CN101152226A - Externally used compound preparation for treating gynecology disease and method for preparing the same - Google Patents
Externally used compound preparation for treating gynecology disease and method for preparing the same Download PDFInfo
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- VKJGBAJNNALVAV-UHFFFAOYSA-M Berberine chloride (TN) Chemical compound [Cl-].C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2 VKJGBAJNNALVAV-UHFFFAOYSA-M 0.000 claims abstract description 27
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a topical compound preparation to treat gynecologic diseases and the preparation method. The preparation is composed by conventional excipients of the following weight accounts and raw medicine: 25 to 100 weight portion of matrine, 25 to 100 weight portion of berberine hydrochloride, 5 to 30 weight portion of selinum alcohol extract, 100 to 300 weight portion of calcined alum and 25 to 100 weight portion of ginseng stem leaf saponin. The raw medicine and excipient are added in according to traditional methods of the technical field to produce any form of preparation, such as suppository, gel, tablet, film and lotion, which are used to treat gynecologic diseases caused by bacteria or vaginalis infection. The preparation of the invention is characterized by stable quality, high safety, definite therapeutic effect and convenient use.
Description
Technical field:
The present invention relates to treat the externally used compound preparation and the preparation method of gynaecopathia, particularly treat the externally used compound preparation and the preparation method of gynaecopathias such as vaginitis, cervical erosion.
Background technology:
Disease of female genital organs such as vaginitis, cervical erosion, cervicitis are class gynecological frequently-occurring diseases, and the cause of disease is many because due to the bacterial infection.The antibacterial that causes the female sex organ inflammation mainly contains streptococcus, staphylococcus and escherichia coli etc., and is also very common by the colpitis that infusorian causes.Above-mentioned disease can cause the painful and very big inconvenience in life of health to the patient in various degree.This class disease can make the state of an illness progressively increase the weight of as can not get treatment in time or malpractice, some in addition can cause malignant change.In the product of the above-mentioned disease of existing treatment, exist the Chinese medicine curative effect slow, the big deficiency that waits of Western medicine side effect.
Summary of the invention:
The object of the present invention is to provide the externally used compound preparation of a kind of steady quality, safety, determined curative effect, treatment gynaecopathia easy to use.
Another object of the present invention provides the preparation method of the externally used compound preparation of this treatment gynaecopathia.
Solution of the present invention is based on the principle of therapy of combining Chinese and Western medicine, and with the deficiency that the length of Chinese medicine is mended Western medicine, the combined effect of performance Chinese medicine and western medicine reduces toxicity, to the west of cure the deficiency of method invigorating middle warmer medicine, learn from other's strong points to offset one's weaknesses, thereby improve curative effect of medication.
The externally used compound preparation of treatment gynaecopathia of the present invention is by the adjuvant of routine and comprise following raw medicaments in portion by weight and make: matrine 25-100 weight portion, berberine hydrochloride 25-100 weight portion, Fructus Cnidii ethanol extraction 5-30 weight portion, dried Alumen 100-300 weight portion and stem and leaf of Radix Ginseng saponin 25-100 weight portion.
The scope of crude drug preferred weight part of preparation externally used compound preparation of the present invention is: matrine 30-80 weight portion, berberine hydrochloride 30-80 weight portion, Fructus Cnidii ethanol extraction 8-15 weight portion, dried Alumen 150-250 weight portion and stem and leaf of Radix Ginseng saponin 30-80 weight portion.
Crude drug optimum weight part of preparation externally used compound preparation of the present invention is: matrine 50 weight portions, berberine hydrochloride 50 weight portions, Fructus Cnidii ethanol extraction 10 weight portions, dried Alumen 200 weight portions and stem and leaf of Radix Ginseng saponin's 50 weight portions.
Above raw material composition calculates by weight, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production also can restrain and be unit, weight can increase or reduce, but the constant rate of the weight proportion between each composition.
Described adjuvant commonly used comprises: Tween-80, polyethylene glycol 1500, polyoxyl stearate, glycerol, Acritamer 940, triethanolamine, ethanol, polyvinylpyrrolidone, magnesium stearate, carboxymethyl starch sodium, lactose, tartaric acid, sodium bicarbonate, polyvinyl alcohol, sodium benzoate, microcrystalline Cellulose, low replacement-hydroxypropyl emthylcellulose or the like.
The above-mentioned raw materials component can match with a certain proportion of common medicinal supplementary material, can be made into according to this area conventional method to comprise a kind of in suppository, gel, tablet (vaginal tablet/effervescent tablet), membrane, the lotion.
The preparation method of above-mentioned gynaecopathia externally used compound preparation comprises the steps:
1) preparation of Fructus Cnidii ethanol extraction
Get Fructus Cnidii medical material ethanol extraction, filtrate filters, merging filtrate, and it is standby or extract dry system is got dry extract standby to make extractum after filtrate concentrates;
2) take by weighing raw material by following weight portion:
Matrine 25-100 weight portion, berberine hydrochloride 25-100 weight portion, Fructus Cnidii ethanol extraction 5-30 weight portion, dried Alumen 100-300 weight portion and stem and leaf of Radix Ginseng saponin 25-100 weight portion;
3) make the externally used compound preparation that is used for gynaecopathia by this area conventional method adding above-mentioned raw materials medicine and adjuvant.
Step 2) raw material that takes by weighing in is preferred: matrine 30-80 weight portion, berberine hydrochloride 30-80 weight portion, Fructus Cnidii ethanol extraction 8-15 weight portion, dried Alumen 150-250 weight portion and stem and leaf of Radix Ginseng saponin 30-80 weight portion.
The optimum of the raw material that takes by weighing step 2) is: matrine 50 weight portions, berberine hydrochloride 50 weight portions, Fructus Cnidii ethanol extraction 10 weight portions, dried Alumen 200 weight portions and stem and leaf of Radix Ginseng saponin's 50 weight portions.
The common formulations preparation method of the externally used compound preparation of the treatment gynaecopathia of the invention described above is as follows:
1) preparation of suppository
Matrine, berberine hydrochloride, dried Alumen and stem and leaf of Radix Ginseng saponin's pulverize separately of above-mentioned weight portion are become 100-200 purpose powder, with the Fructus Cnidii alcohol-extracted extract mix homogeneously of above-mentioned weight portion.Other gets the suppository base heating and dissolves, and dissolving adds the above-mentioned raw materials component, mixes, and pours in the mould, makes suppository.
2) preparation of gel
The dried cream of matrine, berberine hydrochloride, dried Alumen, Fructus Cnidii of above-mentioned weight portion is become fine powder with stem and leaf of Radix Ginseng saponin's pulverize separately, gel substrate is scattered in the water, add the above-mentioned raw materials component, be stirred to evenly, make gel.
3) preparation of tablet (vaginal tablet/effervescent tablet)
The dried cream of matrine, berberine hydrochloride, dried Alumen, Fructus Cnidii of above-mentioned weight portion is become 100-200 purpose powder with stem and leaf of Radix Ginseng saponin's pulverize separately, add the adjuvant mix homogeneously, add adhesive system soft material, granulate, drying adds lubricant, is pressed into vaginal tablet;
The dried cream of matrine, berberine hydrochloride, dried Alumen, Fructus Cnidii of above-mentioned weight portion is become 100-200 purpose powder with stem and leaf of Radix Ginseng saponin's pulverize separately; add the adjuvant separated into two parts and make two kinds of granules of soda acid; with two parts granule mix homogeneously, add lubricant again, be pressed into effervescent tablet.
4) preparation of membrane
The dried cream of matrine, berberine hydrochloride, dried Alumen, Fructus Cnidii of above-mentioned weight portion is become 100-200 purpose powder with stem and leaf of Radix Ginseng saponin's pulverize separately, in addition that filmogen is water-soluble, add the above-mentioned raw materials component, add other adjuvants again, the heat de-airing bubble is filmed after cooling, is drying to obtain.
5) preparation of lotion
The dried cream of matrine, berberine hydrochloride, dried Alumen, Fructus Cnidii of above-mentioned weight portion is become 100-150 order powder with stem and leaf of Radix Ginseng saponin's pulverize separately, it is an amount of to add Tween-80 and water, stir into uniform mixed liquor, other sodium benzoate that takes a morsel, use water dissolution, add water to requirement after adding above-mentioned mixed liquor, stir, to all dissolvings, promptly.
Medicine of the present invention is used for the treatment by antibacterial or trichomonal gynecological inflammation, and each dosage form is used according to the using method of routine, and using dosage uses according to the requirement of individuality.
For showing medicine of the present invention to infected the therapeutical effect of the gynecological inflammation that causes by antibacterial or trichomonacide, this paper is by external bacteriostatic experiment, zoopery and external anti-trichomonal experiment carrying out pharmacodynamics evaluation.Used medicine of the present invention is to contain the fine powder that mixes behind active ingredient matrine, berberine hydrochloride, dried Alumen, the dried cream of Fructus Cnidii and the stem and leaf of Radix Ginseng saponin's pulverize separately in the experiment.
1. external bacteriostasis
Adopt agar culture medium, broth bouillon to cultivate Candida albicans, staphylococcus aureus, escherichia coli, bacillus pyocyaneus, Salmonella typhi, dysentery bacterium.During experiment this invention fine drug powder is mixed with the solution of 200mg/m1 with sterilized water, control drug is used and is controlled Mi Ling, and concentration is 600mg/ml, carries out bacteriostatic experiment with cylinder plate method respectively.Test result following (table 1).
The antibacterial circle diameter of the various antibacterials of table 1 (mm)
| Bacteria name | Candida albicans | Escherichia coli | Staphylococcus aureus | Bacillus pyocyaneus | Bacillus typhi | Dysentery bacterium |
| This product | 18.11 | 14.12 | 20.43 | 12.21 | 18.33 | 19.81 |
| Control Mi Ling | 13.33 | 10.37 | 16.29 | 12.92 | 17.63 | 12.74 |
Experiment shows that medicine of the present invention has obvious external bacteriostasis, and has extensively bacteriostasis, and bacteriostasis is obvious, and Candida albicans, escherichia coli, staphylococcus aureus inhibitory action obviously are better than controlling Mi Ling.
2. to the influence of mixed cell infected animal model
Adopt the rat animal model of Candida albicans, staphylococcus aureus and escherichia coli mixed infection to observe bacteriostasis in the body.Get 40 of female rats during experiment, surgical removal of ovaries.Postoperative subcutaneous injection next day estradiol benzoate 0.2ml/ is (0.4mg) only, and injection in per 3 days 1 time runs through whole experiment.In one week of postoperative, 10 of random chooses are made blank group, all the other 30 modelings, and method is as follows: rat is fixed with holder, vagina inoculation escherichia coli (1 * 10
7CFU/ml), Candida albicans (1 * 10
7CFU/ml), staphylococcus aureus (1 * 10
7CFU/ml) each 0.05ml keeps 10min.After the modeling the 3rd day, with 2ml sterile saline lavation vagina.Get irrigating solution 0.1ml, cultivate also counting with the selectivity differential medium, 3 kinds of antibacterials are all turned out and can think that model sets up.Confirm after the model success these 30 female rats to be divided into 3 groups at random, 10 every group, wherein model group is given excipient, press 60mg/kg and two drug doses of 30mg/kg respectively to medicine of the present invention, every day 1 time, continuous 7 days for other two groups.Blank group and model group such as give at the weight excipient.6h vagina lavation after the last administration is got irrigating solution and is cultivated respectively and count with the selectivity differential medium.Colony counts situation of change (seeing Table 2-4) before and after relatively treating.
Table 2 medicine of the present invention to colibacillary bacteriostasis (n=10,
)
| Group | Clump count logCFU/ml |
| Before the medicine | Behind the medicine | |
| Blank group | 1.57±0.25 | 1.64±0.17 |
| Model group | 4.95±0.10 | 4.47±0.14 △ |
| 60mg/kg dosage group | 4.86±0.11 | 3.04±0.09 * |
| 30mg/kg dosage group | 4.73±0.08 | 3.88±0.11 * |
Model group is compared with the blank group, and p＜0.05 illustrates the coli-infection success of model group; 60mg/kg dosage group is compared with model group with 30mg/kg dosage group, and p＜0.05 illustrates that medicine of the present invention is remarkable to colibacillary bacteriostasis.
Table 3 medicine of the present invention to the oidiomycetic bacteriostasis of white (n=10,
)
| Group | Clump count logCFU/ml | |
| Before the medicine | Behind the medicine | |
| Blank group | 0 | 0 |
| Model group | 4.21±0.08 | 4.14±0.09 △ |
| 60mg/kg dosage group | 4.18±0.08 | 0 * |
| 30mg/kg dosage group | 4.09±0.10 | 2.93±0.34 * |
Model group is compared with the blank group, and p＜0.05 illustrates the candida albicans infection success of model group; 60mg/kg dosage group is compared with model group with 30mg/kg dosage group, and p＜0.05 illustrates that medicine of the present invention is remarkable to the oidiomycetic bacteriostasis of white.
Table 4 medicine of the present invention to the effect of staphylococcus aureus (n=10,
)
| Group | Clump count logCFU/ml | |
| Before the medicine | Behind the medicine | |
| Blank group | 1.21±0.14 | 1.38±0.09 |
| Model group | 4.86±0.15 | 4.62±0.05 △ |
| 60mg/kg dosage group | 4.84±0.24 | 3.47±0.17 * |
| 30mg/kg dosage group | 4.79±0.17 | 4.01±0.29 * |
Model group is compared with the blank group, and p＜0.05 illustrates the infection of staphylococcus aureus success of model group; 60mg/kg dosage group is compared with model group with 30mg/kg dosage group, and p＜0.05 illustrates that medicine of the present invention is remarkable to the bacteriostasis of staphylococcus aureus.
Above result shows that this product can obviously suppress bacterial infection in the rat vagina, illustrates that medicine of the present invention has bacteriostasis in the obvious body.
3. to the effect of mice wound healing promoting
40 of white mice, the back chaeta is sloughed in ether inhalation anesthesia, uses 75% alcohol disinfecting after the normal saline cleaning, drying, and the excision diameter is about the circular holostrome skin of 0.75cm, sets up the skin model of the same area and the degree of depth.Weigh next day, is divided into 4 groups at random, is respectively the high and low dose group of model group, the bright cream group of wound and medicine of the present invention, totally 4 groups.Measure wound area, model group gives vaseline 0.1g during coating, and the positive drug group is created the cream 0.1g that burns, and the high and low dose group of medicine of the present invention gives 0.1g respectively.Be administered once in two hours, successive administration 15 days is measured wound area.Calculate the wound healing percentage rate, its computing formula is:
Area * 100% before wound healing percentage rate=(area after the area-medication before the medication)/medication.
Experimental result sees Table 5.
Table 5 medicine of the present invention is to the influence of mice wound healing effect
| Group | Number of animals (only) | Wound area (mm before the medicine 2) | Wound area (mm behind the medicine 2) | Healing percentage rate (%) |
| Model is formed the cream group high dose group of burning | 10 10 10 | 188.35±26.08 199.92±26.63 188.47±28.52 | 84.81±28.81 26.98±26.24 * 19.23±18.92 *** | 54.97 71.50 89.80 |
| Low dose group | 10 | 186.65±25.47 | 38.96±26.33 ** | 79.35 |
The bright cream group of wound, high dose group and low dose group and model group compare p＜0.01; Experiment shows that medicine of the present invention has obvious promoting healing effect to the mouse skin mucosa injury, and is obvious with the model group comparing difference, and its healing effect obviously is better than creating bright cream.
4. external anti-trichomonal experiment
Separate trichomonas vaginitis from trichomonal vaginitis patient vaginal secretions, adopt the test tube culture method to observe the anti-trichomonal effect, medicine 2h kill ratio of the present invention is 100%, obviously is better than the kill ratio of matched group FUYANPING.
The specific embodiment
The preparation of embodiment 1 Fructus Cnidii ethanol extraction
Get the Fructus Cnidii medical material, fragmentation adds 10 times of amounts of ethanol of 70%, 8 times of amounts, 6 times of amount heating and refluxing extraction respectively 3 times, each 1 hour, filter merging filtrate, filtrate is condensed into the extractum of relative density 1.15～1.25 (60～80 ℃), and it is standby to be dried to dried cream again; Or get the Fructus Cnidii medical material, and fragmentation adds 10 times of amounts of ethanol of 70%, 8 times of amounts, 6 times of amount heating and refluxing extraction respectively 3 times, and each 1 hour, filter, merging filtrate, filtrate is condensed into the extractum of relative density 1.15～1.25 (60～80 ℃), and is standby.
The preparation of embodiment 2 suppositorys
Claim matrine 50g, berberine hydrochloride 50g, dried Alumen 200g and stem and leaf of Radix Ginseng saponin 50g.Pulverize separately is also crossed 150 mesh sieves, mix homogeneously.In addition Fructus cnidii extract 13g and Tween-80 13g mix homogeneously.Taking polyethylene glycol 15001850g, polyoxyethylene stearate (40) ester 850g, glycerol 30g heating and melting adds in the substrate emulsifying with the medicated powder that mixed and Fructus cnidii extract and poured in the bolt mould to the medicinal liquid mix homogeneously in 90 minutes, makes suppository, promptly.
The preparation of embodiment 3 gels
Claim matrine 50g, berberine hydrochloride 50g, dried Alumen 200g, the dried cream 10g of Fructus Cnidii and stem and leaf of Radix Ginseng saponin 50g, pulverize separately is also crossed 100 mesh sieves.Get glycerol 100g, Acritamer 940 75g, fully emulsified moistening and the adding distil water of making is an amount of.Other gets berberine hydrochloride, the dried cream addition polymerization of Fructus Cnidii Pyrusussuriensis ester-8010g, triethanolamine 15g, and ethanol 100ml, an amount of distilled water makes dissolving, joins in the above-mentioned substrate, and the limit edged stirs and makes gel; Add matrine, dried Alumen and stem and leaf of Radix Ginseng saponin again, adding distil water grinds well to 2500g, promptly.
The preparation of embodiment 4 tablets (vaginal tablet/effervescent tablet)
Claim matrine 25g, berberine hydrochloride 25g, dried Alumen 100g, the dried cream 5g of Fructus Cnidii and stem and leaf of Radix Ginseng saponin 25g, pulverize separately is also crossed 150 mesh sieves.Microcrystalline Cellulose 100g, carboxymethyl starch sodium 15g and low replacement-hydroxypropyl emthylcellulose 100g mix homogeneously are adhesive with 5% polyvinylpyrrolidone alcoholic solution, granulate, 60 ℃ of dryings add magnesium stearate 2g, carboxymethyl starch sodium 15g mix homogeneously, are pressed into vaginal tablet.
Claim matrine 25g, berberine hydrochloride 25g, dried Alumen 100g, the dried cream 5g of Fructus Cnidii and stem and leaf of Radix Ginseng saponin 25g, pulverize separately is also crossed 150 mesh sieves.Add lactose 200g and mix homogeneously, separated into two parts, a part of tartarize 120g, mix homogeneously with 5% polyvinylpyrrolidone alcoholic solution, is granulated granulate.Another part adds sodium bicarbonate 100g, and mix homogeneously with 5% polyvinylpyrrolidone alcoholic solution, is granulated 60 ℃ of dryings, granulate.With two parts granule mix homogeneously, adding magnesium stearate 2g is lubricant, the compacting effervescent tablet.
The preparation of embodiment five membrane
Claim matrine 50g, berberine hydrochloride 50g, dried Alumen 200g, the dried cream 10g of Fructus Cnidii and stem and leaf of Radix Ginseng saponin 50g, pulverize separately is also crossed 150 mesh sieves, mix homogeneously.In addition polyvinyl alcohol 300g is dissolved in 1500g water, heating makes it to dissolve into glue, supplies moisture, and is standby.Add above-mentioned fine powder and glycerol 10g, Tween-80 10g, stir, the heat de-airing bubble is filmed after cooling, drying, promptly.
The preparation of embodiment six lotions
Claim matrine 50g, berberine hydrochloride 50g, dried Alumen 200g, the dried cream 10g of Fructus Cnidii and stem and leaf of Radix Ginseng saponin 50g, pulverize separately is also crossed 120 mesh sieves.It is an amount of to add Tween-80 20g and water, is stirred into mixed liquor.Other sodium benzoate that takes a morsel is used water dissolution, adds above-mentioned mixed liquor, adds water to 1500g, is stirred to whole dissolvings, promptly.
Claims (9)
1. externally used compound preparation for the treatment of gynaecopathia, be by the adjuvant of routine and comprise following raw medicaments in portion by weight and make: matrine 25-100 weight portion, berberine hydrochloride 25-100 weight portion, Fructus Cnidii ethanol extraction 5-30 weight portion, dried Alumen 100-300 weight portion and stem and leaf of Radix Ginseng saponin 25-100 weight portion.
2. compound preparation as claimed in claim 1, the weight portion of its crude drug is: matrine 30-80 weight portion, berberine hydrochloride 30-80 weight portion, Fructus Cnidii ethanol extraction 8-15 weight portion, dried Alumen 150-250 weight portion and stem and leaf of Radix Ginseng saponin 30-80 weight portion.
3. compound preparation as claimed in claim 1, the weight portion of its crude drug is: matrine 50 weight portions, berberine hydrochloride 50 weight portions, Fructus Cnidii ethanol extraction 10 weight portions, dried Alumen 200 weight portions and stem and leaf of Radix Ginseng saponin's 50 weight portions.
4. as the described compound preparation of claim 1-3, it is characterized in that: comprise a kind of in suppository, gel, tablet, membrane, the lotion according to what this area conventional method added that described crude drug and adjuvant make.
5. a preparation method for the treatment of the externally used compound preparation of gynaecopathia comprises the steps:
1) preparation of Fructus Cnidii ethanol extraction
Get Fructus Cnidii medical material ethanol extraction, filtrate filters, merging filtrate, and it is standby or extract dry system is got dry extract standby to make extractum after filtrate concentrates;
2) take by weighing raw material by following weight portion:
Matrine 25-100 weight portion, berberine hydrochloride 25-100 weight portion, Fructus Cnidii ethanol extraction 5-30 weight portion, dried Alumen 100-300 weight portion and stem and leaf of Radix Ginseng saponin 25-100 weight portion;
3) make the externally used compound preparation that is used for gynaecopathia by this area conventional method adding above-mentioned raw materials medicine and adjuvant.
6. the preparation method of the described externally used compound preparation of claim 5, step 2 wherein) raw material that takes by weighing in is: matrine 30-80 weight portion, berberine hydrochloride 30-80 weight portion, Fructus Cnidii ethanol extraction 8-15 weight portion, dried Alumen 150-250 weight portion and stem and leaf of Radix Ginseng saponin 30-80 weight portion.
7. the preparation method of the described externally used compound preparation of claim 5, step 2 wherein) raw material that takes by weighing in is: matrine 50 weight portions, berberine hydrochloride 50 weight portions, Fructus Cnidii ethanol extraction 10 weight portions, dried Alumen 200 weight portions and stem and leaf of Radix Ginseng saponin's 50 weight portions.
8. the application of the described compound preparation of claim 1-3 in preparation treatment medicine for gynecopathy.
9. the described application of claim 8 is characterized in that, described gynaecopathia is to infect the gynaecopathia that causes by antibacterial or trichomonacide.
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