AU2015203092B1 - Pharmaceutical composition for treatment of menopausal syndrome and preparation method thereof - Google Patents

Pharmaceutical composition for treatment of menopausal syndrome and preparation method thereof Download PDF

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AU2015203092B1
AU2015203092B1 AU2015203092A AU2015203092A AU2015203092B1 AU 2015203092 B1 AU2015203092 B1 AU 2015203092B1 AU 2015203092 A AU2015203092 A AU 2015203092A AU 2015203092 A AU2015203092 A AU 2015203092A AU 2015203092 B1 AU2015203092 B1 AU 2015203092B1
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parts
pharmaceutical composition
fructus
herbs
treatment
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AU2015203092A
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Wencheng WANG
Luping Yu
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Thisherb Health Pty Ltd
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Thisherb Health Pty Ltd
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Priority to AU2015203092A priority Critical patent/AU2015203092B1/en
Priority to CN201610108706.9A priority patent/CN105664108A/en
Priority to PCT/CN2016/084647 priority patent/WO2016197878A1/en
Priority to GB1718483.9A priority patent/GB2554010A/en
Publication of AU2015203092B1 publication Critical patent/AU2015203092B1/en
Priority to HK18104524.7A priority patent/HK1245097A1/en
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    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
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Abstract

Abstract Disclosed is a pharmaceutical composition for the treatment of Menopausal Syndrome, wherein the pharmaceutical composition is consisted of the following herbs in weight parts: 5 1-3 parts Ramulus Cinnamomi, 0.5-2 parts Rhizoma Zingiberis, 2-4 parts Fructus Schisandrae Chinensis, 2-4 parts Flos Inulae, 3.5-5 parts Herba Lophatheri, 2-4 parts Cortex Moutan Radicis, 0.5-2 parts Fructus Jujubae, 2-4 parts Semen Ziziphi Spinosae, 2-4 parts Fructus Corni, 2-4 parts Radix Rehmanniae Recens, 2-4 parts Radix Codonopsis, and 0.5-2 parts Fructus Gardeniae. All herbs of the composition have synergistic effects to tonify liver and 10 supplement qi, nourish blood and tranquilize mind, clear deficient heat, and relieve restlessness. This invention also discloses a method for preparing the pharmaceutical composition for the treatment of Menopausal Syndrome, which is easy to implement, simple, safe and reliable, and suitable for industrial scale production.

Description

PHARMACEUTICAL COMPOSITION FOR TREATMENT OF MENOPAUSAL SYNDROME AND PREPARATION METHOD THEREOF
FIELD OF THE INVENTION
The present invention relates to a compound preparation of traditional Chinese medicine, in particular to a pharmaceutical composition for the treatment of Menopausal Syndrome and the preparation method thereof.
BACKGROUND OF THE INVENTION
Menopausal syndrome (MPS) is a series of symptoms caused by dropping levels of estrogen. Because the body cannot adapt quickly during menopause, some women will experience more obvious symptoms, but in generally they do not need special treatments. As for the women having severe symptoms even their daily life and work are severely affected, they need to use traditional Chinese medicine to invigorate kidney and bring back to health. It is generally believed that during the menopause transition years, the changes in family and social environment can increase women’s physical and mental burdens so that they are more prone to experience menopausal syndrome or the existing symptoms would be aggravated. For some mentally unstable women, their menopausal syndrome and even moodiness are more apparent. Although menopausal syndrome is caused by sex physiological changes, the incidence is directly related to the level of personal experience and psychological burden. For the ppsychological sensitive menopausal women, any physical discomfort is likely to cause more psychological changes, which lead to a variety of menopausal symptoms. Therefore, it is important to pay attention to the psychological adjustment.
During the treatment for menopausal syndrome, doctors usually recommend oral medication without implanting and intramuscularly injection. Topical applications are limited to senile virginities, and not suitable for long-term applications. It should be noted that the hormone replacement therapy must be sparingly used with cautions for women who have a history of thrombosis, chronic liver and kidney dysfunction, sex hormone dependent tumors, Pyrrole rhodopsin (PAP), severe high blood pressure, diabetes, severe varicose veins and smoking or cannot adhere to a long-term follow-up examination. In addition, women who receive hormone replacement therapy should review their cases or visit a clinic every 3 months. When necessary, a gynecological examination and even ultrasound and endometrial biopsy should be received. In breast examination, it must pay attention to lobular hyperplasia or lumps, and monitor the heart, liver, gall bladder, and blood functions.
At present, there are still many disadvantages in hormone replacement therapy which will bring risks to women undergoing such therapy, such as increasing liver load and the probability incidence of endometrial cancer, breast cancer, thrombotic diseases, cholelithiasis and so on. The topical steroids paste that is available now on the market is also have many shortcomings, such as common occurrences of skin ulcers and allergies due to the envelopment therapy of patch preparations. The poor ventilation of the rubber plaster often leads to skin irritation and allergies, and the curing time of gels in the plaster is not easy to control which causes poor adhesion, paste spillages and other problems.
SUMMARY OF THE INVENTION
The present invention provides a pharmaceutical composition for the treatment of menopausal syndrome and its preparation method. The method is believed to be simple, safe and reliable, and suitable for industrial production.
Disclosed is a pharmaceutical composition for the treatment of Menopausal Syndrome, wherein the pharmaceutical composition is consisted of the following herbs in weight parts: 1-3 parts Ramulus Cinnamomi, 0.5-2 parts Rhizoma Zingiberis, 2-4 parts Fructus Schisandrae Chinensis, 2-4 parts Flos Inulae, 3.5-5 parts Herba Lophatheri, 2-4 parts Cortex Moutan
Radicis, 0.5-2 parts Fructus Jujubae, 2-4 parts Semen Ziziphi Spinosae, 2-4 parts Fructus Corni, 2-4 parts Radix Rehmanniae Recens, 2-4 parts Radix Codonopsis, and 0.5-2 parts Fructus Gardeniae. The pharmaceutical composition for the treatment of Menopausal Syndrome of the present invention has a high degree of safety and ideal effects for ameliorating Menopausal Syndrome. It is believed that the pharmaceutical composition resolves one or more of the technical problems in prior hormone replacement therapy, such as heavy loads on the liver and increasing probability of the incidence of endometrial cancer, breast cancer, thrombotic diseases and cholelithiasis.
Ramulus Cinnamomi is also known as cassia twig or cinnamon twig. Quality: Pungent, Sweet, Warm. Meridians: Heart, Lung, Bladder. Actions: Induces sweating, warms and unblocks Meridian channels, reinforces yang transforming qi, and suppresses qi from rushing upwards.
Rhizoma Zingiberis is also known as dried ginger. Quality: Pungent, Hot. Meridians: Spleen, Stomach, Kidney, Heart, Lung. Actions: Warms the spleen and stomach, restores devastated yang, warms the lung to transform thin mucus, warms and unblocks channels.
Fructus Schisandrae Chinensis is also known as Chinese magnoliavine fruit. Quality: Sour, Sweet, Warm. Meridians: Lung, Heart, Kidney. Actions: Induces astringency, benefits qi for promoting fluid production, nourishes the kidneys and calms the hearts.
Flos Inulae is also known as inula flower. Quality: Bitter, Pungent, Salty, slightly Warm. Meridians: Lung, Spleen, Stomach, Large Intestine. Actions: descends qi, dissipates phlegm, activates water, arrests vomitting.
Herba Lophatheri is also known as lophatherum herb. Quality: Sweet, Bland, Cold. Meridians: Heart, Stomach, Small Intestine. Actions: clears hear-fire, clears annoyance and quenches thirst, increases urine and removes stone.
Cortex Moutan Radicis is also known as tree peony root bark. Quality: Bitter, Pungent, slightly Cold. Meridians: Heart, Liver, Kidney. Actions: clears heat and cools blood, ppromotes blood circulation and removes blood stasis.
Fructus Jujubae is also known as Chinese date. Quality: Sweet, Warm. Meridians: Spleed, Stomach, Heart. Actions: invigorates spleen and replenishes qi, nourishes blood and tranquilizes mind.
Semen Ziziphi Spinosae is also known as spine date seed. Quality: Sweet, Sour, Neutral. Meridians: Liver, Bladder, Heart. Actions: invigorates heart and liver, calms heart and tranquilizes mind, astringes sweat, promotes fluid production.
Fructus Corni is also known as asiatic cornelian cherry fruit. Quality: Sour, Astringent, slightly Warm. Meridians: Liver, Kidney. Actions: invigorates liver and kidney, astringes for relieving desertion.
Radix Rehmanniae Recens is also known as unprocessed rehmannia root. Quality: Sweet, Cold. Meridians: Heart, Liver, Kidney. Actions: clears heat and cools blood, nourishes Yin and promotes fluid production.
Radix Codonopsis is also known as tangshen. Quality: Sweet, Neutral. Meridians: Spleen, Lung. Actions: invigorates spleen and benefits lung, nourishes blood and promotes fluid production.
Fructus Gardeniae is also known as cape jasmine fruit. Quality: Bitter, Cold. Meridians: Heart, Lung, Sanjiao. Actions: clears heat-fire and arrests annoyance, clears heat and promotes diuresis, cools blood and removes toxin.
Preferably, the pharmaceutical composition is consisted of the following herbs in weight ratios: 1- 2.5 parts Ramulus Cinnamomi, 0.5-1.5 parts Rhizoma Zingiberis, 2-3.5 parts Fructus Schisandrae Chinensis, 2-3.5 parts Flos Inulae, 3.5-4.8 parts Herba Lophatheri, 2-3.5 parts Cortex Moutan Radicis, 0.5-1.5 parts Fructus Jujubae, 2-3.5 parts Semen Ziziphi Spinosae, 2- 3.5 parts Fructus Comi, 2-3.5 parts Radix Rehmanniae Recens, 2-3.5 parts Radix Codonopsis, and 0.5-1.5 parts Fructus Gardeniae.
More preferably, the pharmaceutical composition per 30.5g is consisted of the following herbs in weight: Ramulus Cinnamomi 2g, Rhizoma Zingiberislg, Fructus Schisandrae Chinensis 3g, Flos Inulae 3g, Herba Lophatheri 4.5g, Cortex Moutan Radicis 3g, Fructus Jujubae lg, Semen Ziziphi Spinosae 3g, Fructus Corni 3g, Radix Rehmanniae Recens 3g, Radix Codonopsis 3g, and Fructus Gardeniae lg.
Preferably, the pharmaceutical composition for the treatment of menopausal syndrome is manufactured in the form of oral liquid, tablets, capsules, pills, dropping pills, or granules. A method for preparing the pharmaceutical composition for the treatment of menopausal syndrome comprises the following steps that: A. All the 12 herbs are blended and boiling decocted by three times and the amount of water added in the decoction process is 7-10 times the total weight of the herbs, wherein the first decoction for 1.5-3h, the second decoction for l-2h and the third decoction for 0.5-1.5h, when the amount of water added is 7-10 times the total weight of the herbs, the dissolution effects of the herbs will be better during the decoctions, and when the herbs are boiling decocted by three times, the extraction effects of the herbs will be more ideal; B. The filtrates from the three decoctions are combined and concentrated into an extracting solution with relative density of 1.20-1.25; and C. The extracting solution is added with ethanol to a concentration of 50-80%, standing for 24h, and the supernatant is removed and concentrated into an alcohol extract with relative density of 1.12-1.20 which is then dried to obtain the pharmaceutical composition for the treatment of menopausal syndrome, wherein the non-alcohol-soluble substances such as starch, protein, etc. are removed from the decocted extracting solution and forms an extracting solution having a concentration of alcohol by adding ethanol, and then a solid-liquid separation is performed by precipitation at room temperature or preferably lower temperature to improve the concentration and clarity of the alcohol extract and the product quality.
Preferably, the method comprises step D that the pharmaceutical composition is added with starch and homogenized before filling into capsules.
Preferably, the step B further comprises that after the filtrate is combined, the combined filtrate is concentrated into an extract with relative density of 1.20-1.25 at 60 °C.
Preferably, the step C comprises that the supernatant is concentrated into an extract relative density of 1.12-1.20 at 60 °C and spray-dried to obtain the pharmaceutical composition for the treatment of menopausal syndrome.
The present invention is a pharmaceutical composition prepared from traditional medicinal herbs of Ramulus Cinnamomi, Rhizoma Zingiberis, Fructus Schisandrae Chinensis, Flos Inulae, Herba Lophatheri, Cortex Moutan Radicis, Fructus Jujubae, Semen Ziziphi Spinosae, Fructus Comi, Radix Rehmanniae Recens, Radix Codonopsis, and Fructus Gardeniae. After clinical trials, all the 12 herbs have a synergistic effect with the following results: the pharmaceutical composition can supplement the liver and enriches the qi, nourishes the blood and calms the mind, clears internal heat, and relieves worries, which is especially applicable for women with menopausal syndrome that is induced by deficiency of Yin in their livers and kidneys. It is believed that the pharmaceutical composition for the treatment of menopausal syndrome consisted of the raw materials in such ratios offers a high degree of safety and is effective for improving the symptoms of menopause.
It is believed that the preparation method of the present invention is a simple operation, and is environmentally friendly, economic, efficient, non-toxic, and has the prospect of broad applications. DESCRIPTION OF THE PREFERRED EMBODIMENTS Example 1 A pharmaceutical composition for treatment of menopausal syndrome is manufactured in form of pillors, in which the pharmaceutical composition is consisted of the following herbs in weight parts: 1 part Ramulus Cinnamomi, 0.5 part Rhizoma Zingiberis, 2 parts Fructus Schisandrae Chinensis, 2 parts Flos Inulae, 3.5 parts Herba Lophatheri, 2 parts Cortex Moutan Radicis, 0.5 parts Fructus Jujubae, 2 parts Semen Ziziphi Spinosae, 2 parts Fructus Corni, 2 parts Radix Rehmanniae Recens, 2 parts Radix Codonopsis, and 0.5 parts Fructus Gardeniae.
The method for preparing the pharmaceutical composition for the treatment of menopausal syndrome comprises the following steps that: A. All the 12 herbs are blended and boiling decocted by three times and the amount of water added in the decoction process is 7-10 times of the total weight of the herbs, wherein the first decoction for 1.5h, the second decoction for 1.5h and the third decoction for 0.5h; B. The filtrates from the three decoctions are combined and concentrated into an extracting solution with relative density of 1.20; and C. The extracting solution is added with ethanol to a concentration of 50%, standing for 24h, and the supernatant is removed and concentrated into an alcohol extract with relative density of 1.12, and then blended and pelletized to obtain the pharmaceutical composition for the treatment of menopausal syndrome.
Example 2 A pharmaceutical composition for treatment of menopausal syndrome is manufactured in form of oral liquid, in which the pharmaceutical composition is consisted of the following herbs in weight parts: 3 part Ramulus Cinnamomi, 2 part Rhizoma Zingiberis, 4 parts Fructus Schisandrae Chinensis, 4 parts Flos Inulae, 5 parts Herba Lophatheri, 4 parts Cortex Moutan Radicis, 2 parts Fructus Jujubae, 4 parts Semen Ziziphi Spinosae, 4 parts Fructus Corni, 4 parts Radix Rehmanniae Recens, 4 parts Radix Codonopsis, and 2 parts Fructus Gardeniae.
The method for preparing the pharmaceutical composition for the treatment of menopausal syndrome comprises the following steps that: A. All the 12 herbs are blended and boiling decocted by three times and the amount of water added in the decoction process is 10 times of the total weight of the herbs, wherein the first decoction for 3h, the second decoction for 2h and the third decoction for 1.5h; B. The filtrates from the three decoctions are combined and concentrated into an extracting solution with relative density of 1.20 at 60 °C; and C. The extracting solution is added with ethanol to a concentration of 80%, standing for 24h, and the supernatant is removed and concentrated into an alcohol extract with relative density of 1.12 at 60 °C, and then batched and filled to obtain the pharmaceutical composition for the treatment of menopausal syndrome.
Example 3 A pharmaceutical composition for treatment of menopausal syndrome is manufactured in form of tablets, in which the pharmaceutical composition is consisted of the following herbs in weight parts: 2.5 part Ramulus Cinnamomi, 1.5 part Rhizoma Zingiberis, 3.5 parts Fructus Schisandrae Chinensis, 3.5 parts Flos Inulae, 4.8 parts Herba Lophatheri, 3.5 parts Cortex Moutan Radicis, 1.5 parts Fructus Jujubae, 3.5 parts Semen Ziziphi Spinosae, 3.5 parts Fructus Corni, 3.5 parts Radix Rehmanniae Recens, 3.5 parts Radix Codonopsis, and 1.5 parts
Fructus Gardeniae.
The method for preparing the pharmaceutical composition for the treatment of menopausal syndrome comprises the following steps that: A. All the 12 herbs are blended and boiling decocted by three times and the amount of water added in the decoction process is 8 times of the total weight of the herbs, wherein the first decoction for 2h, the second decoction for 1.5h and the third decoction for lh; B. The filtrates from the three decoctions are combined and concentrated into an extracting solution with relative density of 1.23 at 60 °C; and C. The extracting solution is added with ethanol to a concentration of 60%, standing for 24h, and the supernatant is removed and concentrated into an alcohol extract with relative density of 1.15 at 60 °C, and then spray dried, granulated and compressed to obtain the pharmaceutical composition for the treatment of menopausal syndrome.
Example 4 A pharmaceutical composition for treatment of menopausal syndrome is manufactured in form of capsules, in which the pharmaceutical composition is consisted of the following herbs in weight parts: 2 part Ramulus Cinnamomi, 1 part Rhizoma Zingiberis, 3 parts Fructus Schisandrae Chinensis, 3 parts Flos Inulae, 4.5 parts Herba Lophatheri, 3 parts Cortex Moutan Radicis, 1 parts Fructus Jujubae, 3 parts Semen Ziziphi Spinosae, 3 parts Fructus Corni, 3 parts Radix Rehmanniae Recens, 3 parts Radix Codonopsis, and 1 part Fructus Gardeniae.
The method for preparing the pharmaceutical composition for the treatment of menopausal syndrome comprises the following steps that: A. All the 12 herbs are blended and boiling decocted by three times and the amount of water added in the decoction process is 8 times of the total weight of the herbs, wherein the first decoction for 2h, the second decoction for 1.5h and the third decoction for lh; B. The filtrates from the three decoctions are combined and concentrated into an extracting solution with relative density of 1.23 at 60 °C; C. The extracting solution is added with ethanol to a concentration of 80%, standing for 24h, and the supernatant is removed and concentrated into an alcohol extract with relative density of 1.15 at 60 °C, and then spray dried; and D. Adding starch, blending and encapsulating to obtain the pharmaceutical composition for the treatment of menopausal syndrome.
Example 5 A pharmaceutical composition for treatment of menopausal syndrome is manufactured in form of granules, in which the pharmaceutical composition per 30.5g is consisted of the following herbs in weights: Ramulus Cinnamomi 2g, Rhizoma Zingiberis lg, Fructus Schisandrae Chinensis 3g, Flos Inulae 3g, Herba Lophatheri 4.5g, Cortex Moutan Radicis 3g, Fructus Jujubae lg, Semen Ziziphi Spinosae 3g, Fructus Comi 3g, Radix Rehmanniae Recens 3g, Radix Codonopsis 3g, and Fructus Gardeniae lg.
The method for preparing the pharmaceutical composition for the treatment of menopausal syndrome comprises the following steps that: A. All the 12 herbs are blended and boiling decocted by three times and the amount of water added in the decoction process is 10 times of the total weight of the herbs, wherein the first decoction for 3h, the second decoction for 2h and the third decoction for 1.5h; B. The filtrates from the three decoctions are combined and concentrated into an extracting solution with relative density of 1.25 at 60 °C; and C. The extracting solution is added with ethanol to a concentration of 80%, standing for 24h, and the supernatant is removed and concentrated into an alcohol extract with relative density of 1.20 at 60 °C, and then dried and pelletized to obtain the pharmaceutical composition for the treatment of menopausal syndrome.
Example 6 A pharmaceutical composition for treatment of menopausal syndrome is manufactured in form of dripping pills, in which the pharmaceutical composition is consisted of the following herbs in weight parts: 2 part Ramulus Cinnamomi, 1 part Rhizoma Zingiberis, 3 parts Fructus Schisandrae Chinensis, 3 parts Flos Inulae, 4.5 parts Herba Lophatheri, 3 parts Cortex Moutan Radicis, 1 parts Fructus Jujubae, 3 parts Semen Ziziphi Spinosae, 3 parts Fructus Corni, 3 parts Radix Rehmanniae Recens, 3 parts Radix Codonopsis, and 1 part Fructus Gardeniae.
The method for preparing the pharmaceutical composition for the treatment of menopausal syndrome comprises the following steps that: A. All the 12 herbs are blended and boiling decocted by three times and the amount of water added in the decoction process is 10 times of the total weight of the herbs, wherein the first decoction for 3h, the second decoction for 2h and the third decoction for 1.5h; B. The filtrates from the three decoctions are combined and concentrated into an extracting solution with relative density of 1.25 at 60 °C; and C. The extracting solution is added with ethanol to a concentration of 80%, standing for 24h, and the supernatant is removed and concentrated into an alcohol extract with relative density of 1.20 at 60 °C, and then batched and made into pills to obtain the pharmaceutical composition for the treatment of menopausal syndrome.
Example 7 1 Drugs and Materials 1.1 Drug testing and reagents: The pharmaceutical compositions for the treatment of menopausal syndrome in form of capsules obtained in Example 4. 1.2 Animals: Female ICR mice provided by the Experimental Animal Center of Zhejiang Province; animal breeding certificate: Zhejiang Medical Animals No. 2001001. 2 Methods and Results 2.1 Sedative, hypnotic and anticonvulsant effects of menopause capsules on normal mice: 52 pcs ICR mice (female, weight 18~22g) are divided into four groups according to drug administration protocols (the pharmaceutical composition capsules for the treatment of menopausal syndrome obtained from Example 4). A normal control group is fed with water at 0.2ml / lOg per day; and the remaining three test groups are administered orally daily doses of the capsules at 2.0g / kg, 1.0 g / kg, and 0.5 g / kg respectively. At 30 minutes after the first eighth dosing, the independent activity numbers of mice are measured within 5 minutes by a Locomotor activity meter (XZ-4 type, from the Drug Institute of Chinese Academy), and at 30 minutes after the 9th administration, the mice are intraperitoneally injected with 50mg / kg of amyl pentobarbital sodium and their latent sleep time (latency) and sleep time are recorded. At 30 minutes after the 10th dose, the mice are given an intraperitoneal dose of Nikethamide 350mg / kg, and their mortality rate caused by convulsions and seizures is observed. No seizures are calculated as 100 minutes.
Table 1: Sedative and hypnotic effects of menopausal capsules on normal mice (x ± s)
Compared with control group * P <0.05, ** P <0.01
The results in Table 1 show that the menopausal capsule significantly inhibits the occurrence of convulsions and seizures caused by Nikethamide in mice. It also significantly delays and reduces the incidence of seizures. The results suggest that in normal mice, the menopausal capsule has obvious sedative and anticonvulsant effects. 2.2 Sedation effects of Menopausal capsule in elderly female mice: 52pcs ICR mice (15-month-old, female, weigh 28~40g) are divided into four groups according to drug administration protocols (the pharmaceutical composition capsules for the treatment of menopausal syndrome obtained from Example 4). A normal control group is fed with water at 0.2ml / lOg per day; and the remaining three test groups are administered orally daily doses of the capsules at 2.0g / kg, 1.0 g / kg, and 0.5 g / kg respectively. All groups of the mice are bred in a conventional manner in the laboratory for 20 days, and then start to be given the menopausal capsules or an equal volume of water. At 30 minutes after administration on the 10th and 20th day, the independent activity numbers of mice are measured within 5 minutes. At 20 minutes after administration on the 21th day, the mice are intra-peritoneally injected with amphetamine at lOmg / kg and the independent activity numbers of mice are measured within 5 minutes after 10 minutes. At the end of the experiments, the mice are sacrificed and their uterus, ovaries and adrenal glands are removed and weighed.
Table 2: Effect s of the menopausal capsules on sedation of aged mice (x ± s)
The results in Table 2 show that 10-day menopause capsule administration had no significant effect on spontaneous activity in aged mice, but 20 days of administration of high-dose group showed a significant central inhibition. Large-dose menopause capsules and medium-dose groups had significantly inhibited central amphetamine-induced excitement. Menopause capsules increased adrenal weights, but did not demonstrate stimulating effect on the uterus and ovaries. 2.3 Effects of the menopausal capsule on mice with immune function in Yin deficiency: 76 pcs ICR mice (female, weigh 22~25g) are divided into five groups according to drug administration protocols (the pharmaceutical composition capsules for the treatment of menopausal syndrome obtained from Example 4). The first group is a control group that is fed with water at 0.2ml / lOg per day; the second group is fed daily for consecutive 20 days with thyroxine 0.3 mg and reserpine 0.02mg. The remaining three groups are fed orally with thyroxine 0. 3mg and reserpine 0.02mg daily for 20 consecutive days, and concomitantly a daily dose of menopausal pharmaceutical composition at 2.0g / kg, 1.0 g / kg and 0.5 g / kg respectively. On the 14th day, the independent activity numbers of mice are measured. On the 15th day, the mice are given intra peritoneal injection of 5% Sheep erythrocytes at 0.2ml/ mouse. On the 21st day, a sample of blood from the femoral artery is collected, the blood serum is separated and the serum hemolysin level determined. The mouse spleen is removed by sterile technique and the lymphocyte transformation and NK cell killing rate are measured.
Table 3: Effect of menopausal capsule on immune function on Yin deficiency mice (x ± s)
Compared with the model group, * P <0.05
The results in Table 3 show that the thyroxine and reserpine induced weight loss and development of fluffy yellow coat in mice and increased their activities. There was a significant Yin deficiency in symptoms. The menopausal capsules significantly increased body weight in mice and improved their appearance. There was also a significant decline in their independent activity numbers. Yin deficient mice showed significant decrease in their humoral and cellular immune functions. The menopause capsule significantly improved cell immune function (lymphocyte transformation) activity but had no significant impact on the specific humoral immune function (HC50) and NK cell activity of immune deficient mice. 2.4 Protective effect of menopausal capsule on Yin deficiency mice 70 pcs ICR mice (female, weigh 22~24g) are divided into five groups according to drug administration protocols (the pharmaceutical composition capsules for the treatment of menopausal syndrome obtained from Example 4). The first group is a control group that is fed with water 0.2ml / lOg per day; the second group is injected every morning with cortisone acetate lmg / mouse only for 7 days; the remaining three groups are given every morning intramuscular cortisone acetate lmg / mouse only, while the amount of menopausal capsule administered orally every afternoon are 2.0g / kg, 1.0 g / kg, 0.5 g / kg respectively for 7 days. On the third day the mice are given by an intra peritoneal injection of 20% sheep erythrocytes 0.2ml /mouse. One day after the last test solution administration, femoral arterial blood collected, thymus and spleen weighed; organ coefficient calculation, serum lectin and hemolysin level determined.
Table 4: Effect of menopausal capsule on Yang deficiency mice (x ± s)
The results in Table 4 show that the corticosteroids caused significant Yang deficiency symptoms in mice including significant weight loss, fluffy fur, reduced activity, hypothermia, unresponsiveness and so on. The menopausal capsule partially restored corticosteroid-induced weight loss and the general state of the animals was relatively good. Glucocorticoid led to a reduction in the weight of the immune organs in mice and significantly decreased their ability to produce specific antibodies. The menopausal capsules significantly restored the weight of the spleen and thymus in mice, their specific immune function was also restored.
In summary, the above descriptions are only examples of the preferred embodiments of the present invention. Any equivalent changes or modifications to the invention within the scope of the present disclosure are also fallen into the scope of the present invention.
The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement of any form of suggestion that such prior art forms part of the common general knowledge.
It will be understood that the term “comprise” and any of its derivatives (eg comprises, comprising) as used in this specification is to be taken to be inclusive of features to which it refers, and is not meant to exclude the presence of any additional features unless otherwise stated or implied.

Claims (10)

  1. THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
    1. A pharmaceutical composition for the treatment of Menopausal Syndrome, wherein the pharmaceutical composition consists of the following herbs in weight parts: Ramulus Cinnamomi 1-3 parts, Rhizoma Zingiberis 0.5-2 parts, Fructus Schisandrae Chinensis 2-4 parts, Flos Inulae 2-4 parts, Herba Lophatheri 3.5-5 parts, Cortex Moutan Radicis 2-4 parts, Fructus Jujubae 0.5-2 parts, Semen Ziziphi Spinosae 2-4 parts, Fructus Comi 2-4 parts, Radix Rehmanniae Recens 2-4 parts, Radix Codonopsis 2-4 parts, and Fructus Gardeniae 0.5-2 parts.
  2. 2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition consists of the following herbs in weight parts: Ramulus Cinnamomi 1-2.5 parts, Rhizoma Zingiberis 0.5-1.5 parts, Fructus Schisandrae Chinensis 2-3.5 parts, Flos Inulae 2-3.5 parts, Herba Lophatheri 3.5-4.8 parts, Cortex Moutan Radicis 2-3.5 parts, Fructus Jujubae 0.5-1.5 parts, Semen Ziziphi Spinosae 2-3.5 parts, Fructus Comi 2-3.5 parts, Radix Rehmanniae Recens 2-3.5 parts, Radix Codonopsis 2-3.5 parts, and Fructus Gardeniae 0.5-1.5 parts.
  3. 3. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition consists of the following herbs in weight parts: Ramulus Cinnamomi 2 parts, Rhizoma Zingiberis 1 part, Fructus Schisandrae Chinensis 3 parts, Flos Inulae 3 parts, Herba Lophatheri 4.5 parts, Cortex Moutan Radicis 3 parts, Fructus Jujubae 1 part, Semen Ziziphi Spinosae 3 parts, Fructus Comi 3 parts, Radix Rehmanniae Recens 3 parts, Radix Codonopsis 3 parts, and Fructus Gardeniae 1 part.
  4. 4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition per 30.5g consists of the following herbs in weights: Ramulus Cinnamomi 2g, Rhizoma Zingiberis lg, Fructus Schisandrae Chinensis 3g, Flos Inulae 3g, Herba Lophatheri 4.5g, Cortex Moutan Radicis 3g, Fructus Jujubae lg, Semen Ziziphi Spinosae 3g, Fructus Comi 3g, Radix Rehmanniae Recens 3g, Radix Codonopsis 3g, and Fmctus Gardeniae lg.
  5. 5. The pharmaceutical composition of any one of claims 1-4, wherein the pharmaceutical composition is in the form of an oral liquid, tablets, capsules, granules, pills, or dripping pills.
  6. 6. A method for preparing the pharmaceutical composition of any one of claims 1-4, comprising the steps that: A. Blending all the 12 herbs and boiling decocted by three times and the amount of water added in the decoction process is 7-10 times the total weight of the herbs, wherein the first decoction for 1.5-3h, the second decoction for l-2h and the third decoction for 0.5-1.5h; B. Combining the filtrates from the three decoctions and concentrating into an extracting solution with relative density of 1.20-1.25; and C. Adding ethanol to the extracting solution to a concentration of 50-80%, standing for 24h, removing the supernatant and concentrating into an alcohol extract with relative density of 1.12-1.20, and then drying to obtain the pharmaceutical composition.
  7. 7. The method according to claim 6, further comprising step D of adding starch to the pharmaceutical composition, homogenizing the mixture and filling into capsules.
  8. 8. The method according to claim 6, wherein step B comprises combining the filtrates at 60 °C and then concentrating to an extract of relative density of 1.20-1.25.
  9. 9. The method according to claim 6, wherein step C further comprises concentrating the supernatant at 60 °C to an extract of relative density of 1.12-1.20 and then spray drying to obtain the pharmaceutical composition.
  10. 10. A method of treating menopausal syndrome, the method comprising administering the pharmaceutical composition of any one of claims 1 to 5.
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