenches the puckery pain of drop; Urgent, chronic nephropyeltis, cystitis, urinary tract infection belongs to the syndrome of dampness-heat diffusing downward person that suffers from a deficiency of the kidney.
The preparation method of SANJIN PIAN adopts comparatively traditional technology of preparing always, and production technology is comparatively backward, the cost height, and the index active ingredient loss is big, and quality fluctuation is big.
Now provide a kind of more advanced preparation method, its advantage: the mobility of particle of making is good, finished product effective ingredient rate of transform height, steady quality etc.
Summary of the invention:
The invention provides a kind of new preparation method of SANJIN PIAN, this method may further comprise the steps:
(1) extracts
Radix Rosae Laevigatae, YANGKAIKOU, Rhizoma Smilacis Chinensis, Herba lygodii, Herba Centellae are put in the extraction vessel, add water boil, extract 1-3 time, 1-4 hour for the first time, 0.5-3 hour for the second time, the filtrate of extraction concentrated, and was condensed into thick paste (d=1.10～1.45/40～80 ℃, preferred d=1.15～1.20/50～60 ℃), weigh.
(2) dry, granulation
Method 1. spray dryinges: thick paste is placed in the basin, spray drying, the control of drying process parameter is as follows:
Inlet temperature: 150～250 ℃; Leaving air temp: 60～150 ℃; Spray fast 3ml/s～15ml/s.Preferably: inlet temperature: 180～230 ℃; Leaving air temp: 100～120 ℃; Spray fast 6ml/s～12ml/s
Pack in the clean airtight container, weigh record.
One-step palletizing: get the SANJIN PIAN dried cream powder; it is an amount of to add adjuvant (starch, Pulvis Talci etc.); put in the one-step-granulating method hopper; mix homogeneously is a wetting agent with suitable quantity of water or 20%-40% ethanol, makes to add adjuvant (silicon dioxide, magnesium stearate, microcrystalline Cellulose etc. are an amount of) mix homogeneously behind the granule; cross 10 mesh sieves; pack in the clean bucket, weigh record.The temperature parameter control of one-step palletizing: inlet temperature: 30～100 ℃; Leaving air temp: 20～60 ℃.
Method 2. spray-drying processes: get adjuvant (Pulvis Talci, starch etc.) and put in right amount in the spray-drying pelleting machine hopper; mix homogeneously; spray into thick paste; add adjuvant (silicon dioxide, magnesium stearate, microcrystalline Cellulose etc.) in right amount after making granule; mix homogeneously, granulate is in the clean bucket of packing into; weighing, moisture content is controlled between 4.0%～8.0%.
Technological parameter control is as follows:
Inlet temperature: 50-160 ℃, leaving air temp: 40-100 ℃, temperature of charge 50-150 ℃, atomizing pressure 0.1-0.8 MPa, spray velocity 3ml/s～15ml/s.Preferably: inlet temperature: 80-120 ℃, leaving air temp: 80-90 ℃, temperature of charge 60-95 ℃, atomizing pressure 0.2-0.4 MPa, spray velocity 5ml/s～10ml/s.
The dry technology that relates in this method for making can also be traditional methods commonly used such as boulton process, drum-type seasoning, infrared drying, preferably spray drying of the present invention.
The old production method of SANJIN PIAN dry, granulate in outside operation technique such as the differences such as drum-type drying, swing granulation, its extraction process and basically identical of the present invention.
(3) tabletting
The qualified granule of arrangement is progressively added in the feed hopper, and it is heavy to calculate sheet, tabletting, and deserved plain sheet, large stretch of every is equivalent to crude drug 3.5g; Every of small pieces are equivalent to crude drug 2.1g.
(4) coating
Can make film-coat or coated tablet according to the galenic pharmacy routine techniques.
The characteristics of SANJIN PIAN production technology of the present invention are:
1, adopted comparatively advanced production technology: spray drying, granulation technique, better control the technical parameter in spray drying, the granulation, as inlet temperature, leaving air temp etc., the granular mass of making is good, good fluidity, dust is few, favourable tabletting.
2, can prevent the loss (attached laboratory report) of active component in the SANJIN PIAN such as asiaticoside or asiaticoside more by suitable control process parameters; can illustrate through suitably controlling the equal conformance with standard regulation of granule asiaticoside, asiaticoside content that spray-dired parameter is made, obviously the granule asiaticoside of making than drum-type drying, 80% qualification rate height of asiaticoside content by table 1, table 2.
3, adopt spray-drying process technology and spray drying, one-step palletizing technology, can avoid material with environment, personnel contacts, and prevent pollution, improved product quality.Detect granule total number of bacteria that spray drying technologies make less than 10cfu/g by the experiment of the 20 batches of granule hygiologys respectively, qualification rate 100%, meet hygiology standard (experimental data sees Table 3) fully, more much higher than 80% qualification rate of the granule hygiology standard of making after the drum-type drying.
Below pass through the comparative descriptions beneficial effect of the present invention of the old and new's technology.
Old technology and existing new technology compare, and the drying means of central extractum has mainly adopted vacuum drying, and drum-type seasoning etc. are comparatively more backward than spray drying, the granulation of present employing.Enforcement by traditional handicraft and new technology is compared, and new method advantage is obvious.See Table 4.Table 1
| The granule that the spray-drying process technology is produced | The granule that spray drying technology produces | Make granule after the drum-type drying | |||
| Lot number | Asiaticoside assay (standard 〉=0.136%) | Lot number | Asiaticoside assay (standard 〉=0.136%) | Lot number | Asiaticoside assay (standard 〉=0.136%) |
| 0407112 | ?0.141％ | 0406001 | ?0.139％ | 0407060 | ?0.131％ |
| 0407122 | ?0.178％ | 0406002 | ?0.171％ | 0407061 | ?0.170％ |
| 0407136 | ?0.159％ | 0406003 | ?0.159％ | 0407062 | ?0.123％ |
| 0407150 | ?0.178％ | 0406004 | ?0.174％ | 0407063 | ?0.137％ |
| 0408001 | ?0.197％ | 0406005 | ?0.188％ | 0407064 | ?0.145％ |
| 0408002 | ?0.142％ | 0406007 | ?0.145％ | 0407065 | ?0.139％ |
| 0408003 | ?0.158％ | 0406008 | ?0.218％ | 0407066 | ?0.128％ |
| 0408004 | ?0.233％ | 0406009 | ?0.223％ | 0407067 | ?0.146％ |
| 0408005 | ?0.177％ | 0406010 | ?0.166％ | 0407068 | ?0.166％ |
| 0408006 | ?0.187％ | 0406011 | ?0.179％ | 0407069 | ?0.177％ |
| 0408007 | ?0.146％ | 0406012 | ?0.211％ | 0407070 | ?0.190％ |
| 0408008 | ?0.178％ | 0406013 | ?0.202％ | 0407071 | ?0.142％ |
| 0408009 | ?0.169％ | 0406014 | ?0.143％ | 0407072 | ?0.143％ |
| 0408010 | ?0.190％ | 0406015 | ?0.161％ | 0407073 | ?0.189％ |
| 0408011 | ?0.196％ | 0406016 | ?0.146％ | 0407074 | ?0.160％ |
| 0408012 | ?0.145％ | 0406017 | ?0.148％ | 0407075 | ?0.154％ |
| 0408013 | ?0.174％ | 0406018 | ?0.215％ | 0407076 | ?0.138％ |
| 0408014 | ?0.160％ | 0406019 | ?0.197％ | 0407077 | ?0.155％ |
| 0408015 | ?0.165％ | 0406020 | ?0.202％ | 0407078 | ?0.135％ |
| 0408016 | ?0.189％ | 0406021 | ?0.168％ | 0407079 | ?0.148％ |
| Total qualification rate | ?100％ | Total qualification rate | ?100％ | Total qualification rate | ?80％ |
Table 2
| The granule that the spray-drying process technology is produced | The granule that spray drying technology produces | Make granule after the drum-type drying | |||
| Lot number | Asiaticoside assay (standard 〉=0.136%) | Lot number | Asiaticoside assay (standard 〉=0.136%) | Lot number | Asiaticoside assay (standard 〉=0.136%) |
| 0407112 | ?0.145％ | 0406001 | ?0.155％ | 0407060 | ?0.137％ |
| 0407122 | ?0.188％ | 0406002 | ?0.183％ | 0407061 | ?0.150％ |
| 0407136 | ?0.199％ | 0406003 | ?0.159％ | 0407062 | ?0.133％ |
| 0407150 | ?0.178％ | 0406004 | ?0.146％ | 0407063 | ?0.139％ |
| 0408001 | ?0.187％ | 0406005 | ?0.197％ | 0407064 | ?0.155％ |
| 0408002 | ?0.152％ | 0406007 | ?0.152％ | 0407065 | ?0.145％ |
| 0408003 | ?0.168％ | 0406008 | ?0.170％ | 0407066 | ?0.128％ |
| 0408004 | ?0.157％ | 0406009 | ?0.165％ | 0407067 | ?0.176％ |
| 0408005 | ?0.174％ | 0406010 | ?0.164％ | 0407068 | ?0.166％ |
| 0408006 | ?0.159％ | 0406011 | ?0.147％ | 0407069 | ?0.171％ |
| 0408007 | ?0.147％ | 0406012 | ?0.177％ | 0407070 | ?0.194％ |
| 0408008 | ?0.176％ | 0406013 | ?0.166％ | 0407071 | ?0.132％ |
| 0408009 | ?0.198％ | 0406014 | ?0.198％ | 0407072 | ?0.153％ |
| 0408010 | ?0.149％ | 0406015 | ?0.145％ | 0407073 | ?0.181％ |
| 0408011 | ?0.201％ | 0406016 | ?0.171％ | 0407074 | ?0.158％ |
| 0408012 | ?0.190％ | 0406017 | ?0.166％ | 0407075 | ?0.151％ |
| 0408013 | ?0.150％ | 0406018 | ?0.152％ | 0407076 | ?0.164％ |
| 0408014 | ?0.167％ | 0406019 | ?0.156％ | 0407077 | ?0.195％ |
| 0408015 | ?0.165％ | 0406020 | ?0.198％ | 0407078 | ?0.121％ |
| 0408016 | ?0.169％ | 0406021 | ?0.173％ | 0407079 | ?0.178％ |
| Total qualification rate | ?100％ | Total qualification rate | ?100％ | Total qualification rate | ?80％ |
Table 3
| The granule that the spray-drying process technology is produced | The granule that spray drying technology produces | Make granule after the drum-type drying | |||
| Lot number | Hygiology | Lot number | Hygiology | Lot number | Hygiology |
| Total number of bacteria | Total number of bacteria | Total number of bacteria | |||
| ?0407112 | ＜10 | ?0406001 | ＜10 | ?0407060 | ??15 |
| ?0407122 | ＜10 | ?0406002 | ＜10 | ?0407061 | ＜10 |
| ?0407136 | ＜10 | ?0406003 | ＜10 | ?0407062 | ＜10 |
| ?0407150 | ＜10 | ?0406004 | ＜10 | ?0407063 | ＜10 |
| ?0408001 | ＜10 | ?0406005 | ＜10 | ?0407064 | ??16 |
| ?0408002 | ＜10 | ?0406007 | ＜10 | ?0407065 | ＜10 |
| ?0408003 | ＜10 | ?0406008 | ＜10 | ?0407066 | ??11 |
| ?0408004 | ＜10 | ?0406009 | ＜10 | ?0407067 | ＜10 |
| ?0408005 | ＜10 | ?0406010 | ＜10 | ?0407068 | ＜10 |
| ?0408006 | ＜10 | ?0406011 | ＜10 | ?0407069 | ＜10 |
| ?0408007 | ＜10 | ?0406012 | ＜10 | ?0407070 | ??12 |
| ?0408008 | ＜10 | ?0406013 | ＜10 | ?0407071 | ＜10 |
| ?0408009 | ＜10 | ?0406014 | ＜10 | ?0407072 | ??40 |
| ?0408010 | ＜10 | ?0406015 | ＜10 | ?0407073 | ＜10 |
| ?0408011 | ＜10 | ?0406016 | ＜10 | ?0407074 | ＜10 |
| ?0408012 | ＜10 | ?0406017 | ＜10 | ?0407075 | ＜10 |
| ?0408013 | ＜10 | ?0406018 | ＜10 | ?0407076 | ＜10 |
| ?0408014 | ＜10 | ?0406019 | ＜10 | ?0407077 | ＜10 |
| ?0408015 | ＜10 | ?0406020 | ＜10 | ?0407078 | ＜10 |
| ?0408016 | ＜10 | ?0406021 | ＜10 | ?0407079 | ＜10 |
Table 3
| Project | The effect of traditional handicraft | The beneficial effect that new technology produces |
| Color | Because drying time is long, temperature is higher, and color is dark, shows pitchy | Temperature is the end of than, and drying time is short, and is of light color, shows yellowish-brown, helps improving the effective ingredient of product |
| Pellet moisture | Higher, 4.0%～8%, it is bigger to fluctuate, and higher often the causing of moisture done over again | Generally be stabilized in 4.0%～5.0% |
| Grain graininess | 60～80 purposes are in the majority, and are mobile poor | 40～60 purposes are in the majority, and are better mobile, help tabletting |
| The granule compressibility | Generally, tablet hardness is softer, and mainly being that moisture is higher causes. | Better, tablet hardness is big |
| Cost of labor | Higher, average every batch needs 8-9 people/working day | Low, average every batch needs 5-6 people/working day |
| The seasoning operation | Caking phenomenon is often arranged | Caking phenomenon is more rare |
| End product quality | Poor stability, the active constituent content instability is as asiaticoside or asiaticoside assay instability | Good stability, active constituent content is stable, favorable reproducibility |
| Hygiology relatively | The production process link is many, and the open type operating unit is arranged, and easily pollutes | The production process link is few, the technological operation good leak tightness, and pollution probability is little |
The specific embodiment:
Further specify the present invention by the following examples.
Embodiment 1
With crude drug Radix Rosae Laevigatae, YANGKAIKOU, Rhizoma Smilacis Chinensis, Herba lygodii, Herba Centellae etc. according to recipe quantity ratio 80: 40: 40: put extraction vessel at 24: 24, add water boil, extract secondary, 2 hours for the first time, 1 hour for the second time, the filtrate of extracting is put concentrated, is condensed into thick paste thick paste (d=1.20/60 ℃), weighs or surveys volume.
Granulate:
Thick paste is placed in the basin, spray drying, the control of drying process parameter is as follows:
Inlet temperature: 200 ℃; Leaving air temp: 110 ℃; Spray fast 10ml/s.
Pack in the clean airtight container, weigh record.
Get the SANJIN PIAN dried cream powder, add Pulvis Talci, dried starch is an amount of, put in the one-step-granulating method hopper; with 30% ethanol is wetting agent, makes to add adjuvant (silicon dioxide, magnesium stearate, microcrystalline Cellulose are an amount of) mix homogeneously behind the granule, crosses 50 mesh sieves; pack in the clean bucket, weigh record.
Tabletting: will put qualified granule in order and progressively add in the feed hopper, it is heavy to calculate sheet, tabletting.
Coating: according to galenic pharmacy routine techniques bag film-coat.
Embodiment 2
With crude drug Radix Rosae Laevigatae, YANGKAIKOU, Rhizoma Smilacis Chinensis, Herba lygodii, Herba Centellae etc. according to recipe quantity ratio 80: 40: 40: put extraction vessel at 24: 24, add water boil, extract secondary, 2 hours for the first time, 1 hour for the second time, the filtrate of extracting is put concentrated, is condensed into thick paste thick paste (d=1.20/60 ℃), weighs or surveys volume.
Granulate:
Get Pulvis Talci, starch and put in right amount in the spray-drying pelleting machine hopper, spray into thick paste, make that to add adjuvant (silicon dioxide, magnesium stearate, microcrystalline Cellulose etc.) behind the granule an amount of; mix homogeneously, granulate is in the clean bucket of packing into; weighing, moisture content is controlled between 4.0%～8.0%.
Technological parameter control is as follows:
Inlet temperature: 50-160 ℃, leaving air temp: 40-100 ℃, temperature of charge 50-150 ℃, atomizing pressure 0.1-0.8 MPa, spray velocity 3ml/s～15ml/s.
Tabletting: will put qualified granule in order and progressively add in the feed hopper, it is heavy to calculate sheet, tabletting.
Coating: according to galenic pharmacy routine techniques bag film-coat or sugar-coat.
Claims (9)
1, a kind of preparation method of SANJIN PIAN is characterized in that, this method is made up of following steps:
(1) Radix Rosae Laevigatae, YANGKAIKOU, Rhizoma Smilacis Chinensis, Herba lygodii, Herba Centellae are used water extraction, get extract extractum,
(2) extract extractum and medicine acceptable carrier mix, spray drying, granulation,
(3) tabletting,
(4) coating.
2, the preparation method of claim 1, it is characterized in that, be to add water boil with water extraction described in the step (), extract 1-3 time, the granule of system described in the step (two) is selected from following two kinds of methods: method a. spray drying extract extractum, this dry extract and medicine acceptable carrier are mixed, granulate; The direct spray-drying process of method b..
3, the preparation method of claim 2 is characterized in that, described method a places thick paste in the basin, and spray drying is packed in the clean airtight container, weighs record.Control process parameters is as follows when dry: inlet temperature: 150～250 ℃; Leaving air temp: 60～150 ℃; Spray fast 3ml/s～15ml/s.
4, the preparation method of claim 3 is characterized in that, described when dry control process parameters as follows: inlet temperature: 180～230 ℃; Leaving air temp: 100～120 ℃; Spray fast 6ml/s～12ml/s.
5, the preparation method of claim 2 is characterized in that, granulates among the described method a and can adopt the one-step palletizing technology, and technological parameter is controlled to be: inlet temperature: 30～100 ℃; Leaving air temp: 20～60 ℃.
6, the preparation method of claim 2; it is characterized in that; the direct spray-drying process of described method b is that Pulvis Talci, starch are put in the spray-drying pelleting machine hopper; spray into density and be 1.10～1.45/40～80 ℃ thick paste; add right amount of auxiliary materials after making granule; mix homogeneously, particulate moisture content is controlled between 4.0%～8.0%.
7, the preparation method of claim 2 is characterized in that, described method of granulating preferably spray drying granulation technique.
8, the preparation method of claim 6 is characterized in that, described spray drying technology is granulated and adopted following technological parameter:
Inlet temperature: 50～160 ℃,
Leaving air temp: 40～100 ℃,
Temperature of charge: 50～150 ℃,
Atomizing pressure: 0.1～0.8 MPa,
Spray velocity: 3ml/s～15ml/s.
9, the preparation method of claim 6 is characterized in that, described spray drying technology is granulated and adopted following technological parameter:
Technological parameter control is as follows:
Inlet temperature: 80～120 ℃,
Leaving air temp: 80～90 ℃
Temperature of charge: 60～95 ℃,
Atomizing pressure: 0.2～0.4 MPa,
Spray velocity: 5ml/s～10ml/s.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100736280A CN100431580C (en) | 2004-08-30 | 2004-08-30 | Method for preparing 'Sanjin tablet' |
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| CNB2004100736280A CN100431580C (en) | 2004-08-30 | 2004-08-30 | Method for preparing 'Sanjin tablet' |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007152B (en) * | 2006-01-24 | 2013-04-10 | 四川升和药业股份有限公司 | A preparation method of 'Sanjin' dispersible tablets |
| CN114652799A (en) * | 2020-12-22 | 2022-06-24 | 桂林三金药业股份有限公司 | Sanjin Chinese medicinal composition and preparation method thereof |
| CN114712467A (en) * | 2020-12-22 | 2022-07-08 | 桂林三金药业股份有限公司 | Sanjin tablets and preparation method thereof |
-
2004
- 2004-08-30 CN CNB2004100736280A patent/CN100431580C/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007152B (en) * | 2006-01-24 | 2013-04-10 | 四川升和药业股份有限公司 | A preparation method of 'Sanjin' dispersible tablets |
| CN114652799A (en) * | 2020-12-22 | 2022-06-24 | 桂林三金药业股份有限公司 | Sanjin Chinese medicinal composition and preparation method thereof |
| CN114712467A (en) * | 2020-12-22 | 2022-07-08 | 桂林三金药业股份有限公司 | Sanjin tablets and preparation method thereof |
| CN114652799B (en) * | 2020-12-22 | 2023-09-05 | 桂林三金药业股份有限公司 | Sanjin traditional Chinese medicine composition and preparation method thereof |
| CN114712467B (en) * | 2020-12-22 | 2023-09-05 | 桂林三金药业股份有限公司 | Sanjin tablet and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100431580C (en) | 2008-11-12 |
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