CN1298365C - Granule of Jingangteng for treating inflammatory gynecopathy and its preparation method - Google Patents
Granule of Jingangteng for treating inflammatory gynecopathy and its preparation method Download PDFInfo
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- CN1298365C CN1298365C CNB031146449A CN03114644A CN1298365C CN 1298365 C CN1298365 C CN 1298365C CN B031146449 A CNB031146449 A CN B031146449A CN 03114644 A CN03114644 A CN 03114644A CN 1298365 C CN1298365 C CN 1298365C
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Abstract
The present invention relates to a medicine for treating gynaecologic inflammation, which is granular formulation and is prepared from bock greenbrier rhizome. The present invention also discloses a preparation method of the medicine. The bock greenbrier rhizome granular formulation has the efficacy of clearing away heat and toxic material and dispersing swelling and dissipating binds, and is mainly used for treating annexitis, inflammatory masses of annexitis and various kinds of gynecological inflammation. The present invention has the advantages of stable quality, obvious curative effect, etc., and is convenient to admit and carry and easy to preserve and transport.
Description
Affiliated technical field
The invention belongs to the preparing technical field of pharmaceuticals, relate to a kind of Chinese patent medicine preparation that is used for the treatment of gynaecological inflammation disease and preparation method thereof.
Background technology
Gynecological's inflammatory diseases such as adnexitis, inflammatory masses of ovarian appendages etc. are commonly encountered diseases, frequently-occurring diseases clinically, at present, it is existing many that this area is used to prevent and treat the medicine of gynecological's inflammatory diseases, particularly some Chinese medicine preparations have also formed rather original curative effect advantage in clinical practice, but because the sickness rate height of gynecological's inflammatory diseases and pathomechanism are comparatively complicated, more existing pharmaceutical preparatioies still can not be satisfied clinical and needs market fully, still await scientific research institution and personnel and do further exploration to develop even more ideal new Chinese medicine." the Sanitation Ministry medicine standard " (the 9th of Chinese patent medicine square preparation) record kind " Rhizoma Smilacis Bockii syrup " be with main product in East China and the liliaceous plant on ground such as Guangxi, Hunan, Hubei dry rhizome----the Chinese herbal medicine Rhizoma Smilacis Bockii that pulls out chinaroot greenbrier (Smi Lax china L) be the syrup that raw material is made, has heat-clearing and toxic substances removing, the dispersing swelling and dissipating binds function, be mainly used in treatment rheumatic arthritis, traumatic injury, cellulitis, gastroenteritis etc. clinically, also can be used for treating the multiple inflammation disease of adnexitis, inflammatory masses of ovarian appendages and gynecological.But syrup also exists many weak points in actual use, and, taking dose not obvious as pharmacological action be big, be difficult for preserving, inconvenience etc. is carried in transportation.Because this area was less to the research of chemical constituent, pharmacological action and the novel form of Rhizoma Smilacis Bockii in the past, furthermore was subjected to the restriction of use approach and some other factors, the development of other dosage form of Rhizoma Smilacis Bockii medicine is not seen in report so far as yet.
Summary of the invention
The object of the present invention is to provide a kind of taking convenience, be easy to storage and transport, to the granule of ' Jingangteng ' of treatment gynaecological inflammation disease determined curative effect.
Another object of the present invention is to provide the preparation method of above-mentioned granule of ' Jingangteng '.
A kind of medicine for the treatment of gynaecological inflammation disease provided by the invention is to be soluble granule or the suspension ability granule that raw material is made with the Chinese herbal medicine Rhizoma Smilacis Bockii.
The preparation method of Rhizoma Smilacis Bockii soluble granule provided by the invention may further comprise the steps:
(1) get Rhizoma Smilacis Bockii, add 8～15 times of decoctings and boil 2～4 times, each 0.5～3 hour, collecting decoction filtered, and it is 1.05～1.10 clear paste that filtrate is concentrated into relative density.
(2) get above-mentioned clear paste, add ethanol, make that to contain amount of alcohol in the solution be 40～60%, left standstill 24～72 hours, filter, filtrate recycling ethanol is concentrated into about 1.20 (60 ℃ of heat are surveyed) of relative density, promptly gets pure clear paste;
(3) get 1 part of above-mentioned pure clear paste, add 1～6 part of adjuvant, granulate, drying, packing promptly gets soluble granule of the present invention.
The described adjuvant of the invention described above soluble granule is the one or more combination thing of pharmaceutical field adjuvant commonly used when preparing granule, comprise that excipient such as sucrose, dextrin, soluble starch etc. and correctives such as stevioside, cyclamate, protein sugar, A Siba are sweet, glycyrrhizin etc., can be that any one uses separately or several being used in combination in the above-mentioned adjuvant.
The preparation method of Rhizoma Smilacis Bockii suspension ability granule provided by the invention may further comprise the steps:
(1) get 85～90% of Rhizoma Smilacis Bockii total amount, add 3～10 times of amount 40～85% soak with ethanol after 2～24 hours, heating and refluxing extraction 2～4 times, each 1～4 hour, merge extractive liquid, filtered, and it is 1.10～1.25 thick paste that filtrate decompression is concentrated into relative density.
(2) get above-mentioned thick paste,, be ground into fine powder at 50～60 ℃ of following vacuum dryings.
(3) get the Rhizoma Smilacis Bockii of surplus, be ground into fine powder,, granulate with above-mentioned steps (2) gained fine powder mixing, drying, granulate, packing promptly gets suspension ability granule of the present invention.
Granule of ' Jingangteng ' of the present invention has the effect of heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, is used for the multiple inflammation disease of adnexitis and inflammatory masses of ovarian appendages and gynecological, have take with easy to carry, be easy to advantages such as storage and transport, steady quality, determined curative effect.
The invention will be further described below by embodiment and toxicology and pharmacology experimental result.
Embodiment 1
Get Rhizoma Smilacis Bockii 3000g, decoct with water three times, each 1 hour, collecting decoction, filter, it is 1.05 that filtrate is concentrated into relative density, adds ethanol, makes that to contain amount of alcohol in the solution be 40%, left standstill 24 hours, and filtered, filtrate recycling ethanol is concentrated into the clear paste of relative density about 1.20 (60 ℃ of heat are surveyed); 1 part of qinghuo reagent, 4 parts of sucrose, 1 part in dextrin, mixing is made granule, drying, packing promptly makes the sacchariferous soluble granule of the present invention.
Embodiment 2
Get Rhizoma Smilacis Bockii 3000g, decoct with water 2 times, each 1.5 hours, collecting decoction, filter, it is 1.10 that filtrate is concentrated into relative density, adds ethanol, makes that to contain amount of alcohol in the solution be 45%, left standstill 36 hours, and filtered, filtrate recycling ethanol is concentrated into the clear paste of relative density about 1.22 (60 ℃ of heat are surveyed); 1 part of qinghuo reagent, 5 parts in dextrin, 0.035 part of stevioside, mixing is made particle drying, and packing promptly makes the soluble granule of sugar-free of the present invention.
Embodiment 3
(1) get Rhizoma Smilacis Bockii 4320g, the 3800g that takes out wherein added 6 times of amount 70% soak with ethanol after 15 hours, heating and refluxing extraction 2 times, and each 2.5 hours, merge extractive liquid, filtered, and filtrate decompression is concentrated into the thick paste that relative density is 1.18 (60 ℃).
(2) get above-mentioned thick paste,, be ground into fine powder at 50～60 ℃ of following vacuum dryings.
(3) get the Rhizoma Smilacis Bockii of above-mentioned steps (1) surplus, be ground into fine powder,, granulate with above-mentioned steps (2) gained fine powder mixing, drying, granulate, packing promptly makes the suspension ability granule of sugar-free of the present invention.
The present invention is to provide a kind of natural drug for the treatment of gynaecological inflammation disease, for proving its therapeutic effect and safety, the inventor uses the granule for preparing by the method that provides in the foregoing description 1 to carry out toxicity and pharmacodynamics test, and result of study is as follows:
One, acute toxicity test
Granule of the present invention is irritated stomach by 200g/kg/ time one day 3 times and is given 20 mices (each 10 of male and female), and none is only dead in 7 days, does not find obvious acute toxicity, and this dosage is equivalent to 400 times of clinical adult's consumption (75g/ days).
Two, long term toxicity test
Granule of the present invention is selected 67.5g/kg (low dosage), 135g/kg (high dose) for use.According to 70kg body weight adult and animal body surface area ratio, dose,equivalent calculates, and is respectively 10 times, 20 times consumption gastric infusion, successive administration 6 days, drug withdrawal one day, continuous 2 months.Measure body weight weekly, increase normally, it is all normal to observe the animal activity behavior every day, hair color light, moist, feces is normal, after 2 months, gets hematometry physiochemical indice, hepatic and renal function, relevant organ coefficient and pathological examination all with the normal rats no significant difference.Residue rat after 2 weeks of drug withdrawal carries out above-mentioned relevant index and detects with examination toxicity, reversibility and have or not the time-delay toxic reaction.The every index of result all with the normal rats no significant difference.Show the clinic trial dosage safety, no overt toxicity reaction.
Three, cure mainly relevant Pharmacodynamic test of active extract with function
(1) in-vitro antibacterial test
Adopt the developmental tube method to measure the particulate vitro antibacterial activity of the present invention, result of the test shows granule of the present invention to staphylococcus aureus, streptococcus, streptococcus faecalis, escherichia coli, bacillus pyocyaneus, especially to staphylococcus aureus, streptococcus m IC
50Difference 0.00625g/ml and 0.025g/ml.Results suggest granule of the present invention has the effect of certain heat-clearing and toxic substances removing.
(2) antiinflammatory action
1, the mice caused by dimethylbenzene xylene ear swelling is tested the granule of the present invention to mice ig 97.5,146.25g/kg, a continuous week, the suppression ratio of ear swelling is respectively 18.88+2.62 and 15.27 ± 3.92 due to the xylol, 175.5g/kg the suppression ratio of Rhizoma Smilacis Bockii syrup is 18.07 ± 4.53, the granule effect of the present invention of Isodose is better than Rhizoma Smilacis Bockii syrup.
2, the continuous ig of rat granule of the present invention is given in the PARA FORMALDEHYDE PRILLS(91,95) influence that causes rat paw edema, and 27g/kg is to having remarkable inhibitory action in 2-6 hour behind scl0% formaldehyde, rat paw edema is had remarkable inhibitory action in 2-10 hour behind the 54g/kg group scl0% formaldehyde.The granule suppression ratio height of the present invention of Isodose, long action time.
Above result of the test prompting granule of the present invention has stronger detumescence dissipating blood stasis effect, and granule detumescence dissipating blood stasis effect is better than syrup.
(3) immunization
1, puts to death for the continuous gastric infusion of mice after 10 days to the influence of little immune organ weight and measure spleen and thymic weight, the result shows that 97.5g/kg granule of the present invention can obviously alleviate spleen and thymic weight, 146.25g/kg group is obviously influence not, but 146.25g/kg all obviously is better than 175.5g/kg Rhizoma Smilacis Bockii syrup group (P＜0.05).
2, give granule of the present invention continuously for mice to the influence of reticuloendothelial system (RES) and adopt of the influence of carbon clearance method mensuration after 10 days the RES function.The result shows that granule 97.5 of the present invention, 146.25g/kg do not have obvious influence to phagocytic index K, and high dose group can obviously improve alpha index.
3, LT influence is passed through to irritate stomach granule of the present invention in continuous 10 days to mice the phytohaemagglutinin (PHA) of the first five 10mg/kg of intramuscular injection every day simultaneously.Last administration posterior orbit is got blood, counting lymphoblast and transitional-cell number, and calculate lymhocyte transformation rate.The result shows: granule 97.5 of the present invention, 146.25g/kg all can obviously increase lymphocytic conversion.
More than test shows that granule of the present invention is relevant with dosage to the influence of immune organ, and high agent group has stronger immunological enhancement.
(4) to the influence of clotting time of mice
Mice was irritated stomach granule 97.5 of the present invention, 146.25g/kg in continuous six days, measure clotting time with capillary tube method, the result shows that granule of the present invention can obviously prolong the clotting time of normal mouse; 97.5,146.25g/kg all obviously is better than 175.5g/kg Rhizoma Smilacis Bockii syrup group (P＜0.01).Point out it that certain effect of invigorating blood circulation is arranged, and the granule effect of invigorating blood circulation significantly is better than syrup.
Conclusion: this test is by studying the particulate pharmacological action of the present invention aspect heat-clearing and toxic substances removing, the strengthening the body resistance, and carried out drug effect with Rhizoma Smilacis Bockii syrup and compared, more than test shows that granule of the present invention obviously is being better than the Rhizoma Smilacis Bockii syrup group to influence, the antiinflammatory action of immune organ pipe and aspect invigorating blood circulation, though do not have significant difference in other test, 146.25g/kg granule of the present invention all slightly is better than the 175.5g/kg Rhizoma Smilacis Bockii syrup.Therefore the particulate pharmacological action of the present invention obviously is better than Rhizoma Smilacis Bockii syrup on the whole.
Claims (6)
1, a kind of granule of ' Jingangteng ' for the treatment of gynaecological inflammation disease is characterized in that being is Sugarless type soluble granule or the Sugarless type suspension ability granule that raw material is made with the Chinese medicine Rhizoma Smilacis Bockii.
2, a kind of method for preparing the described granule of ' Jingangteng ' of claim 1 is characterized in that may further comprise the steps:
(1) get Rhizoma Smilacis Bockii, add 8～15 times of water gagings and decoct 2～4 times, each 0.5～3 hour, collecting decoction filtered, and it is 1.05～1.10 clear paste that filtrate is concentrated into relative density;
(2) get above-mentioned clear paste, add ethanol, make that to contain ethanol content in the solution be 40～60%, left standstill 24～72 hours, filter, filtrate recycling ethanol, it is about 1.20 to be concentrated into relative density, promptly gets pure clear paste;
(3) get 1 part of above-mentioned pure clear paste, add 1～6 part of adjuvant, granulate, drying, granulate, packing promptly gets the Sugarless type soluble granule.
3, preparation method according to claim 2, wherein added adjuvant can be in dextrin, soluble starch, stevioside or the protein sugar a kind of/multiple.
3, a kind of method for preparing the described granule of ' Jingangteng ' of claim 1 is characterized in that may further comprise the steps:
(1) get the 85-90% of Rhizoma Smilacis Bockii total amount, add 3～10 times of amount 40～85% soak with ethanol after 2～24 hours, heating and refluxing extraction 2～4 times, each 1～4 hour, merge extractive liquid, filtered, and it is 1.10～1.25 thick paste that filtrate decompression is concentrated into relative density;
(2) get above-mentioned thick paste,, be ground into fine powder at 50～60 ℃ of following vacuum dryings;
(3) get the Rhizoma Smilacis Bockii of surplus, be ground into fine powder,, granulate with the fine powder mixing of above-mentioned steps gained, drying, granulate, packing promptly gets Sugarless type suspension ability granule.
4, an a kind of Rhizoma Smilacis Bockii Sugarless type soluble granule for the treatment of gynaecological inflammation disease is characterised in that by 1 part of Rhizoma Smilacis Bockii clear paste, 5 parts in dextrin, 0.035 part of composition of stevioside.
5, a kind of method for preparing the described Rhizoma Smilacis Bockii Sugarless type of claim 4 soluble granule is characterized in that may further comprise the steps:
(1) get Rhizoma Smilacis Bockii, add 8～15 times of water gagings and decoct 2 times, each 1.5 hours, collecting decoction filtered, and it is 1.10 clear paste that filtrate is concentrated into relative density;
(2) get above-mentioned clear paste, add ethanol, make that to contain ethanol content in the solution be 45%, left standstill 36 hours, filter, filtrate recycling ethanol, it is about 1.22 to be concentrated into relative density, promptly gets pure clear paste;
(3) get 1 part of above-mentioned pure clear paste, add 5 parts in dextrin, 0.035 part of stevioside, mixing is granulated, drying, granulate, packing promptly gets the Sugarless type soluble granule.
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| CNB031146449A CN1298365C (en) | 2003-04-16 | 2003-04-16 | Granule of Jingangteng for treating inflammatory gynecopathy and its preparation method |
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| CNB031146449A CN1298365C (en) | 2003-04-16 | 2003-04-16 | Granule of Jingangteng for treating inflammatory gynecopathy and its preparation method |
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| CN1446572A CN1446572A (en) | 2003-10-08 |
| CN1298365C true CN1298365C (en) | 2007-02-07 |
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| CN102335143A (en) * | 2011-10-10 | 2012-02-01 | 广西润达制药股份有限公司 | New process for preparing (sugar-free) smilax bockii warb granules |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1368162A (en) * | 2001-02-02 | 2002-09-11 | 杨孟君 | Nano medicine 'Jingangteng' and its preparing process |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1368162A (en) * | 2001-02-02 | 2002-09-11 | 杨孟君 | Nano medicine 'Jingangteng' and its preparing process |
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| CN1446572A (en) | 2003-10-08 |
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