CN112022988B - Traditional Chinese medicine composition with effect of preventing and/or treating dysmenorrhea and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition with effect of preventing and/or treating dysmenorrhea and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 3-9 parts of galangal, 4-12 parts of fingered citron, 4-12 parts of rose and 1-5 parts of pseudo-ginseng. The traditional Chinese medicine composition is obtained by researching and summarizing clinical experiences of the inventor for many years according to the theory of traditional Chinese medicine, and is analyzed, researched and verified. The formula is reasonable, the medicinal ingredients are few and fine, the preparation method is simple, the medicine is convenient to take, and pharmacodynamic experiments prove that the medicine has a good treatment effect on dysmenorrheal.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition and a preparation method and application thereof.
Background
Dysmenorrhea refers to the pain and distention of the lower abdomen before and after menstruation or during menstruation, accompanied by soreness of the waist or other discomfort, and the pain may extend to the sacral, lumbar and back and even involve the thighs and feet. Each time the menstruation cycle occurs, severe cases may be accompanied by nausea, vomiting, cold sweat and profound effects on the quality of life. The dysmenorrhea is divided into primary dysmenorrhea and secondary dysmenorrhea, wherein the primary dysmenorrhea refers to dysmenorrhea with no organic lesions in reproductive organs, and generally occurs at the beginning of or 6-24 months after incipient wetness, and the pain lasts for 8-72 h; secondary dysmenorrhea refers to dysmenorrhea caused by pelvic organic diseases, such as endometriosis, adenomyosis, pelvic inflammatory disease, etc., and occurs at a time 2 years after normal menstruation. Epidemiological studies have shown that primary dysmenorrhea is currently the most common disease in gynaecology, affecting 50% of women worldwide, of which 10% have severe symptoms. In china, 33.2% of women suffer from dysmenorrhea, with primary dysmenorrhea having a prevalence of 60% to 80% among college students in women in china. Primary dysmenorrhea is generally due to several reasons: endocrine factors, cast shedding of endometrium, uterine dysplasia, cervical stenosis, mental factors, poor physical resources, physical constitution factors and the like.
Clinically, western medicine mainly treats dysmenorrhea by oral chemical preparations, and currently, ovulation-inhibiting drugs and non-steroidal anti-inflammatory analgesics are most widely applied. However, oral contraceptives are prone to cause heavy bleeding and hypertension, and long-term administration of hormone drugs is prone to cause sequelae such as cancer, osteoporosis and obesity; nonsteroidal anti-inflammatory drugs are prone to cause gastric mucosal damage. The traditional Chinese medicine has unique advantages and rich experience in treating dysmenorrhea, and has obvious clinical curative effect. There are many commercially available Chinese patent medicines for treating dysmenorrhea, such as WUJIBAIFENG pill, TONGJINGBAO granule, HUAHONG tablet, and rhizoma corydalis analgesic tablet. Most Chinese patent medicines such as Huahong tablets are used for treating secondary dysmenorrhea; part of Chinese patent medicines have various medicinal flavors and large dosage; some traditional Chinese medicines with pain relieving effect but high toxicity such as asarum, rhizoma pinellinae praeparata and the like are often added in the common formula of the Chinese patent medicines, and long-term administration is not suitable. Therefore, a medicament for treating primary dysmenorrhea with definite curative effect, small toxic and side effect and strong general adaptability is urgently needed in the market.
Modern Chinese medicine considers that the causes of dysmenorrhea include qi stagnation and blood stasis, cold accumulation in cells, damp-heat accumulation, deficiency of qi and blood, and deficiency of liver and kidney. Therefore, dysmenorrhea can be classified into qi-stagnation and blood-stasis type dysmenorrhea, cold-congealing and blood-stasis type dysmenorrhea, damp (phlegm) heat stasis type dysmenorrhea, and the like. Chinese patent CN102488763A discloses a Chinese medicinal composition for treating dysmenorrhea, which comprises four Chinese medicinal herbs including radix Angelicae sinensis, radix Notoginseng, flos Carthami, and flos Rosae Rugosae; wherein, the angelica has the efficacies of enriching and activating blood, regulating menstruation and relieving pain; the pseudo-ginseng has the effects of removing blood stasis, stopping bleeding, relieving swelling and relieving pain; the safflower has the functions of promoting blood circulation, stimulating the menstrual flow, removing blood stasis and relieving pain; the flos Rosae Rugosae has effects of activating qi-flowing, resolving stagnation, regulating blood, and relieving pain. According to the efficacy of angelica, pseudo-ginseng, safflower and rose and the usage amount of the angelica, pseudo-ginseng, safflower and rose in the patent CN102488763A, the traditional Chinese medicine composition consisting of the four medicines of angelica, pseudo-ginseng, safflower, rose and the like disclosed in the patent CN102488763A can be only used for dysmenorrheal caused by qi stagnation and blood stasis, but can not be used for dysmenorrheal of other types. In addition, the traditional Chinese medicine composition uses safflower which has certain toxic and side effects, so that the traditional Chinese medicine composition also has the defect that the traditional Chinese medicine composition is not suitable for long-term use.
Disclosure of Invention
The present invention is directed to solving, at least to some extent, one of the problems in the related art.
The invention provides a traditional Chinese medicine composition, which is characterized by being prepared from the following traditional Chinese medicine raw materials: galangal, fingered citron, rose and pseudo-ginseng.
The medicinal material selection is obtained by the inventor through researching and summarizing clinical experience for many years according to the theory of traditional Chinese medicine, and through analysis, research and verification. The Chinese medicinal composition comprising rhizoma Alpiniae Officinarum, fructus Citri Sarcodactylis, flos Rosae Rugosae and Notoginseng radix can be used for preventing and treating dysmenorrhea; the composition overcomes the defects of complicated and various medicinal flavors of most Chinese patent medicines, has simple and reasonable prescription, exact curative effect and cheap and easily obtained raw materials.
Further research by the inventor shows that the traditional Chinese medicine composition consisting of the four medicines of galangal, fingered citron, rose, pseudo-ginseng and the like can play the roles of inhibiting uterine smooth muscle contraction, easing pain and activating blood circulation, thereby effectively preventing and treating dysmenorrhea.
According to the theory of traditional Chinese medicine: in the prescription of the invention, the pseudo-ginseng is warm in nature, sweet in taste and slightly bitter, enters liver and stomach channels, and has the effects of dissipating blood stasis, stopping bleeding, reducing swelling and relieving pain. The rose is warm in nature, sweet and slightly bitter in taste, enters liver and spleen channels, and has the effects of promoting qi circulation, relieving depression, regulating blood and relieving pain. The galangal can dispel cold to relieve pain, and the fingered citron can sooth liver and regulate qi, resolve phlegm and relieve chest stuffiness. The medicines are matched with the effects of promoting qi and blood circulation, regulating menstruation and relieving pain, so that qi and blood of thoroughfare and conception vessels and uterus are smooth, and the medicine is painless when being used for treating dysmenorrheal caused by qi stagnation and blood stasis, and also can be used for treating dysmenorrheal caused by cold coagulation and blood stasis and dysmenorrheal caused by damp (phlegm) heat stasis.
Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 3-9 parts of galangal, 4-12 parts of fingered citron, 4-12 parts of rose and 1-5 parts of pseudo-ginseng.
Further preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 4-6 parts of galangal, 6-8 parts of fingered citron, 6-8 parts of rose and 2-3 parts of pseudo-ginseng.
Most preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 6 parts of galangal, 8 parts of fingered citron, 8 parts of rose and 3 parts of pseudo-ginseng.
The selection and the dosage of the medicinal materials are obtained by the inventor through researching and summarizing clinical experiences of years according to the theory of traditional Chinese medicine, and are analyzed, researched and verified. The traditional Chinese medicine composition consisting of the four medicines of the galangal, the fingered citron, the rose, the pseudo-ginseng and the like in parts by weight can be used for preventing and treating the dysmenorrhea and has an obvious effect; the composition overcomes the defects of complicated and various medicinal flavors of most Chinese patent medicines, has simple and reasonable prescription, exact curative effect, cheap and easily obtained raw materials, convenient medication and lower cost.
Further research by the inventor shows that the traditional Chinese medicine composition consisting of the four medicines of the galangal, the finger citron, the rose, the pseudo-ginseng and the like in parts by weight can more effectively play the roles of inhibiting uterine smooth muscle contraction, easing pain and activating blood circulation, thereby more effectively preventing and treating dysmenorrheal.
The pharmacological actions of various raw materials of the invention are as follows:
galangal rhizome: is dried rhizome of Alpinia officinarum Hance of Zingiberaceae. Hot in nature and pungent in flavor, enter spleen and stomach meridians. Has effects in warming stomach, relieving vomit, dispelling cold, and relieving pain, and can be used for treating abdominal psychroalgia, stomach cold emesis, belch, and acid regurgitation.
Fingered citron: is dried fruit of Rutaceae plant fructus Citri Sarcodactylis Citrus medica L. It is warm in nature, pungent, bitter and sour in flavor, and enters liver, spleen, stomach and lung meridians. Has effects of dispersing stagnated liver qi, regulating stomach function and relieving pain, and can be used for treating stagnation of liver-qi and stomach-qi, epigastric fullness, anorexia, emesis, cough and excessive phlegm.
And (3) rose: is dried flower bud of Rose rugosa thunb. It is warm in nature, sweet in taste and slightly bitter in flavor, and enters liver and spleen meridians. Has effects in promoting qi circulation, resolving stagnation, regulating blood circulation, and relieving pain, and can be used for treating liver and stomach qi pain, anorexia, emesis, menoxenia, and traumatic injury.
Pseudo-ginseng: is dried root and rhizome of Panax notoginseng (Burk.) F.H.Chen of Araliaceae. It is warm in nature, sweet in taste and slightly bitter in flavor, and enters liver and stomach meridians. Has effects in removing blood stasis, stopping bleeding, relieving swelling, and relieving pain, and can be used for treating hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic hemorrhage, thoracico-abdominal pain, and traumatic injury with swelling and pain.
The second aspect of the present invention provides a method for preparing the above-mentioned Chinese medicinal composition, which comprises the following steps:
(1) decocting rhizoma Alpiniae Officinarum, fructus Citri Sarcodactylis, flos Rosae Rugosae and Notoginseng radix in water to obtain decoction;
(2) concentrating and drying the decoction to obtain an extract, thus obtaining the traditional Chinese medicine composition.
Preferably, the weight of the water in the step (1) is 5-20 times of the weight of the traditional Chinese medicine raw material medicine; the decocting times are 1-3 times, and each time is 0.5-1.5 hr.
The research of the inventor shows that the traditional Chinese medicine composition can be effectively prepared by adopting the method.
Further, after the step (2), further comprising:
and (3) crushing the extract prepared in the step (2) to obtain medicinal powder, thus obtaining the traditional Chinese medicine composition.
The research of the inventor shows that the extract is crushed into medicinal powder, so that the preparation of subsequent dosage forms can be facilitated.
The third aspect of the present invention provides a medicament for treating dysmenorrhea, which comprises the above Chinese medicinal composition as an effective ingredient.
The composition is further added with pharmaceutically acceptable auxiliary materials to be prepared into tablets, concentrated pills, granules, capsules or oral liquid preparations.
The auxiliary materials are conventional pharmaceutic adjuvant. The preparation method of the dosage form adopts a conventional pharmaceutical method in pharmacy.
The medicament for treating dysmenorrhea takes the traditional Chinese medicine composition as an effective component, and has a remarkable effect of treating dysmenorrhea.
The fourth aspect of the invention provides the application of the traditional Chinese medicine composition in preparing medicines or health products.
Specifically, the medicament is a medicament for preventing and/or treating dysmenorrhea.
Specifically, the medicine is a medicine for inhibiting uterine smooth muscle contraction, a medicine with an analgesic effect and/or a medicine with a blood activating effect.
The health product can be health food or functional beverage.
Compared with the prior art, the invention has the following advantages and beneficial effects:
(1) the selection and the dosage of the medicinal materials are obtained by the inventor through researching and summarizing years of clinical experience according to the theory of traditional Chinese medicine, and are analyzed, researched and verified. The invention overcomes the defects of complex and various medicinal flavors of most Chinese patent medicines, and has simple and reasonable prescription and exact curative effect. According to the theory of traditional Chinese medicine: the traditional Chinese medicine composition consisting of the four medicines of galangal, fingered citron, rose and pseudo-ginseng can prevent and treat qi stagnation and blood stasis type dysmenorrhea, and can also give consideration to cold accumulation and blood stasis type dysmenorrhea and damp (phlegm) heat stasis type dysmenorrhea; almost all dysmenorrhea types are covered. In addition, the traditional Chinese medicine composition does not contain medicinal materials with toxic or side effects, and can be taken for a long time.
(2) The traditional Chinese medicine composition provided by the invention can inhibit spontaneous contraction of isolated uterine smooth muscle of a mouse, and also has an inhibiting effect on isolated uterine smooth muscle contraction caused by oxytocin.
(2) The traditional Chinese medicine composition can prolong the latency of mouse writhing reaction caused by oxytocin, reduce the times of writhing, has better analgesic treatment effect on mouse dysmenorrheal models caused by oxytocin, and has higher activity in a high-dose group than that of a positive medicine of cassia twig and poria cocos capsule.
(3) The traditional Chinese medicine composition can increase the opening number of the crossing points of the uterine ligament capillary vessels of rats, and has stronger blood circulation activating effect than that of a positive medicine of cassia twig and poria cocos capsule.
(4) The traditional Chinese medicine composition disclosed by the invention is low in toxicity in vivo.
(5) The traditional Chinese medicine composition for treating dysmenorrhea has the advantages of strong general applicability, simple preparation method, convenient medication and lower cost, and is suitable for industrial production.
Detailed Description
The present invention will be described in further detail with reference to specific examples, but the present invention is not limited to these examples in any way. Equivalents made in accordance with the present disclosure are intended to be within the scope of the present invention.
EXAMPLE 1 preparation of the Chinese medicinal composition
Pulverizing rhizoma Alpiniae Officinarum 0.6kg, fructus Citri Sarcodactylis 0.8kg, flos Rosae Rugosae 0.8kg, and Notoginseng radix 0.3kg into coarse powder, and mixing. Adding 12.5L of water for decocting for 1.5h for the first time, adding 10L of water for decocting for 1h for the second time, adding 10L of water for decocting for 0.5h for the third time, decocting for 3 times, mixing decoctions, standing to 50 ℃, concentrating the liquid medicine under reduced pressure and drying to obtain 309g of extract (yield 12.36%), crushing and sieving with a 100-mesh sieve to obtain medicinal powder, namely the traditional Chinese medicine composition.
EXAMPLE 2 preparation of the Chinese medicinal composition
Pulverizing 1.8kg of rhizoma Alpiniae Officinarum, 2.5kg of fructus Citri Sarcodactylis, 2.5kg of flos Rosae Rugosae, and 1.2kg of Notoginseng radix into coarse powder, and mixing. Adding 50L of water for decocting for 1.5h for the first time, adding 40L of water for decocting for 1.5h for the second time, adding 35L of water for decocting for 1h for the third time, decocting for 3 times, mixing decoctions, standing to 60 ℃, concentrating the liquid medicine under reduced pressure, drying to obtain 1.072kg of extract (yield 13.4%), crushing, and sieving with a 100-mesh sieve to obtain medicinal powder, namely the traditional Chinese medicine composition.
Example 3 acute toxicity test in mice
Animals: 40 Kunming mice with the weight of 18-22 g and half female and half male were purchased from the center of Guangdong province medical experimental animals.
Medicine preparation: the traditional Chinese medicine composition is prepared in example 1.
The experimental method comprises the following steps: kunming mice were randomly divided into experimental groups (dose: 20g per kg body weight) and negative control groups (1g/dL carboxymethylcellulose) of 20 mice per group, half male and half female. Mice were gavaged 2 times at 2h intervals for 7d and animals were recorded for intoxication symptoms and death.
The experimental results are as follows: during the test period, no significant symptoms and no death occurred in both groups of mice. The traditional Chinese medicine composition of the invention is used for female and male mice to take oral LD50The weight average of each kilogram of the body is more than 20g according to the acute toxicityAnd (c) the test substance belongs to a nontoxic class substance.
Example 4 Effect of Chinese medicinal composition on spontaneous contraction of Ex vivo uterine smooth muscle in mouse
Animals: 40 Kunming mice with the weight of 18-22 g and female bodies are purchased from the center of Guangdong province medical experimental animals.
Medicine preparation: guizhi Fuling Jiaonang (Jiangsu Kangyuan pharmaceutical industry Co., Ltd.); diethylstilbestrol (shanghai comaijie pharmaceutical limited); the traditional Chinese medicine composition is prepared in example 1.
The main apparatus is as follows: an intelligent super constant temperature water tank; a tension transducer.
The experimental method comprises the following steps:
(1) grouping experiments: the 40 mice were randomly divided into four groups, a cassia twig and poria capsule group, a traditional Chinese medicine composition high dose group, a traditional Chinese medicine composition medium dose group and a traditional Chinese medicine composition low dose group.
(2) Preparation of mouse in vitro uterus specimen: the female mice were infertile and injected subcutaneously with diethylstilbestrol 0.05mg/0.025 ml/mouse 3 consecutive days prior to the experiment to synchronize the uterus of each mouse and enhance the sensitivity of the myometrium to the drug. On day 4, the mice were sacrificed by dislocation of the cervical vertebrae, the abdomen was dissected, the uterus was taken out, and immediately placed in a glass dish containing the typhoid solution. Slightly stripping adipose tissue and connective tissue on uterine wall, finding out one uterine horn, tying two ends with thread, connecting one end with tension transducer and the other end with support in bath, placing in constant temperature bath containing 20ml of nutrient solution, setting temperature at 37 deg.C, introducing oxygen, and maintaining 50-70 bubbles per minute. Loading uterus with 1g, balancing for 30min, and changing fluid for 2-3 times. After the uterine contraction is stabilized, the contraction curve of the uterine smooth muscle in a normal state within 10min is recorded, and the uterine contraction frequency (contraction times/10 min) and the uterine contraction intensity (g) are calculated.
(3) Adding medicine: adding the medicines prepared from the nutrient solution respectively, adding medicine volume of 200 μ l, recording uterine contraction curve 10min after adding medicine, and calculating contraction frequency and contraction strength.
The experimental results are as follows: compared with the traditional Chinese medicine composition before dosing 10min after the cassia twig and poria cocos capsule composition is dosed, the uterine contraction frequency and the uterine contraction strength are both obviously reduced (P is less than 0.05); compared with the traditional Chinese medicine composition before dosing 10min after dosing, the traditional Chinese medicine composition has the advantages that the uterine contraction frequency is remarkably reduced (P is less than 0.05), and the contraction strength is remarkably reduced (P is less than 0.01); after the traditional Chinese medicine composition is added into the high and medium dosage groups, compared with the traditional Chinese medicine composition before the traditional Chinese medicine composition is added into the medicine, the uterine contraction frequency and the uterine contraction strength are both obviously reduced (P is less than 0.01). Specific results are shown in tables 1 and 2.
TABLE 1 Effect on frequency of contraction of Normal isolated uterus
Note: p <0.05, P <0.01 for each group compared to each other before and after administration
TABLE 2 Effect on the contractile Strength of Normal isolated uterus
Note: p <0.05, P <0.01 for each group compared to each other before and after administration
And (4) experimental conclusion: the cassia twig and poria cocos capsules and the high and medium-low dose groups of the traditional Chinese medicine composition can obviously inhibit spontaneous contraction of isolated uterus, and the contraction frequency and the contraction strength of the capsules are obviously reduced, and the traditional Chinese medicine composition has a stronger inhibition effect than the positive medicine, namely the cassia twig and poria cocos capsules, and has a better treatment effect on dysmenorrheal.
Example 5 Effect of Chinese medicinal composition on in vitro uterine smooth muscle contraction caused by oxytocin
Animals: 40 Kunming mice with the weight of 18-22 g and female bodies are purchased from the center of Guangdong province medical experimental animals.
Medicine preparation: guizhi Fuling Jiaonang (Jiangsu Kangyuan pharmaceutical industry Co., Ltd.); diethylstilbestrol (shanghai comaijie pharmaceutical limited); oxytocin injection (shanghai he feng pharmaceuticals, ltd); the traditional Chinese medicine composition is prepared in example 1.
The main apparatus is as follows: an intelligent super constant temperature water tank; tension transducer
The experimental method comprises the following steps:
(1) grouping experiments: the 40 mice were randomly divided into four groups, a cassia twig and poria capsule group, a traditional Chinese medicine composition high dose group, a traditional Chinese medicine composition medium dose group and a traditional Chinese medicine composition low dose group.
(2) Preparation of mouse in vitro uterus specimen: the female mice were infertile and injected subcutaneously with diethylstilbestrol 0.05mg/0.025 ml/mouse 3 consecutive days prior to the experiment to synchronize the uterus of each mouse and enhance the sensitivity of the myometrium to the drug. On day 4, the mice were sacrificed by dislocation of the cervical vertebrae, the abdomen was dissected, the uterus was taken out, and immediately placed in a glass dish containing the typhoid solution. Slightly stripping adipose tissue and connective tissue on uterine wall, finding out one uterine horn, tying two ends with thread, connecting one end with tension transducer and the other end with support in bath, placing in constant temperature bath containing 20ml of nutrient solution, setting temperature at 37 deg.C, introducing oxygen, and maintaining 50-70 bubbles per minute. Loading uterus with 1g, balancing for 30min, and changing fluid for 2-3 times. After the uterine contraction is stabilized, the contraction curve of the uterine smooth muscle in a normal state within 10min is recorded, and the uterine contraction frequency (contraction times/10 min) and the uterine contraction intensity (g) are calculated.
(3) Oxytocin (final concentration 5IU/L) was added and 10min curve was recorded after the rhythm was stable.
(4) Adding medicine: adding the medicines prepared from the nutrient solution respectively, adding medicine volume of 200 μ l, recording uterine contraction curve 10min after adding medicine, and calculating contraction frequency and contraction strength.
The experimental results are as follows: after the cassia twig and poria cocos capsule is added with the medicine for 10min, compared with the medicine added with oxytocin, the uterine contraction frequency and the contraction strength are both obviously reduced (P is less than 0.05); compared with the traditional Chinese medicine composition added with oxytocin 10min after the low-dose group is added with the medicine, the uterine contraction frequency is remarkably reduced (P is less than 0.05), and the contraction strength is remarkably reduced (P is less than 0.01); after the traditional Chinese medicine composition is added with medicine, compared with the traditional Chinese medicine composition added with oxytocin, the uterine contraction frequency and the uterine contraction strength are both obviously reduced (P is less than 0.01); compared with the traditional Chinese medicine composition added with oxytocin after the high-dose group of the traditional Chinese medicine composition is added with the medicine, the contraction frequency is obviously reduced (P is less than 0.01), and the contraction strength is obviously reduced (P is less than 0.005). Specific results are shown in tables 3 and 4.
TABLE 3 Effect on frequency of contraction of Normal isolated uterus
Note: p <0.05, P <0.01 for each group compared to each other before and after administration
TABLE 4 Effect on the contractile Strength of Normal isolated uterus
Note: p <0.05, P <0.01, P <0.005 after each group was dosed compared to after addition of oxytocin.
And (4) experimental conclusion: the cassia twig and poria cocos capsules and the high, medium and low dose groups of the traditional Chinese medicine composition can obviously inhibit in-vitro uterine smooth muscle contraction caused by oxytocin, and the contraction frequency and the contraction strength are obviously reduced.
Example 6 Effect of the Chinese medicinal composition on oxytocin-induced dysmenorrheal model in mice
Animals: 60 Kunming mice with the weight of 18-22 g and female bodies are purchased from the center of medical experimental animals in Guangdong province.
Medicine preparation: aspirin (guangdong jiuming pharmaceutical co., ltd.), estradiol benzoate (guangxing pharmaceutical co., ltd., white cloud mountain, guangzhou), oxytocin (shanghai hufeng pharmaceutical co., ltd.), and the Chinese medicinal composition was the one prepared in example 1.
The experimental method comprises the following steps:
(1) grouping experiments: the 60 Kunming mice are randomly divided into six groups, namely a normal control group, a model group, an aspirin positive control group, a traditional Chinese medicine composition high-dose group, a traditional Chinese medicine composition medium-dose group and a traditional Chinese medicine composition low-dose group, wherein each group contains 10 mice, and the administration dose is shown in a table 5.
(2) Administration: the positive Chinese medicinal materials and the high, medium and low dosage groups of the Chinese medicinal composition are continuously infused with stomach for 10 days according to dosage, and the normal control group and the model group are infused with 0.2mL of physiological saline every day. In addition to the normal control group, the other groups were simultaneously subcutaneously injected with estradiol benzoate at 2mg/kg daily.
(3) 1h after the administration on the 10 th day, the mice in each group are subjected to intraperitoneal injection of oxytocin by 25U/kg, the writhing latency period and the writhing frequency of the mice within 30min after the injection are recorded, the analgesic rate is calculated, and the experimental results are shown in a table 5. Percent (%) analgesia is (mean of torsion in model group-mean of torsion in administration group)/mean of torsion in model group × 100%.
TABLE 5 influence of Chinese medicinal composition on oxytocin-induced dysmenorrheal model in mice
Note: p in comparison with model control group<0.05，**P<0.01，***P<0.005; in contrast to the normal control group,#P<0.05，##P<0.01，###P<0.01。
the experimental results are as follows: after 10 continuous days of subcutaneous injection of estradiol benzoate, the abdominal cavity is injected with oxytocin, the rat dysmenorrheal can be caused, compared with a normal control group, the model group has the advantages that the torsion latency is remarkably prolonged (P is less than 0.005), the torsion frequency is remarkably reduced (P is less than 0.005), and the model building is successful. Compared with a model control group, the high, medium and low dosage groups of the traditional Chinese medicine composition can obviously prolong the incubation period of mouse writhing reaction and reduce the times of writhing, and have significant difference (P is less than 0.05); the analgesic rate of the high-dose group of the traditional Chinese medicine composition is higher than that of the positive medicine group, which shows that the high-dose group of the traditional Chinese medicine composition has better analgesic effect.
Example 7 effect on number of open sites of capillary cross-overs in rat uterine ligaments.
Animals: 50 Kunming rats, female, with the weight of 180-220 g, were purchased from Guangdong province medical laboratory animal center.
Medicine preparation: guizhi Fuling Jiaonang (Jiangsu Kangyuan pharmaceutical industry Co., Ltd.); the traditional Chinese medicine composition is prepared in example 1.
The experimental method comprises the following steps:
(1) grouping: the 50 Kunming rats are randomly divided into five groups, each group comprises 10 rats, and the rats are respectively a control group, a positive medicine group and a traditional Chinese medicine composition high, medium and low dose groups.
(2) Administration: the test drugs were administered by gavage, and the control group was administered with an equal volume of physiological saline for three consecutive days.
(3) Injecting pentobarbital sodium into abdominal cavity at a dose of 50mg/kg for anesthesia, cutting open abdominal cavity to pull out uterus and ligament, fixing in 10mL Rockwell physiological balanced solution, controlling temperature at 37 deg.C, stabilizing for 30min, observing and counting capillary at 1mm before administration with 4 × 10 times inverted microscope2The number of crossing points in the range, the pylorus ligation, the administration volume of each group in duodenum was 4mL, the normal control group was administered with physiological saline of the same volume, and the number of crossing of the capillary network points was observed by the same method 30min after administration. Percent increase (%) - (open capillary cross-site after administration-open capillary cross-site in control group)/open capillary cross-site in control group × 100％。
TABLE 6 influence of Chinese medicinal composition on the number of open cross-dots of rat capillary
Note: p <0.05, P <0.01, P <0.005, compared to control.
The experimental results are as follows: as can be seen from table 6, the number of open capillary cross-over points measured by the high, medium and low dose groups of the traditional Chinese medicine composition and the cinnamomi poria group was significantly increased (P <0.05) compared to the control group; the activity of the middle-dose group and the high-dose group of the traditional Chinese medicine composition is stronger than that of the positive medicine of the cassia twig and the tuckahoe, which shows that the traditional Chinese medicine composition has stronger blood circulation activating effect than that of the positive medicine of the cassia twig and the tuckahoe capsule.
Example 8 preparation of a Chinese medicinal composition capsule for the treatment of dysmenorrhea
Taking 60g of the traditional Chinese medicine composition prepared in the example 1, 150g of starch and 20g of carboxymethyl starch, mixing uniformly, adding 70% ethanol to prepare a soft material, sieving, drying, granulating, adding 0.62g of magnesium stearate, mixing uniformly, filling into No. 1 capsules, preparing into 1000 capsules, and polishing to obtain the traditional Chinese medicine composition capsules. Each capsule contains 60mg of the Chinese medicinal composition. It is administered orally 2 capsules each time, 3 times daily.
Example 9 preparation of Chinese medicinal composition granule for treating dysmenorrhea
Taking 120g of the traditional Chinese medicine composition prepared in the embodiment 2, adding an appropriate amount of one or more of diluting auxiliary materials such as silicon dioxide, starch mannitol, xylitol, sorbitol, glycine and the like, drying, uniformly mixing, adding an appropriate adhesive such as one or more of PEG200, microcrystalline cellulose, gelatin slurry, starch slurry, syrup and the like, granulating, and finishing granules to prepare 1000 doses of granules, wherein each dose contains 120mg of the traditional Chinese medicine composition, and the oral administration is carried out for 1 bag each time and 3 times a day.
Claims (11)
1. A traditional Chinese medicine composition with the effect of preventing and/or treating dysmenorrhea is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 3-9 parts of galangal, 4-12 parts of fingered citron, 4-12 parts of rose and 1-5 parts of pseudo-ginseng.
2. The traditional Chinese medicine composition with the effect of preventing and/or treating dysmenorrhea according to claim 1, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 4-6 parts of galangal, 6-8 parts of fingered citron, 6-8 parts of rose and 2-3 parts of pseudo-ginseng.
3. The traditional Chinese medicine composition with the effect of preventing and/or treating dysmenorrhea according to claim 1, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 6 parts of galangal, 8 parts of fingered citron, 8 parts of rose and 3 parts of pseudo-ginseng.
4. A method for preparing the traditional Chinese medicine composition with the effect of preventing and/or treating dysmenorrhea according to any one of claims 1 to 3, which is characterized by comprising the following steps:
(1) decocting rhizoma Alpiniae Officinarum, fructus Citri Sarcodactylis, flos Rosae Rugosae and Notoginseng radix in water to obtain decoction;
(2) concentrating and drying the decoction to obtain an extract, thus obtaining the traditional Chinese medicine composition.
5. The method according to claim 4, wherein the amount of water used in step (1) is 5-20 times of the weight of the bulk drug of the Chinese medicinal material; the decocting times are 1-3 times, and each time is 0.5-1.5 hr.
6. The method of claim 4, further comprising after step (2):
and (3) crushing the extract prepared in the step (2) to obtain medicinal powder, thus obtaining the traditional Chinese medicine composition.
7. A medicament for treating dysmenorrhea, characterized by comprising the Chinese medicinal composition for preventing and/or treating dysmenorrhea according to any one of claims 1 to 3 as an active ingredient.
8. The medicament for treating dysmenorrhea according to claim 7, wherein the medicament is further added with pharmaceutically acceptable excipients to prepare tablets, concentrated pills, granules, capsules or oral liquid preparations.
9. Use of the Chinese medicinal composition for preventing and/or treating dysmenorrhea according to any one of claims 1-3 in the preparation of a medicament.
10. The use according to claim 9, wherein the medicament is a medicament for the prevention and/or treatment of dysmenorrhea.
11. The use according to claim 9, wherein the medicament is a medicament for inhibiting uterine smooth muscle contraction, a medicament having analgesic effect and/or a medicament having blood activating effect.
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| CN1785410A (en) * | 2005-11-09 | 2006-06-14 | 广州中一药业有限公司 | Preparation method of ready prepared chinese medicinal granules for treathing pains |
| CN102488763A (en) * | 2011-12-28 | 2012-06-13 | 吕慧侠 | Composition with functions of treating dysmenorrhoea and beautifying |
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| CN1785410A (en) * | 2005-11-09 | 2006-06-14 | 广州中一药业有限公司 | Preparation method of ready prepared chinese medicinal granules for treathing pains |
| CN102488763A (en) * | 2011-12-28 | 2012-06-13 | 吕慧侠 | Composition with functions of treating dysmenorrhoea and beautifying |
Non-Patent Citations (2)
| Title |
|---|
| 妇女痛经的药膳食疗;王美英，等;《中药材》;20031231;第26卷(第12期);第921-922页 * |
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