CN101791375A - Chinese compound preparation for prevention and treatment of gynecological hemorrhagic disease - Google Patents
Chinese compound preparation for prevention and treatment of gynecological hemorrhagic disease Download PDFInfo
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- CN101791375A CN101791375A CN200910248627A CN200910248627A CN101791375A CN 101791375 A CN101791375 A CN 101791375A CN 200910248627 A CN200910248627 A CN 200910248627A CN 200910248627 A CN200910248627 A CN 200910248627A CN 101791375 A CN101791375 A CN 101791375A
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Abstract
The invention relates to a Chinese compound preparation for prevention and treatment of gynecological hemorrhagic diseases, which is prepared with the following bulk pharmaceuticals: cuttlebone, rhizoma bletillae, radix cyathulae, radix pseudo-ginseng, radix astragali and liquorice. The preparation process comprises the following steps: extracting active components of the bulk pharmaceuticals, adding excipients acceptable for medical preparation, and preparing required particles, capsules or tablets. The Chinese compound preparation has the functions of stopping bleeding, eliminating the blood stasis and replenishing qi, and has the advantages of stopping bleeding without leaving blood stasis when being used for treating the gynecological hemorrhage.
Description
Technical field
The present invention relates to a kind of compound Chinese medicinal preparation, be specifically related to a kind of compound Chinese medicinal preparation that is used to prevent and treat gynecological bleeding, belong to the compound Chinese medicinal preparation field.
Background technology
Gynecological bleeding claims gynecological's blood disorder again, be meant that the neuroendocrine system dysfunction of regulating reproduction causes a kind of disease of metrorrhagia, be equivalent to motherland's medical science " metrorrhagia " category, as menorrhagia, menostaxis, dripping not to the utmost, hemorrhage, the hysteromyoma hemorrhage of hemorrhage behind the cycle disorder, dysfunctional uterine hemorrhage, hemorrhage due to placement of IUD, artificial abortion, postpartum subinvolution of uterus, endometrial hyperplasia, the hemorrhage lamp of ovarian cyst, being typical clinically commonly encountered diseases, frequently-occurring disease, also is one of difficult disease of comparatively paying close attention to of gynecological.Seek a kind of effective medicine preparation is this area problem to be solved always.
Summary of the invention
The object of the present invention is to provide a kind of the have blood of holding back hemostasis, blood stasis dispersing and fresh blood promoting, benefiting qi and nourishing blood function, be used to prevent and treat the compound Chinese medicinal preparation of gynecological bleeding card.
Compound Chinese medicinal preparation of the present invention is the preparation of being made by following raw material medicaments, used crude drug is an Os Sepiae, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, Radix Cyathulae, the Radix Astragali and Radix Glycyrrhizae, weight proportion between each crude drug is an Os Sepiae 200-350 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 200-350 weight portion, Radix Notoginseng 100-200 weight portion, Radix Cyathulae 100-200 weight portion, Radix Astragali 100-200 weight portion, Radix Glycyrrhizae 50-150 weight portion, be preferably Os Sepiae 290-350 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 250-300 weight portion, Radix Notoginseng 100-150 weight portion, Radix Cyathulae 150-200 weight portion, Radix Astragali 150-200 weight portion, Radix Glycyrrhizae 50-100 weight portion is specially Os Sepiae 300 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 260 weight portions, Radix Notoginseng 100 weight portions, Radix Cyathulae 170 weight portions, the Radix Astragali 150 weight portions, Radix Glycyrrhizae 70 weight portions.
The preparation unit form of compound Chinese medicinal preparation of the present invention can be any one in tablet, capsule, granule, pill, syrup, oral liquid, fluid extract, the powder, is preferably tablet, capsule and granule.
The preparation method of compound Chinese medicinal preparation of the present invention comprises the steps:
(1) get the Os Sepiae of recipe quantity, be ground into fine powder, cross 80 mesh sieves, standby;
(2) get the Radix Cyathulae of recipe quantity, be ground into coarse powder,, filter with the alcohol reflux of 60%-80% 2-4 time, merging filtrate, filtrate decompression is concentrated into the concentrated solution that relative density is 1.10-1.15, and is standby;
(3) get Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, the Radix Astragali and the Radix Glycyrrhizae of recipe quantity, pulverize separately becomes coarse powder, merge, to be incorporated into through the Radix Cyathulae filtering residue of ethanol extraction in the above-mentioned medicinal material coarse powder, with water boiling and extraction 2-4 time, filter merging filtrate, filtrate decompression is concentrated into the concentrated solution that relative density is 1.10-1.15, and is standby;
(4) concentrated solution with above-mentioned (2) (3) gained merges, and mixing adds Os Sepiae fine powder and the required adjuvant of preparation through pulverizing, and the system soft material is granulated, and drying behind the granulate, is made required tablet, capsule or granule promptly.
Among the present invention, Os Sepiae has astringing to arrest bleeding, relieving leukorrhea by astringents, and the effect of skin ulcer is held back in antacid, is used for Peptic Ulcers, hyperchlorhydria, hematemesis and epistaxis, metrorrhagia is had blood in stool, and is principal agent in the side.The Pseudobulbus Bletillae (Rhizoma Bletillae) bitterness is slightly cold, and has astringing to arrest bleeding, the detumescence and promoting granulation effect, being used for hemoptysis spits blood, traumatic hemorrhage, Radix Notoginseng have the effect of hemostasis repercussive, subduing swelling and relieving pain, hemostasis and do not stay the stasis of blood, the sweet little bitterness of Radix Cyathulae is flat, have the effect that blood circulation promoting and blood stasis dispelling stimulates the menstrual flow, conducting blood to flow downwards, and it is descending to draw all medicines, more than three the flavor, be ministerial drug altogether.The Radix Astragali has the effect of invigorating QI to consolidate the body surface resistance, can be used for deficient qi and blood, uterine prolapse, be adjuvant drug, the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription is messenger drug, all medicines share, make hemorrhagely must end, blood stasis must change, and can benefiting QI and nourishing blood, full side's giving consideration to both the incidental and fundamental, simultaneous elimination and reinforcement, " having in ending ", " have in the change and end ", lead to puckery and usefulness, make hemostasis not stay the stasis of blood, and assistant with the product of QI invigorating with strengthening the body resistance, have therapeutical effect preferably for gynecologic blood diseases.
Specific embodiment
Below further specify the enforcement of compound Chinese medicinal preparation of the present invention from preparation embodiment.
Embodiment 1
Prescription
Os Sepiae 300g, Pseudobulbus Bletillae (Rhizoma Bletillae) 260g, Radix Notoginseng 100g, Radix Cyathulae 170g, Radix Astragali 150g, Radix Glycyrrhizae 70g
Get Os Sepiae, be ground into fine powder, cross 80 mesh sieves, standby;
Radix Cyathulae is ground into coarse powder, 8 times of amount alcohol reflux of 60% 3 times, and each 1.5h filters, and it is 1.10 concentrated solution that filtrate decompression is concentrated into relative density, standby;
Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, the Radix Astragali, Radix Glycyrrhizae are pulverized and are claimed to mix coarse powder, and the Radix Cyathulae filtering residue is joined in the mixed medicinal material coarse powder, and with the distillation water boiling and extraction of 10 times of amounts 3 times, each 2h filters, and it is 1.10 concentrated solution that filtrate is concentrated into relative density;
Twice concentrated solution merged, and mix homogeneously adds the Os Sepiae fine powder that crushes, and adds lactose 125g lactose, mix homogeneously, and the system soft material is granulated, and 60 ℃ of dry granulate add the 8g magnesium stearate again, and mix homogeneously is pressed into 1000, promptly.
Embodiment 2
Prescription
Os Sepiae 350g, Pseudobulbus Bletillae (Rhizoma Bletillae) 200g, Radix Notoginseng 200g, Radix Cyathulae 100g, Radix Astragali 100g, Radix Glycyrrhizae 50g
Get Os Sepiae, be ground into fine powder, cross 80 mesh sieves, standby;
Radix Cyathulae is ground into coarse powder, 8 times of amount alcohol reflux of 70% 3 times, and each 1h filters, and it is 1.05 concentrated solution that filtrate decompression is concentrated into relative density, standby;
Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, the Radix Astragali, Radix Glycyrrhizae are pulverized and are claimed to mix coarse powder, and the Radix Cyathulae filtering residue is joined in the mixed medicinal material coarse powder, and with the distillation water boiling and extraction of 10 times of amounts 3 times, each 1.5h filters, and it is 1.05 concentrated solution that filtrate is concentrated into relative density;
Twice concentrated solution merged, and mix homogeneously adds the Os Sepiae fine powder that crushes, and adds lactose 100g starch, mix homogeneously, and the system soft material is granulated, and 60 ℃ of dry granulate are in 1000 the hard capsule softgel shells of packing into, promptly.
Embodiment 3
Os Sepiae 200g, Pseudobulbus Bletillae (Rhizoma Bletillae) 350g, Radix Notoginseng 100g, Radix Cyathulae 200g, Radix Astragali 200g, Radix Glycyrrhizae 150g
Get Os Sepiae, be ground into fine powder, cross 80 mesh sieves, standby;
Radix Cyathulae is ground into coarse powder, 8 times of amount alcohol reflux of 80% 3 times, and each 1.5h filters, and it is 1.10 concentrated solution that filtrate decompression is concentrated into relative density, standby;
Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, the Radix Astragali, Radix Glycyrrhizae are pulverized and are claimed to mix coarse powder, and the Radix Cyathulae filtering residue is joined in the mixed medicinal material coarse powder, and with the distillation water boiling and extraction of 10 times of amounts 3 times, each 2h filters, and it is 1.10 concentrated solution that filtrate is concentrated into relative density;
Twice concentrated solution merged, and mix homogeneously adds the Os Sepiae fine powder that crushes, and adds lactose 125g lactose, mix homogeneously, and the system soft material is granulated, and 60 ℃ of dry granulate are made granule promptly.
Below further specify beneficial effect of the present invention from pharmacology embodiment, among the embodiment, prescription and preparation method that used compound Chinese medicinal preparation of the present invention is according to embodiment 1 obtain.
One, the influence that rat is shunk at the body uterine smooth muscle
Medicine: compound Chinese medicinal preparation of the present invention; Oxytocin inj, Anhui BBCA Pharmaceuticals Co., Ltd. produces; Diethylstilbestrol injection, Shanghai GM medicinal liquid limited company produces; Urethane, Liaoning Gekko Swinhonis medicinal liquid company limited is produced.
Animal: 40 of cleaning level SD rats, Healthy female unpregnancy, body constitution amount 200-250g.
40 rats are divided into 5 groups at random; both matched groups; positive controls; compound Chinese medicinal preparation height of the present invention (the 3.2g crude drug/kg); in (the 1.6g crude drug/kg); low dose group (the 0.8g crude drug/kg); 2d presses 0.5mg/ subcutaneous injection diethylstilbestrol 2 times before test; manually impel animal to be in proestrus or rutting period; to improve the sensitivity of uterine smooth muscle to medicine; during test; press document (Qi Chen. herbal pharmacology research methodology [M]. Beijing: method People's Health Publisher .1996:471-472.); behind the lumbar injection 20% urethane 5ml/kg anesthetized rat; facing upward the position is fixed on the Mus plate; cut 3cm at hypogastric region along the abdomen median line behind the preserved skin; open the abdominal cavity; find out the uterus, left side; separate surrounding tissue; with uterus, left side terminal with the fine rule 2cm that slings; be connected on the 10g muscular tension transducer; open RM6240 multi-path physiology signal processing system; zeroing; calibration; two; on the input interface of four-way tonotransducer is installed; channel pattern is selected tension force; scanning speed 25ms/div; sensitivity 1.87g; it is 30Hz that the DC filtering regulating frequency is selected in time Changshu; the uterus relax contract stablize 30min after; record 10min normal activity curve; the oxytocin of every rat muscle injection of positive controls subsequently 0.1U; compound Chinese medicinal preparation of the present invention is big; in; the small dose group rat gives the suspension medicine of corresponding dosage from duodenum; the administration volume is 10ml/kg; matched group gives the equal-volume normal saline; write down before the administration 0-10min behind the 10min and administration respectively; 10-20min; 20-30min; 30-40min; 40-50min; 50-60min uterine smooth muscle contraction frequency and amplitude; calculate administration front and back frequency and amplitude variations value respectively, value before the value-administration after changing value=administration.
Influence to rat carrier uterine smooth muscle shrinkage amplitude, see Table 1, as can be seen from Table 1, compare with matched group, oxytocin, the big compound Chinese medicinal preparation 10-50min of the present invention, middle dosage are at 20-50min, the low dose of shrinkage amplitude (P＜0.05 or P＜0.01) that can obviously increase uterine smooth muscle during the 30-40 people, and big or middle dosage increases the shrinkage amplitude effect and the oxytocin suitable (P＞0.05) of uterine smooth muscle when 30-50min; Compare with the heavy dose group, middle dosage group is suitable with heavy dose of group in the effect of each time period, a little less than the small dose group effect relatively.
Table 1 compound Chinese medicinal preparation of the present invention to rat at the influence of body uterine smooth muscle shrinkage amplitude (x ± s)
Compare with matched group,
*P＜0.05,
*P＜0.01; Compare with positive controls,
﹠amp;P＜0.05,
﹠amp; ﹠amp;P＜0.01
To the influence of rat at body uterine smooth muscle contraction frequency, see Table 2, as can be seen from Table 2, compare with matched group, oxytocin can obviously increase the contraction frequency (P＜0.01) of rat uterus smooth muscle at 10-50min, the big or middle dosage of Chinese medicine compound of the present invention at 30-50min, and low dose of effect is not obvious, but effect trend is arranged, heavy dose of at 40-60min, middle dosage during at 30-60min, the contraction frequency effect and the oxytocin that increase uterine smooth muscle are suitable, low dose of act on a little less than.
Table 2 pair rat is at the influence of body uterine smooth muscle contraction frequency (x ± s)
Compare with matched group,
*P＜0.01; Compare with positive controls,
﹠amp;P＜0.05,
﹠amp; ﹠amp;P＜0.01
Two, to the influence of early pregnancy rat uterus blood
The SD rat, female 220-250g, male 250-300g
Medicine: 1 following gained preparation of the embodiment of the invention; GONGXUENING JIAONANG (production of YUNNAN BAIYAO Group Co.,Ltd); Mifepristone (as long as Hua Lian, Shanghai is company limited production), the time spent is configured to suspension with the 5g/L sodium carboxymethyl cellulose; Misoprostol (Zizhu Pharmaceutical Co., Ltd., Beijing's production), the time spent is configured to suspension with the 5g/L sodium carboxymethyl cellulose.
Female during rat 20:00 every day, hero mates in 2: 1 ratios, carry out vaginal smear examination next day during 08:00, to find that sperm is gestation the 1st day, when the 7th day 08:00 and 18:00, gavage mifepristone (13.8mg/kg) and misoprostol (135ug/kg) respectively, cause the incomplete abortion model, quantitative cotton balls 1 each (cotton balls weighs 75-80mg, and is half side with the plastic sheeting parcel, spills urethra with resistant to blood and backflows) is inserted in colleague's intravaginal.Take out cotton balls with 08:00 and 18:00 next day respectively, puts into the airtight stored refrigerated of plastic bag, replaces a new cotton balls and intravaginal simultaneously, observes the vaginal hemorrhage situation, continuously to the 14th day.
Get 48 pregnant rats, 8 of modeling rats are not the blank group, all the other 40 modeling rats are with advancing to be divided into 5 groups: model control group, GONGXUENING group (0.1g/kg), Chinese medicine compound group of the present invention (g/kg), each is organized in modeling next day (the 8th day) and begins to irritate stomach, continuously 7d.
Metrorrhagia quantitative determination: use hemoglobin straw, rat tail vein blood sampling 0.02ml, add among the 50g/LNaOH solution 4ml, mixing is stand-by, place every Mus metrorrhagia every day cotton balls of collecting in the beaker respectively, add an amount of 50g/L NaOH according to the situation of amount of bleeding and soak extruding and wash the cotton balls bloodstain by rubbing with the hands, the solution after embathing is poured in another beaker and is preserved, and adds an amount of 50g/L NaOH again and soaks cotton balls, bloodstain is washed in extruding by rubbing with the hands, pour the preservation container into, according to cotton balls bloodstain eluting situation, whether decision embathes 1-2 time again, with all lixiviating solution mixings of priority, write down all 50g/L NaOH total amounts, get the 5mL lixiviating solution and filter, incite somebody to action filtering lixiviating solution 4ml respectively, the 50g/L NaOH solution 4ml of rat tail vein blood, with 50g/L NaOH is the blank pipe, and in 546nm wavelength record absorbance (A) value, computing formula is:
The V1=dilution used 50g/L NaOH amount of tail vein (4ml)
The used 50g/L NaOH amount of V2=lixiviate uterus blood (ml)
The result shows that compound Chinese medicinal preparation of the present invention can reduce early pregnancy rat uterus amount of bleeding, and with the model group ratio, middle and high dosage group difference has significance, sees Table 3.
Table 3 compound Chinese medicinal preparation of the present invention is to the influence of early pregnancy rat uterus amount of bleeding (x ± s)
Compare with model control group,
*P＜0.05,
*P＜0.01
Three, function of promoting blood circulation to disperse blood clots
40 of male and female rats, be divided at random matched group, stasis syndrome model group, Chinese medicine compound height of the present invention (3.2g crude drug/kg), in (1.6g crude drug/kg), low (three dosage groups of 0.8g crude drug/kg), every group 8, all animals is with the mark forage feed, 3 times/day, 1h irritates stomach with the 10ml/kg normal saline behind matched group and the blood stasis model group rat last every day feeding, be total to 10d, behind the high, medium and low dosage group last every day feeding 1h by 3.2,1.6,0.8g/kg dosage gives suspension oral gavage of the present invention, the filling gastric capacity is 10ml/kg, altogether 10d.
Reference literature (Qi Chen. herbal pharmacology test method [M]. Beijing: People's Health Publisher, 1996:564) method, 1h after the 10d administration, the normal saline of control rats subcutaneous injection lamp capacity, do not put into frozen water, other respectively organizes the adrenalin hydrochloride of the equal subcutaneous injection 0.08mg/100g of rat, grouping is put into the back and is taken out, inject adrenalin hydrochloride 0.08mg/100g behind the 2h once more, put into 0 ℃ of frozen water 5min once more, used animal fasting 12h, normal drinking-water, after modeling finished 18h, femoral artery was got blood, the anticoagulant that is equipped with heparin in vitro, automatic blood viscosity measurement whole blood viscosity is economized with Puli in the concussion back, the blood plasma viscosity, erythrocyte overstocks, the every hemorheology index of erythrocyte aggregation index lamp.
Influence to whole blood viscosity: Chinese medicine compound 3.2g/kg of the present invention can obviously reduce stasis syndrome disease rat low cut (4s-1) and in cut the whole blood specific viscosity of (60s-1), see Table 4
Table 4 Chinese medicine compound of the present invention is to the influence of whole blood viscosity (x ± s)
Compare with the blood stasis model group,
*P＜0.05.
Influence to blood plasma specific viscosity and packed cell volume: Chinese medicine compound 3.2g/kg1.6g/kg of the present invention can obviously reduce model group rat plasma specific viscosity and packed cell volume, sees Table 5.
Table 5 Chinese medicine compound of the present invention is to (x ± s) such as the influence of blood plasma viscosity etc.
Claims (5)
- One kind the prevention and the treatment gynecological hemorrhagic disease compound Chinese medicinal preparation, it is characterized in that being made by following bulk drugs: Os Sepiae, Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, Radix Cyathulae, the Radix Astragali and Radix Glycyrrhizae, described each crude drug weight proportion are Os Sepiae 200-350 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 200-350 weight portion, Radix Notoginseng 100-200 weight portion, Radix Cyathulae 100-200 weight portion, Radix Astragali 100-200 weight portion, Radix Glycyrrhizae 50-150 weight portion.
- 2. compound Chinese medicinal preparation according to claim 1 is characterized in that the weight proportion between each crude drug is Os Sepiae 290-350 weight portion, Pseudobulbus Bletillae (Rhizoma Bletillae) 250-300 weight portion, Radix Notoginseng 100-150 weight portion, Radix Cyathulae 150-200 weight portion, Radix Astragali 150-200 weight portion, Radix Glycyrrhizae 50-100 weight portion.
- 3. compound Chinese medicinal preparation according to claim 1 is characterized in that the weight proportion between each crude drug is Os Sepiae 300 weight portions, Pseudobulbus Bletillae (Rhizoma Bletillae) 260 weight portions, Radix Notoginseng 100 weight portions, Radix Cyathulae 170 weight portions, the Radix Astragali 150 weight portions, Radix Glycyrrhizae 70 weight portions.
- 4. according to the described compound Chinese medicinal preparation of any claim in the claim 1 to 3, the dosage form of wherein said preparation is any one in capsule, tablet or the granule.
- 5. a method for preparing the described compound Chinese medicinal preparation of any claim in the claim 1 to 3 is characterized in that comprising the steps:(1) get the Os Sepiae of recipe quantity, be ground into fine powder, cross 80 mesh sieves, standby;(2) get the Radix Cyathulae of recipe quantity, be ground into coarse powder,, filter with the alcohol reflux of 60%-80% 2-4 time, merging filtrate, filtrate decompression is concentrated into the concentrated solution that relative density is 1.10-1.15, and is standby;(3) get Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, the Radix Astragali and the Radix Glycyrrhizae of recipe quantity, pulverize separately becomes coarse powder, merge, to be incorporated into through the Radix Cyathulae filtering residue of ethanol extraction in the above-mentioned medicinal material coarse powder, with water boiling and extraction 2-4 time, filter merging filtrate, filtrate decompression is concentrated into the concentrated solution that relative density is 1.10-1.15, and is standby;(4) concentrated solution with above-mentioned (2) (3) gained merges, and mixing adds Os Sepiae fine powder and the required adjuvant of preparation through pulverizing, and the system soft material is granulated, and drying behind the granulate, is made required tablet, capsule or granule promptly.
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