CN1579482A - Blood-supplementing traditional Chinese medicine preparation and its production method - Google Patents

Abstract

The invention provides a kind of traditional Chinese medicine preparation for enriching blood. The preparation is prepared scientifically from Chinese medicines such as Polygonum multiflorum (red, system), longan meat (longan), etc. according to the theory of traditional Chinese medicine. Then it is mixed with longan meat, extracted with water, and made into oral liquid, capsules, granules, and tablets by modern pharmaceutical production processes such as alcohol precipitation. The medicine has the effects of nourishing the heart and spleen, nourishing qi and blood, increasing hemoglobin, increasing the number of red blood cells, increasing cholesterol in high-density lipoprotein (HDL-C), lowering cholesterol, and anti-aging. It is mainly used to treat palpitations, forgetfulness, insomnia, dizziness, fatigue, anemia, hyperlipidemia and other diseases caused by deficiency of both heart and spleen, and deficiency of both qi and blood. The curative effect is remarkable.

Description

A kind of traditional Chinese medicine preparation for enriching blood and its production method

technical field

The invention relates to a traditional Chinese medicine preparation for nourishing blood, in particular to a medicine for treating blood deficiency and insomnia and a production method thereof.

Background technique

The deficiency of blood referred to in traditional Chinese medicine refers to the reduction of the number of red blood cells and the amount of hemoglobin per unit volume of blood in modern medicine, including iron deficiency anemia, hemorrhagic anemia, hemolytic anemia, anemia caused by lack of anti-anemia factors, and aplastic disorder anemia of various causes. The traditional Chinese medical science is collectively referred to as deficiency of blood. There are many reasons for it, such as blood loss, eating disorder, physical weakness after illness, etc., which can consume Qi and blood, and cause spleen and kidney deficiency, which cannot biochemically cause Qi and blood. The main clinical manifestations are sallow complexion, pale lips, dizziness, tinnitus, drowsiness, fatigue, palpitation, shortness of breath, insomnia, and decreased red blood cell count and hemoglobin. The clinical incidence of this disease is very high, such as postpartum, postoperative, and post-ill, no matter in rural areas or cities, there are a large number of patients, and it is a common disease.

The principle of treatment for blood deficiency should be to replenish blood, but at the same time pay attention to replenishing qi, because replenishing qi can generate blood. It is also necessary to distinguish the primary and secondary of spleen deficiency and kidney deficiency, and give methods of nourishing the spleen and kidney respectively, so as to strengthen the origin of Qi and blood biochemistry. Qi and blood deficiency syndrome, the clinical manifestations are pale complexion, dizziness, shortness of breath, palpitation, and fatigue. Licorice, red dates. Addition and subtraction, palpitation and insomnia, add cooked jujube kernel and schisandra. Deficiency of both heart and spleen. Clinical manifestations include palpitations, fatigue, lack of appetite, abdominal distension, loose stools, tongue ulceration and weak pulse. Weakness of temper, insufficient production of blood, or lack of power to govern, and blood overflowing outside the veins can all lead to deficiency of heart blood. Insufficient effort, unable to transform into qi, then the spleen is also weak, the two often affect each other, or it is a syndrome of deficiency of both heart and spleen. Insufficient blood, the heart loses its nourishment, and palpitations; insufficiency of temper, impaired transportation and transformation, so less food, abdominal distension, and loose stools. Deficiency of both qi and blood, decreased functional activity, so mental fatigue, pale tongue, thready and weak pulse are all symptoms of insufficiency of qi and blood. The treatment method is to replenish qi and blood, invigorate the spleen and nourish the heart. The representative prescription is Guixin Decoction, which contains ginseng, astragalus, angelica, atractylodes macrocephala, Fushen, polygala, longan meat, jujube seed, roasted licorice, ginger, and jujube. Liver and kidney yin deficiency syndrome, clinical manifestations include palpitations, tinnitus, dizziness, dysphoria, dry mouth, the treatment method is to nourish the liver and kidney. Magnet, Angelica, Paeoniae Alba. Addition and subtraction, subcutaneous bleeding, plus donkey-hide gelatin, Agrimony. At present, Chinese patent medicines, such as Shengxue pills, include velvet antler, Phellodendron cortex, yam, Atractylodes macrocephala (stir-fried), mulberry branches, white lentils (stir-fried), Ziheche; Angelica, Chuanxiong, Paeoniae Alba, Rehmannia, Astragalus, Cinnamon. Shouwu Wan, medicines include sunburned Shouwu, Rehmannia glutinosa, Achyranthes bidentata, mulberry, Ligustrum lucidum, Eclipta chinensis, mulberry leaves, black sesame, Cuscuta, Rosa laevigata, Hezhicao, psoralen, silver flower, etc. Others include Angelica Yangxue Pills. The above-mentioned medicines have complex prescriptions and complex ingredients. In addition to high costs, it is difficult to control the active ingredients and product stability during the production process, which is the main problem in the modernization of traditional Chinese medicine.

After searching, we also found relevant patent documents as follows:

1. <Application No.> 97103837 <Authorization Announcement Date> February 16, 2000 <Invention Name> A Chinese patent medicine for treating cerebrovascular diseases <Applicant> Huang Zhaoyuan Huang Dan, New District, Heshan Town, Pujiang County, Chengdu City, Sichuan Province <Abstract > The present invention discloses a Chinese patent medicine for treating cerebrovascular diseases. The medicine is a medicine made from the following pharmaceutical composition: Radix Astragali: 10-20 parts Codonopsis: 10-20 parts Polygonum multiflorum: 1-20 parts Lycium barbarum: 10 parts -20 parts of longan: 10-20 parts of Chinese yam: 10-20 parts of Chinese angelica: 10-20 parts Salvia: 5-15 parts Jujube skin: 5-15 parts Cuscuta: 5-15 parts Gastrodia elata: 5-15 parts Rehmannia glutinosa: 15-25 parts Mother-of-pearl: 25-35 parts Perrin: 5-15 parts. It has a good therapeutic effect on cerebral thrombosis, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage and brain atrophy.

2. <Application No.> 95100046 <Invention Name> bodybuilding drink and its preparation method <Applicant> Li Cun, No. 13, Gate 2, 43rd Floor, Sanlihe District 3, Fuwai, Beijing <Abstract> A bodybuilding drink and its preparation method, Use hawthorn, fleece-flower root, orange peel, mint, cassia seed, cinnamon bark, longan meat, and dried apricot as raw materials. They are respectively soaked in water and filtered to become a stock solution. They are mixed in a certain proportion, among which: hawthorn juice 40-50% Shouwu juice 28-30% Ginger Juice 2-3% Orange Peel Juice 3.5-4% Mint Juice 5-6% Cassia Juice 2-3% Cinnamon Bark Juice 4.5-5% Guiyuan Gravy 3-6% Dried Apricot Juice 2-3% Add a small amount of sugar, vinegar or citric acid, and flavorings to make a fitness drink. It contains a variety of amino systems, which can lower blood pressure and cholesterol, soften blood vessels and inhibit obesity. It is suitable for all ages to drink.

3. <Application No.> 95100383 <Invention Name> Fatelong Health Beverage <Applicant> Cao Shixuan, No. 47, Minzhu Road, Wuchang, Wuhan City, Hubei Province <Abstract> The present invention discloses a Fatelong health drink, which consists of 9-10%, 9-10% mulberry, 9-10% Poria, 4-5% black sesame, 4-5% walnut, 11-12% black date, 14-15% longan, 9-10% black soybean , 3-6% of arborvitae leaves, 9-10% of citrus fruit, 13-16% of Shouwu, and sucrose powder are prepared in a certain proportion, and then the raw materials are decocted, concentrated, mixed, granulated, and dried. The invention has simple equipment and easy method, and has the functions of nourishing yin, tonifying deficiency, tonifying kidney, strengthening brain, nourishing blood and consolidating essence, promoting hair cell metabolism and hair regeneration, and effectively preventing various types of hair loss, withered yellow and early graying, and is weak to the body. , depression, insomnia, and neurasthenia have obvious rehabilitation and health effects.

4. <Application Number>94113767<Authorization Announcement Date>July 05, 2000<Invention Name>Black-bone Chicken and Lycium Barbarum Nutritious Blood Tonic Wine<Applicant> Li Farong, Room 205, Building 2, Dormitory of General Factory of Traditional Chinese Medicine, Shihe Road, Hefei City, Anhui Province<Abstract >A black-bone chicken and wolfberry nutrition blood-replenishing wine, the prescription has the following ingredients and proportions: black-bone chicken: wolfberry: shiitake mushrooms: red dates: longan, angelica, amomum, ligustrum lucidum, Polygonum multiflorum, tangerine peel, Ophiopogon japonicus, Atractylodes macrocephala, Rehmannia glutinosa, Polygonatum, Codonopsis, Radix Paeoniae Alba, Licorice Root, Chuanxiong = 1: 0.3～0.5: 0.05～0.1: 0.02～0.05: 0.002～0.005; (2), the liquor used for extraction is grain liquor with an alcohol content above 55 degrees, and the dosage is: black-bone chicken : Liquor=1:30～40, it is made by extracting with water and liquor successively after formulating and then processing. The present invention dissolves and replenishes qi and blood, invigorates the spleen and lungs, nourishes the liver and kidneys, guides the circulation of qi, and promotes blood circulation and removes blood stasis. Patients with cancer and various chronic diseases take it.

5. <Application No.> 93120022 <Invention Name> beauty care oral liquid and ointment <Applicant> Dai Mingchang, Donghang Village, Qiaotou Town, Yongjia County, Zhejiang Province <Abstract> This invention relates to a food using traditional Chinese medicine: the composition of its raw materials ( Weight) is: longan meat 5-10% donkey-hide gelatin 0.5-2% walnut meat 10-20% wolfberry 10-15% red jujube (pitted) 10-20% shouwu 5-10% black sesame 10-15% pearl Powder 0.2-0.8% honey 25-35%, the composition is processed into a kind of beauty cream and oral liquid with special beauty effect by scientific formula. It has the effects of replenishing qi and blood, beautifying the face, anti-aging, and improving human immunity. Adhere to taking a small amount every day for more than 45 days, it can make the skin rosy and healthy, tender and shiny, and have the effect of anti-wrinkle and black hair.

6. <Application No.> 97107444 <Invention Name> A Tonic Wine and Its Preparation Method <Applicant> Sichuan Kangda Building Materials Industry (Group) Company, No. 1 Weibo Road, Weiyuan County, Sichuan Province <Abstract> Disclosure of the Invention A nourishing wine and a preparation method thereof are characterized in that: the composition includes: 10-12 grams of ginseng, 9-11 grams of black snake, 9-12 grams of Shouwu 9-12 grams of longan, 7.5-11 grams of rock sugar, 2 grams of sorghum wine, 500 grams of mineral water The preparation process of 110 grams is: A. Raw material processing a. Stir-fry Shouwu with zhusha, stir-fry zhusha with high fire to 80°C-150°C, put Shouwu in and continue to stir-fry, fry Shouwu to yellow, take out Shouwu, Brush off the cinnabar on Shouwu with a brush, and break it into small pieces with a hammer. b. Slice or section or break ginseng, black snake, and longan into granules. The flakes are 30-60mm long and 10-30mm thick , the nodal shape is 50-100mm long, and the diameter of the granular shape is 10-30mm. B. Soaking and extracting the juice Put the processed raw materials in a sealed container and soak them in high-quality sorghum wine at 56-60 degrees for 30-40 days , use a leather tube or a wine pump to suck out the soaked wine, filter it with a 70-120 mesh filter cloth, and then add 50-60 degrees of high-quality sorghum wine to continue soaking for 30-40 days, and then use a leather tube or a wine pump to drain the wine The soaked wine is sucked out, and the juice is filtered with 70-120 mesh. The main process is raw material treatment, soaking and juice extraction, blending, seasoning and aging, and inspection and packaging. Advantages, it can nourish yin and strengthen yang, promote human health, and is rich in various nutritional elements beneficial to human body.

7. <Application No.>97119951<Invention Name>Health Replenishing Liquid <Applicant> Zhou Kaiwei, Group 16, 17th Committee, Fumin Street, Xinfu District, Fushun City, Liaoning Province <Inventor> Zhou Kaiwei <Abstract> This invention belongs to a health care product, According to the regulation mechanism of nutrients and medicines that people tend to lack, it is made with corresponding Chinese herbal medicines. The percentage by weight of each component is: with white wine as 100% of the component, the proportioning ratios of other Chinese herbal medicines are respectively: wolfberry fruit 4-5%; ant 3-3.5%; curculigo curculigo 2.5-3%; 2.4-2.8%; Longan meat 2-2.4%; Cistanche 2.4-2.8%; Polygonum multiflorum 4-4.4%. The invigorating liquid has the functions of nourishing qi and blood, nourishing essence and strengthening the kidney, strengthening the body and strengthening yang, and regulating physiological balance.

8. <Application No.> 93110081 <Invention Name> Brain-enhancing Medicine <Applicant> Jiangxi Huiren Pharmaceutical Co., Ltd., No. 31 Huoju Street, High-tech Development Zone, Nanchang City, Jiangxi Province Zhijian brain traditional Chinese medicine. The main components of the medicine of the present invention are Polygonum multiflorum 325-425g, Boziren 150-200g, Longan meat 100-150g, Polygonatum 325-425g, Ligustrum lucidum 325-425g, Mulberry 325-425g, Lotus seeds 150-200g, Polygala 150- 200g. Through pharmacodynamics, toxicology and stability experiments and clinical verification, the present invention has obvious effects of nourishing the heart and kidney, nourishing blood and regulating the liver, strengthening the brain and improving intelligence, and the total effective rate of treating MR is 82% through clinical observation, and the total effective rate of treating MBD is 82%. The effective rate is 96%.

9. <Application No.> 94102628 <Invention Name> Jingqishen Oral Liquid Preparation Method <Applicant> Chen Changyi, Mailbox No. 27, Hanzhong City, Shaanxi Province <Abstract> The present invention belongs to an oral Chinese medicine preparation for health care and strengthening of middle-aged and elderly people. It is the traditional Chinese medicine Polygonum multiflorum, Rehmannia glutinosa, Rehmannia glutinosa, Lycium barbarum, Angelica, Eucommia ulmoides, Lotus seeds, Cistanche, American ginseng, Achyranthes bidentata, Gastrodia elata, agarwood, windproof, longan meat, walnut meat, astragalus, fairy spleen, Caulis Spatholobus, Yizhiren After the traditional Chinese medicines such as amomum, Liushenqu, and dodder are prepared in a certain proportion, they are mixed and decocted to obtain thick juice. Jingqishen Oral Liquid has the effects of nourishing yin and strengthening yang, nourishing qi and neutralizing the body, strengthening the brain and refreshing the mind, blackening the beard and hair, strengthening bones and muscles, improving eyesight, moisturizing the skin, and prolonging life. After more than 20 years of clinical observation, the health care effect is very good without any side effects.

From the above-mentioned published documents, it is understood that the traditional Chinese medicines or health care products and beverage formulas for nourishing qi and blood, nourishing yin, tonifying deficiency and tonifying kidney are relatively complex, and some active ingredients cannot be fully utilized. Either soak in edible wine, or carry out simple water extraction and decoction to obtain, and the product quality is difficult to control.

Contents of the invention

The purpose of the present invention is to provide a kind of blood deficiency, insomnia specificity, remarkable curative effect, formula is not complicated, raw material source is relatively easy, production capacity is big, price is cheap, product active ingredient and stability are easy to control, easy to detect. Chinese patent medicines and production methods.

The main active ingredients of the raw materials of the blood-enriching traditional Chinese medicine preparation of the present invention are Polygonum multiflorum and longan meat, and it is made of the following raw materials in parts by weight:

4-10 parts of Polygonum multiflorum, 3-7 parts of longan meat.

Described Radix Polygoni Multiflori is unprocessed Radix Polygoni Multiflori, also claims Radix Polygoni Multiflori Red, raw Polygonum multiflorum.

The longan meat is a dry product obtained by drying the fresh fruit longan meat without adding any additives.

In the production process of this medicine, the processing of Polygonum multiflorum adopts new methods instead of traditional old methods. There are three main active ingredients of Polygonum multiflorum: 2, 3, 5, 4'-tetrahydroxystilbene-β-D-glucoside, The content can be as high as 1.2%, which is the main indicator of quality control; phospholipids, of which lecithin is as high as about 3.7%; hydroxyanthraquinone compounds, the content is 1.1%. Stilbene is water-soluble, phospholipids have great solubility in non-polar solvents and water, anthraquinone compound-bound forms are soluble in water but free forms are insoluble, and the efficacy and toxicity of raw and prepared Shouwu are very different. Large, because the chemical composition of Radix Polygoni Multiflori has changed after a long period of high heat, such as easily soluble bound anthraquinones into insoluble free anthraquinones. No, on the other hand, the toxicity of Shouwu is significantly lower than that of raw Shouwu, but the nourishing effect is significantly enhanced. Therefore, the focus of Shouwu is to replenish blood, while the focus of Shouwu is to activate blood. The traditional Chinese medicine Polygonum multiflorum is prepared by stewing and steaming, that is, black soybean juice (10kg of black soybeans, appropriate amount of water, boiled for about 4 hours, boiled for about 15kg of juice, boiled with soybean dregs for about 3 hours, boiled for about 10kg of juice, combined to obtain Black soybean juice (about 25kg), after stirring, put it in the tank and seal it tightly, put it in a water pot and cook it for more than 32 hours, steam nine times and dry it nine times, the inside and outside are tan, black and shiny. The present invention uses an innovative high-temperature and high-pressure method to slice (or crush) the raw (dry) Radix Polygoni Multiflori, soak it in water, put it in a steam pressure cooker, pass steam to make the temperature reach 118°C to 124°C, and take it out for use after 6 to 10 hours. The same effect can be obtained. After many years of repeated research and comparison, animal pharmacodynamics, pharmacology, and toxicology tests have proved the best results. If the time is too long and the temperature is too high, the curative effect will be reduced, and if the time is too short and the temperature is too low, it will not be effective. Obtain curative effect of Radix Polygoni Multiflori and eliminate toxicity. After repeated research, selected drug prescriptions from them, and finally invented a medicine with good curative effect, simplified prescription, easy control of process and quality, good stability of active ingredients, low energy consumption, cheap price, rich sources of raw materials, suitable for modernization Feasible Chinese patent medicine with advanced industrial production and technology.

Polygonum multiflorum and longan meat can be found in the "Chinese Pharmacopoeia" and other traditional Chinese medicine manuals for their aliases, Latin names, origins, and usage. In order to understand the mechanism of the present invention's disease treatment, the effect, preparation method and the effect in the prescription of each flavor of Chinese medicine in the prescription are now set forth as follows:

Longan meat, known as longan in Guangxi, nourishes the heart and spleen, nourishes blood and calms the nerves. For insufficient qi and blood, palpitation, forgetfulness, insomnia, blood deficiency and chlorosis. Polygonum multiflorum is used to invigorate liver and kidney, benefit essence and blood, black beard and hair, and strengthen muscles and bones. Used for blood deficiency and chlorosis, dizziness and tinnitus, premature graying of beard and hair, soreness of waist and knees, numbness of limbs, metrorrhagia and vaginal discharge, chronic malaria and physical weakness; hyperlipidemia. The combined use of the two medicines can significantly enhance the effects of nourishing blood, invigorating qi and calming the nerves, and has the effect of lowering blood cholesterol and increasing blood high-density lipoprotein cholesterol (HDL-C).

Although the traditional Chinese medicine preparations reported in the open literature also include Radix Polygoni Multiflori and longan meat, in order to see the content of the two alone as blood-enriching traditional Chinese medicine preparations, and the preparation method of Polygonum multiflorum is completely new, so that its active ingredients can be fully utilized.

The above-mentioned prescriptions can be used for the treatment of qi and blood deficiency, palpitations, forgetful insomnia, dizziness, fatigue, premature graying of beard and hair, soreness of the waist and knees, numbness of limbs, hyperlipidemia, etc., for patients to take as decoction; more suitable for modern Pharmaceutical companies extract its active ingredients and make capsules, granules, oral liquids, tablets and other pharmaceutical dosage forms. The specific production methods are as follows:

1. The production method of oral liquid:

①. Cut Polygonum multiflorum (red, raw, dry) into thin slices or crush it, soak it in water for several hours (4-6), put it in a container, put it in a steam pressure cooker, let it steam, and control the temperature at 118°C to 124°C. For 6-10 hours, take it out and cool it for later use.

②. Prepare Polygonum multiflorum and longan meat, after quantification, put it in a medicine pot, add 5-8 times of water, heat and boil for extraction, 2-3 hours. Take out the liquid medicine, add appropriate amount of water to the medicine dregs, heat and boil for extraction, 1-2 hours. Take out the medicinal solution and combine the two extracts. The intermediate extract solution A was obtained.

③. Heating and concentration. Put the liquid A in the concentration pot, heat and concentrate, take it out and cool it, and obtain the middle extract liquid B.

④. Ethanol precipitation. Add 95% ethanol to solution B, the ratio (volume) of 95% ethanol to solution B is 3:1. mix. Let stand at 4-8°C for 24 hours. Filter (to precipitate). The middle extract liquid C was obtained.

⑤. Recovery of ethanol. Put liquid C in the ethanol recovery device, and recover ethanol by steam heating. Take out the recovered liquid, heat it to concentrate, take it out and cool it, and obtain liquid D.

⑥. Remove tannins. Add an appropriate amount of 3-5% edible gelatin solution into the D liquid, stir while adding, and obvious white turbidity appears until the turbidity does not continue to increase. Put it in a 4°C-8°C refrigerator (or in a cold room), let it stand for 16-24 hours, and filter to remove the precipitate. Obtain filtrate E liquid.

⑦. Ethanol reprecipitation. Add 95% ethanol to liquid E, and the ratio of liquid E to 95% ethanol is 1:3. Stir to combine. Put it in a refrigerator or a cold room at 4 to 8°C, and let it stand for 16 to 24 hours. Take out and filter to remove the precipitate. Obtain filtrate F liquid.

⑧. Recovery of ethanol. Put liquid F in the ethanol recovery device, and recover ethanol by steam heating. Properly heat and concentrate the medicinal liquid to obtain medicinal liquid G.

⑨. Take liquid G and mix it with an appropriate amount of syrup and other auxiliary materials, fill it, and sterilize it to obtain a finished oral liquid.

2. The production method of capsules:

①. Polygonum multiflorum processing, drug extraction, purification and other technological processes are the same as oral liquid. Get G liquid. Liquid G is concentrated into liquid extract, spray-dried to obtain dry cream powder H as an intermediate product.

②. Take H and mix with appropriate amount of auxiliary materials, granulate, pack into capsules, pack and subpackage to obtain finished capsules.

3. Production method of granules:

①. Polygonum multiflorum processing, drug extraction, purification and other processes are the same as capsules to obtain dry cream powder H.

②. Mix H with appropriate amount of auxiliary materials, granulate, dry, and pack separately to obtain finished granules.

4. The production method of the tablet:

①. The process of processing, extracting and purifying Polygonum Polygoni Multiflori is the same as that of capsules to obtain liquid extract.

②. Take the liquid extract and mix with appropriate amount of auxiliary materials, granulate, compress into tablets, and pack to obtain finished tablets.

How to use:

Oral liquid, 2-3 times a day, 10ml each time; capsule, 2-3 times a day, 2 capsules each time, 0.5g each; granule, 2-3 times a day, 1 bag each time, 7g per bag ; Tablets 2-3 times a day, 2-3 tablets each time, 0.3 grams per tablet.

Compared with the prior art, the present invention's outstanding substantive features and remarkable progress are:

1. The present invention has optimized the above-mentioned Chinese medicine under the guidance of the theory of traditional Chinese medicine, scientific compatibility, making, cooperating with each other, learning from each other's strengths, synergistic effect, nourishing both qi and blood, and enhancing the calming and tranquilizing effect. At the same time, the amount of medication is small, which is conducive to the control of active ingredients and product stability.

2. The preparation of Shouwu by this medicine adopts a brand-new preparation method, that is, high temperature and high pressure method. Compared with the traditional method, it has the advantages of short time, low energy consumption, high efficiency, no change in curative effect, and full use of its active ingredients, which is suitable for large-scale production in the modern Chinese medicine industry. Our research group began to study this method in 1988, and it was applied to large-scale industrial production in 1993. After years of use, it has been proved that the efficiency and curative effect of the present invention are remarkable. It is an advanced industrial production process with strong operability and is suitable for modern industrial mass production.

3. Through experiments and clinical verification, the present invention has the effects of nourishing the heart and spleen, nourishing qi and nourishing blood, and is suitable for diseases such as deficiency of both qi and blood, palpitation, forgetfulness, insomnia, dizziness, fatigue and fatigue, and the total clinical effective rate is high. (up to 94.2%).

4. analyze from the angle of modern medicine, the present invention has improving hemoglobin (Hb) and erythrocyte quantity, reduces serum total cholesterol (T-Ch), improves cholesterol content in serum high-density lipoprotein, improves SOD activity in liver tissue and blood.

5. The raw materials are easy to obtain, the formula is scientific, the production technology is advanced, and the operability is strong. The product is moderately priced and suitable for industrialized production.

6. In production, according to the properties of active ingredients and preparation requirements of each traditional Chinese medicine, water extraction, alcohol precipitation, gelatin detoxification ingredients, and corresponding sterilization methods are used in the production process, so that the finished product retains high active ingredients and is not easy to deteriorate. long term.

7. Acute toxicity studies, long-term toxicity studies and clinical trials of the product of the present invention prove that it is safe to use the product of the present invention according to the intended daily dose and course of treatment.

Detailed ways

The following are embodiments of the invention:

Embodiment one:

Weigh the following traditional Chinese medicine ingredients (unit: g)

Polygonum multiflorum 4, longan meat 3,

①The production steps are: take 5g of Radix Polygoni Multiflori (red, dry) slices, soak them in water for 6 hours, put them in a container, put them in a steam pressure cooker, heat them with steam, adjust the temperature to 120°C, continue for 6 hours, take them out and cool them down to obtain the first Wu.

②Take the Shouwu and longan meat prepared above, add 5-8 times of water, heat and boil for 2-3 hours, pour out the liquid medicine, add appropriate amount of water, continue to heat and boil for 2 hours to extract. Pour out the liquid medicine and combine with the previous liquid medicine. Get liquid A liquid.

③ Heating and concentration. Put liquid A in the concentration pot, heat and concentrate to an appropriate volume. Obtained extract concentrate liquid B.

④Ethanol precipitation. Mix 95% ethanol with liquid B in a volume ratio (3:1), stir, and place in a 4-8 refrigerator or ice room for 24 hours. Filter to remove precipitate. Extract liquid C was obtained.

⑤ recovery of ethanol. Put liquid C in the ethanol recovery device, and heat to recover ethanol. Take out the liquid medicine, heat and concentrate. Get liquid D.

⑥Add 3%-5% edible gelatin solution to liquid D. While adding and stirring, obvious white turbidity appears until the white color does not continue to increase. Put it in a refrigerator at 4°C to 8°C, and let it stand for 16-24 hours. Filter to remove precipitate. Obtain filtrate E liquid.

⑦ Add 95% ethanol to liquid E, and the ratio of ethanol to liquid E is 3:1. Stir, put in a refrigerator at 4°C-8°C, and let stand for 16 to 24 hours. Filter to remove the precipitate to obtain the filtrate F liquid.

⑧ recovery of ethanol. Put liquid F in the ethanol recovery device, heat and recover ethanol. The medicinal liquid is heated and concentrated to obtain liquid G, which is added with an appropriate amount of syrup and auxiliary materials, filled, sealed, and sterilized to obtain the finished product "Head of Head Oral Liquid" (also known as "Wuyuan Buxue Capsule").

Embodiment two:

Weigh the following traditional Chinese medicine ingredients: (unit: g)

Shouwu 6 Longan Meat 4

Its production process is:

①The processing of Radix Polygoni Multiflori, extracting and purifying all the medicines are taken as oral liquid to obtain liquid G. Heating and concentrating into liquid extract, spray drying, to obtain dry cream powder H.

②Take the dry cream powder H, mix it with appropriate amount of auxiliary materials, granulate it, pack it into capsules, and pack it with aluminum foil to get the finished product. (Also known as "Wuyuan Buxue Capsule")

Embodiment three:

Weigh the following traditional Chinese medicine ingredients: (unit: g)

Shouwu 8 Longan Meat 5

Its production process is:

①The processing of Radix Polygoni Multiflori, all drug extraction, purification and other processes follow the procedures of Yuanshoubuxue Capsules to obtain dry cream powder H.

②Take dry cream powder H, mix with appropriate amount of auxiliary materials, granulate, pack separately, and pack to obtain a finished product, 7g per bag, the product name is "Yuan Shou Xue Granules" (also known as "Wuyuan Buxue Capsules").

Embodiment four:

Weigh the following traditional Chinese medicine ingredients: (unit: g)

Polygonum multiflorum 9 Longan meat 6

Its production process is:

① Polygonum multiflorum processing technology, all medicines are extracted and purified according to oral liquid. Get G liquid.

② Concentrate liquid G into extract. Mix with auxiliary materials such as honey or brown sugar, make pills, pack, and the name of the pill product is "Yuan Shou Bu Xue Pill" (also known as "Wuyuan Bu Xue Capsule").

Embodiment five:

Weigh the following traditional Chinese medicine ingredients: (unit: g)

Polygonum multiflorum 10 Longan meat 7

Its production process is:

① Polygonum multiflorum processing technology, all medicines are extracted and purified according to oral liquid. Get G liquid.

② Concentrate liquid G into extract. Mix with auxiliary materials, compress into tablets, pack, and the finished product name is "Head of Heads Buxue Tablets" (also known as "Wuyuan Buxue Capsules").

Following is the clinical research report of the present invention:

The medicine of the present invention entrusts three provincial hospitals (People's Hospital of Guangxi District, the first and second affiliated hospitals of Guangxi College of Traditional Chinese Medicine) to carry out clinical verification work, and the working steps and experimental results are as follows:

clinical information

1. General information:

There were 210 cases in the treatment group and the control group, 70 cases were observed in the First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine, 70 cases were observed in the Second Affiliated Hospital, and 70 cases were observed in the People's Hospital of Guangxi District.

The included observation objects were all patients with TCM syndrome of deficiency of both heart and spleen or patients with deficiency of both qi and blood. In the treatment group, 120 cases (60 cases of deficiency of both heart and spleen and 60 cases of deficiency of both qi and blood) were given Yuanshou Oral Liquid. In the control group, 90 cases (60 cases with deficiency of both heart and spleen and 30 cases with deficiency of both qi and blood) were treated with Bainile Oral Liquid. There was no significant difference in gender and age distribution between the treatment group and the control group (P>0.05). (See Table 1).

2. Diagnostic criteria:

(1) TCM diagnostic criteria:

1. Deficiency of both heart and spleen: palpitations, insomnia, dreaminess, forgetfulness, decreased appetite, spleen distention, loose stools, fatigue, pale tongue, thready and weak pulse.

2. Deficiency of both qi and blood: lack of qi, lazy speech, fatigue and spontaneous sweating, pale complexion, palpitations, insomnia, dizziness, pale tongue with white coating, thready and weak pulse.

(2) Western medicine diagnostic criteria: Western medicine diseases involved in this syndrome refer to "Clinical Disease Diagnosis Based on Cure and Improvement Standards"

observation method

A total of 210 cases were observed and randomly divided into 2 groups, of which 120 cases were in the treatment group, taking Fushou Oral Liquid, 10ml each time, 3 times a day, for 4 weeks. The 90 cases in the control group, the Bainile oral liquid produced by the pharmaceutical factory of Guangxi College of Traditional Chinese Medicine, 15ml each time, 3 times a day, for 4 weeks. A detailed physical examination was routinely performed on the subjects before the experiment, and those who met the case selection criteria were included in the observation objects. After the test, patients were followed up once a week to inquire about their medication and record their condition and side effects. Blood routine was checked before and after the test for those with Qi and blood deficiency syndrome. Evaluate the curative effect by syndrome method. Efficacy judgments were made by the observers. No other drugs were used during the observation period.

treatment result

1. Criteria for evaluation of curative effect:

1. Short-term cure: the main symptom disappears, and the witness points decrease by more than 91%.

2. Significant effect: the main symptoms are improved by 2 grades, and the witness points are reduced by 61-90%.

3. Effective: the main symptoms are improved by 1 level, and the witness points are reduced by 31-60%.

4. Ineffective: No improvement in the main symptoms, and the witness score is reduced by less than 30%.

2. Treatment results:

1. Effects on various symptoms: see Table 2. It can be seen from the table that after the treatment of patients with two diseases in the treatment group and the control group, the scores of various witnesses decreased very significantly (P<0.01), suggesting that the two drugs can effectively treat heart palpitations, insomnia, forgetfulness, anorexia, Abdominal distension and loose stools can significantly improve symptoms such as fatigue, dizziness, palpitations and insomnia of Qi and blood deficiency syndrome.

2. Comparison before and after physical and chemical inspection: see Table 2. It can be seen from the table that the peripheral blood Hb and RBC of the two groups of patients all increased significantly after treatment, suggesting that the two groups of drugs can significantly increase the content of human blood Hb and RBC.

3. Comparison of curative effect between the two groups: see Table 3. There were 120 cases in the treatment group, with a total effective rate of 94.2%, and 90 cases in the control group, with a total effective rate of 94.4%. There was no significant difference in curative effect between the two groups using Ri di analysis (P>0.05).

side effect

No obvious adverse reactions and toxic side effects occurred in the two groups of patients during the observation period.

Typical cases

Example 1. Huang, female, 45 years old, went to the doctor for half a year due to palpitation and shortness of breath. The patient felt palpitations for half a year, accompanied by insomnia, forgetfulness, reduced diet, abdominal pain, no desire to eat, loose stools, twice a day, and fatigue at work.

Inspection: the general condition is acceptable, no abnormality is found in the lung and abdomen examination, the tongue is light red, the fur is thin and white, and the pulse is thready and weak. Electrocardiogram was normal. Chinese medicine diagnosis: heart palpitations (deficiency of both heart and spleen). Western medicine diagnosis: menopausal syndrome. Give the head of state oral liquid treatment, each 10ml, every day 3 times. Symptoms such as abdominal distension, decreased appetite, and loose stools improved significantly after taking the medicine for 1 week. After taking the medicine for 2 weeks, the insomnia and palpitations were alleviated. After 3 weeks, I can fall asleep normally, and the stool turns into a shape, once a day. After 4 weeks, all symptoms disappeared except mild palpitation and forgetfulness. Efficacy evaluation: markedly effective.

Example 2. Lei Mou, male, 40 years old, went to the doctor for two months due to dizziness and fatigue after having blood in the stool. The patient was hospitalized two months earlier with tarry stools. Diagnosed as upper gastrointestinal bleeding. After treatment, the blood in stool disappeared and he was discharged from hospital. However, after being discharged from the hospital, he was still dizzy and weak, especially when he squatted and stood up for a long time. Accompanied by palpitations, shortness of breath and lazy speech, and sweating when moving. Examination: complexion is slightly pale, no abnormality is found in cardiopulmonary abdominal examination. Pale tongue, thin white fur, thready and weak pulse. Peripheral blood Hb100g/L, RBC3.4×10 ¹² /L. Chinese medicine diagnosis: dizziness (deficiency of both Qi and blood). Western medicine diagnosis: hemorrhagic anemia. Give the head of state oral liquid treatment. 10ml each time, 3 times a day. After taking the medicine for 1 week, the spontaneous sweating symptom disappeared, and the remaining symptoms were alleviated. After 3 weeks, in addition to still having slight palpitations, symptoms such as fatigue, dizziness, lack of breath and lazy speech disappeared. After the course of treatment, peripheral blood re-examination: Hb120g/L, RBC4.0×10 ¹² /L. Efficacy evaluation: markedly effective.

Summary

The above information prompts:

1. Yuanshou Oral Liquid has the effects of calming the heart, invigorating the spleen, invigorating qi and blood, and can be used for heart palpitations, insomnia, dreaminess, fatigue, fatigue, dizziness and other symptoms caused by fatigue, heartburn, and insufficient qi and blood.

2. Head of State Oral Liquid can increase the content of hemoglobin and red blood cells in human blood.

3. There were 120 cases in this group, the total effective rate was 94.2%, and the curative effect was not significantly different from that of Bainile Oral Liquid produced by Guangxi College of Traditional Chinese Medicine Pharmaceutical Factory.

4. This product is safe and reliable, 120 cases, no obvious adverse reactions and side effects were found during the observation period.

       Table 1. Treatment group and control group gender (example), age (X±SD) comparison

                                                              

Male Female Age Male Female Age

Deficiency of heart and spleen 26 34 45.28±11.79 30 30 46.77±11.40

Qi and blood deficiency 23 37 46.37±12.93 10 20 42.20±11.50

Comparison of gender and age between the two groups, all P values > 0.05

             Table 2 Comparison of witness scores and physical and chemical examinations before and after treatment (X±SD)

                                                      

n Before treatment After treatment n Before treatment After treatment

Deficiency of both heart and spleen:

Palpitations 51 2.69±1.13 1.01±0.77 54 3.10±1.20 1.20±0.87

Insomnia 56 3.40±0.93 1.20±0.94 53 3.30±0.97 1.27±0.79

Forgetful 57 2.63±1.00 1.52±0.86 58 3.02±1.05 1.63±0.90

Anorexia 37 2.32±1.07 0.70±0.70 53 2.88±1.03 0.70±0.68

Abdominal distension 34 1.76±1.26 0.54±0.73 39 1.98±1.27 0.61±0.69

Loose stool 41 1.76±0.97 0.50±0.66 37 1.99±0.67 0.54±0.61

Qi and blood deficiency syndrome:

Less angry and lazy 57 3.32±1.00 1.17±0.72 27 3.50±0.85 1.00±1.10

Fatigue 60 1.43±0.97 1.63±0.94 58 4.33±0.92 1.67±1.09

Pale 53 2.03±0.91 1.51±0.82 29 3.40±1.07 1.23±0.83

Palpitations 51 2.94±1.03 0.67±0.77 28 2.90±1.13 0.63±0.03

Insomnia 42 2.34±1.19 0.91±0.88 20 2.47±1.47 1.02±0.96

Dizziness 54 3.98±0.95 1.79±0.68 30 4.73±0.93 2.07±0.94

Hb(g/L) 60 108.52±14.72 117.33±13.8 30 100.20±10.19 114.27±10.19

RBC(10/L) 60 3.56±0.39 3.84±0.31 30 3.32±0.40 3.03±0.46

         Table 3 Comparison of curative effect between the treatment group and the control group (Ridit) analysis

                              , 

Syndrome of Deficiency of Heart and Spleen

Treatment group 60 3 25 29 3 0.4582

1.5862 ＞ 0.05

Control group 60 6 31 21 2 0.5418

Qi and blood deficiency syndrome

Treatment group 60 2 32 22 4 0.4930

...

Control group 30 4 13 10 3 0.5141

total curative effect

Treatment group 120 5 57 51 7 0.4760

                                              

Control group 90 10 44 31 5 0.5321

Clinical research leader:

Zhou Wenguang, Deputy Chief Physician of Integrated Traditional Chinese and Western Medicine in the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine

Each clinical leader:

Zhou Deli, Deputy Chief Physician of the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine

He Hui, Deputy Chief Physician of the Second Affiliated Hospital of Guangxi University of Traditional Chinese Medicine

Liu Qingfen, Deputy Chief Physician, People's Hospital of Guangxi District

Experimental Study:

Effect of Yuanshou Oral Liquid on HDL-C and LCAT of Mice

(Researchers: Zhang Shuqiu, Huang Yunzhong, Lu Caizhen, Li Min)

Animals: mice, Kunming species, healthy, weighing 18-22g, 66 mice were divided into three groups: experimental group 1, experimental group 2, and control group.

Dosing method: the experimental group was given 8 times the adult dose, and the second group was given 2 times the adult dose, intragastrically, once a day. 30 consecutive days. The control group was perfused with distilled water with the same volume.

test methods:

At the end of the experiment, blood was taken from the eyeball, the serum was separated, and the activities of high-density lipoprotein cholesterol (HDL-C) and lecithin cholesterol acyltransferase (LCAT) were measured.

Experimental results:

     Table 1 Comparison of HDL-C content between the experimental group and the control group (unit: mmoL/L)

Groups Number of cases HDL-C(X±SD) P value

Experimental group 22 3.74±1.82 P＜0.01

Experimental group 2 22 3.06±0.70 P＜0.01

Control group (rat) 22 1.95±1.00

Control group (human) 22 1.33±0.71

The HDL-C of the experimental group was significantly higher than that of the control group (P<0.01)

Table 2 Comparison of LCAT activity in mouse serum (mmol/m·h ^-1 )

Group n Enzyme activity unit P value

Experimental group 21 8.45

Control group 21 4.13 ＜0.01

The LCAT of the experimental group was significantly higher than that of the control group (P<0.01).

Claims (2)

1, a kind of blood tonic preparation is characterized in that: it is to be made by the raw material of following parts by weight:

Radix Polygoni Multiflori 4-10 part, Arillus Longan 3-7 part;

Described Radix Polygoni Multiflori is without the Radix Polygoni Multiflori dry tablet of making;

Described Arillus Longan is that the fresh fruit Arillus Longan is not added the sun-dried dry product that obtains of any additives.

2, a kind of production method of blood tonic preparation as claimed in claim 1 is characterized in that: its production stage is

(1) get Radix Polygoni Multiflori, use water infiltration 6 hours, put in the container, put in the steam pressure cooker, heat logical steam, temperature transfers to 120 ℃, continues 6 hours, takes out and cools off, and gets Radix Polygoni Multiflori Preparata;

(2) get above Radix Polygoni Multiflori Preparata, Arillus Longan adds 5-8 times of water, and heated and boiled was extracted 2-3 hour, and the medicinal liquid that falls comes out, and adds suitable quantity of water again, continues heated and boiled and extracts 2 hours.Pour out medicinal liquid, with medicinal liquid merging last time.Get medicinal liquid A liquid; Heating concentrates.A liquid is placed in the concentration pan, and heating concentrates, to an amount of volume.Must extract concentrated solution B liquid;

(3) ethanol precipitation mixes by 3: 1 volume ratio with B liquid with 95% ethanol, stirs, and puts in 4-8 ℃ of refrigerator or the icehouse and places 24 hours, crosses the elimination precipitation.Get extracting solution C liquid;

(4) reclaim ethanol, C liquid is put in the alcohol recovering device heating recovery ethanol.Take out medicinal liquid, heating concentrates.Get D liquid;

(5) add 3%-5% edible Gelatinum oxhide solution in D liquid, the limit edged stirs, occur tangible white opacity,, till not continuing to increase to white, put in 4 ℃ to the 8 ℃ refrigerators, left standstill 16-24 hour, cross the elimination precipitation.Get filtrate E liquid; Add 95% ethanol in E liquid, ethanol and E liquid stir in 3 to 1 ratios, put in 4 ℃ of-8 ℃ of refrigerators, leave standstill 16 to 24 hours, cross elimination and precipitate, and get filtrate F liquid;

(6) reclaim ethanol, F liquid is put in the alcohol recovering device heating recovery ethanol.The medicinal liquid heating concentrates, and gets G liquid, makes oral liquid, or adds appropriate amount of auxiliary materials, makes capsule, tablet, granule and pharmaceutically available dosage form product.