CN105456528A - Suppository for treating gynecological inflammation and preparation method thereof - Google Patents
Suppository for treating gynecological inflammation and preparation method thereof Download PDFInfo
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- CN105456528A CN105456528A CN201410448374.XA CN201410448374A CN105456528A CN 105456528 A CN105456528 A CN 105456528A CN 201410448374 A CN201410448374 A CN 201410448374A CN 105456528 A CN105456528 A CN 105456528A
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Abstract
The invention relates to a suppository for treating gynecological inflammation and a preparation method thereof. The suppository is prepared from, by weight, nakedflower beautyberry leaf extract equivalent to 200-240 parts of nakedflower beautyberry leaf medical material crude drug, 38-41 parts of polyethylene glycol 6000 and 67-71 parts of polyethylene glycol 1500. The preparation method of the suppository comprises the steps that the polyethylene glycol 6000 and the polyethylene glycol 1500 are taken to be heated and melted, heat preservation is conducted at the temperature ranging from 55 DEG C to 70 DEG C, and a matrix is is prepared for use; the nakedflower beautyberry leaf extract is taken, water is added to prepare extract, and heat preservation is conducted at the temperature ranging from 45 DEG C to 70 DEG C for use; the matrix is divided into three parts at the proportion of 1-1.5 to 2-2.5 to 3-4, under the condition of stirring, the matrix is slowly added into nakedflower beautyberry leaf thick paste for three times, the mixture is stirred to be uniform, heat preservation is conducted at the temperature ranging from 50 DEG C to 65 DEG C, suppository filling, cooling, sealing, suppository shearing are conducted, and the suppository is obtained. The suppository nakedflower beautyberry leaf extract is dispersed evenly in the matrix, caking does not exist, the suppository is not prone to softening and deformation at room temperature, storing is easy, the bioavailability is improved, and irritation does not exist.
Description
Technical field
The invention belongs to suppository field, particularly a kind of suppository for the treatment of gynecological inflammation and preparation method thereof.
Background technology
Callicarpa nudiflora (CallicarpanudifloraHook.etArn.) is Verenaceae (Verbenaceae) Callicarpa plant, and main product is in China Hainan, and also there is distribution in Guangdong, Guangxi.Root, the leaf of Callicarpa nudiflora can be used as medicine, and have antibacterial anti hemorrhagic, eliminating inflammation and expelling toxin, dissipating blood stasis for subsidence of swelling, effect of wind-expelling and dispelling dampness, cure mainly suppurative inflammation, acute infectious hepatitis, respiratory tract and the disease such as digestive tract hemorrhage, wound hemorrhage, burn and traumatic hemorrhage etc. are controlled in external.
Callicarpa nudiflora is that raw material has made multiple folk prescription or compound preparation at present, as Callicarpa nudiflora sheet, Callicarpa nudiflora capsule, Callicarpa nudiflora mixture etc., but to treat gynecological inflammation, topical is better than the dosage form of Formulations for systemic administration, and wherein the advantage of suppository is particularly evident.
But do the Chinese medicine suppository of matrix composition at present on the market with PEG, all there is following problem: when 1. preparing bolt, obviously, every content of dispersion is uneven, and structural capacity is bad, easily smashes loose for substrate and Chinese medicine extract layering; 2. Chinese medicine extract not can be uniformly dispersed in substrate, and medicine is at wound surface skewness, and bioavailability is low; 3. suppository easily deliquescing, distortion at normal temperatures; 4. there is slight zest; 5. patient's poor compliance, the residue flowed out from vagina after bolt uses pollutes underwear.
Summary of the invention
The object of the invention is to provide a kind of suppository for the treatment of gynecological inflammation, and active constituent content is high, not easily deliquescing, distortion under room temperature, is easy to preserve, and drug effect is good, nonirritant.The present invention also provides the preparation method of the suppository of above-mentioned treatment gynecological inflammation.
For achieving the above object, the present invention is by the following technical solutions:
Treat a suppository for gynecological inflammation, be made up of the component of following parts by weight:
Be equivalent to the Callicarpa nudiflora extract of 180-240 part Callicarpa nudiflora medical material
Polyethylene glycol 6000 38-41 part polyethylene glycol 1500 67-71 part.
Further, above-mentioned suppository, the parts by weight of each component are:
Be equivalent to the Callicarpa nudiflora extract of 200 parts of Callicarpa nudiflora medical materials
Polyethylene glycol 6000 41 parts of polyethylene glycol 1500s 71 parts.
Above-mentioned suppository, in the extract that described Callicarpa nudiflora extract is prepared by any method following any one or appoint several mixture:
(1) Callicarpa nudiflora medical material, adds water or rare alcoholic solvent, heating extraction 1-3 time, merge extractive liquid, filters, and filtrate concentrates, dry Callicarpa nudiflora extract;
(2) Callicarpa nudiflora medical material, squeezing obtains pressed liquor, filters, concentrated, dry Callicarpa nudiflora extract;
(3) method (2) gained press residue adds water or rare alcoholic solvent, heating extraction 1-3 time, and extracting solution filters, concentrated, dry Callicarpa nudiflora extract.
Further, above-mentioned suppository, described Callicarpa nudiflora extract is through activated carbon decolorizing or macroporous resin adsorption decolouring.
Further, above-mentioned suppository, described Callicarpa nudiflora extract is through HP-20 resin decolorization.
The preparation method of above-mentioned suppository, comprises the following steps:
(1) taking polyethylene glycol 6000, polyethylene glycol 1500 heating and melting, 55-70 DEG C of insulation, makes substrate, for subsequent use;
(2) get Callicarpa nudiflora extract, after molten in advance with water, colloid mill grinds, and 45-70 DEG C of water bath heat preservation, makes Callicarpa nudiflora thick paste, for subsequent use, the weight of described water be Callicarpa nudiflora thick paste and matrix weight and 12.1%-14.8%;
(3) substrate that step (1) is obtained is divided into three parts in the ratio of 1-1.5:2-2.5:3-4, lower point of stirring slowly joins in Callicarpa nudiflora thick paste for three times, stirs, 50-65 DEG C of insulation;
(4) by the mixture that step (3) is obtained, fill with bolt, cooling, sealing, cut bolt, to obtain final product.
Further, the preparation method of above-mentioned suppository, in step (1), holding temperature is 60-64 DEG C.
Further, the preparation method of above-mentioned suppository, in step (2), holding temperature is 55-60 DEG C.
Further, the preparation method of above-mentioned suppository, in step (3), holding temperature is 58-63 DEG C.
Further, the preparation method of above-mentioned suppository, in step (3), stirs 5-10 minute after adding a substrate, then adds lower a substrate.
Further, the preparation method of above-mentioned suppository, substrate is divided into three parts in the ratio of 1:2:3 in (3) by step, and lower point of stirring slowly joins in Callicarpa nudiflora thick paste for three times, stirs.
In the present invention, Callicarpa nudiflora medical material number is in dry product, and fresh medical material is by giving money as a gift.
The technical problem that inventor exists for existing suppository conducts in-depth research, and details are as follows:
One, Callicarpa nudiflora thick paste and Polyethylene Glycol substrate hybrid mode are investigated
Take 650g polyethylene glycol 6000 and 1133g polyethylene glycol 1500, heating and melting, make Callicarpa nudiflora Polyethylene Glycol substrate (being called for short Polyethylene Glycol substrate).
Get Callicarpa nudiflora extract 2 parts, every part of 1000g, use 1000g water and 900g water stirring and dissolving respectively, cross colloid mill 10 minutes, make Callicarpa nudiflora thick paste, prepare LUOHUAZIZHU SHUAN by following scheme respectively.
Table 1 Callicarpa nudiflora thick paste and Polyethylene Glycol substrate hybrid mode plan of survey
Table 2 Callicarpa nudiflora thick paste and Polyethylene Glycol substrate hybrid mode investigate result
From above result: (1) and direct mixed phase ratio, the gradation of Polyethylene Glycol substrate adds and is conducive to Callicarpa nudiflora thick paste and mixes with Polyethylene Glycol substrate, gained bolt evenly, without lamination; (2) after Polyethylene Glycol substrate mixes with Callicarpa nudiflora thick paste, then with colloid mill grinding, be unfavorable for that thick paste disperses further, cause layering, occur stain; (3) LUOHUAZIZHU SHUAN water content 14.78% is compared with 13.33%, melt and become time limit no significant difference, but hardness, dispersed homogeneous degree has different.
Two, LUOHUAZIZHU SHUAN preparation temperature is investigated
Take 660g polyethylene glycol 6000 and 1151g polyethylene glycol 1500, heating and melting, make Callicarpa nudiflora Polyethylene Glycol substrate (being called for short Polyethylene Glycol substrate).
Get Callicarpa nudiflora extract 400g, the 400g that adds water (temperature is higher than 90 DEG C), after stirring, colloid mill grinding, makes Callicarpa nudiflora thick paste, prepares LUOHUAZIZHU SHUAN respectively by following scheme.
Table 3 LUOHUAZIZHU SHUAN preparation temperature is investigated
From above result: temperature when filling effect and mixing is relevant, and temperature is too high, occurs stain in mixture, and time lengthening can coalescent precipitation, lower than 65 DEG C, the obviously improvement of stain and precipitation.
Three, LUOHUAZIZHU SHUAN amount of water is investigated
Get Callicarpa nudiflora extract 400g, add water 300g, crosses colloid mill 10 minutes after stirring and dissolving, obtained Callicarpa nudiflora thick paste.
Table 4 LUOHUAZIZHU SHUAN raw material dosage and amount of water are investigated
Water content %=[thick paste weight * (6/ (8+6))+water weight]/(thick paste weight+Polyethylene Glycol substrate weight+water weight) * 100
From above result: water content is between 12.1%-14.8%, and thick paste is mixed homogeneously with polyethylene glycol groups mass-energy, and obtained LUOHUAZIZHU SHUAN is neither too hard, nor too soft, not easily deliquescing, distortion.
Four, active carbon and resin decolorization are investigated
Get proper amount of active carbon, join the Callicarpa nudiflora dry extract solution of 10mg/ml, leave standstill 60 minutes, filter, measure the concentration of filtrate percent of decolourization and total phenols, total flavones and total saponins.
Get quantity of resin dress post respectively, the Callicarpa nudiflora dry extract solution of configuration 10mg/ml, after often kind of resin loading 200ml, respectively uses 200ml80% ethanol elution after deionized water rinsing.Measure the concentration of total phenols, total flavones and total saponins in each eluent.
The impact that table 5 active carbon decolours on Callicarpa nudiflora
Table 6 active carbon is on the impact of Callicarpa nudiflora total flavones, total saponins, total phenols
The impact that table 7 resin decolours on Callicarpa nudiflora
Table 8 resin is on the impact of Callicarpa nudiflora total flavones
Table 9 seven kinds of resins are on the impact of Callicarpa nudiflora total saponins
Table 10 seven kinds of resins are on the impact of Callicarpa nudiflora total phenols
Jointly consider through decolouring, total phenols, total flavones and total saponins four indexs, HP-20 resin decolorization effect is best.
Beneficial effect of the present invention:
(1) its Callicarpa nudiflora thick paste of gained suppository of the present invention is mixed homogeneously with substrate, and without layering, without precipitation, drug distribution is even, good stability;
(2) Callicarpa nudiflora extract is evenly distributed in substrate, and with wound surface uniform contact after drug release, bioavailability is high, and drug effect strengthens further;
(3) under gained suppository room temperature of the present invention, hardness is moderate, indeformable or deliquescing, is convenient to transport and preserves;
(4) gained suppository of the present invention is verified through irritant experiment, nonirritant;
(5) gained suppository mesostroma of the present invention is mixed homogeneously with thick paste, and thick paste is through desolventing technology, and the debris flowed out from vagina after using does not pollute underwear.
Detailed description of the invention
The preparation of embodiment 1 LUOHUAZIZHU SHUAN
Raw material is taken by following weight portion:
The dry medical material 1800g of Callicarpa nudiflora
Polyethylene glycol 6000 410g polyethylene glycol 1500 700g.
(1) Callicarpa nudiflora medical material, adds ethanol, heating extraction 1 time, merge extractive liquid, filters, and filtrate concentrates, dry Callicarpa nudiflora extract;
(2) taking polyethylene glycol 6000, polyethylene glycol 1500 heating and melting, 65-70 DEG C of insulation, makes substrate, for subsequent use;
(3) get Callicarpa nudiflora extract, after molten in advance with 192g water, colloid mill grinds to form extractum, and 65-70 DEG C of insulation, makes Callicarpa nudiflora extractum, for subsequent use, the weight of described water be Callicarpa nudiflora thick paste and matrix weight and 12.8%;
(4) substrate that step (2) is obtained is divided into three parts by 1:2.5:3, lower point of stirring slowly joins in Callicarpa nudiflora extractum for three times, stirs, 60-65 DEG C of insulation;
(5) by the mixture that step (4) is obtained, fill with bolt, cooling, sealing, cut bolt, to obtain final product.
The preparation of embodiment 2 LUOHUAZIZHU SHUAN
Raw material is taken by following weight portion:
The dry medical material 2000g of Callicarpa nudiflora
Polyethylene glycol 6000 406g polyethylene glycol 1500 708g.
(1) Callicarpa nudiflora medical material, the heating extraction that adds water 3 times, merge extractive liquid, filters, filtrate, by HP-20 macroporous adsorbent resin column chromatography, washes cylinder with water, discards water lotion, use 10%-90% ethanol elution, eluent filters, concentrated, dry Callicarpa nudiflora extract;
(2) taking polyethylene glycol 6000, polyethylene glycol 1500 heating and melting, 60-64 DEG C of insulation, makes substrate, for subsequent use;
(3) get Callicarpa nudiflora extract, after molten in advance with 216g water, colloid mill grinds to form extractum, and 50-55 DEG C of insulation, makes Callicarpa nudiflora extractum, for subsequent use, the weight of described water be Callicarpa nudiflora thick paste and matrix weight and 13.9%;
(4) substrate that step (2) is obtained is divided into three parts by 1:2:3, lower point of stirring slowly joins in Callicarpa nudiflora extractum for three times, stirs, 58-63 DEG C of insulation;
(5) by the mixture that step (4) is obtained, fill with bolt, cooling, sealing, cut bolt, to obtain final product.
The preparation of embodiment 3 LUOHUAZIZHU SHUAN
Raw material is taken by following weight portion:
The fresh medical material 8035g of Callicarpa nudiflora
Polyethylene glycol 6000 400g polyethylene glycol 1500 670g.
(1) get Callicarpa nudiflora medical material, add water and be broken into homogenate, squeezing obtains pressed liquor and press residue, and press residue adds water or rare alcoholic solvent, heating extraction 2 times, and extracting solution and pressed liquor merge, filters, and concentrates, dry must Callicarpa nudiflora extract;
(2) taking polyethylene glycol 6000, polyethylene glycol 1500 heating and melting, 55-60 DEG C of insulation, makes substrate, for subsequent use;
(3) get Callicarpa nudiflora extract, after molten in advance with 185g water, colloid mill grinds to form extractum, and 45-50 DEG C of insulation, makes Callicarpa nudiflora extractum, for subsequent use, the weight of described water be Callicarpa nudiflora thick paste and matrix weight and 12.1%;
(4) substrate that step (2) is obtained is divided into three parts by 1.5:2.5:4, lower point of stirring slowly joins in Callicarpa nudiflora extractum for three times, stirs, 50-55 DEG C of insulation;
(5) by the mixture that step (4) is obtained, fill with bolt, cooling, sealing, cut bolt, to obtain final product.
The preparation of embodiment 4 LUOHUAZIZHU SHUAN
Raw material is taken by following weight portion:
The fresh medical material 6945g of Callicarpa nudiflora
Polyethylene glycol 6000 380g polyethylene glycol 1500 700g.
(1) Callicarpa nudiflora medical material, adds ethanol and is broken into homogenate, and squeezing obtains pressed liquor and press residue, press residue adds ethanol, heating extraction 3 times, and extracting solution and pressed liquor merge, filter, filtrate, by macroporous adsorbent resin column chromatography, washes cylinder with water, discards water lotion, use 10%-90% ethanol elution, eluent filters, concentrated, dry Callicarpa nudiflora extract.
(2) taking polyethylene glycol 6000, polyethylene glycol 1500 heating and melting, 60-64 DEG C of insulation, makes substrate, for subsequent use;
(3) get Callicarpa nudiflora extract, after molten in advance with 228g water, colloid mill grinds to form extractum, and 55-60 DEG C of insulation, makes Callicarpa nudiflora extractum, for subsequent use, the weight of described water be Callicarpa nudiflora thick paste and matrix weight and 14.8%;
(4) substrate that step (2) is obtained is divided into three parts by 1:2:3.5, lower point of stirring slowly joins in Callicarpa nudiflora extractum for three times, stirs, 55-60 DEG C of insulation;
(5) by the mixture that step (4) is obtained, fill with bolt, cooling, sealing, cut bolt, to obtain final product.
Embodiment 5 LUOHUAZIZHU SHUAN pharmacodynamic experiment
(1) LUOHUAZIZHU SHUAN is to the effect of candida albicans vaginitis
Excision rats with bilateral ovary, after wound heals completely, carry out vaginal smear examination, get oophorectomize completely, without the rat of oestrous cycle appearance, injection estradiol benzoate 10mg/kg, injection in every 3 days 1 time, continuous review vaginal secretions smear, visible a large amount of keratinocyte, maintains artificial rutting period until experiment terminates.Except Normal group, all the other are often only in artificial estrous rat vagina implantation concentration is 2.5 × 10
6the Candida albicans liquid 0.1mL of cfu/mL, every day 1 time, for three days on end.5-7 days afterwards visible rat pudendum red and swollen, there is a large amount of white secretions.
Except Normal group, all the other rats are divided into matched group, miconazole group at random, the high, medium and low dosage group of LUOHUAZIZHU SHUAN that uses embodiment 2 method to prepare (0.2,0.1,0.05g/kg), every day vagina administration 1 time, continuous 7 days.After administration in the 3rd day, the 7th day, get vaginal secretions detect albicans growth situation, as shown in table 10.
Table 11 LUOHUAZIZHU SHUAN is on the impact of candida albicans vaginitis
Compare with Normal group: P < 0.01; Compare with model control group:
#p < 0.05,
##p < 0.01
With above-mentioned experimental technique, embodiment 1,3,4 gained LUOHUAZIZHU SHUAN on the impact of candida albicans vaginitis as following table 12
Table 12 embodiment 1,3,4 gained LUOHUAZIZHU SHUAN is on the impact of candida albicans vaginitis
Compare with Normal group: P < 0.01; Compare with model control group:
#p < 0.05,
##p < 0.01
Bacterial vaginitis
Except Normal group, all the other are often only in artificial estrous rat vagina and inject gonococcus-staphylococcus aureus-escherichia coli mixed bacteria liquid (gonococcus 8 × 10
9cfu/mL, staphylococcus aureus 1.8 × 10
8cfu/mL, escherichia coli 1.8 × 10
8cfu/mL).0.25mL/100g, 1 time every other day, continuous 3 times.6 days afterwards visible rat pudendum red and swollen, there is secretions.
Except Normal group, all the other rats are divided into matched group, miconazole group at random, the high, medium and low dosage group of LUOHUAZIZHU SHUAN that uses embodiment 2 method to prepare (0.2,0.1,0.05g/kg), every day vagina administration 1 time, continuous 6 days.After drug withdrawal, time sky is got vaginal secretions and is detected gonococcal infection growing state, as shown in table 11.
Table 13 LUOHUAZIZHU SHUAN is on the impact of bacterial vaginitis
Compare with Normal group: P < 0.05; Compare with model control group:
#p < 0.05,
##p < 0.01
Embodiment 1,3,4 gained LUOHUAZIZHU SHUAN on the impact of bacterial vaginitis as following table 13
Table 14 embodiment 1,3,4 gained LUOHUAZIZHU SHUAN is on the impact of bacterial vaginitis
Compare with Normal group: P < 0.05; Compare with model control group:
#p < 0.05,
##p < 0.01
Embodiment 6 Vaginal irritation effects is tested
(1) single administration is to the irritant test of rat vagina tissue
Get the adult female rats 70 of body weight at 220g-250g, be divided into 7 groups at random, often organize 10, the LUOHUAZIZHU SHUAN of embodiment 1-4 is 0.10g/, and the commercially available LUOHUAZIZHU SHUAN 0.10g/ of comparative example only; Vehicle group 0.1g/kg, blank group normal saline 0.10ml/ are only.Get test medicine and make 0.05g, 0.10g spile respectively, be placed in vagina 1cm place, keep 4 hours, observe drug absorption situation simultaneously, vaginal secretions change and systemic conditions.Put to death rat after 24 hours, peel off downwards to vaginal orifice in fundus of uterus, take out vagina, perusal vagina and surrounding tissue and vaginal mucosa are with or without the change of hyperemia, edema, secretions.Carry out irritant reaction scoring by table 12 and calculate mean scores, carrying out stimulation degree evaluation by table 13.
Table 15 vaginal mucosa irritation reaction standards of grading
| Morphologic change | Rank scores |
| Vaginal mucosa (1) vaginal mucosa is without change or without obviously changing | 0 |
| (2) vaginal mucosal surfaces blood vessel mild hyperaemia takes on a red color | 1 |
| (3) vaginal mucosal surfaces is red and swollen | 2 |
| (4) vaginal mucosal surfaces congestion is aubergine and accompanies erosion | 3 |
| Secretions (1) color is without change, transparent on a small quantity | 0 |
| (2) Se Lvebai, amount slightly increases | 1 |
| (3) color turns white thick, measures more outflow vagina | 2 |
| (4) yellow skin is thick, and amount increases and is full of vagina and has abnormal flavour | 3 |
| Total score | 6 |
Table 16 vaginal mucosa irritation degree evaluation standard
| Stimulation degree | Mean scores |
| (1) nonirritant | 0-0.5 |
| (2) slight zest | 0.6-2.5 |
| (3) moderate zest | 2.6-4.5 |
| (4) severe zest | 4.6-6.0 |
Conclusion: the once daily of the large small dose group of LUOHUAZIZHU SHUAN, excipient, matched group, perusal irritant reaction mean scores is 0, shows that once daily is to rat vagina mucosa nonirritant.In table 14.
Table 17 once daily irritant reaction result
| Group | Dosage | Size of animal | Mean scores | Conclusion |
| Blank group | 0.10ml/ only | 10 | 0 | Nonirritant |
| Vehicle group | 0.10g/ only | 10 | 0 | Nonirritant |
| Embodiment 1 | 0.10g/ only | 10 | 0 | Nonirritant |
| Embodiment 2 | 0.10g/ only | 10 | 0 | Nonirritant |
| Embodiment 3 | 0.10g/ only | 10 | 0 | Nonirritant |
| Embodiment 4 | 0.10g/ only | 10 | 0 | Nonirritant |
| Comparative example | 0.10g/ only | 10 | 0 | Nonirritant |
(2) multiple dosing is to the irritant test of rat vagina tissue
The grouping of multiple dosing test, dosage, medication and test method are all tested identical with single administration.Once a day, successive administration one week, puts to death 5 in last administration and takes out vagina, perusal itemized record after 24 hours.All the other 5 are carried out convalescent period observation, put to death after seven days, perusal itemized record.
Conclusion: LUOHUAZIZHU SHUAN experimental group, vehicle group successive administration seven days and convalescent period observe, and general state is all good, appetite is normal, indistinction between each group.Perusal: except comparative example group 4/10 makes an exception, other group vagina and surrounding tissue have been showed no obvious hyperemia, the abnormal change of edema and secretions, the evaluation score value of irritant reaction is all less than 0.5, with matched group zero difference.In table 15, table 16.
The table 18 successive administration vaginal irritation reaction result of seven days
| Group | Dosage | Administration time | Size of animal | Mean scores | Conclusion |
| Blank group | 0.10ml/ only | 7 | 10 | 0.00 | Nonirritant |
| Vehicle group | 0.10g/ only | 7 | 10 | 0.00 | Nonirritant |
| Embodiment 1 | 0.10g/ only | 7 | 10 | 0.00 | Nonirritant |
| Embodiment 2 | 0.10g/ only | 7 | 10 | 0.00 | Nonirritant |
| Embodiment 3 | 0.10g/ only | 7 | 10 | 0.00 | Nonirritant |
| Embodiment 4 | 0.10g/ only | 7 | 10 | 0.00 | Nonirritant |
| Comparative example | 0.10g/ only | 7 | 10 | 0.40 | Nonirritant |
The vaginal irritation reaction result of seven days table 19 convalescent periods
| Group | Dosage | Administration time | Size of animal | Mean scores | Conclusion |
| Blank group | 0.10ml/ only | 7 | 5 | 0.0 | Nonirritant |
| Vehicle group | 0.10g/ only | 7 | 5 | 0.0 | Nonirritant |
| Embodiment 1 | 0.10g/ only | 7 | 5 | 0.0 | Nonirritant |
| Embodiment 2 | 0.10g/ only | 7 | 5 | 0.0 | Nonirritant |
| Embodiment 3 | 0.10g/ only | 7 | 5 | 0.0 | Nonirritant |
| Embodiment 4 | 0.10g/ only | 7 | 5 | 0.0 | Nonirritant |
| Comparative example | 0.10g/ only | 7 | 5 | 0.1 | Nonirritant |
Claims (11)
1. treat a suppository for gynecological inflammation, it is characterized in that, be made up of the component of following parts by weight:
Be equivalent to the Callicarpa nudiflora extract of 180-240 part Callicarpa nudiflora medical material
Polyethylene glycol 6000 38-41 part polyethylene glycol 1500 67-71 part.
2. suppository as claimed in claim 1, it is characterized in that, the parts by weight of each component are:
Be equivalent to the Callicarpa nudiflora extract of 200 parts of Callicarpa nudiflora medical materials
Polyethylene glycol 6000 41 parts of polyethylene glycol 1500s 71 parts.
3. suppository as claimed in claim 1, is characterized in that, in the extract that described Callicarpa nudiflora extract is prepared by any method following any one or appoint several mixture:
(1) Callicarpa nudiflora medical material, adds water or rare alcoholic solvent, heating extraction 1-3 time, merge extractive liquid, filters, and filtrate concentrates, dry Callicarpa nudiflora extract;
(2) Callicarpa nudiflora medical material, squeezing obtains pressed liquor, filters, concentrated, dry Callicarpa nudiflora extract;
(3) method (2) gained press residue adds water or rare alcoholic solvent, heating extraction 1-3 time, and extracting solution filters, concentrated, dry Callicarpa nudiflora extract.
4. suppository as claimed in claim 3, is characterized in that, described Callicarpa nudiflora extract is through activated carbon decolorizing or macroporous resin adsorption decolouring.
5. suppository as claimed in claim 4, it is characterized in that, described Callicarpa nudiflora extract is through HP-20 resin decolorization.
6. the preparation method of suppository as claimed in claim 1, is characterized in that, comprise the following steps:
(1) taking polyethylene glycol 6000, polyethylene glycol 1500 heating and melting, 55-70 DEG C of insulation, makes substrate, for subsequent use;
(2) get Callicarpa nudiflora extract, after molten in advance with water, colloid mill grinds, and 45-70 DEG C of insulation, makes Callicarpa nudiflora thick paste, for subsequent use, the weight of described water be Callicarpa nudiflora thick paste and matrix weight and 12.1%-14.8%;
(3) substrate that step (1) is obtained is divided into three parts in the ratio of 1-1.5:2-2.5:3-4, lower point of stirring slowly joins in Callicarpa nudiflora thick paste for three times, stirs, 50-65 DEG C of insulation;
(4) by the mixture that step (3) is obtained, fill with bolt, cooling, sealing, cut bolt, to obtain final product.
7. the preparation method of suppository as claimed in claim 6, it is characterized in that, in step (1), holding temperature is 60-64 DEG C.
8. the preparation method of suppository as claimed in claim 6, it is characterized in that, in step (2), holding temperature is 55-60 DEG C.
9. the preparation method of suppository as claimed in claim 6, it is characterized in that, in step (3), holding temperature is 58-63 DEG C.
10. the preparation method of suppository as claimed in claim 6, is characterized in that, in step (3), stir 5-10 minute after adding a substrate, then add lower a substrate.
The preparation method of 11. suppositorys as claimed in claim 6, it is characterized in that, substrate is divided into three parts in the ratio of 1:2:3 in (3) by step, and lower point of stirring slowly joins in Callicarpa nudiflora thick paste for three times, stirs.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410448374.XA CN105456528A (en) | 2014-09-04 | 2014-09-04 | Suppository for treating gynecological inflammation and preparation method thereof |
| CN202110750513.4A CN113350427A (en) | 2014-09-04 | 2014-09-04 | Suppository for treating gynecological inflammation and preparation method thereof |
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| CN201410448374.XA CN105456528A (en) | 2014-09-04 | 2014-09-04 | Suppository for treating gynecological inflammation and preparation method thereof |
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| CN202110750513.4A Division CN113350427A (en) | 2014-09-04 | 2014-09-04 | Suppository for treating gynecological inflammation and preparation method thereof |
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| CN105456528A true CN105456528A (en) | 2016-04-06 |
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| CN201410448374.XA Pending CN105456528A (en) | 2014-09-04 | 2014-09-04 | Suppository for treating gynecological inflammation and preparation method thereof |
| CN202110750513.4A Pending CN113350427A (en) | 2014-09-04 | 2014-09-04 | Suppository for treating gynecological inflammation and preparation method thereof |
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| CN202110750513.4A Pending CN113350427A (en) | 2014-09-04 | 2014-09-04 | Suppository for treating gynecological inflammation and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111067973A (en) * | 2019-12-30 | 2020-04-28 | 海南医学院 | Callicarpa nudiflora gel for treating gynecological inflammation |
| CN112516225A (en) * | 2019-09-17 | 2021-03-19 | 海南九芝堂药业有限公司 | Application of callicarpa nudiflora in preparation of medicine for adjusting vaginal flora disorder and medicine thereof |
| CN114788846A (en) * | 2022-04-08 | 2022-07-26 | 广东梅州职业技术学院 | Callicarpa kwangsiensis compound preparation and preparation method and application thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1739682A (en) * | 2005-09-05 | 2006-03-01 | 北京泛美华医药科技发展有限公司 | Nudiflorous beautyberry soft capsule for body cavity and its prepn |
| CN102258637A (en) * | 2011-07-19 | 2011-11-30 | 九芝堂股份有限公司 | Callicarpa nudiflora extract, and preparation method and application thereof |
| CN103520380A (en) * | 2013-10-11 | 2014-01-22 | 哈尔滨欧替药业有限公司 | Callicarpa nudiflora expandable vaginal suppository, and preparation method and detection method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102048909A (en) * | 2009-10-28 | 2011-05-11 | 江西省药物研究所 | Callicarpa nudiflora effective part with hemostatic effect and pharmaceutical preparation thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1739682A (en) * | 2005-09-05 | 2006-03-01 | 北京泛美华医药科技发展有限公司 | Nudiflorous beautyberry soft capsule for body cavity and its prepn |
| CN102258637A (en) * | 2011-07-19 | 2011-11-30 | 九芝堂股份有限公司 | Callicarpa nudiflora extract, and preparation method and application thereof |
| CN103520380A (en) * | 2013-10-11 | 2014-01-22 | 哈尔滨欧替药业有限公司 | Callicarpa nudiflora expandable vaginal suppository, and preparation method and detection method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112516225A (en) * | 2019-09-17 | 2021-03-19 | 海南九芝堂药业有限公司 | Application of callicarpa nudiflora in preparation of medicine for adjusting vaginal flora disorder and medicine thereof |
| CN111067973A (en) * | 2019-12-30 | 2020-04-28 | 海南医学院 | Callicarpa nudiflora gel for treating gynecological inflammation |
| CN114788846A (en) * | 2022-04-08 | 2022-07-26 | 广东梅州职业技术学院 | Callicarpa kwangsiensis compound preparation and preparation method and application thereof |
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| CN113350427A (en) | 2021-09-07 |
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Application publication date: 20160406 |