Application of black borneol in preparation of Mongolian medicine for treating uremia moderate metabolic acidosis

Abstract

The invention discloses application of black borneol in preparation of a Mongolian medicine for treating uremia moderate metabolic acidosis, and belongs to the technical field of biological medicine. The Mongolian medicine is applied by taking processed black borneol as an active ingredient. Clinical observation and verification prove that the Mongolian medicine has an excellent treatment effect in improvement of carbon dioxide binding force and reduction of creatinine. Therefore, a theoretical basis is provided for clinical application of the black borneol, and guidance is provided for further development of the black borneol. The quality and the curative effect of the black borneol are improved by optimizing the preparation process of the black borneol. By means of improving the processing method, improving the extraction efficiency and the like, a more stable and effective black borneol preparation can be prepared. The Mongolian medicine can be used for promoting application and development of the Mongolian medicine in uremia treatment. By developing the Mongolian medicine black borneol with unique curative effect and low side effect, more treatment choices and possibilities can be provided for uremia patients.

Description

Technical Field

[0001] The invention belongs to the technical field of biomedicine, and particularly relates to application of black borneol in preparing Mongolian medicine for treating moderate metabolic acidosis of uremia. Background Art

[0002] Uremia is the result of the gradual deterioration of various primary or secondary kidney diseases, which gradually develop into renal insufficiency and eventually develop into renal insufficiency. When serum creatinine reaches 700μmol / L or above, it enters the uremia stage. Due to the decline in renal function, the kidneys of uremia patients cannot effectively remove metabolic waste from the body, resulting in the retention of acidic substances in the body, thus causing metabolic acidosis. This acidosis is mainly caused by metabolic factors, and its root cause is uremia, so it is also called uremic metabolic acidosis.

[0003] The existing technology for the treatment of uremia includes:

[0004] (1) Drug treatment:

[0005] The recommended drug treatment for uremia usually includes potassium excretion drugs (such as torsemide tablets), calcium supplements (such as calcium carbonate tablets, calcium gluconate oral solution), acid-base balance regulating drugs (such as potassium citrate granules, sodium bicarbonate tablets), etc. These drugs help to lower blood potassium, supplement calcium ions, and correct acid-base imbalance. For patients with metabolic acidosis, especially those with uremia and metabolic acidosis, sodium bicarbonate injection is a commonly used therapeutic drug, which can alkalize urine, reduce the solubility of uric acid in urine, and promote its excretion.

[0006] (2) Dialysis treatment:

[0007] Dialysis therapy is one of the common treatments for patients with uremia, including peritoneal dialysis and hemodialysis. Both dialysis methods can effectively remove toxins and wastes accumulated in the body, including substances that cause metabolic acidosis. Peritoneal dialysis uses the peritoneum as a semipermeable membrane to remove waste and fluid accumulation in the body, and is suitable for patients with uremia. Hemodialysis can quickly and effectively remove toxins and wastes accumulated in the body. When traditional treatments are ineffective or there are serious complications, hemodialysis should be started immediately.

[0008] (3) Kidney transplantation:

[0009] Kidney transplantation is another effective treatment for patients with uremia, which can restore the patient's renal function and thus resolve uremia and its complications, including metabolic acidosis.

[0010] With the aging of the population and the increasing incidence of chronic kidney disease, the number of patients with uremia is also increasing. Therefore, the demand for therapeutic drugs and treatments for uremia and its complications (such as metabolic acidosis) is also increasing. At present, many scientific research institutions and enterprises at home and abroad are actively developing new drugs and treatments for uremia. These new drugs and new methods are designed to improve treatment effects, reduce side effects and costs, and improve the quality of life of patients. At the same time, the treatment of uremia combined with metabolic acidosis has also received increasing attention. Researchers are exploring more effective drug combinations and treatments to better solve this clinical problem.

[0011] However, uremia is a serious kidney disease, and its treatment faces many challenges. Existing treatments, such as dialysis and kidney transplantation, can prolong the patient's life to a certain extent, but there are many inconveniences and risks. In the treatment of uremia, the safety and effectiveness of drugs are crucial. However, existing therapeutic drugs often have problems such as large side effects and unstable efficacy.

[0012] Mongolian medicine believes that the kidney is located in Bada Gan, and is mainly characterized by kidney waist pain, abnormal urination and edema. Kidney disease is caused by the predominance of Bada Gan and He Yi, which affects the kidney and fights with Xila, affecting the kidney and causing physiological dysfunction of the kidney. The original balanced and coordinated relationship between the three roots and the seven elements in the human body is broken, which causes the predominance of Bada Gan and the disorder of the interdependence between He Yi, and then changes the normal function of the kidney, and finally causes the water metabolism and kidney function of the human body to be disordered. This phenomenon is called kidney disease. Uremia is a concept of modern medicine. Mongolian medicine believes that uremia belongs to the category of "Boren Arihaga disease". Mongolian medicine can be summarized into three types according to the cause of the disease: cold type, He Yi type, and heat type. According to the site of the disease, it can be divided into four categories: cardiogenic, renal, white vein and spleen and stomach. The spleen and stomach uremia has symptoms such as abdominal distension, loss of appetite, indigestion, nausea, vomiting, and diarrhea. Drugs such as Haodaodun-10, Gagula-4, Harigaburi-10, Altan Aru-5, Altan Aru-7, and Yihehar-12 are commonly used in clinical treatment.

[0013] The symptoms of spleen and gastric uremia in Mongolian medicine are basically similar to the symptoms of uremic metabolic acidosis in modern medicine. In Mongolian medicine, the Harigabuji-10 compound or a compound containing Harigabuji ingredients is often used to treat spleen and gastric uremia, but it is found in clinical practice that this drug has many ingredients and long-term use will increase the burden on the kidneys.

[0014] Therefore, it is of great significance to develop new therapeutic drugs and methods, especially Mongolian medicines with unique therapeutic effects and lower side effects. Summary of the invention

[0015] In order to solve the above problems, the purpose of the present invention is to provide a single drug of black borneol for use in the preparation of Mongolian medicine for treating moderate metabolic acidosis of uremia, wherein the Mongolian medicine single drug is used as an active ingredient after processing black borneol. The Mongolian medicine single drug can play a role in improving carbon dioxide binding capacity, reducing creatinine, and inhibiting gastric acid secretion.

[0016] The present invention is achieved through the following technical solutions:

[0017] Application of black borneol in the preparation of Mongolian medicine for treating moderate metabolic acidosis in uremia.

[0018] Application of black borneol in the preparation of Mongolian medicine for inhibiting gastric acid secretion.

[0019] Application of black borneol in the preparation of Mongolian medicine for improving carbon dioxide binding capacity and reducing creatinine.

[0020] A Mongolian medicine containing black borneol, which takes black borneol as the main active ingredient and also includes pharmaceutically acceptable auxiliary materials for Mongolian medicine, and is prepared into a pharmaceutically corresponding dosage form.

[0021] Black borneol, called Harigaburi in Mongolian (in "Infallible Mongolian Medicine Mirror"), is an animal medicine, first recorded in "Recognizing Medicines with White Crystals", and is one of the commonly used medicinal materials in Mongolian and Tibetan medicine prescriptions. Black borneol is a carbonized product made by high-temperature calcination of dried feces of wild boars, a Suidae animal. It tastes bitter, is pungent, and is warm. It is used for cold "Xi Ri" disease, indigestion, jaundice, "Xi Ri" bloating, "Xi Ri" epidemic, "sticky" epidemic, stomach "Xi Ri", "sticky" sha and other diseases. Therefore, Harigaburi was selected as a single drug, and the clinical efficacy was observed.

[0022] A Mongolian medicine for treating moderate metabolic acidosis of uremia, wherein the active ingredient in the Mongolian medicine is black borneol.

[0023] Preferably, the black borneol is prepared by a calcination method.

[0024] Preferably, the method for preparing black borneol comprises the following steps:

[0025] S1. Material preparation:

[0026] Select clean, dry and unspoiled wild boar dung as raw material, prepare iron or earthenware as the concoction container, and yellow salt mud for sealing;

[0027] S2. Preheat the container and add the medicinal materials and seal it:

[0028] After preheating the iron or earthenware to a predetermined temperature, put the dried wild boar manure into the preheated container. The amount added should not exceed 2 / 3 of the container to ensure that the medicinal materials can be fully calcined and will not overflow. Seal the container mouth tightly with yellow salt mud.

[0029] S3. Preparation:

[0030] Place the sealed container on a fire source and heat it. When a few grains of millet and a heavy object are placed on the top of the container, and the millet turns brown or water drips from the top of the container into beads, stop heating.

[0031] S4, cooling and removal:

[0032] After the container has cooled naturally, open the sealed port and take out the prepared material to obtain black borneol.

[0033] Preferably, in S2, the predetermined temperature is not less than 45°C.

[0034] Preferably, the black ice flakes are in a burnt and glowing state.

[0035] Preferably, the black borneol is crushed by a crusher and filtered through a 80-100 mesh sieve.

[0036] Compared with the prior art, the present invention has at least the following technical effects:

[0037] (I) The present invention provides a single drug of black borneol for use in the preparation of Mongolian medicine for treating moderate metabolic acidosis in uremia. The Mongolian medicine uses processed black borneol as an active ingredient. The Mongolian medicine has been verified through clinical observation and confirmed to have excellent therapeutic effects in improving carbon dioxide binding capacity and reducing creatinine. This helps to provide a theoretical basis for the clinical application of black borneol and provide guidance for its further development.

[0038] (II) The technical solution of this application provides a process for preparing black borneol, which optimizes the preparation process of black borneol to improve its quality and efficacy. By improving the preparation method and increasing the extraction efficiency, a more stable and effective black borneol preparation can be prepared.

[0039] (III) The technical solution of this application is committed to improving the safety and effectiveness of the use of black borneol. Through rigorous clinical trials, the safety and effectiveness of black borneol in the treatment of moderate metabolic acidosis in uremia are further ensured.

[0040] (IV) The present invention can be used to promote the application and development of Mongolian medicine in the treatment of uremia. By developing Mongolian medicine black borneol with unique therapeutic effects and low side effects, more treatment options and possibilities can be provided for uremia patients. DETAILED DESCRIPTION

[0041] The embodiments of the present invention will be described in detail below in conjunction with examples. However, those skilled in the art will understand that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention. The specific conditions not specified in the examples are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used without indicating the manufacturer are all conventional products that can be purchased commercially.

[0042] Clinical observation experiment:

[0043] 1. Experimental research objectives:

[0044] The main purpose is to observe the clinical efficacy of Mongolian medicine Harigaburi (black borneol) in the treatment of moderate metabolic acidosis in uremia, and to provide a new treatment plan for moderate metabolic acidosis in uremia.

[0045] 2. Research Features:

[0046] The first use of a single drug to treat moderate metabolic acidosis in uremia can reduce the burden on the kidneys, with few side effects, low cost and high reliability.

[0047] 3. Innovation points:

[0048] The present invention is the first to use a single drug to treat the disease, which can enrich theoretical knowledge.

[0049] 4. Research content:

[0050] 4.1 Research Methods

[0051] A total of 60 patients who were diagnosed with uremia in the moderate metabolic acidosis stage at the Xilin Gol League Mongolian Medicine Hospital in recent years and met the inclusion criteria, and who voluntarily participated in this experiment and signed the informed consent form were collected. According to the Doll's clinical case randomization table, the collected cases were randomly divided into an experimental group (Mongolian medicine group) of 30 cases and a control group (sodium bicarbonate tablet group) of 30 cases. Patients who met the inclusion criteria filled out the informed consent form.

[0052] Table 1 Doll's clinical case randomization table

[0053]

[0054]

[0055] Usage: For outpatients, add the consultation date and the last two digits of the outpatient serial number, take the last two digits of the sum and look up the table. Those whose tens digit and ones digit intersect to T will be arranged in the treatment group, and those whose tens digit and ones digit intersect to C will be arranged in the control group.

[0056] 4.2 Experimental plan

[0057] Diagnostic criteria:

[0058] 4.2.1 Western medicine diagnostic criteria for uremia:

[0059] The diagnosis of uremia refers to the diagnostic criteria for CKD stage 5 in the 2018 edition of "Internal Medicine".

[0060] (1) GFR < 15 ml / (min·1.73 m 2 ) ≥ 3 months with or without evidence of renal impairment.

[0061] (2) Maintenance hemodialysis patients

[0062] GFR calculation formula: Male GFR = (140-age) × body weight (kg) × 1.23 / Scr (μmol / L)

[0063] Female GFR = Male GFR × 0.85

[0064] 4.2.2 Diagnostic criteria for metabolic acidosis:

[0065] The standards were formulated with reference to the New Edition of Clinical Laboratory Medicine published by Military Medical Science Press in 2004. Moderate metabolic acidosis was mainly selected in this study.

[0066] (1) Mild: 18mmol / L≤CO2-CP<22mmol / L

[0067] (2) Moderate: 14.47mmol / L≤CO2-CP<18mmol / L

[0068] (3) Severe: 4.49mmol / L≤CO2-CP<14.47mmol / L

[0069] (4) Extremely severe: CO2-CP<4.49mmol / L

[0070] 4.2.3 Mongolian medicine diagnostic criteria for moderate metabolic acidosis stage of uremia:

[0071] Refer to Cesurongzabu's "Mongolian Internal Medicine" for the diagnostic evaluation of the moderate metabolic acidosis stage of uremia.

[0072] (1) Clinical manifestations: abnormal urination, edema, urinary retention or frequent urination, tinnitus, abdominal distension, loss of appetite, indigestion, nausea and vomiting.

[0073] (2) Pulse and tongue: The pulse is weak, the tongue is red, and has a thin white coating.

[0074] 4.2.4 Case inclusion criteria:

[0075] (1) Meet the above-mentioned diagnostic criteria for moderate metabolic acidosis of uremia in Western medicine;

[0076] (2) 18-60 years old, regardless of gender;

[0077] (3) Voluntarily participate in clinical observation and sign the informed consent form;

[0078] (4) good compliance, able to understand and cooperate with researchers in data collection;

[0079] 4.2.5 Exclusion criteria:

[0080] (1) Not meeting the above-mentioned Western medical diagnostic criteria for moderate metabolic acidosis of uremia;

[0081] (2) having a major mental illness or insufficient intelligence;

[0082] (3) Combined with severe organic dysfunction;

[0083] (4) poor compliance and failure to take the test as required;

[0084] 4.2.6 Case exclusion and dropout criteria

[0085] (1) Failure to take medication as directed after enrollment;

[0086] (2) Those who have allergic reactions to drugs and have other serious complications;

[0087] (3) severe adverse reactions occur;

[0088] (4) did not meet the inclusion criteria and were mistakenly included;

[0089] (5) Request to give up or lose contact during the test;

[0090] 4.2.7 Treatment options

[0091] (1) Observation group: The patients were given Mongolian medicine Harigaburi (black borneol) (provided by the preparation room of Xilin Gol League Mongolian Medicine Hospital), with a dosage of 1 g, orally, twice a day. The treatment lasted for 14 days.

[0092] (2) Control group: The mice were treated with sodium bicarbonate tablets (purchased from Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd., national medicine standard: H35021110), with a dosage of 1 g, orally, 3 times a day, for a total of 14 days.

[0093] 4.2.8 Observation indicators and methods

[0094] The general condition, clinical symptoms, renal function, seven ion items and blood gas analysis of patients with uremia in the moderate metabolic acidosis stage were observed before and after treatment to compare the efficacy of this therapy on patients with uremia in the moderate metabolic acidosis stage.

[0095] 4.2.9 Efficacy indicators:

[0096] Western medicine efficacy evaluation standards: formulated with reference to the standards proposed in the New Edition of Clinical Laboratory Medicine published by the Military Medical Science Press in 2004.

[0097] (1) Recovery: 22mmol / L≤CO2-CP.

[0098] (2) Significant effect: 18mmol / L≤CO2-CP<22mmol / L.

[0099] (3) Effective: 14.47mmol / L≤CO2-CP<18mmo1 / L.

[0100] (4) Ineffective: 14.47mmol / L>CO2-CP.

[0101] Mongolian medical efficacy evaluation standards: refer to the kidney Arihaga efficacy evaluation defined in the "Mongolian Medical Disease Diagnosis and Efficacy Standards".

[0102] (1) Markedly effective: Clinical symptoms of Mongolian medicine completely disappeared and laboratory tests were normal.

[0103] (2) Improvement: Mongolian medicine clinical symptoms and laboratory tests improve.

[0104] (3) Ineffective: There is no significant improvement in the clinical symptoms and signs of Mongolian medicine, or they worsen.

[0105] 5. Experimental results:

[0106] 5.1 Clinical efficacy analysis:

[0107] Grouping Case Significant effect Improvement invalid Treatment Group 30 22 12 3 Control group 30 15 8 0

[0108] 5.2 Carbon dioxide binding capacity test

[0109]

[0110]

[0111] 5.3 Creatinine test

[0112] Case Creatinine before treatment After treatment, creatinine Case 1 775 551 Case 2 1388 1026 Case 3 910 954 Case 4 958 878 Case 5 780 661 Case 6 681 636 Case 7 1273 838 Case 8 618 345 Case 9 890 611 Case 10 490 567 Case 11 792 1099 Case 12 496 631 Case 13 989 898 Case 14 1021 657 Case 15 844 870 Case 16 633 459 Case 17 697 886 Case 18 1125 1155 Case 19 1171 638

[0113] After screening the clinical observation data, it can be seen from the above cases that the treatment group (using black borneol alone) has significantly better efficacy than the control group in improving carbon dioxide binding capacity and reducing creatinine.

[0114] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the protection scope of the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. Application of black borneol in the preparation of Mongolian medicine for the treatment of moderate metabolic acidosis in uremia.

2. Application of black borneol in the preparation of Mongolian medicine for inhibiting gastric acid secretion.

3. Application of black borneol in the preparation of Mongolian medicine for improving carbon dioxide binding capacity and reducing creatinine.

4. A Mongolian medicine containing black borneol, characterized in that: The Mongolian medicine uses black borneol as the main active ingredient and also includes pharmaceutically acceptable auxiliary materials for Mongolian medicine to prepare a pharmaceutically corresponding dosage form.

5. A Mongolian medicine for treating moderate metabolic acidosis in uremia, characterized in that: The active ingredient in the Mongolian medicine is black borneol.

6. A Mongolian medicine for treating moderate metabolic acidosis in uremia according to claim 5, characterized in that: The black borneol is prepared by a calcination and stewing method.

7. A Mongolian medicine for treating moderate metabolic acidosis in uremia according to claim 5, characterized in that: The preparation method of black borneol comprises the following steps: S1. Material preparation: Select clean, dry and unspoiled wild boar dung as raw material, prepare iron or earthenware as the concoction container, and yellow salt mud for sealing; S2. Preheat the container and add the medicinal materials and seal it: After preheating the iron or earthenware to a predetermined temperature, put the dried wild boar manure into the preheated container. The amount added should not exceed 2 / 3 of the container to ensure that the medicinal materials can be fully calcined and will not overflow. Seal the container mouth tightly with yellow salt mud. S3. Preparation: Place the sealed container on a fire source and heat it. When a few grains of millet and a heavy object are placed on the top of the container, and the millet turns brown or water drips from the top of the container into beads, stop heating. S4, cooling and removal: After the container has cooled naturally, open the sealed port and take out the prepared material to obtain black borneol.

8. The Mongolian medicine for treating moderate metabolic acidosis in uremia according to claim 7, characterized in that: In S2, the predetermined temperature is not less than 45°C.

9. The Mongolian medicine for treating moderate metabolic acidosis in uremia according to claim 7, characterized in that: The black borneol is in a burnt and glowing state.

10. The Mongolian medicine for treating moderate metabolic acidosis in uremia according to claim 7, characterized in that: The black borneol is crushed by a crusher and passed through a 80-100 mesh filter screen to obtain the obtained product.

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