Tablet suitable for senile comprehensive diabetes mellitus and preparation method thereof

Abstract

The invention discloses a tablet suitable for senile comprehensive diabetes and a preparation method thereof. The tablet is prepared from a formula I and a formula II, wherein the formula I comprises powder radix trichosanthis, coptis chinensis, radix rehmanniae recen, rhizoma anemarrhenae, rhizoma nelumbinis, schisandra chinensis, dendrobe, cortex moutan, gardenia and liquorice; a formula II: radix polygonati officinalis, radix ophiopogonis, adenophora stricta, astragalus membranaceus, semen boitae and polygala tenuifolia; and a formula III is prepared from radix rehmanniae preparata, pulp of dogwood fruit, Chinese yam, medlar, rhizoma alismatis, radix aconiti carmichaeli, cinnamon, tortoise plastron, mantis egg-case, codonopsis pilosula, bighead atractylodes rhizome and magnetite. The traditional Chinese medicine fully retains the pharmacological activity of each component, achieves the effects of clearing heat, moistening dryness, reinforcing qi, nourishing yin, warming yin and nourishing kidney, can be used for comprehensive treatment of senile diabetes mellitus with diseases such as yin deficiency, excessive heat, qi-blood deficiency, yin-yang deficiency and the like, and has a good effect through clinical test verification.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a tablet suitable for senile comprehensive diabetes and a preparation method thereof. BACKGROUND

[0002] Diabetes is a common disease, which is caused by multiple factors and characterized by chronic hyperglycemia. It is caused by insufficient secretion of insulin or dysfunction of insulin, endocrine disorder, resulting in substance metabolism disorder, high sugar, high fat, protein metabolism, water and electrolyte disorder. Its typical symptoms are "three more and one less", i.e. polyuria, polydipsia, polyphagia and weight loss, which can be accompanied by skin itching. Long-term carbohydrate and fat, protein metabolism disorder can also cause the occurrence of various chronic complications, involving the function of all organs in the body, such as eye, kidney, nerve, heart, blood vessel and other tissues and organs chronic progressive disease, function decline and failure; severe or stress can cause acute severe metabolic disorder, such as diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic syndrome. The elderly are more susceptible to this disease due to the decline of body function and metabolic capacity. The onset of diabetes is caused by genetic and environmental factors, and the elderly are more susceptible to insulin resistance and insufficient insulin action caused by physiological aging and pathological factors.

[0003] Diabetes belongs to the category of "consumption" and "consumption" in traditional Chinese medicine.

[0004] Traditional Chinese medicine believes that the formation of diabetes is mainly due to deficiency of body yin, improper diet, emotional disorder, overwork and excessive desire, which consumes yin of lung, stomach and kidney, and causes xiaoke disease due to yin deficiency and dryness-heat. The pathogenesis is yin deficiency and dryness-heat, the yin deficiency is the root of the disease, and the dryness-heat is the symptom of the disease. In the late stage of the disease, qi and yin can be damaged. Yin and yang are both deficient, and even other diseases occur. In addition, the occurrence of this disease is often related to blood stasis.

[0005] In clinical treatment, the most common acute symptom of diabetic patients is diabetic ketoacidosis. Diabetic ketoacidosis is caused by lack of pancreatic islets and severe glucose metabolism disorder, which develops to accelerate fat decomposition, accumulation of serum ketone bodies, and causes clinical syndrome with high blood glucose, high ketonemia and metabolic acidosis as the main changes. The performance is deep and fast breathing, rotten apple smell in exhalation, dry mouth, headache, etc. Severe cases may have varying degrees of consciousness disorder, even coma. The incidence of diabetic ketoacidosis is generally 11.1% to 14.6% of inpatient diabetic patients.

[0006] Old people often have no typical symptoms of diabetes when they have diabetes. Literature reports that the first manifestation of elderly diabetic patients without diabetes symptoms is ketoacidosis, accounting for 9.0% (16 / 178). The incidence of ketoacidosis in hospitalized elderly diabetic patients is 18.4% (103 / 561).

[0007] The onset of diabetic ketoacidosis is due to relative or absolute deficiency of insulin in the body, and increased secretion of hormones such as glucagon, cortisol and growth hormone, which antagonize insulin, causing accelerated glycogenolysis, enhanced anaplerotic decomposition, increased hepatic glucose output, resulting in high blood glucose, accelerated lipolysis, increased ketone body production and decreased utilization. When the accumulation of serum ketone bodies exceeds the normal level and causes pathogenic ketonemia, it is clinically referred to as "ketosis". When the accumulation of major ketone acids such as acetoacetate and β-hydroxybutyrate causes metabolic acidosis, it is referred to as "ketoacidosis". At this time, in addition to the significant increase in blood glucose and strong positive urine glucose, blood ketones are often > 5 mmol / L, PH 7.35, and CO2 binding capacity < 13.5 mmol / L. If the condition is severe and develops into coma, it is called "diabetic ketoacidosis coma", which is simply referred to as "diabetic coma".

[0008] Older comprehensive diabetic patients are more common in adult type (non-insulin dependent type) diabetes. Generally, the serum insulin level is not low, and theoretically, the chance of developing diabetic ketoacidosis is less than that of young type (insulin dependent type) diabetes. However, elderly diabetic patients are prone to infection, and once infected, the body's secretion of glucagon and cortisol increases, which can easily lead to ketoacidosis.

[0009] Currently, diabetes has become a non-communicable epidemic, with a rising prevalence rate. With the arrival of aging, the number of elderly diabetic patients will further increase, therefore, it is urgent to study the prevention and treatment of elderly comprehensive diabetes.

[0011] Traditional Chinese medicine believes that the treatment of elderly comprehensive diabetes should be based on syndrome differentiation, combined with clinical manifestations and syndrome analysis to choose different prescriptions and dosage forms. Although the elderly have more deficiency syndrome, they can have deficiency and excess, so the priority is to differentiate between deficiency and excess, and the second is to differentiate between different types of deficiency, such as yin deficiency, qi and yin deficiency, and yin and yang deficiency. The third is to differentiate between heat, turbidity and blood stasis. If the disease course is prolonged and symptoms such as stroke, restlessness, nausea and vomiting, and coma occur, it is usually due to the decline of vital qi and the rampant of evil qi, with poor prognosis.

[0012] The treatment of elderly comprehensive diabetes in traditional Chinese medicine should pay attention to the appropriate treatment of deficiency and excess, "treat excess without forgetting deficiency", "treat deficiency without forgetting excess". According to the different types of deficiency and excess, or tonifying qi and nourishing yin or nourishing yin and warming kidney, the treatment of nourishing yin and kidney throughout the treatment process, removing evil with clearing heat and purging fire, promoting blood circulation and removing blood stasis, and transforming phlegm and turbidity are the main methods. As it is said in "Medical Heart Enlightenment·Sanxia" chapter: "treat upper sanxia by promoting lung function and clearing stomach", "treat middle sanxia by clearing stomach and treating kidney", and "treat lower sanxia by tonifying kidney and supplementing lung", which can be regarded as a deep understanding of the important basis for treating this disease.

[0013] Due to physiological aging, the movement system of the elderly also has a series of anatomical and physiological changes, the body function declines, the strain capacity decreases, the acute and chronic injuries increase, the repair capacity decreases, and the sequelae increase. Therefore, how to improve the prevention and treatment of the movement system diseases of the elderly on the basis of comprehensively understanding these characteristics and maximize the rehabilitation of the movement system diseases of the elderly.

[0014] The effect of a drug is affected by the body's disposition of the drug on one hand, and depends on the reaction of the tissue to the drug, that is, the sensitivity of the tissue on the other hand. With the increase of age, the histology of the body changes, which inevitably leads to the change of the effect of the drug, that is, the difference in the effect of the drug between the elderly and the young. The difference is not only reflected in the strength of the effect of the drug, but sometimes even in the nature of the effect, which causes great difference in the effect of the drug.

[0015] At present, there is no special drug for the elderly patients with comprehensive diabetes, and it is still necessary to treat each symptom and type. SUMMARY

[0016] The purpose of the present application is to provide a tablet suitable for the elderly patients with diabetes, which is safe and effective, and convenient to take, and a preparation method thereof.

[0017] The present application is realized by adopting the following technical scheme, a tablet suitable for the elderly patients with comprehensive diabetes and a preparation method thereof, which is prepared from a first formula, a second formula and a third formula, the first formula is prepared from the following raw materials in a proportion: Radix Trichosanthis 75-300 parts, Rhizoma Coptidis 15-90 parts, Radix Rehmanniae 30-180 parts, Rhizoma Anemarrhenae 25-100 parts, Rhizoma Alismatis 60-240 parts, Fructus Schisandrae 25-100 parts, Dendrobium 50-200 parts, Radix Paeoniae Rubra 50-200 parts, Fructus Gardeniae 25-100 parts, and Radix Glycyrrhizae 15-60 parts; the second formula is prepared from the following raw materials in a proportion: Rhizoma Polygonati 50-150 parts, Radix Ophiopogonis 40-120 parts, Radix Adenophorae 40-120 parts, Radix Astragali 75-300 parts, Semen Platycladi 40-120 parts, Radix Polygalae 40-120 parts; and the third formula is prepared from the following raw materials in a proportion: Radix Rehmanniae Praeparata 50-150 parts, Fructus Corni 50-150 parts, Radix Rehmanniae 60-170 parts, Fructus Lycii 50-150 parts, Rhizoma Alismatis 50-150 parts, Radix Aconiti 15-60 parts, Cinnamomum Cassia 15-60 parts, Plastrum Testudinis 30-90 parts, Melo 30-100 parts, Radix Codonopsis 50-150 parts, Rhizoma Atractylodis Macrocephalae 50-150 parts, and Magnetitum 30-100 parts.

[0018] Further preferably, the prescription one is made of the following raw materials in the following proportions: Radix Trichosanthis 150-300 parts, Rhizoma Coptidis 30-90 parts, Radix Rehmanniae 60-180 parts, Rhizoma Anemarrhenae 50-100 parts, Rhizoma Alismatis 120-240 parts, Fructus Schisandrae 50-100 parts, Dendrobium 100-200 parts, Radix Paeoniae Alba 100-200 parts, Fructus Gardeniae 50-100 parts, and Radix Glycyrrhizae 30-60 parts; the prescription two is made of the following raw materials in the following proportions: Rhizoma Polygonati 100-150 parts, Radix Ophiopogonis 80-120 parts, Radix Adenophorae 80-120 parts, Radix Astragali 150-300 parts, Semen Platycladi 80-120 parts, and Radix Polygalae 80-120 parts; and the prescription three is made of the following raw materials in the following proportions: Radix Rehmanniae Praeparata 100-150 parts, Fructus Corni 100-150 parts, Radix Pseudostellariae 120-170 parts, Fructus Lycii 100-150 parts, Rhizoma Alismatis 100-150 parts, Radix Aconiti 30-60 parts, Cinnamomum Cassia 30-60 parts, Plastrum Testudinis 60-90 parts, Carapax Trunculi 60-100 parts, Radix Codonopsis 100-150 parts, Rhizoma Atractylodis Macrocephalae 100-150 parts, and Magnetitum 60-100 parts.

[0019] A preparation method of a tablet suitable for old-age comprehensive diabetes, which comprises the following steps: 1. preparing prescription one standby powder, according to the proportion, taking each raw material of prescription one, crushing and powdering and mixing uniformly, sieving, fumigation and disinfection, obtaining loose, uniform and consistent dry powder, constant temperature storage at 15-20℃ for standby; 2. preparing prescription two standby powder, according to the proportion, taking each raw material of prescription two, crushing and powdering and mixing uniformly, sieving, fumigation and disinfection, obtaining loose, uniform and consistent dry powder, constant temperature storage at 15-20℃ for standby; 3. preparing prescription three standby powder, according to the proportion, taking each raw material of prescription three, crushing and powdering and mixing uniformly, sieving, fumigation and disinfection, obtaining loose, uniform and consistent dry powder, constant temperature storage at 15-20℃ for standby; 4. mixing uniformly the standby powder obtained in steps 1-3, and keeping it dry, loose and uniform in color, disinfecting, constant temperature and dry storage for standby; 5. wetting the standby powder obtained in step 4 with distilled water (1% distilled water per 100 kg), using a tablet press to press and tablet, obtaining tablet-shaped tablets; 6. packaging the tablet-shaped tablets obtained in step 5, disinfecting, obtaining finished product tablets.

[0020] The constant temperature storage of the three groups of dry powder in steps 1-3 is 15-20℃.

[0021] In order to avoid the medicinal material degeneration, keep the efficacy, and store, the fumigation and disinfection in steps 1-6 of the present application is that 80-120g of the powder is fumigated and disinfected with the mixed fumigation of 80-120g of the aconite leaf and the wormwood leaf for 50-60 minutes, wherein the mixed ratio of the wormwood leaf and the aconite leaf is 80% of the wormwood leaf and 20% of the aconite leaf by weight.

[0022] The raw materials and pharmacology of the three groups used in the present application are as follows: Group one: Radix Trichosanthis is the dry root of Trichosanthes kirilowii or T. japonicus. It is collected in autumn and winter, washed, peeled, cut into sections or split into petals, and dried. Processing: soak, moisten, cut into slices, and dry. Property: sweet, bitter, and cold. Function and indication: produce saliva to relieve thirst, discharge pus and reduce swelling. It is used for treating thirst in heat, diabetes, and carbuncle.

[0023] Rhizoma Coptidis is the dry root of Coptis chinensis, C. deltoidea, or C. teeta. The above three are respectively called "Wei Lian", "Ya Lian", and "Yun Lian". It is collected in autumn, cleaned, dried, and the residual root hairs are removed. Processing: remove impurities, crush, or cut into slices after moistening, and dry. Rhizoma Coptidis with wine: take clean Rhizoma Coptidis, and stir-fry with yellow rice wine according to the wine stir-frying method. 12.5 kg of yellow rice wine is used for 100 kg of Rhizoma Coptidis. Rhizoma Coptidis with ginger juice: take clean Rhizoma Coptidis, and stir-fry with ginger juice according to the ginger juice stir-frying method. 12.5 kg of fresh ginger is used for 100 kg of clean Rhizoma Coptidis. Property: bitter and cold. Function and indication: clear heat, detoxify, clear heat, and dry dampness. It is used for treating heat in warm disease, hematemesis, hemoptysis, damp-heat distention and vomiting, dysentery, enteritis, red eyes with swelling and pain, tongue and mouth sores, otitis media, and carbuncle, sore, and ulcer. Rhizoma Coptidis with wine: clear heat and detoxify. It is used for treating heat in warm disease, hematemesis, hemoptysis, and carbuncle, sore, and ulcer.

[0024] Radix Rehmanniae is the fresh or dry tuber of Rehmannia glutinosa. It is collected in autumn, cleaned, and the root head and root hairs are removed. The fresh one is called "fresh Radix Rehmanniae", and the dry one is called "Radix Rehmanniae". Processing: remove impurities, clean, moisten, cut into slices, and dry. Charred Radix Rehmanniae: take Radix Rehmanniae slices, and char according to the charred method. Property: sweet and cold. Function and indication: clear heat, cool blood, and produce saliva. It is used for treating heat in warm disease, fever, and red rash, hematemesis, hemoptysis, hematuria, sore throat, and swollen throat. Radix Rehmanniae: nourish yin, clear heat, and stop bleeding. It is used for treating heat in warm disease, red rash, yin deficiency, diabetes, hematemesis, hemoptysis, hematuria, and metrorrhagia.

[0025] Rhizoma Anemarrhenae is the dry root of Anemarrhena asphodeloides. It is collected in spring and autumn, cleaned, and dried. The root hairs and mud are removed, and it is called "Mao Anemarrhena". The outer skin is removed, dried, and called "Anemarrhena Meat". Processing: remove impurities, clean, moisten, cut into slices or sections, and dry. Property: bitter and cold. Function and indication: clear heat and relieve restlessness, and nourish yin. It is used for treating heat and thirst, lung heat and dry cough, diabetes, and afternoon fever.

[0026] Lotus node, for the lotus plant Nelumbo nucifera Gaertn. Dried rhizome node part. In autumn and winter, the rhizome (lotus) is dug, the node part is cut, washed and dried, and the root hairs are removed. Processing: Lotus node: remove impurities, wash and dry. Lotus node carbon: take clean lotus node, fry to the surface black and internal yellow brown according to the carbon method. Nature and taste: sweet, astringent, flat. Function and treatment: stop bleeding, remove stasis. For bleeding, hemoptysis, hematuria, metrorrhagia.

[0027] Schisandra, for the Magnoliaceae Schisandra chinensis or the dried mature fruit of the central China Schisandra. The former is commonly known as "North Schisandra", and the latter is commonly known as "South Schisandra". In autumn, when the fruit is mature, it is picked, dried or steamed and dried, and the peduncle and impurities are removed. Processing: Schisandra: remove impurities. Vinegar Schisandra: take clean Schisandra, steam with vinegar until black according to the vinegar steaming method. Function and treatment: astringe lung, nourish kidney, produce saliva, stop diarrhea. For lung deficiency wheezing and cough, saliva deficiency and thirst, night sweat, chronic diarrhea, neurasthenia.

[0028] Dendrobium, for the fresh or dried stems of Dendrobium candidum Wall. ex. Lindl., Dendrobium nobile Lindl., Dendrobium chrysostachys Paxt., Dendrobium fimbriatum or Dendrobium officinale Kimura. It can be collected throughout the year, and the fresh ones are removed from the roots and mud; the dry ones are collected, removed from impurities, slightly boiled with hot water or softened with oven, and then rubbed and dried until the leaf sheath is rubbed clean. After cutting off part of the root, Dendrobium officinale is twisted into a spiral or spring shape while frying, dried and called "earring Dendrobium". Processing: Remove the residual roots, wash and cut into segments. Nature and taste: sweet, mild, cold. Function and treatment: nourish yin and stomach, produce saliva and stop thirst. For heat disease and saliva, dry mouth and thirst, post-disease heat.

[0029] Danpi, for the dried root bark of Paeonia suffruticosa Andr. of Ranunculaceae. In autumn, the root part is dug, the fine roots are removed, and the root bark is peeled off and dried. Processing: Wash quickly, cut into slices after moistening, and dry. Nature and taste: bitter, pungent, cold. Function and treatment: clear blood heat, disperse blood stasis. For hot disease with macula, rash, hematemesis, metrorrhagia, hot flashes, dysmenorrhea, amenorrhea, abscess.

[0030] Gardenia, for the dried mature fruit of Gardenia jasminoides Ellis of Rubiaceae. The fruit is harvested when it is red and yellow in September-November. Remove the pedicel and impurities, steam until the gas is out or slightly boil in boiling water, take out and dry. Processing: Gardenia: remove impurities and break. Fried gardenia: take clean gardenia, fry until yellow brown according to the frying method. Gardenia char: take clean gardenia, fry until yellow brown according to the frying method. Nature and taste: bitter, cold. Function and treatment: clear heat and relieve restlessness, cool blood and remove stasis. For hot disease with restlessness, jaundice, red eyes, metrorrhagia, hematemesis, hematuria, hot and toxic sores; external treatment of sprains and contusions, blood clots and pain.

[0031] Gancao, the dried root and rhizome of Glycyrrhiza uralensis Fisch., G. inflata Bat. or G. glabra L. It is harvested in spring and autumn, removed from the rootlets, and dried. Processing: Gancao: remove impurities, wash, soak, slice, and dry. Mihuanggancao: take Gancao slices, fry with honey water until yellow, and cool down. Function and Indications: clear heat and resolve toxin, relieve cough and reduce sputum, and tonify the spleen and stomach. It is used for sore throat, cough, palpitation, abdominal pain, ulcer, and sores.

[0032] Group Two: Yuzhi, the dried rhizome of Polygonatum sibiricum Red., is harvested in autumn, removed from the rootlets, washed, dried until soft, repeatedly kneaded and dried until no hard core, and dried. Processing: remove impurities, wash, soak, slice or segment, and dry. Property: sweet and neutral. Function and Indications: nourish yin and moisten dryness, and generate fluid to relieve thirst. It is used for dry mouth and throat, dry cough with little sputum, heart palpitation, and diabetes.

[0033] Maidong, the dried tuber of Ophiopogon japonicus (Thunb.) Ker-Gawl, is harvested in summer, washed, repeatedly exposed to the sun, stacked, dried until 70-80%, removed from the rootlets, and dried. Processing: remove impurities, wash, soak, flatten, and dry. Property: sweet, bitter, and cold. Function and Indications: nourish yin, generate fluid, moisten the lung, and relieve cough. It is used for dry cough, dry mouth, heart palpitation, and pharyngeal diphtheria.

[0034] Shashen, the dried root of Hedysarum polybotrys Hand.-Mazz., Hedysarum alpinum Fisch. or several species of Hedysarum, is harvested in spring and autumn, removed from the rootlets, washed, peeled, washed, and dried. Processing: remove the rootlets, wash, soak, slice, and dry. Property: sweet and cold. Function and Indications: moisten the lung, resolve phlegm, and relieve cough. It is used for cough with sticky sputum, dry mouth, and dry throat.

[0035] Huangqi, the dried root of Astragalus membranaceus (Fisch.) Bunge, A. mongholicus Bunge or A. complanatus R. Br., is harvested in spring and autumn, removed from the rootlets and root head, and dried. Processing: remove impurities, wash, soak, slice, and dry. Mihuangqi: take Huangqi slices, fry with honey water until yellow, and cool down. Property: sweet and warm. Function and Indications: tonify qi, strengthen the body resistance, promote urination, promote pus discharge, and promote tissue regeneration. It is used for shortness of breath, heart palpitation, prostration, spontaneous sweating, body weakness, edema, chronic nephritis, chronic diarrhea, and sores.

[0036] Baiziren, the dried mature seed of Platycladus orientalis (L.) Franco, is harvested in autumn and winter, dried, removed from the seed coat, and collected. Processing: Baiziren: remove impurities and residual seed coat. Baiziren cream: take clean Baiziren, grind, wrap with paper, heat, squeeze out the oil, and grind. Property: sweet and neutral. Function and Indications: nourish the heart, calm the mind, and moisten the intestines. It is used for palpitation, insomnia, and constipation.

[0037] Jujube, the dried root of Jujube or Ovateleaf Jujube. Dig up in spring and autumn, remove the rootlets and dirt, and dry. Processing: Jujube: remove impurities, wash, soak, cut into pieces, and dry. Prepared Jujube: add liquorice, decoct, remove the dregs, add the cleaned Jujube, and simmer until the liquor is absorbed. Nature: bitter, pungent, and warm. Function and Indication: calm the nerves, and remove phlegm. Used for palpitation, forgetfulness, insomnia, and dreaminess.

[0038] Group Prescription Three: Rehmannia, the dried tuber of Rehmannia glutinosa. Dig up in autumn, remove the rootlets and dirt, and dry. Processing: (1) soak the cleaned Rehmannia in liquor until the liquor is absorbed, remove, and dry until the outer skin is slightly dry. Use 50 kg of liquor for every 100 kg of Rehmannia. (2) steam the cleaned Rehmannia until it is black and moist, remove, and dry until it is about 80% dry. Nature: sweet, bitter, and slightly warm. Function and Indication: nourish Yin and blood. Used for Yin deficiency, blood deficiency, dizziness, tinnitus, weakness of the waist and knees, diabetes, spermatorrhea, and metrorrhagia.

[0039] Cornel, the dried ripe pericarp of Cornus officinalis. Collect the fruit in late autumn and early winter when the pericarp turns red, dry, and roast with moderate heat or briefly boil in boiling water, remove the seeds, and dry. Processing: remove impurities and residual seeds. Prepared Cornus officinalis: (1) simmer the dried pericarp in liquor until the liquor is absorbed. (2) steam the dried pericarp for 4-6 hours, and stew for 6-8 hours until the color is dark purple. Nature: sour, astringent, and slightly warm. Function and Indication: tonify the liver and kidney, astringe the essence, and stop sweating. Used for tinnitus and dizziness, weakness of the waist and knees, spontaneous sweating, frequent urination, spermatorrhea, and menorrhagia.

[0040] Chinese yam, the dried rhizome of Dioscorea opposita. Dig up in winter when the stems and leaves wither, remove the rootlets, wash, and dry. Processing: remove impurities, soak, and dry. Fried Chinese yam: roast the Chinese yam slices until they are yellow. Nature: sweet and neutral. Function and Indication: tonify the spleen and stomach, and benefit the lung and kidney. Used for diarrhea due to spleen deficiency, cough due to lung deficiency, diabetes, frequent urination, spermatorrhea, and leukorrhea.

[0041] Medlar, the dried ripe fruit of Lycium barbarum. Collect the fruit in summer and autumn when it turns orange-red, dry, and roast with moderate heat or briefly boil in boiling water, remove the stems, and dry. Nature: sweet and neutral. Function and Indication: nourish the liver and kidney, and benefit the essence and eyesight. Used for dizziness, dizziness, tinnitus, weakness of the waist and knees, and diabetes.

[0042] Alisma orientale, the dried tuber of Alisma orientale (Sam.) Juz. It is harvested when the stems and leaves begin to wither in winter, washed, dried, and the fibrous roots and coarse bark are removed. Processing: Alisma orientale: Remove impurities, soak slightly, moisten thoroughly, slice, and dry. Salt-processed Alisma orientale: Take the sliced Alisma orientale and stir-fry with salt water according to the salt-water frying method until the surface shows a slightly yellow color. Nature and flavor: Sweet, cold. Functions and indications: Diuretic, clearing away damp-heat. Used for dysuria, urinary tract infection, edema, phlegm-fluid retention, dizziness.

[0043] Aconite Lateralis Preparata, the processed lateral root of Aconitum carmichaeli Debx. It is harvested from late June to early August, the mother root, fibrous roots and mud are removed, commonly known as muddy aconite lateralis, and processed into prepared aconite slices. Processing: Black prepared aconite slices and white prepared aconite slices are directly used in medicine. Nature and flavor: Pungent, very hot, toxic. Functions and indications: Restoring yang, warming the interior to dispel cold, relieving pain. Used for collapse of yang with profuse sweating, cold limbs, cold pain in the epigastrium and abdomen, deficiency-cold diarrhea, arthralgia due to cold-dampness, edema due to yang deficiency, heart failure, edema of chronic nephritis.

[0044] Cinnamomum cassia Presl, the dried bark of Cinnamomum cassia Presl. It is mostly peeled in autumn and dried in the shade. Processing: Remove impurities and coarse bark, and pound before use. Nature and flavor: Pungent, sweet, very hot. Functions and indications: Tonifying yang, warming the kidney, dispelling cold, promoting blood circulation, relieving pain. Used for cold limbs with weak pulse, cold pain in the epigastrium, abdomen and waist, deficiency-cold asthma, deficiency-cold diarrhea, dysmenorrhea, amenorrhea, hypotension, cold abscess.

[0045] Plastrum Testudinis, the ventral carapace of Chinemys reevesii (Gray). It can be captured throughout the year, mostly in autumn and winter. After capture, it is killed or scalded to death with boiling water, the ventral carapace is peeled off, the remaining flesh is removed, and it is dried in the sun. Processing: Plastrum Testudinis: Soak, remove all the flesh and skin, wash, expose to the sun during the day and dew at night until there is no odor. Vinegar-processed Plastrum Testudinis: Take the clean Plastrum Testudinis, stir-fry with sand according to the frying method until the surface shows a light yellow color, take out, sieve out the sand, quench with vinegar, take out, and dry. For every 100 kg of Plastrum Testudinis, 20 kg of vinegar is used. Nature and flavor: Salty, sweet, slightly cold. Functions and indications: Nourishing yin and suppressing yang, tonifying the kidney and strengthening the bones. Used for yin deficiency with hectic fever, night sweating, tuberculosis, convulsion due to yin injury in the late stage of febrile disease, weakness of the waist and knees, metrorrhagia and metrostaxis, hemorrhoids and fistulas.

[0046] Ootheca Mantidis, the dried egg masses of Tenodera sinensis Saussure, Statilia maculata (Thunb.) and Hierodula patellifera (Serville). They are commonly known as "round ootheca mantidis", "long ootheca mantidis" and "black ootheca mantidis" respectively. It is harvested from late autumn to the next spring, impurities are removed, the eggs are steamed to death, and it is dried. Processing: Remove impurities, steam thoroughly, dry, and cut into pieces before use. Nature and flavor: Sweet, salty, flat. Functions and indications: Tonifying the kidney, astringing sperm, diuretic, arresting leukorrhea. Used for enuresis, frequent urination, leukorrhea, spermatorrhea.

[0047] Codonopsis pilosula (Franch.) Nannf., the dried root of Codonopsis pilosula (Franch.) Nannf. It is harvested in autumn, washed and dried in the sun. Processing: Remove impurities, wash, moisten thoroughly, cut into sections, and dry for standby. Processing: Remove impurities, wash, moisten thoroughly, cut, and dry. Nature and flavor: Sweet, flat, tonifying qi and strengthening the spleen. Used for qi deficiency with palpitation, lassitude, anorexia and loose stools.

[0048] Baizhu, the dried rhizome of Atractylodes macrocephala Koidz, is of the family Compositae. It is harvested in winter when the lower leaves are yellow and the upper leaves are brittle, cleaned, dried or sun-dried, and then the roots are removed. Processing: Baizhu: remove impurities, clean, soak, slice, and dry. Chao Baizhu: take Baizhu slices, and stir-fry until the color is dark according to the bran stir-frying method. Property: sweet, bitter, and warm. Function and Indication: invigorating the spleen and drying dampness. It is used for spleen deficiency, poor appetite, abdominal distension, diarrhea, phlegm-dampness, dizziness, and edema.

[0049] Cishi, the isometric magnetite, mainly contains Fe3O4. After being dug, the impurities are removed. Processing: Cishi: remove impurities and crush. Liao Cishi: take clean Cishi, and calcine until red and transparent according to the calcining method. Immediately pour into vinegar to quench, take out, dry, and grind into coarse powder. 20-30 kg of vinegar is used for every 100 kg of Cishi. Property: pungent and cold. Function and Indication: subduing yang, absorbing qi, calming and tranquilizing the mind. It is used for blurred vision, tinnitus and deafness, palpitation and insomnia, and qi-dampness.

[0050] The present application is based on the physical condition of the elderly and the characteristics of the symptoms of senile comprehensive diabetes, and on the basis of traditional Chinese medicine dialectical treatment, the pharmacological properties of each traditional Chinese medicine raw material are fully analyzed, and scientific compounding is carried out, so that the pharmacological properties of each component are fully exerted, and the heat-dryness, qi-yin and kidney-nourishing, and yin-nourishing and kidney-nourishing can be achieved. It can be used for the comprehensive treatment of senile diabetes with heat, blood deficiency and yin-yang deficiency, and the like. Clinical trials have verified that it has good effect.

[0051] By adopting the above technical scheme, the present application better achieves the purpose of the application, adopts pure traditional Chinese medicine products as raw materials, reasonably formulates the prescription, and combines various drugs to clear heat and dryness, benefit qi and nourish yin, warm yin and nourish kidney, so that the elderly patients can directly take orally without the need for classification treatment, and the use is convenient. DETAILED DESCRIPTION

[0052] The present application will be further described below in combination with examples. Example 1

[0053] A tablet suitable for senile comprehensive diabetes and a preparation method thereof are prepared from prescription one, prescription two and prescription three. Prescription one is prepared from the following raw materials in the following proportions: Radix Trichosanthis 150 parts, Rhizoma Coptidis 30 parts, Radix Rehmanniae 60 parts, Rhizoma Anemarrhenae 50 parts, Lotus node 120 parts, Fructus Schisandrae 50 parts, Dendrobium 100 parts, Radix Paeoniae Alba 100 parts, Fructus Gardeniae 50 parts, and Radix Glycyrrhizae 30 parts. Prescription two is prepared from the following raw materials in the following proportions: Radix Polygonati 100 parts, Radix Ophiopogonis 80 parts, Radix Adenophorae 80 parts, Radix Paeoniae Alba 150 parts, Semen Platycladi 80 parts, Radix Polygalae 80 parts. Prescription three is prepared from the following raw materials in the following proportions: Radix Rehmanniae Praeparata 100 parts, Fructus Corni 100 parts, Radix Rehmanniae 120 parts, Fructus Lycii 100 parts, Rhizoma Alismatis 100 parts, Radix Aconiti 30 parts, Cinnamomum Cassia 30 parts, Plastrum Testudinis 60 parts, Sang Piao Xiao 60 parts, Radix Codonopsis 100 parts, Rhizoma Atractylodis Macrocephalae 100 parts, and Cishi 60 parts.

[0054] A preparation method of a tablet suitable for old comprehensive diabetes, comprising the following steps: 1. Preparing a standby powder of formula one, according to the proportion, weighing each raw material of formula one, crushing and mixing uniformly, sieving, fumigation and disinfection for 60 minutes, obtaining loose, uniform and dry powder, 20℃ constant temperature storage for standby; 2. Preparing a standby powder of formula two, according to the proportion, weighing each raw material of formula two, crushing and mixing uniformly, sieving, fumigation and disinfection, obtaining loose, uniform and dry powder, 20℃ constant temperature storage for standby; 3. Preparing a standby powder of formula three, according to the proportion, weighing each raw material of formula three, crushing and mixing uniformly, sieving, fumigation and disinfection, obtaining loose, uniform and dry powder, 20℃ constant temperature storage for standby; 4. Mixing the standby powder obtained in steps 1-3 uniformly, sieving, removing the filter residue that cannot pass through the sieve, and keeping it dry, loose and uniform in color, disinfecting, sealing, constant temperature drying and storage for standby; 5. Wetting the standby powder obtained in step 4 with distilled water (1% distilled water per 100 kg), using a tablet press to press and tablet, 0.38g per tablet, obtaining tablet-shaped medicine tablets; 6. Packaging the tablet-shaped medicine tablets obtained in step 5, disinfecting, obtaining the finished product tablets.

[0055] The fumigation and disinfection in steps 1-3 of this example is 100g of 20% aconite leaves and 80% wormwood leaves per 1000g of powder, fumigation and disinfection for 60 minutes. Example 2

[0056] A tablet suitable for old comprehensive diabetes and its preparation method, which is made of formula one, formula two and formula three, formula one is made of the following proportion of raw materials: 75 parts of radix trichosanthis, 15 parts of rhizoma coptidis, 30 parts of radix rehmanniae, 25 parts of radix anemarrhenae, 60 parts of lotus node, 25 parts of schisandra chinensis, 50 parts of dendrobium, 50 parts of peony root, 25 parts of gardenia, 15 parts of licorice; formula two is made of the following proportion of raw materials: 50 parts of polygonatum, 40 parts of ophiopogon, 40 parts of adenosma, 75 parts of astragalus, 40 parts of platycladus orientalis, 40 parts of milkwort; formula three is made of the following proportion of raw materials: 50 parts of prepared rehmannia, 50 parts of dogwood fruit, 60 parts of Chinese yam, 50 parts of medlar, 50 parts of alisma, 15 parts of aconite, 15 parts of cassia, 30 parts of turtle shell, 30 parts of sand worm, 50 parts of codonopsis, 50 parts of atractylodes, 30 parts of magnetite.

[0057] The fumigation and disinfection in steps 1-3 of this example is 125g of 20% aconite leaves and 80% wormwood leaves per 1000g of powder, fumigation and disinfection for 55 minutes.

[0058] The constant temperature storage temperature of the dry powder in this example is 15℃.

[0059] The same as example 1. Example 3

[0060] A tablet for senile comprehensive diabetes and a preparation method thereof, which is prepared from formula one, formula two and formula three, formula one is prepared from the following raw materials in the following proportions: Radix Trichosanthis 300 parts, Rhizoma Coptidis 90 parts, Radix Rehmanniae 180 parts, Rhizoma Anemarrhenae 100 parts, Rhizoma Alismatis 240 parts, Fructus Schisandrae 100 parts, Dendrobium 200 parts, Radix Paeoniae Alba 200 parts, Fructus Gardeniae 100 parts, and Radix Glycyrrhizae 60 parts; formula two is prepared from the following raw materials in the following proportions: Rhizoma Polygonati 150 parts, Radix Ophiopogonis 120 parts, Radix Adenophorae 120 parts, Radix Astragali 300 parts, Semen Platycladi 120 parts, Radix Polygalae 120 parts; and formula three is prepared from the following raw materials in the following proportions: Radix Rehmanniae Praeparata 150 parts, Fructus Corni 150 parts, Radix Pseudostellariae 170 parts, Fructus Lycii 150 parts, Rhizoma Alismatis 150 parts, Radix Aconiti 60 parts, Cinnamomum Cassia 60 parts, Plastrum Testudinis 90 parts, Melo Concha Arcae 100 parts, Radix Codonopsis 150 parts, Rhizoma Atractylodis Macrocephalae 150 parts, and Magnetitum 100 parts.

[0061] The fumigation and disinfection in steps 1-6 of the example is that 20% of Aconitum leaves and 80% of Artemisia leaves are mixed to a total of 150g per 1000g of powder, and fumigation and disinfection is performed for 50 minutes.

[0062] The constant temperature storage temperature of the dried powder of the example is 18℃.

[0063] The rest is the same as in example 1.

[0064] Diabetes is a common chronic disease in the elderly, and its prevalence increases with age. Diabetes belongs to the category of diabetes in traditional Chinese medicine. In recent years, there have been many reports on the research and treatment of diabetes based on traditional Chinese medicine dialectical typing. Most of them are based on the theory of yin deficiency and dry heat. However, there are few treatments for senile diabetes from the perspective of spleen and kidney. The clinical trials of the present application are based on the physiological changes and pathological characteristics of the elderly, and adopt the principles of invigorating the spleen and kidney, promoting blood circulation and removing blood stasis in traditional Chinese medicine to treat senile comprehensive diabetes, and satisfactory results are achieved.

[0065] Senile comprehensive diabetes can be divided into yin deficiency and heat, qi and yin deficiency, and yin and yang deficiency according to clinical dialectical typing. In the trial process, the physiological changes and pathological characteristics of the elderly were analyzed, and the treatment principles of each type of clinical manifestation and syndrome were studied. The principles of invigorating the spleen and kidney, promoting blood circulation and removing blood stasis in traditional Chinese medicine were adopted to observe and record the treatment effect of the tablet of the present application.

[0066] Table 1: Study on the treatment of senile diabetes based on traditional Chinese medicine dialectical typing

[0067] 94 cases of senile diabetes patients were selected, including 64 males and 30 females, with the oldest being 79 years old and the youngest being 50 years old, with the longest course of 8 years and the shortest course of 12 months.

[0068] 94 patients clinical manifestations include dry mouth, thirst, drink, frequent urination, cloudy urine, soreness of the waist and knees, shortness of breath, fatigue, edema, weakness or gradually emaciated and other positive signs of weakness, tongue dark red or have blood clots, white or less moss, pulse. According to the age of the patients belonging to 94 patients were grouped into 5 groups, oral tablets prepared in the example 1 of the present invention, 3 times a day, 3 pieces each time, and supplemented by low-salt diet, appropriate exercise, track observations and record the effects of medication, drug effects include: marked effect, effective and ineffective. Drug effects according to the following standards for evaluation, marked effect: clinical symptoms disappeared, fasting blood glucose decreased to 6.6 mmol / L, urine sugar negative, stable for more than 1 year; effective: clinical symptoms improved significantly, fasting blood glucose decreased by more than 50%, blood glucose 6.6-8.26.6 mmol / L, urine sugar- or +; ineffective: clinical symptoms improved not too obvious, fasting blood glucose less than 50%, urine sugar + + ~ + + +.

[0069] Treatment results statistics seen in Table 2: the invention of Chinese medicine tablets 94 cases of elderly patients with diabetes treatment results statistics. As shown in Table 2, 5 groups of patients treated 94 cases, 71 cases were markedly effective, accounting for 75.53%; effective in 13 cases, accounting for 13.83%, 10 cases were ineffective, accounting for 10.63%; effective, a total of 84 cases, the total effective rate was 88.53%, 50-55 years of age group of patients with 11 cases were markedly effective, the total effective rate was 90.82%, 56-60 years of age group of patients with 12 cases were markedly effective, the total effective rate was 91.67%; 61-65 years of age group were markedly effective in 35 cases, the total effective rate was 92.1%; 66-70 years of age group were markedly effective in 13 cases, accounting for 86.67% of the total effective rate; 71-79 years of age group were markedly effective in 15 cases, accounting for 83.33% of the total effective rate. The table shows that the younger the age, the higher the cure rate, the older the age, the lower the cure rate. From the total effective rate of 94 cases was 89.36%.

[0070] Table 2 The invention of Chinese medicine tablets 94 cases of elderly patients with diabetes treatment results statistics

[0071] From the above results, although the elderly comprehensive diabetes is mostly deficiency syndrome, but can be deficiency with real, so the first is to distinguish between deficiency and excess, the main and secondary, the second is the different of deficiency syndrome, such as yin deficiency, qi and yin deficiency, yin and yang deficiency, so the dialectic should be clear about the different of deficiency, the third is the different of heat, blood stasis and blood stasis. The traditional method of treating elderly diabetes should be treated according to syndrome differentiation, combined with clinical manifestations and syndrome analysis to select different prescription and dosage form. The tablet for the elderly comprehensive diabetes of the application is prepared from (1) radix trichosanthis, rhizoma coptidis, radix rehmanniae, radix anemarrhenae, lotus node, schisandra chinensis, dendrobium, peony, gardenia, licorice; (2) polygonatum, ophiopogon, adenosma, astragalus, cypress seed, milkwort; (3) prepared rehmannia, dogwood fruit, Chinese yam, medlar, alisma, aconite, cassia, turtle plate, sand worm, codonopsis, atractylodes, magnetite. It is prepared on the basis of the different dosage forms of traditional Chinese medicine dialectical treatment, and the prescription is scientific and accurate. The tablet has the functions of clearing heat and moistening dryness, benefiting qi and nourishing yin, warming yin and nourishing kidney, especially suitable for the clinical treatment of elderly type 2 diabetes and various types, which can effectively treat the syndrome differentiation of yin deficiency and heat, qi and blood deficiency and yin and yang deficiency in traditional Chinese medicine, and has good therapeutic effect.

Claims

1. A tablet suitable for elderly patients with comprehensive diabetes, characterized in that... It is composed of three formulas: Formula 1, Formula 2, and Formula 3. Formula 1 is made from the following ingredients in the specified proportions: 75-300 parts of Trichosanthes kirilowii root, 15-90 parts of Coptis chinensis root, 30-180 parts of Rehmannia glutinosa root, 25-100 parts of Anemarrhena asphodeloides rhizome, 60-240 parts of Nelumbo nucifera rhizome, 25-100 parts of Schisandra chinensis fruit, 50-200 parts of Dendrobium nobile root, 50-200 parts of Paeonia suffruticosa root bark, 25-100 parts of Gardenia jasminoides fruit, and 15-60 parts of Glycyrrhiza uralensis root. Formula 2 is made from the following ingredients in the specified proportions: 50-150 parts of Polygonatum odoratum rhizome, 40-120 parts of Ophiopogon japonicus root, and 4 parts of Adenophora stricta root. Formula 3 is made from the following ingredients in the following proportions: 0-120 parts of Rehmannia glutinosa, 75-300 parts of Astragalus membranaceus, 40-120 parts of Platycladus orientalis seed, and 40-120 parts of Polygala tenuifolia; Formula 3 is made from the following ingredients in the following proportions: 50-150 parts of Rehmannia glutinosa, 50-150 parts of Cornus officinalis, 60-170 parts of Dioscorea opposita, 50-150 parts of Lycium barbarum, 50-150 parts of Alisma plantago-aquatica, 15-60 parts of Aconitum carmichaelii, 15-60 parts of Cinnamomum cassia, 30-90 parts of Testudinis plastrum, 30-100 parts of Mantis religiosa ootheca, 50-150 parts of Codonopsis pilosula, 50-150 parts of Atractylodes macrocephala, and 30-100 parts of Magnetite.

2. The tablet for elderly patients with comprehensive diabetes mellitus according to claim 1, characterized in that... Formula 1 is made from the following ingredients in the specified proportions: 150-300 parts of Trichosanthes kirilowii root, 30-90 parts of Coptis chinensis root, 60-180 parts of Rehmannia glutinosa root, 50-100 parts of Anemarrhena asphodeloides rhizome, 120-240 parts of Nelumbo nucifera rhizome, 50-100 parts of Schisandra chinensis fruit, 100-200 parts of Dendrobium nobile root, 100-200 parts of Paeonia suffruticosa root bark, 50-100 parts of Gardenia jasminoides fruit, and 30-60 parts of Glycyrrhiza uralensis root. Formula 2 is made from the following ingredients in the specified proportions: 100-150 parts of Polygonatum odoratum rhizome, 80-120 parts of Ophiopogon japonicus root, 80-120 parts of Adenophora stricta root, and 1 part of Astragalus membranaceus root. Formula 3 is made from the following ingredients in the following proportions: 50-300 parts of Rehmannia glutinosa, 80-120 parts of Cornus officinalis, 80-120 parts of Dioscorea opposita, 100-150 parts of Lycium barbarum, 100-150 parts of Alisma plantago-aquatica, 30-60 parts of Aconitum carmichaelii, 30-60 parts of Cinnamomum cassia, 60-90 parts of Testudinis plastrum, 60-100 parts of Mantis religiosa ootheca, 100-150 parts of Codonopsis pilosula, 100-150 parts of Atractylodes macrocephala, and 60-100 parts of Magnetite.

3. A tablet suitable for elderly patients with comprehensive diabetes mellitus according to claim 1 or 2, characterized in that... Its preparation method includes the following steps: (1) Prepare the powder for use in Formula 1. Weigh each raw material of Formula 1 according to the ratio, grind them into powder and mix them evenly. Sieve, fumigate and sterilize to obtain a loose and uniformly colored dry powder. Store at a constant temperature of 15-20℃ for later use. (2) Prepare the powder for use in Formula 2. Weigh each raw material of Formula 2 according to the ratio, grind them into powder and mix them evenly. Sieve, fumigate and sterilize to obtain a loose and uniformly colored dry powder. Store at a constant temperature of 15-20℃ for later use. (3) Prepare the powder for use of Formula 3. Weigh each raw material of Formula 3 according to the ratio, crush and grind them into powder, mix them evenly, sieve them, and then fumigate and sterilize them to obtain a loose and uniformly colored dry powder. Store it at a constant temperature of 15-20℃ for later use. (4) Mix the prepared powder obtained in steps (1)-(3) evenly, keep it dry and loose with uniform color, sterilize, dry at a constant temperature and store for later use. (5) Moisten the powder obtained in step (4) with distilled water (add 1% distilled water per 100 kg), and compress it into tablets using a tablet press to obtain tablets; (6) Package and sterilize the tablets obtained in step (5) to obtain the finished tablets.

4. The method for preparing a tablet suitable for elderly patients with comprehensive diabetes mellitus according to claim 3, characterized in that... In steps (1) to (3), the three components of the dried powder are stored at a constant temperature of 15–20°C.

5. A method for preparing a tablet suitable for elderly patients with comprehensive diabetes according to claim 3, characterized in that... The fumigation disinfection in steps (1) to (3) involves fumigating 1000g of powder with a mixture of 80g to 120g of aconite leaves and mugwort leaves for 50 to 60 minutes. The mixing ratio of mugwort leaves and aconite leaves is 80% mugwort leaves and 20% aconite leaves by weight.

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