CN102335392B - Rhizoma smilacis chinensis dispersion tablet and preparing process thereof - Google Patents
Rhizoma smilacis chinensis dispersion tablet and preparing process thereof Download PDFInfo
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- CN102335392B CN102335392B CN 201110299723 CN201110299723A CN102335392B CN 102335392 B CN102335392 B CN 102335392B CN 201110299723 CN201110299723 CN 201110299723 CN 201110299723 A CN201110299723 A CN 201110299723A CN 102335392 B CN102335392 B CN 102335392B
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to a rhizoma smilacis chinensis dispersion tablet and a preparing process thereof. The rhizoma smilacis chinensis dispersion tablet is prepared from the following components in parts by weight: 600 parts of rhizoma smilacis chinensis, 2000 parts of rhizoma cyperi, 1000 parts of herba leonuri, 1000 parts of caulis mahoniae, 800 parts of caulis spatholobi, 800 parts of ligusticum wallichii, 600 parts of common turmeric, 300 parts of safflower, 300 parts of red dates, 1000 parts of angelica, 50 parts of microcrystalline cellulose, 125 parts of mannitol, 12.5 parts of aspartame, 20 parts of micronization silica gel, 67.5 parts of sodium starch glycolate and 5 parts of magnesium stearate. The dispersion tablet is convenient to use and has low cost, high bioavailability and a good curative effect for treating gynecological inflammation such as cervicitis, chronic pelvic inflammatory disease and the like. The invention also provides a simple and feasible preparing process.
Description
Technical field
The present invention relates to a kind of China root greenbrier dispersible tablet and preparation technology thereof of the preparation take Rhizoma Smilacis Bockii extract as primary raw material; Belong to field of medicaments.
Background technology
Rhizoma Smilacis Bockii medicine name Rhizoma Smilacis Chinensis has another name called Rhizoma Smilacis Scobinicaulis, belongs to liliaceous plant, and property is sweet, warm, and is nontoxic, can wind-damp dispelling, diuresis, detumescence poison, clinically can be used for treating surgery actute infection, rheumatic arthritis, cancerous protuberance etc.Rhizoma Smilacis Bockii is the dry rhizome of liliaceous plant Rhizoma Smilacis Chinensis (Smilax china L); Begin to be stated from " Mingyi Bielu ", have another name called Rhizoma Smilacis Chinensis, Rhizoma Smilacis Bockii, horse Galle, muscles and bones pillar, red light fruit in the Compendium of Material Medica.The property sweet, sour, flat, the merit of tool expelling wind and removing dampness, removing toxic substances and promoting subsidence of swelling.Can be used for wind-damp dispelling, diuresis, detumescence poison, control arthralgia, edema, furuncle.'Jingangteng ' is used for the treatment of gynecological inflammation such as adnexitis, chronic pelvic inflammatory disease determined curative effect, and toxic and side effects is few.Rhizoma Smilacis Bockii mainly contains kaempferol, kaempferol glucoside, dihydrokaempferol, Quercetin, isorhamnetin, smilacin A, B, C, diosgenin A, dioscin, Gracillin unit, methyl diosgenin, the former Rhizoma Dioscoreae soap of 2-Alpha-hydroxy-methyl time aglycon, 4-methylene-glutamic acid, 4-methyl-glutamic acid, smilacin etc.; In known plant chemical ingredient, flavonoid and steroid saponin are the main effective ingredient of Rhizoma Smilacis Bockii.
Gynecological inflammation mainly refers to women genitals's inflammation.Comprise the female vulva inflammation that a variety of causes causes, vaginitis, cervicitis, the diseases such as pelvic inflammatory disease, the caused misery of gynecological inflammation has middle hypogastralgia, lumbago, menoxenia, Pruritus, dysmenorrhea, leucorrhea is many, the symptoms such as sexual anhedonia, gynecological inflammation is women's commonly encountered diseases, easily send out disease, gynecological inflammation not only can be given a birth because of the woman, artificial abortion, medicine stream and menstrual period, tired, endogenous courses of infection in the situation that the body constitution such as operation reduce and getting, also can be unclean because of female article, menstrual period are unhygienic, sterilization does not sternly suffer exogenous courses of infection and suffers from unclean sexual life and the operation process, having a strong impact on for a long time women's physical and mental health, many patients are ashamed of seeking medical advice or not free hospital treatment, affect again and again the state of an illness adversely, so that caused serious consequence. and the treatment of all kinds of gynecological checking be unable to do without medicine for many years always, the application physiotherapy that has in chronic phase, but how unsatisfactory on the curative effect, and relapse rate is quite high.
At present, the clinical treatment gynecological inflammation mainly contains two aspect means, a kind of is that the Western medicine antibiotic is treated, although the method can be alleviated some clinical symptoms, ties up heavily fortified point because some reasons such as the easy recurrent of gynecological inflammation and Antibiotic resistance cause antibiotic treatment to be taken a step; Another kind is to use Chinese medicine lotion, and the method patient's medication in therapeutic process is very difficult, and because most Chinese medicine lotions have very heavy flavour of a drug, brings huge negative effect to the patient, thereby cause the compliance of patient's medication poor.
Summary of the invention
The object of the present invention is to provide a kind of taking convenience, be beneficial to storage, bioavailability is high, to treatment gynecological inflammation such as the curative effect of disease such as cervicitis, chronic pelvic inflammatory disease are definite, toxic and side effects is few China root greenbrier dispersible tablet and preparation technology thereof.
Technical scheme provided by the invention is: a kind of China root greenbrier dispersible tablet is comprised of the one-tenth branch of following weight proportioning: Rhizoma Smilacis Bockii 6000, Rhizoma Cyperi 2000, Herba Leonuri 1000, Caulis Mahoniae 1000, Caulis Spatholobi 800, Rhizoma Chuanxiong 800, Radix Curcumae 600, Flos Carthami 300, Fructus Jujubae 300, Radix Angelicae Sinensis 100, microcrystalline Cellulose 50, mannitol 125, aspartame 12.5, micropowder silica gel 20, carboxymethylstach sodium 67.5, magnesium stearate 5.
Its preparation technology's flow process is:
A) extract: get Rhizoma Smilacis Bockii, decoct with water secondary, each 3 hours, add the water of 8 times of weight the first time, filter and collect filtrate, then add for the second time the water of 4 times of weight, filter collection filtrate, merge the filtrate of twice collection.
B) get Rhizoma Cyperi, Herba Leonuri, Caulis Mahoniae, Caulis Spatholobi, Rhizoma Chuanxiong, Radix Curcumae, the decocting that Flos Carthami, Fructus Jujubae, Radix Angelicae Sinensis add 5 times of weight boiled 3 hours, filtered, and collected filtrate.
C) concentrated: with step a) and step b) filtrate merge, in 60 ℃ filtrate is concentrated into the clear paste that relative density is 1.06～1.09g/ml.
D) precipitate with ethanol: add ethanol, make to contain the alcohol amount and reach 50% (volume ratio), and to regulate pH with the NaOH of 1M be 7.5, left standstill 24 hours, filtration in filtrate behind the Recycled ethanol, and is concentrated into the thick paste shape with filtrate, and 70 ℃ of vacuum dryings become dry extract.
E) granulate: get above-mentioned dry extract, pulverize, cross 100 mesh sieves, add microcrystalline Cellulose, mannitol, aspartame, micropowder silica gel, mixing, granulation, drying.
F) add carboxymethylstach sodium, magnesium stearate, mixing, tabletting, and get final product.
This product is that taupe is to tan tablet; Sweet, little hardship of distinguishing the flavor of.
Usage and consumption: swallow or add aqueous dispersion after take.One time 5,3 times on the one.
The specific embodiment
Embodiment 1
A kind of China root greenbrier dispersible tablet is comprised of following compositions: Rhizoma Smilacis Bockii 6000g, Rhizoma Cyperi 2000g, Herba Leonuri 1000g, Caulis Mahoniae 1000g, Caulis Spatholobi 800g, Rhizoma Chuanxiong 800g, Radix Curcumae 600g, Flos Carthami 300g, Fructus Jujubae 300, Radix Angelicae Sinensis 100g, microcrystalline Cellulose 50g, mannitol 125g, aspartame 12.5g, micropowder silica gel 20g, carboxymethylstach sodium 67.5g, magnesium stearate 5g.
Its preparation technology's flow process is:
A) extract: get Rhizoma Smilacis Bockii 6000g, decoct with water secondary, each 3 hours, add the water of 8 times of weight the first time, filter and collect filtrate, then add for the second time the water of 4 times of weight, filter collection filtrate, merge the filtrate of twice collection.
B) get Rhizoma Cyperi 2000g, Herba Leonuri 1000g, Caulis Mahoniae 1000g, Caulis Spatholobi 800g, Rhizoma Chuanxiong 800g, Radix Curcumae 600g, Flos Carthami 300g, Fructus Jujubae 300g, Radix Angelicae Sinensis 100g, the decocting that adds 5 times of weight boiled 3 hours, filtered, and collected filtrate.
C) concentrated: with step a) and step b) filtrate merge, in 60 ℃ filtrate is concentrated into the clear paste that relative density is 1.06～1.09g/ml.
D) precipitate with ethanol: add ethanol, make to contain the alcohol amount and reach 50% (volume ratio), and to regulate pH with the NaOH of 1M be 7.5, left standstill 24 hours, filtration in filtrate behind the Recycled ethanol, and is concentrated into the thick paste shape with filtrate, and 70 ℃ of vacuum dryings become dry extract.
E) granulate: get above-mentioned dry extract, pulverize, cross 100 mesh sieves, add an amount of microcrystalline Cellulose, mannitol, aspartame, micropowder silica gel, mixing, granulation, drying.
F) add an amount of carboxymethylstach sodium, magnesium stearate, mixing is pressed into 1000, and get final product.
The product quality parameters of utilizing preparation technology of the present invention to obtain is as follows: table 1
Embodiment 2: the therapeutic effect experiment:
One, animal experiment:
1, trial drug: 1, medicine of the present invention (0.5g/ sheet), control drug: FUKE QIANJIN PIAN, 0.32g/ sheet (production of a thousand pieces of gold pharmaceutcal corporation, Ltd).
2, experiment process: said medicine is soaked in an amount of meat soup, and fully vibration makes its dissolving.Remove by filter insoluble medicinal residues, with aperture 0.22 μ m ultra micro filter filtration sterilization, it is for subsequent use that sterile liquid medicine is put 4 ℃ of Refrigerator stores.The experimental bacteria of cultivation in 37 ℃, 24 hours is inoculated in meat soup, puts 37 ℃ of common incubators, cultivated in 24 hours, turbidimetry is carried out count of bacteria, is deployed into 10 with meat soup
6CFU/ml bacterium liquid is for subsequent use.Use meat soup by 10% (250mg medicine/ml medicinal liquid, take the result of pharmacology preliminary experiment as basis, and with reference to the definite maximum safe and effective concentration of clinical common dose) carry out continuous two times of gradient dilutions for starting point, be added to successively on the 96 porocyte culture plates 0.2ml/ hole.Adding concentration is 10 again
6The experimental bacteria liquid 0.01ml/ hole of CFU/ml.Set up simultaneously the contrast of antibacterial and culture medium.Put 4 ℃ of effects 12 hours, in 37 ℃ of common incubators, cultivation in 48 hours, observed result.Be minimal inhibitory concentration (MIC) without the little drug level of bacterial growth Kongzui.Successively each culture without the bacterial growth hole is diluted 10 times with sterile distilled water again, draw the 0.01ml dibbling dull and stereotyped in plain agar, putting 37 ℃ of common incubators, cultivated in 48 hours, is minimal bactericidal concentration (MBC) without the corresponding medicine Cmin in bacterial growth dibbling zone.
3, result of the test:. the medicine group sees Table 2 to the antibacterial experiment result of 3 kinds of common reference cultures of gynecological.
Compare with the drugs compared group, there is significant difference P＜0.05.
Two, toxicity test:
Wistar Oral Administration in Rats administration said preparation 1.0g/kg is adopted in this experiment, successive administration 90 days, 2 weeks of Reversible observe, growth of animal state, movable diet, hematology, blood biochemical, organs and tissues structure all have no significant effect during observing the rat administration and after the drug withdrawal, wherein the said preparation consumption is 1.0g/kg, quite 20 times of quantity, show that clinical drug safety is reliable.
Three, analgesic experiment:
Mice acetic acid is caused the effect of writhing response: 30 of mices, be divided at random 3 groups, be administered once every day, gastric infusion is 5 days continuously, and behind last gastric infusion 1h, lumbar injection 0.6% glacial acetic acid 0.2ml/ only, observe mouse writhing number of times in the 20min, the results are shown in Table 3.
| Group | Mice number (only) | Writhing number of times (30min) |
| The normal saline group | 10 | 39.19 |
| Matched group | 10 | 10.78 |
| The present invention | 10 | 9.08 |
Four, antiinflammatory action:
Get 30 of rats, be divided at random 3 groups, be administered once every day, gavage medicine 7d, behind last administration 1h, in left sufficient plantar aponeurosis hemostasis 1% carrageenin 0.1ml/ only, behind the 3h, cut swollen foot from Mus left hind joint, weigh, peeling shreds, and steeps 40min in the 5ml normal saline, get supernatant 0.5ml, add 2ml 10.5N KOH methanol solution, isomerization 20min in 50 ℃ of water-baths adds methanol again and is diluted to 20ml, survey its optical density with 751 type spectrophotometer wavelength 278nm, try to achieve the PGE total content.The results are shown in Table 4.
| Group | Mice number (only) | PEG content (ug/g) |
| The normal saline group | 10 | 54.45 |
| Matched group | 10 | 23.18 |
| The present invention | 10 | 19.65 |
Clinical therapeutic efficacy:
Clinically use through 120 routine Patients with Pelvic Inflammatory Diseases, obtained good curative effect, statistical result is as follows: always cure 109 examples, invalid 11 examples, total effective rate 91%; Clinically use through 90 routine virus in patients with cervicitis, also obtained good curative effect, statistical result is as follows: always cure 72 examples, invalid 18 examples, total effective rate 80%.
Model case:
Case 1: Lee, woman, 45 years old.Patient's disease: lower abdomen has pain, and menstruation is unpunctual, and leucorrhea is many, and doing gynecologial examination to the People's Hospital, Lingbao City is serious symptom cervical erosion, and cervix uteri three degree are rotten to the corn.
Treatment: take the medicine of the present invention's preparation, one day three times, each 5, take continuously three courses for the treatment of, each one week of the course for the treatment of.Lower abdomen is not painful, and leucorrhea is normal, and cervix uteri is soft ruddy, and is smooth, and all are normal.
Case 2: chapter, woman, 33 years old.Patient's disease: recently menstruation is inaccurate, and leucorrhea is many, and pudendum is very itched, and lower abdomen has painful sense, pelvic inflammatory disease.Treatment: take the medicine of the present invention's preparation, one day three times, each 5, take continuously three courses for the treatment of, each one week of the course for the treatment of.Lower abdomen has slight painful sense, and itching of vagina disappears, and leucorrhea reduces, and inflammation disappears.
Although, above with general explanation and the specific embodiment detailed explanation having been done in this case, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, the modification of doing without departing from theon the basis of the spirit of the present invention or improvement all belong to the scope of protection of present invention.
Claims (3)
1. a China root greenbrier dispersible tablet for the treatment of gynecological inflammation is characterized in that, is comprised of the one-tenth branch of following weight proportioning: Rhizoma Smilacis Bockii 6000, Rhizoma Cyperi 2000, Herba Leonuri 1000, Caulis Mahoniae 1000, Caulis Spatholobi 800, Rhizoma Chuanxiong 800, Radix Curcumae 600, Flos Carthami 300, Fructus Jujubae 300, Radix Angelicae Sinensis 100, microcrystalline Cellulose 50, mannitol 125, aspartame 12.5, micropowder silica gel 20, carboxymethylstach sodium 67.5, magnesium stearate 5.
2. the preparation method of China root greenbrier dispersible tablet as claimed in claim 1 is characterized in that:
A) extract: get Rhizoma Smilacis Bockii, decoct with water secondary, each 3 hours, add the water of 8 times of weight the first time, filter and collect filtrate, then add for the second time the water of 4 times of weight, filter collection filtrate, merge the filtrate of twice collection;
B) get Rhizoma Cyperi, Herba Leonuri, Caulis Mahoniae, Caulis Spatholobi, Rhizoma Chuanxiong, Radix Curcumae, Flos Carthami, Fructus Jujubae, Radix Angelicae Sinensis, the decocting that adds 5 times of weight boiled 3 hours, filtered, and collected filtrate;
C) concentrated: with step a) and step b) filtrate merge, in 60 ℃ filtrate is concentrated into the clear paste that relative density is 1.06～1.09g/ml;
D) precipitate with ethanol: add ethanol, make to contain the alcohol amount and reach 50%, and to regulate pH with the NaOH of 1M be 7.5, left standstill 24 hours, filtration, filtrate recycling ethanol, and be concentrated into the thick paste shape, 70 ℃ of vacuum dryings become dry extract;
E) granulate: get above-mentioned dry extract, pulverize, cross 100 mesh sieves, add microcrystalline Cellulose, mannitol, aspartame, micropowder silica gel, mixing, granulation, drying;
F) add carboxymethylstach sodium, magnesium stearate, mixing, tabletting, and get final product.
3. China root greenbrier dispersible tablet as claimed in claim 1 is characterized in that, described dispersible tablet is used for the treatment of pelvic inflammatory disease or cervicitis.
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| 复方氨酚葡锌分散片处方及其制备工艺研究;李萌 等;《中国现代应用药学》;20100331;第27卷(第3期);235-239 * |
| 李萌 等.复方氨酚葡锌分散片处方及其制备工艺研究.《中国现代应用药学》.2010,第27卷(第3期),235-239. |
| 治疗慢性盆腔炎中药的研究进展;王敏杰 等;《药物评价研究》;20101231;第33卷(第6期);461-466 * |
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