CN100411657C - Green biota body cleaning effervescent particle preparation - Google Patents

Green biota body cleaning effervescent particle preparation Download PDF

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Publication number
CN100411657C
CN100411657C CNB2005101353393A CN200510135339A CN100411657C CN 100411657 C CN100411657 C CN 100411657C CN B2005101353393 A CNB2005101353393 A CN B2005101353393A CN 200510135339 A CN200510135339 A CN 200510135339A CN 100411657 C CN100411657 C CN 100411657C
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ethanol
radix
hours
adds
dry extract
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CN1824078A (en
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韩渤
腾健
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Jiuquan great profit Pharmaceutical Co., Ltd.
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韩渤
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Abstract

The present invention relates to a green cypress effervescent granular preparation for cleaning a body, which is prepared from 400g of lightyellow sophora roots, 266.7g of coptis, 400g of phellodendron, 133.3g of zanthoxylum, 400g of common cnidium fruit, 400g of astragalus roots, 400g of tuber fleeceflower root, 400g of belvedere fruit, 400g of indigowoad leaves, 400g of red peony and 400g of angelica.

Description

A kind of green biota body cleaning effervescent particle preparation
Technical field:
The present invention relates to a kind of Chinese medicine bubble vine formulations, particularly a kind of green biota body cleaning effervescent particle preparation, said preparation has heat-clearing and toxic substances removing, damp eliminating parasite killing, antalgesic-antipruritic effect.
Background technology:
Qingbai cleaning lotion is a kind of pharmaceutical preparation that is used for gynaecopathias such as vaginitis, Gong Jingyan, and domestic have a launch.The quality standard of Qingbai cleaning lotion is numbered WS-11134-(ZD-1134)-2002.
Because the prescription taste of Chinese medicine is many, contains multiple different composition, causes Qingbai cleaning lotion to separate out precipitate easily, make difficult quality control, affect the treatment, and the Qingbai cleaning lotion amount is big, therefore carrying and use inconvenience are necessary to select a kind of more superior Qingbai cleaning preparation.
Qingbai cleaning lotion is prepared into granular preparation can be addressed the above problem, during use granule is dissolved in the water and gets final product, discover, Qingbai cleaning lotion is made the plain particles preparation, because its complicated component is various, make the dissolution velocity of effective ingredient slow, use still inconvenience, through selecting, we have found a kind of rapidly-soluble way of Qingbai cleaning granule that makes, the Qingbai cleaning preparation is made rapidly-soluble effervescent granule with barbotage, thereby selected most preferred prescription to solve technical barrier simultaneously.
Summary of the invention:
The invention provides a kind of Qingbai cleaning effervescence granular preparation, described Qingbai cleaning is a kind of title of medicine, and Qingbai cleaning lotion has had launch, and Qingbai cleaning lotion has following Chinese medicine preparation:
Radix Sophorae Flavescentis 400g Rhizoma Coptidis 266.7g Cortex Phellodendri 400g
Pericarpium Zanthoxyli 133.3g Fructus Cnidii 400g Radix Astragali 400g
Radix Polygoni Multiflori 400g Fructus Kochiae 400g Folium Isatidis 400g
Radix Paeoniae Rubra 400g Radix Angelicae Sinensis 400g
The present invention uses above prescription, through the transformation of technology and pharmaceutical formulation is provided, prepares a kind of Qingbai cleaning effervescence granular preparation.
Qingbai cleaning effervescence granular preparation of the present invention, be by the raw material of Chinese medicine of above-mentioned prescription is processed through extraction or other modes, make pharmaceutically active substance, subsequently, with this material is raw material, add the medicine acceptable carrier when needing, make effervescence granular preparation of the present invention according to the routine techniques of galenic pharmacy.Described active substance
7, the bubble rattan granular preparation of claim 1 is characterized in that, it is composed as follows to fill a prescription:
Dry extract 200-400g
Lactose 300-500g
Citric acid 100-200g
Sodium bicarbonate 100-200g
Ethanol 200-400ml
Make 1000g.
8, the bubble rattan granular preparation of claim 1 is characterized in that, it is composed as follows to fill a prescription:
Dry extract 300g
Lactose 300g
Citric acid 150g
Sodium bicarbonate 150g
Ethanol 220ml
Make 1000g.
9, the preparation method of the bubble rattan granular preparation of claim 1, it is characterized in that, process following steps: with ten Herba indigoferae Pseudotinctoriae in claim 1 prescription, decocting boils twice, adds 6-10 times of water gaging for the first time and decocts 2 hours, adds 5-9 times of water gaging for the second time and decocts 1.5 hours, collecting decoction, filter, being evaporated to relative density is the 1.20-1.25 clear paste, adds ethanol, make and contain alcohol amount and reach 70%, left standstill 48 hours, and filtered decompression recycling ethanol, be evaporated to relative density 1.35-1.38, vacuum drying is ground into fine powder, gets dry extract; Through with above dry extract and the blended step of medicine acceptable carrier that is fit to make effervescence granular preparation, promptly can be made into effervescence granular preparation of the present invention again.
10, the preparation method of claim 9 is characterized in that, described mixing is selected from following steps:
1) dry extract adds lactose 300g, sodium bicarbonate 150g, citric acid 150g, and mixing adds ethanol system soft material, and the 12-20 mesh sieve is granulated, 60-80 ℃ of drying, and 12-20 mesh sieve granulate is made about 1000g;
2) dry extract is divided into two minutes, a lactose 150g, the sodium bicarbonate 150g of adding, mixing adds ethanol system soft material, and the 12-20 mesh sieve is granulated, 60-80 ℃ of drying, 12-20 mesh sieve granulate gets granule I; Another part adds lactose 150g, citric acid 150g, and mixing adds ethanol system soft material, and the 12-20 mesh sieve is granulated, 60-80 ℃ of drying, and 12-20 mesh sieve granulate gets granule II;
Lactose 300-500g
Citric acid 100-200g
Sodium bicarbonate 100-200g
Ethanol 200-400ml
Make 1000g
Most preferred prescription is composed as follows
Dry extract 300g
Lactose 300g
Citric acid 150g
Sodium bicarbonate 150g
Ethanol 220ml
Make 1000g
Wherein ethanol is the ethanol of 50-100% concentration, is preferably 95%.
The above dry extract preferred manufacturing procedure is as follows:
Above ten simply in will writing out a prescription, and decocting boils twice, adds 6-10 times of water gaging for the first time and decocted 2 hours, add for the second time 5-9 times of water gaging and decocted 1.5 hours, collecting decoction filters, being evaporated to relative density is 1.20 ~ 1.25 (50 ℃) clear paste, adds ethanol, makes to contain the alcohol amount and reach 70%, left standstill 48 hours, and filtered decompression recycling ethanol, be evaporated to relative density 1.35 ~ 1.38 (60 ℃), vacuum drying is ground into fine powder, gets dry extract.
The above effervescence granular preparation preferred manufacturing procedure is seen embodiment
Its prescription of effervescence granular preparation of the present invention is formed the process screening and is obtained, and concrete screening process is as follows:
3.2 molding prescription design:
This product dry extract is that viscosity is bigger through water extract-alcohol precipitation after drying gained, and according to the character of dry extract, selecting 95% alcoholic solution is binding agent, tentatively gropes to accomplish 3g/ bag (ampoule), and the molding of granule ability so press ten prescriptions of 3g/ bag design, sees Table 1.With particulate angle of repose, melting, granularity serves as to investigate index, investigates and the results are shown in Table 2.
Ten prescriptions of table 1 design
Figure C20051013533900051
Figure C20051013533900061
Method for making: former, adjuvant were pulverized 100 sieves, standby.Take by weighing extract powder and adjuvant by recipe quantity, mix homogeneously adds 95% ethanol system soft material, and 18 mesh sieves are granulated, 60~80 ℃ of dryings, and 18 mesh sieve granulate are made about 1000g, promptly.
3.3 investigate the index and the method for inspection thereof:
Particulate angle of repose: get midbody particle, measure angle of repose, fixing cone bottom diameter (2R), the mensuration accumulative height of granule (h), α angle of repose of count particles, α=arctg (h/R) by fixing conical bottom method.
Melting: the effervescent granule melting inspection method of pressing under an appendix I of Chinese Pharmacopoeia version in 2005 the C granule item is checked; get this product granule 3g; put in the beaker that fills 200ml water; water temperature is at 15-25 ℃; should be able to produce gas rapidly and be the effervescent shape, and endoparticle should be dispersed or dissolved in the water fully in 5 minutes.
Granularity: can not cross No. one and sieve and the summation that can cross No. five sieves, must not cross 15%.(measuring) according to the two sieve methods of an appendix XI of Chinese Pharmacopoeia version in 2005 B granulometry second method.
Prescription is investigated the result: by the above-mentioned investigation index and the method for inspection thereof.Ten prescriptions to design are investigated, and the results are shown in Table 2.
The investigation result of ten prescriptions of table 2
Figure C20051013533900062
Figure C20051013533900071
Conclusion: investigate results according to ten prescriptions, ten prescriptions all meet the requirement of effervescent granule, but it is five comparatively desirable wherein to write out a prescription, and melting is very fast, and granularity is better, and mobility of particle is also better.So select prescription five, main adjuvant is selected lactose 300g, citric acid 150g, sodium bicarbonate 150g in the prescription.
Advantage of the present invention is as follows:
1, change it into effervescent granule, compare with former dosage form washing liquid, dosage form is advanced; 2, effervescent granule is solid preparation, and is more stable than liquid preparation; 3, this effervescent granule once only needs to use 3g, and is littler than the consumption of a 10ml of lotion, is convenient to transportation; 4, the quality standard of former dosage form is too simple, is unfavorable for controlling the inherent quality of product; 5, effervescent granule will be done comprehensively to improve to quality standard; 6, dissolving is fast, and abnormal smells from the patient is good, packs little etc.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1:
Radix Sophorae Flavescentis 400g Rhizoma Coptidis 266.7g Cortex Phellodendri 400g
Pericarpium Zanthoxyli 133.3g Fructus Cnidii 400g Radix Astragali 400g
Radix Polygoni Multiflori 400g Fructus Kochiae 400g Folium Isatidis 400g
Radix Paeoniae Rubra 400g Radix Angelicae Sinensis 400g
More than ten medical materials simply, decoct with water twice, add 6-10 times of water gaging for the first time and decocted 2 hours, add for the second time 5-9 times of water gaging and decocted 1.5 hours, collecting decoction filters, being evaporated to relative density is 1.20~1.25 (50 ℃) clear paste, adds ethanol, makes to contain the alcohol amount and reach 70%, left standstill 48 hours, and filtered decompression recycling ethanol, be evaporated to relative density 1.35~1.38 (60 ℃), vacuum drying is ground into fine powder, adds lactose 300g, sodium bicarbonate 150g, citric acid 150g, mixing, add ethanol (concentration is more than 95%) system soft material, the 12-20 mesh sieve is granulated, 60~80 ℃ of dryings, 12-20 mesh sieve granulate, make about 1000g, packing, promptly.(3g/ bag, every g is equivalent to the 4.0g crude drug).
Embodiment 2:
Radix Sophorae Flavescentis 400g Rhizoma Coptidis 266.7g Cortex Phellodendri 400g
Pericarpium Zanthoxyli 133.3g Fructus Cnidii 400g Radix Astragali 400g
Radix Polygoni Multiflori 400g Fructus Kochiae 400g Folium Isatidis 400g
Radix Paeoniae Rubra 400g Radix Angelicae Sinensis 400g
More than ten medical materials simply, decoct with water twice, add 6-10 times of water gaging for the first time and decocted 2 hours, add for the second time 5-9 times of water gaging and decocted 1.5 hours, collecting decoction filters, being evaporated to relative density is 1.20~1.25 (50 ℃) clear paste, adds ethanol, makes to contain the alcohol amount and reach 70%, left standstill 48 hours, filter, decompression recycling ethanol is evaporated to relative density 1.35~1.38 (60 ℃), vacuum drying, be ground into fine powder, dry extract is divided into two fens, a lactose 150g that adds, sodium bicarbonate 150g, mixing, add ethanol (concentration is more than 95%) system soft material, the 12-20 mesh sieve is granulated, 60~80 ℃ of dryings, 12-20 mesh sieve granulate gets granule I; Another part adds lactose 150g, citric acid 150g, and mixing adds ethanol (concentration is more than 95%) system soft material, and the 12-20 mesh sieve is granulated, 60~80 ℃ of dryings, and 12-20 mesh sieve granulate gets granule II.Granule I and granule II mix homogeneously are made about 1000g, packing, promptly.(3g/ bag, every g is equivalent to the 4.0g crude drug).
Embodiment 3:
Radix Sophorae Flavescentis 400g Rhizoma Coptidis 266.7g Cortex Phellodendri 400g
Pericarpium Zanthoxyli 133.3g Fructus Cnidii 400g Radix Astragali 400g
Radix Polygoni Multiflori 400g Fructus Kochiae 400g Folium Isatidis 400g
Radix Paeoniae Rubra 400g Radix Angelicae Sinensis 400g
More than ten medical materials simply, decoct with water twice, add 6-10 times of water gaging for the first time and decocted 2 hours, adding for the second time 5-9 times of water gaging decocted 1.5 hours, collecting decoction filters, and being evaporated to relative density is 1.20~1.25 (50 ℃) clear paste, add ethanol, make to contain alcohol amount and reach 70%, left standstill 48 hours, filter, decompression recycling ethanol, be evaporated to relative density 1.35~1.38 (60 ℃), vacuum drying is ground into fine powder, add lactose 300g, sodium bicarbonate 150g, citric acid 150g, mixing, dry granulation is made about 1000g, packing, promptly.(3g/ bag, every g is equivalent to the 4.0g crude drug).

Claims (1)

1. green biota body cleaning effervescent particle preparation, its Chinese medicine proportioning raw materials is:
Radix Sophorae Flavescentis 400g Rhizoma Coptidis 266.7g Cortex Phellodendri 400g
Pericarpium Zanthoxyli 133.3g Fructus Cnidii 400g Radix Astragali 400g
Radix Polygoni Multiflori 400g Fructus Kochiae 400g Folium Isatidis 400g
Radix Paeoniae Rubra 400g Radix Angelicae Sinensis 400g
It is characterized in that it is composed as follows to make the particulate prescription of 1000g:
Dry extract 300g
Lactose 300g
Citric acid 150g
Sodium bicarbonate 150g
Ethanol 220ml
Its preparation method is as follows:
Ten Herba indigoferae Pseudotinctoriae in the prescription, decocting boils twice, adds 6-10 times of water gaging for the first time and decocts 2 hours, add for the second time 5-9 times of water gaging and decocted 1.5 hours, collecting decoction filters, being evaporated to relative density is the 1.20-1.25 clear paste, adds ethanol, makes to contain the alcohol amount and reach 70%, left standstill 48 hours, and filtered decompression recycling ethanol, be evaporated to relative density 1.35-1.38, vacuum drying is ground into fine powder, gets dry extract; Dry extract adds lactose 300g, sodium bicarbonate 150g, citric acid 150g, and mixing adds ethanol system soft material, and the 12-20 mesh sieve is granulated, 60-80 ℃ of drying, and 12-20 mesh sieve granulate is made 1000g.
CNB2005101353393A 2005-12-30 2005-12-30 Green biota body cleaning effervescent particle preparation Expired - Fee Related CN100411657C (en)

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Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100417409C (en) * 2006-12-28 2008-09-10 西安仁仁药业有限公司 Chinese medicine external use lotion for treating woman reproduction system inflammation
CN102961556B (en) * 2011-08-31 2014-01-29 肖凡 External washing lotion for prevention and treatment of gynecological inflammation
CN102793828B (en) * 2012-08-09 2014-04-16 西安太极药业有限公司 Externally-used washing lotion for treating female vulvitis and colpitis and preparation method thereof

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
中药泡腾片及工艺研究进展. 田秀峰等.中国中药杂志,第29卷第7期. 2004
中药泡腾片及工艺研究进展. 田秀峰等.中国中药杂志,第29卷第7期. 2004 *
中药颗粒及辅料的研究进展. 罗友华等.海峡药学,第14卷第1期. 2002
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