CN110251606B - Traditional Chinese medicine composition with sleep improving effect and preparation method thereof - Google Patents
Traditional Chinese medicine composition with sleep improving effect and preparation method thereof Download PDFInfo
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A61P25/00—Drugs for disorders of the nervous system
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- A23C2240/00—Use or particular additives or ingredients
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Abstract
The invention discloses a traditional Chinese medicine composition with a function of improving sleep, which is prepared from the following raw materials in parts by weight: 30-300 parts of spina date seed, 30-300 parts of prepared rehmannia root, 15-150 parts of dogwood, 15-150 parts of Chinese yam and 15-150 parts of motherwort. The preparation method comprises respectively decocting semen Ziziphi Spinosae, radix rehmanniae Preparata, Corni fructus, rhizoma Dioscoreae, and herba Leonuri in water, extracting, and filtering; mixing filtrates, freeze drying, and pulverizing to obtain water-extracted dry extract powder; dissolving the obtained dry extract powder and adjuvants in water, and making into health food with different dosage forms and flavors. According to the invention, the formula is selected according to the theory and clinical experience of traditional Chinese medical science food therapy recuperation, the traditional extraction method is adopted to extract the effective components by water decoction, the functional food capable of effectively improving sleep is provided, the whole formula is compatible for use, the functional food has the function of improving sleep, is safe and effective, has no toxic or side effect after long-term administration, and can be eaten for a long time.
Description
Technical Field
The invention belongs to the technical field of health-care food, and particularly relates to a traditional Chinese medicine composition with a sleep improving function and a method for preparing health-care food by using the same.
Background
Sleep is the most important and fundamental physiological activity of humans, sufficient and high quality sleep is necessary for humans, which accounts for approximately one-third of the time during a person's lifetime. Good sleep is a main sign of physical and mental health and is a basic physiological requirement of human beings. The fatigue can be eliminated and the physical strength can be recovered when the people sleep; protecting brain and restoring energy; enhancing immunity and recovering body; promoting growth; delaying aging; protecting mental health and caring skin. However, with the rapid development of Chinese economy, the living cost is gradually increased, the social competition is more and more intense, the pressure from various aspects of life, work, learning and the like born by people is increased, and most people are in a state of high mental stress for a long time. If the condition is not effectively improved, the sleep quality is affected, and insomnia is caused in severe cases. In recent years, insomnia is mainly manifested by insufficient sleep time and depth, difficulty in sleeping for light people, or difficulty in sleeping, waking when sleeping, or incapability of sleeping after waking, and insomnia for heavy people all night. In addition, insomnia affects the normal secretion of various hormones in the body, disturbs the distribution level of various hormones, causes the endocrine system of the human body to be disordered, and affects the normal development of the human body. Frequent insomnia can lead to inattention, reduced comprehension and reduced learning efficiency, thereby affecting the working state of people; the long-term insomnia can reduce the immunity of human bodies, lower the capability of disease resistance and rehabilitation, induce the attack of original diseases, and induce or aggravate cardiovascular and cerebrovascular diseases, cancers, diabetes, gastrointestinal diseases and the like in severe cases, even cause the generation of mental diseases, and shorten the life span.
At present, Western medicine is one of the main means for treating insomnia. The medicines for treating insomnia in the market mainly comprise barbiturates, melatonin and the like. Most of the medicines can shorten the time of falling asleep, prolong the sleep time and improve the sleep quality, but after the medicines are taken, side effects such as morning insomnia, daytime anxiety, addiction to the medicines and dependence of organisms are easily caused, and the medicines are not suitable for insomnia people of all ages.
The traditional Chinese medicine considers that insomnia is related to malnutrition of five internal organs and imbalance of yin and yang, and sleep can be improved only by calming heart and soothing nerves, nourishing yin and invigorating spleen to regulate balance of yin and yang of an organism. The five medicines are combined, and the tonifying and purging are performed simultaneously, and the tonifying is mainly performed, so that the Chinese medicinal composition has the functions of replenishing essence and marrow, nourishing blood and liver, calming heart and tranquilizing mind and improving sleep. In addition, the Chinese herbal medicine is more and more popular with consumers due to the advantages of mild medicine property, safety, no toxicity, difficult generation of drug resistance, suitability for long-term taking and the like.
So far, no other documents and patent publications report health-care food for improving the sleep of human bodies by adopting the formula.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for improving sleep and prepare the traditional Chinese medicine composition into health food, wherein the formula contains spina date seed, prepared rehmannia root, dogwood, Chinese yam and motherwort, the principles of traditional Chinese medicine syndrome differentiation and treatment are followed, the traditional Chinese medicines in the formula supplement each other, and the traditional Chinese medicine composition has an obvious effect of improving sleep.
The invention is realized by adopting the following technical scheme:
a traditional Chinese medicine composition with sleep improvement effect is prepared from the following components in parts by weight: 30-300 parts of spina date seed, 30-300 parts of prepared rehmannia root, 15-150 parts of dogwood, 15-150 parts of Chinese yam and 15-150 parts of motherwort.
Preferably, the preparation method comprises the following preparation raw materials in parts by weight: 30-60 parts of spina date seed, 30-60 parts of prepared rehmannia root, 30-60 parts of dogwood, 30-120 parts of Chinese yam and 30-120 parts of motherwort.
Further preferably, the preparation method comprises the following preparation raw materials in parts by weight: 60 parts of spina date seed, 60 parts of prepared rehmannia root, 30-40 parts of dogwood, 30-40 parts of Chinese yam and 30-60 parts of motherwort.
The daily dosage is not more than 15g of spina date seed, not more than 15g of prepared rehmannia root, not more than 12g of dogwood, not more than 30g of Chinese yam and not more than 30g of motherwort.
The application of the raw material medicine formula in preparing the health-care food for improving sleep is as follows.
The method for preparing the health food by using the traditional Chinese medicine composition with the sleep improving effect comprises the following steps: weighing semen Ziziphi Spinosae, radix rehmanniae Preparata, Corni fructus, rhizoma Dioscoreae, and herba Leonuri according to formula ratio, placing in extraction tank, decocting in water for 2 times, adding 10 times of water for the first time, adding 8 times of water for the second time, extracting for 1 hr and 45 min respectively, filtering, and mixing the filtrates to obtain extractive solution; concentrating the extract to obtain thick extract; vacuum freeze drying at-60 deg.C to-40 deg.C under-0.06 to-0.08 Mpa to obtain dry extract powder; dissolving the dry extract powder in purified water, mixing with adjuvant acceptable for health food, and making into health food in different dosage forms such as oral liquid, milk tea, etc., and optionally adding antiseptic (potassium sorbate), correctant, etc.
Compared with the prior art, the invention has the following advantages:
1. the invention selects the formula according to the theory and clinical experience of traditional Chinese medical science food therapy recuperation, adopts pure natural raw materials, extracts different functional components by the traditional water decoction method, provides a functional food capable of effectively improving sleep, selects all the medicines in the formula as the raw materials which are allowed to be used as health food and have homology of medicine and food in China, and strictly limits the dosage within the national regulation range, so the invention is safe and effective, has no toxic or side effect after long-term use, does not generate side effect and mental dependence on human body, and can be eaten for a long time.
2. The formula of the invention takes the spina date seed as a monarch drug, and the spina date seed has the effects of nourishing blood, tonifying liver, calming heart and soothing nerves, thereby being beneficial to improving the sleep quality and improving the sleep effect; the prepared rehmannia root, the dogwood fruit and the Chinese yam are ministerial drugs, the prepared rehmannia root is used for replenishing essence and benefiting marrow and nourishing yin essence, the dogwood fruit can nourish liver and kidney and can nourish essence, and the Chinese yam is used for tonifying spleen and kidney, so that the three drugs can tonify kidney and strengthen essence and can also tonify spleen to help the source of postnatal transformation; motherwort herb can promote blood circulation and induce diuresis, and has the effect of inducing diuresis, which is beneficial to nourishing kidney essence. The five medicines of the formula are combined, and the functions of replenishing essence and benefiting marrow, nourishing blood and tonifying liver, calming heart and tranquilizing mind and improving sleep are achieved by taking tonification as a main part and combining tonification and purgation.
3. Functional tests prove that the health food belongs to the actual non-toxic level, has the function of improving sleep, is simple to prepare, is environment-friendly and has wide application prospect.
The invention has reasonable design, selects the formula according to the theory and clinical experience of traditional Chinese medical science food therapy recuperation, adopts the traditional extraction method to extract the functional components by water decoction, provides functional food capable of effectively improving sleep, has the function of improving sleep by complete formula use, is safe and effective, has no toxic or side effect after long-term use, and can be eaten for a long time.
Detailed Description
The following provides a detailed description of specific embodiments of the present invention.
Example 1
A traditional Chinese medicine composition of a health food for improving sleep is prepared from the following raw materials in parts by weight: 60g of spina date seed, 60g of prepared rehmannia root, 30g of dogwood, 30g of Chinese yam and 30g of motherwort.
The method for preparing the health food by utilizing the traditional Chinese medicine composition comprises the following steps:
step (1), water decoction: putting spina date seed, prepared rehmannia root, dogwood, Chinese yam and motherwort into a decoction bag, adding water, soaking for 30 minutes, decocting for 2 times, adding water with the weight 10 times of the total weight of the raw materials for the first time, decocting for 1 hour, adding water with the weight 8 times of the total weight of the raw materials for the second time, decocting for 45 minutes, combining the decoctions, squeezing dregs of a decoction, and filtering to obtain a water decoction;
step (2), concentrating and drying: heating the water extractive solution, concentrating to obtain extract, freeze drying at-40 deg.C, and pulverizing to obtain water extract powder;
and (3) dissolving the dry paste powder in purified water, and adding a proper amount of white granulated sugar and 0.3% of potassium sorbate to prepare the oral liquid.
The prepared oral liquid is used as a sample to perform a mouse test for improving the sleep function, and the test example is as follows:
the oral liquid of the composition obtained in example 1 is tested by SPF male mice to prove that the health food of the present invention has the effect of improving sleep.
1. Laboratory animal
The SPF male mouse weighs 18-22 g, and the experimental mouse is provided by Schbefu (Beijing) biotechnology limited, and the qualification number of the experimental animal is as follows: 11401500042028. the temperature of the animal raising room is 20-25 ℃, and the humidity is 40-70%.
2. Dosage design
120 mice were randomly divided into 3 groups of 40 mice each (10 mice per experiment), namely a blank control group, a low dose group (2.3 g of raw drug material/kg) and a high dose group (9.2 g of raw drug material/kg), and the test groups were gavaged with the corresponding drugs, and the blank control group was gavaged with purified water, all of which were 10 ml/kg.
3. Experimental methods
3.1, direct sleep test
And observing the sleep phenomenon of the mice in the test object group and the blank control group after the mice are fed with the test object and the purified water. Judging the sleep phenomenon: the disappearance of the righting reflex is used as an index for sleeping. When the mouse is placed in the supine position, the body can not be turned to the prone position within 30s, namely the turning-over reflection disappears, and the mouse enters sleep. The recovery of the righting reflex is the awakening of the animal, and the time from disappearance of the righting reflex to recovery is the sleeping time of the animal. The number of animals falling asleep and the sleeping time of the blank control group and the test sample group were recorded.
3.2 test for prolonging sleep time of sodium pentobarbital
And (3) after the animals are given the test object for 30min in the last time, injecting 50mg/kg of pentobarbital sodium solution into the abdominal cavity of each group of animals, wherein the injection amount is 10ml/kg, calculating the sleep time of each mouse by taking the disappearance of the righting reflex for 60s as an index, and observing whether the test object can prolong the sleep time of the pentobarbital sodium.
3.3 sub-threshold dose hypnotic test of sodium pentobarbital
After animals are given the test object for 30min in the last time, 30mg/kg sodium pentobarbital solution is injected into the abdominal cavity of each group of animals, the injection amount is 10ml/kg, and the number of the animals falling asleep within 30 minutes is recorded (the animals with turning over the positive reflex disappears for more than 1 minute).
3.4 test for sleep latency of sodium barbiturate
And (3) after the animals are fed with the test substance for 30min at the last time, injecting 300mg/kg of barbital sodium solution into the abdominal cavity of each group of animals, wherein the injection amount is 10ml/kg, taking the disappearance of the righting reflex as an index, recording the sleep latency of the animals in the blank control group and the test sample group, and observing the influence of the test sample on the sleep latency of the barbital sodium.
4. Test results
4.1, direct sleep test results
After the test sample is given, the activity of each dose group mouse is normal, and the phenomenon that the mouse directly sleeps does not occur.
4.2 test results for prolonging sleep time of sodium pentobarbital
Compared with the blank control group, the test substance low and high dose groups can obviously prolong the sleep time of the pentobarbital sodium induced mice (P<0.05), the result of the experiment can be judged to be positive, and the result is shown in table 1.
TABLE 1 results of prolonging sleep time of pentobarbital sodium in mice: (X±SD）
Note: compared with the blank control group, the composition of the composition,* P<0.05。
4.3 sub-threshold dose hypnotic test of sodium pentobarbital
Compared with the blank control group, the low-dose group and the high-dose group of the tested object both have sleeping animals, and the sleeping number of the animals in the low-dose group is more than that in the high-dose group, but the statistical difference is not generated, which is shown in the table 2.
TABLE 2 Sulfinitral dose hypnotic test results for sodium pentobarbital
Note: compared with the blank control group, the composition of the composition,* P<0.05，** P<0.01。
4.4 results of sleep latency test of sodium barbiturate
Compared with the blank control group, the low and high dose groups of the test substance can obviously shorten the sleep latency period of the barbiturate sodium, and the difference has significant statistical significance: (P<0.05), the result of the experiment can be judged to be positive, and the result is shown in table 3.
TABLE 3 results of the sodium barbiturate sleep latency test: (X±SD）
Note: compared with the blank control group, the composition of the composition,* P<0.05。
4.5, summary
The three experiments of the experiment for prolonging the sleep time of the sodium pentobarbital, the experiment for hypnotizing the sodium pentobarbital at the subthreshold dose and the experiment for sleep latency of the sodium pentobarbital are positive and have no obvious direct sleep effect, so that the test sample can be judged to have the function of improving the sleep.
Example 2
A traditional Chinese medicine composition of a health food for improving sleep is prepared from the following raw materials in parts by weight: 60g of spina date seed, 60g of prepared rehmannia root, 40g of dogwood, 40g of Chinese yam and 60g of motherwort.
The method for preparing the health food by utilizing the traditional Chinese medicine composition comprises the following steps:
step (1), water decoction: putting spina date seed, prepared rehmannia root, dogwood, Chinese yam and motherwort into a decoction bag, adding water, soaking for 30 minutes, decocting for 2 times, adding water with the weight 10 times of the total weight of the raw materials for the first time, decocting for 1 hour, adding water with the weight 8 times of the total weight of the raw materials for the second time, decocting for 45 minutes, combining the decoctions, squeezing dregs of a decoction, and filtering to obtain a water decoction;
step (2), concentrating and drying: heating the water extractive solution, concentrating to obtain extract, freeze drying at-40 deg.C, and pulverizing to obtain water extract powder;
and (3) dissolving the dry paste powder, a proper proportion of milk powder and white granulated sugar in water to obtain the milk tea.
The prepared milk tea is used as a sample to perform a mouse test for improving the sleep function, and the test example is as follows:
the milk tea composition obtained in example 2 was used as a test subject to demonstrate that the health food of the present invention has the effect of improving sleep by SPF male mice.
1. Test animal selection
The SPF male mouse weighs 18-22 g, and the test mouse is provided by Schbefu (Beijing) biotechnology limited, and the qualification number of the test animal is as follows: 11401500042028. the temperature of the animal raising room is 20-25 ℃, and the humidity is 40-70%.
2. Dose selection
120 mice were randomly divided into 3 groups of 40 mice each (10 mice per experiment), namely a blank control group, a low dose group (2.2 g/kg of raw drug material), and a high dose group (8.8 g/kg of raw drug material), and the test groups were gavaged with the corresponding drugs, and the blank control group was gavaged with purified water, all of which were 10 ml/kg.
3. Test method
3.1, direct sleep test
And observing the sleep phenomenon of the mice in the test object group and the blank control group after the mice are fed with the test object and drinking water. Judging the sleep phenomenon: the disappearance of the righting reflex is used as an index for sleeping. When the mouse is placed in the supine position, the body can not be turned to the prone position within 30 seconds, namely the turning-over reflection disappears, and the mouse enters sleep. The recovery of the righting reflex is the awakening of the animal, and the time from disappearance of the righting reflex to recovery is the sleeping time of the animal. The number of animals falling asleep and the sleeping time of the blank control group and the test sample group were recorded.
3.2 test for prolonging sleep time of sodium pentobarbital
And (3) after the animals are given the test object for 30min in the last time, injecting 50mg/kg of pentobarbital sodium solution into the abdominal cavity of each group of animals, wherein the injection amount is 1ml/kg, calculating the sleep time of each mouse by taking the disappearance of righting reflex for 60s as an index, and observing whether the test object can prolong the sleep time of the pentobarbital sodium.
3.3 sub-threshold dose hypnotic test of sodium pentobarbital
After animals are given the test object for 30min in the last time, 30mg/kg sodium pentobarbital solution is injected into the abdominal cavity of each group of animals, the injection amount is 10ml/kg, and the number of the animals falling asleep within 30 minutes is recorded (the animals with turning over the positive reflex disappears for more than 1 minute).
3.4 test for sleep latency of sodium barbiturate
And (3) after the animals are fed with the test substance for 30min at the last time, injecting 300mg/kg of barbital sodium solution into the abdominal cavity of each group of animals, wherein the injection amount is 10ml/kg, taking the disappearance of the righting reflex as an index, recording the sleep latency of the animals in the blank control group and the test sample group, and observing the influence of the test sample on the sleep latency of the barbital sodium.
4. Test results
4.1 direct sleep test results
After the test sample is given, the activity of each dose group mouse is normal, and the phenomenon that the mouse directly sleeps does not occur.
4.2 test results for prolonging sleep time of sodium pentobarbital
Compared with the blank control group, the test substance low and high dose groups both significantly prolong the sleep time of the pentobarbital sodium induced mice (P<0.05), the result of the experiment can be judged to be positive, and the result is shown in table 4.
TABLE 4 results of prolonging sleep time of pentobarbital sodium in mice: (X±SD）
Note: compared with the blank control group, the composition of the composition,* P<0.05。
4.3 sub-threshold dose hypnotic test of sodium pentobarbital
The subjects had sleeping animals in both the low and high dose groups compared to the blank control group, but there was no statistical difference, see table 5.
TABLE 5 Sulfinitral dose hypnotic test results for sodium pentobarbital
Note: compared with the blank control group, the composition of the composition,* P<0.05。
4.4 results of sleep latency test of sodium barbiturate
Compared with the blank control group, the test substance high-dose group can obviously shorten the sleep latency time of the barbiturate sodium, and the difference has significant statistical significance (P<0.05), the result of the experiment can be judged to be positive, and the result can be shown in table 6.
TABLE 6 results of the sodium barbiturate sleep latency test (X±SD）
Note: compared with the blank control group, the composition of the composition,* P<0.05。
4.5, summary
The three experiments of the experiment for prolonging the sleep time of the sodium pentobarbital, the experiment for hypnotizing the sodium pentobarbital at the subthreshold dose and the experiment for sleep latency of the sodium pentobarbital are positive and have no obvious direct sleep effect, so that the test sample can be judged to have the function of improving the sleep.
Example 3
Oral acute toxicity test (MTD) in mice:
1. animal sources: sbefu (beijing) biotechnology limited, KM mice, quality certification for experimental animals: no. 11401500050054.
2. Dose design: 40 Kunming mice of 18 g-21 g with half each male and female are selected for testing. Animals had free access to food and water during the trial. Gavage is carried out for 2 times at intervals of 6h at a dose of 20ml/kg BW, the dose is equivalent to 177.1g of crude drug/kg BW (which is equivalent to 759 times of daily intake of human body), the animals are continuously observed for 14d, general states, weight changes, toxic signs, death situations and the like of the animals are observed and recorded, and the Maximum Tolerated Dose (MTD) is determined.
3. The sample administration route comprises the following steps: the administration was by intragastric administration with an intragastric volume of 20ml/kg BW.
4. Test results
The test samples were gavaged 2 times for mice of both sexes at a gavage dose of 177.1g crude drug/kg BW, and the animals were normal during 14 days of observation, and had no abnormal conditions such as toxic signs and death. At 15d, the test animals were sacrificed for gross anatomical examination and no major organs were visibly abnormal. The oral Maximum Tolerated Dose (MTD) of the test samples was greater than 177.1g/kg BW in both male and female mice. The test sample is of non-toxic grade according to the acute toxicity grading standard. The results are shown in tables 7 to 10.
Table 7 animal death number distribution table (male, n = 10)
Table 8 animal redistribution chart (male, n = 10)
Table 9 distribution of animal mortality (female, n = 10)
Table 10 animal redistribution chart (female, n = 10)
Therefore, the health food is nontoxic under experimental conditions and has the function of improving the sleep.
In a word, the traditional Chinese medicine composition with the sleep improving function for preparing the health food can be used for assisting in improving sleep safely and effectively without toxic and side effects, helping sub-health people to improve uncomfortable symptoms and improving sleep quality.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and substitutions can be made without departing from the technical principle of the present invention, and these modifications and substitutions should also be regarded as the protection scope of the present invention.
Claims (5)
1. A traditional Chinese medicine composition with sleep improvement effect is characterized in that: the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30-60 parts of spina date seed, 30-60 parts of prepared rehmannia root, 30-60 parts of dogwood, 30-120 parts of Chinese yam and 30-120 parts of motherwort.
2. The traditional Chinese medicine composition with sleep improvement effect according to claim 1, which is characterized in that: the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 60 parts of spina date seed, 60 parts of prepared rehmannia root, 30-40 parts of dogwood, 30-40 parts of Chinese yam and 30-60 parts of motherwort.
3. A method for preparing a health food using the traditional Chinese medicine composition with sleep improvement effect of claim 1 or 2, which is characterized in that: the method comprises the following steps:
(1) respectively taking the spina date seed, the prepared rehmannia root, the dogwood, the Chinese yam and the motherwort according to the formula proportion, decocting and extracting the materials by water, and filtering the decoction;
(2) mixing the filtrates, freeze drying, and pulverizing to obtain water-extracted dry extract powder;
(3) dissolving the obtained dry extract powder and adjuvants in water, and making into health food with different dosage forms and flavors;
(4) filling and sterilizing to obtain the product.
4. The method of claim 3, wherein: the auxiliary materials comprise auxiliary materials required for preparing oral liquid or auxiliary materials required for preparing milk tea.
5. The method of claim 4, wherein: in the step (1), decocting and extracting for 2 times by water, adding 10 times of water for the first time, adding 8 times of water for the second time, extracting for 1 hour and 45 minutes respectively, and filtering;
in the step (2), combining the two filtrates to obtain an extracting solution; concentrating the extract to obtain thick extract; vacuum freeze drying at-60 deg.C to-40 deg.C under-0.06 to-0.08 Mpa to obtain dry extract powder.
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| CN102671137A (en) * | 2012-05-28 | 2012-09-19 | 石家庄平安医院有限公司 | Medicine composition for treating diabetic nephropathy and preparation method of medicine composition |
| CN104208554A (en) * | 2014-09-19 | 2014-12-17 | 胡康有 | Traditional Chinese medicine mainly for treating multiple female diseases |
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| CN104208554A (en) * | 2014-09-19 | 2014-12-17 | 胡康有 | Traditional Chinese medicine mainly for treating multiple female diseases |
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