A traditional Chinese medicine preparation and application thereof in improving endocrine disorder

Abstract

The application discloses a traditional Chinese medicine preparation and application thereof in improving endocrine disorder, and the traditional Chinese medicine preparation is composed of 100-180 parts of a combined extract of spina date seed and radix codonopsis, 20-40 parts of an extract of semen cassiae, 10-30 parts of an extract of angelica sinensis and 10-30 parts of an extract of dendrobium officinale in terms of weight percentage. The application can effectively regulate endocrine gland function of a patient, enhance self-regulation of endocrine glands in the body and improve the endocrine disorder of the patient.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to a traditional Chinese medicine preparation and its application in improving endocrine disorders. Background Technology

[0002] Endocrine disorders refer to a disruption in the body's endocrine system, leading to an imbalance in the secretion of various hormones and triggering a series of physiological and pathological changes. The endocrine system consists of endocrine glands, scattered endocrine cells, and the hormones they secrete, participating in the regulation of many physiological activities and life phenomena, including metabolism, growth and development, reproduction, and aging. When the body's endocrine system is disrupted, various signs and symptoms appear, especially in women where the symptoms are more pronounced.

[0003] The causes of endocrine disorders may include: 1) Environmental factors: such as seasonal changes, rapid climate change, and environmental pollution, all of which can affect endocrine function; 2) Physiological factors: with age, the body's endocrine glands' regulatory ability declines, easily leading to endocrine disorders. In addition, heredity may also lead to endocrine disorders; 3) Emotional factors: psychological factors have a significant impact on the endocrine system. The stress from work, life, and family can cause nervous tension, and abnormal emotional changes can disrupt hormone secretion, leading to endocrine disorders; 4) Nutritional factors: the body needs sufficient and appropriate nutrition to maintain normal physiological functions. A long-term monotonous diet or excessive dieting can lead to malnutrition and trigger endocrine disorders. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine preparation and its application in improving endocrine disorders.

[0005] The technical solution of the present invention is: a traditional Chinese medicine preparation, which, by weight, is composed of the following traditional Chinese medicine ingredients: 100-180 parts of Ziziphus jujuba seed-Codonopsis pilosula compound extract, 20-40 parts of Cuscuta chinensis extract, 10-30 parts of Angelica sinensis extract, and 10-30 parts of Dendrobium officinale extract;

[0006] The mass ratio of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in the jujube seed-codonopsis compound extract is (3-5): (0.5-2): (2-4): (1-2): (0.2-1).

[0007] Note: Patients with endocrine disorders may experience a decline in the self-regulation function of their endocrine glands, leading to endocrine imbalances. For example, during menopause in women, estrogen levels decrease again while androgen levels have not yet been replenished, making them prone to endocrine disorders. Abnormal biological rhythms, negative emotions, and other factors can also affect the endocrine system, causing endocrine disorders. Malnutrition and other factors can also impair endocrine gland function, resulting in endocrine imbalances. The traditional Chinese medicine preparation of this invention can effectively regulate the endocrine gland function of patients, enhance the self-regulation of the endocrine glands, and improve endocrine disorders.

[0008] By adjusting the proportions of jujube seed saponins a, b, codonopinion I, codonoside I, and codonopinine in the jujube seed-codonopsis compound extract, the therapeutic effects of traditional Chinese medicine preparations on endocrine gland function can be made more targeted.

[0009] Jujube seed saponin a (C58H94O26) has sedative, hypnotic, analgesic, anticonvulsant, and antipyretic pharmacological effects, while jujube seed saponin b (C52H84O21) has antioxidant, anti-inflammatory, antibacterial, and antitumor pharmacological effects, and also has certain protective effects on the cardiovascular and nervous systems.

[0010] Codonopinion I (C29H42O18) can help eliminate free radicals in the body, protect cells from oxidative stress damage, delay the aging process of cells, improve the body's stress state, enhance physical endurance and adaptability, and improve the function of the nervous system. Codonopinia glycoside has a certain sedative effect, which can improve sleep quality and relieve anxiety symptoms. It can achieve its sedative effect by regulating the transmission and release of neurotransmitters and affecting the function of the nervous system, and can also regulate the metabolism of prostaglandins. Codonopinine can inhibit the central nervous system to a certain extent, but excessive intake can cause symptoms such as drowsiness.

[0011] Therefore, it is evident that the proportion of each component in the compound extract of jujube seed and codonopsis is very important. Excessive dosage may lead to excessive intake and cause drug side effects, such as arrhythmia, drowsiness, or significant drug dependence, requiring long-term use for regulation and control. All of these are not conducive to the patient's endocrine regulation.

[0012] Cuscuta chinensis extract has the effect of nourishing the kidneys, promoting metabolism and blood circulation, and increasing sex hormone levels. Cuscuta chinensis extract also contains dodder alkaloids, flavonoids and vitamin E, which have antioxidant activity and can scavenge free radicals.

[0013] Angelica extract can relieve stress and improve sleep. It can regulate endocrine disorders caused by long-term stress and lack of sleep. It can soothe the mind and body, promote the body's natural balance, and has antioxidant and free radical scavenging effects, which can delay the decline of the endocrine gland's self-regulation function.

[0014] Dendrobium extract contains a variety of plant hormones, which can regulate the endocrine system, promote hormone secretion, and relieve discomfort symptoms such as hot flashes, night sweats, and insomnia, thereby improving patients' endocrine disorders.

[0015] Furthermore, by weight, it is composed of the following traditional Chinese medicine ingredients: 140-160 parts of Ziziphus jujuba seed-Codonopsis pilosula compound extract, 30-35 parts of Cuscuta chinensis extract, 15-20 parts of Angelica sinensis extract, and 20-25 parts of Dendrobium officinale extract.

[0016] Note: Within the original compatibility range, the use of the above-mentioned combination of traditional Chinese medicine preparations can better regulate the endocrine gland function of patients, enhance the self-regulation of the endocrine glands, improve endocrine disorders, reduce adverse reactions of traditional Chinese medicine, and increase efficacy.

[0017] Furthermore, the mass ratio of jujube seed saponin a, jujube seed saponin b, codonopin I, codonopsis alkaloid and codonopsis alkaloid in the jujube seed-codonopsis compound extract is (4.2-4.5): (1-1.5): (2.1-2.7): (1.2-1.6): (0.4-0.7).

[0018] Note: Within the original compatibility range, using the above-mentioned combination of Ziziphus jujuba seed and Codonopsis pilosula compound extract can better regulate the endocrine gland function of patients, improve the efficacy of improving endocrine disorders, reduce adverse drug side effects such as arrhythmia and drowsiness, and improve the effect of medication on patients.

[0019] Furthermore, traditional Chinese medicine preparations are in the form of pills, granules, or capsules.

[0020] Explanation: Pills have a longer-lasting effect. Compared to decoctions, most pills are absorbed more slowly, thus their effects can last longer, making them particularly suitable for treating endocrine disorders. Granules can mask the unpleasant odor of the medication, making them more comfortable for patients to take. Taking them with warm water also facilitates drug release and action, improving the overall effect. Capsules improve drug stability. Encasing the medication in a capsule reduces the influence of air, light, and moisture, providing a degree of shielding, protection, and stability. Appropriate coating materials can be selected as needed for encapsulation, giving the medication a sustained-release effect. For example, enteric-coated capsules can target the release of the drug in the small intestine, ensuring a localized release.

[0021] Furthermore, the method for preparing the capsules includes the following steps:

[0022] 1) Mix the jujube seed-codonopsis compound extract, dodder seed extract, angelica extract and dendrobium extract according to the weight parts, and freeze at low temperature to obtain a solid mixed medicine solution;

[0023] 2) The solid mixed drug solution is placed in a freeze dryer for freeze drying. The solid water in the solid mixed drug solution is removed by sublimation through vacuum and heating to obtain freeze-dried mixed drug.

[0024] 3) The freeze-dried mixed drugs are pulverized to obtain drug powder, and then the drug powder is packaged into capsules at a ratio of 0.4-0.5g per capsule to obtain capsule dosage.

[0025] Note: The above preparation method can effectively prepare jujube seed-codonopsis compound extract, dodder seed extract, angelica extract and dendrobium extract into a traditional Chinese medicine preparation (capsule) for the treatment of endocrine disorders. By filling the powder into the capsule shell, the influence of air, light and moisture can be reduced, the stability of the drug can be improved, and it is easier to carry out mass production and drug transportation.

[0026] Furthermore, the preparation method of the pills includes the following steps:

[0027] 1) Mix the compound extracts of jujube seed and codonopsis root, dodder seed extract, angelica extract and dendrobium extract according to the weight parts to obtain a mixed medicine solution. Then mix the mixed medicine solution with the pill matrix at a mass ratio of 1:(2~3) and then add it into the pill making machine to make pills.

[0028] The pill matrix, by weight, consists of 20-30 parts starch, 2-5 parts gum arabic, and 4-6 parts honey.

[0029] 2) Place the prepared wet pills in a sugar coating machine and sprinkle on the coating powder, which accounts for 7-10% of the total wet pills. Then dry the pills so that each pill has a moisture content of 2-5% of its weight. Screen the round plain pills with a particle size of 4-5 mm and coat them with a thin film to obtain qualified pills.

[0030] Note: The above preparation method allows for the direct use of jujube seed-codonopsis compound extract, dodder seed extract, angelica extract, and dendrobium extract in the preparation of drug pill paste. The powder used for the topping can be easily digestible hawthorn powder or tangerine peel powder, or it can be powder from the production process of traditional Chinese medicine preparations (capsules). By making traditional Chinese medicine preparations into pills, the duration of efficacy can be increased, the frequency of administration can be reduced, and the unpleasant odor of the drug itself can be masked, making it more acceptable to patients and reducing drug dependence.

[0031] Furthermore, the method for preparing granules includes the following steps:

[0032] 1) Mix the jujube seed-codonopsis compound extract, dodder seed extract, angelica extract and dendrobium extract according to the weight parts, and reduce the water content from 30% to 10% to obtain a concentrated mixed medicine solution;

[0033] 2) Add starch and sucrose to the concentrated mixed medicine solution at a mass ratio of 1:(1.5~1.8):(0.2~0.5), extrude to granulate, and dry to obtain granules.

[0034] Note: The above preparation method can effectively prepare jujube seed-codonopsis compound extract, dodder seed extract, angelica extract, and dendrobium extract into a traditional Chinese medicine preparation (granules) for the treatment of endocrine disorders. Due to the introduction of starch and sucrose, the unpleasant smell of the medicine itself can be greatly improved, making it more acceptable to patients. It does not require decoction or special preparation process, making it more convenient for patients to take and also facilitating dosage control to ensure efficacy. Moreover, the bagged packaging makes it easy to carry and prevents moisture and deterioration. At the same time, the medicine can quickly enter the body to exert its effects.

[0035] The present invention also discloses the application of a traditional Chinese medicine preparation in improving endocrine disorders.

[0036] Explanation: The traditional Chinese medicine preparation of this invention can fundamentally improve endocrine disorders by regulating the function of endocrine glands, preventing the recurrence of the condition, and adjusting the body's endocrine system to restore its normal function, thereby improving various symptoms caused by endocrine disorders. At the same time, it can also improve the body's immune function, enhance the body's disease resistance, and prevent the occurrence of other diseases caused by endocrine disorders.

[0037] The beneficial effects of this invention are:

[0038] (1) The traditional Chinese medicine preparation of the present invention can effectively regulate the endocrine gland function of patients and enhance the self-regulation of the endocrine glands in patients, thereby improving the endocrine disorders of patients; and by adjusting the proportion of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in the jujube seed-codonopsis compound extract, the traditional Chinese medicine preparation can be more targeted in regulating the endocrine gland function and enhance the conditioning effect on patients with endocrine disorders.

[0039] (2) In addition to the original decoction, the traditional Chinese medicine preparation of the present invention also provides three kinds of medicine: pills, granules and capsules. It can be selected according to the needs of various user groups. The traditional Chinese medicine preparation (pills), traditional Chinese medicine preparation (granules) and traditional Chinese medicine preparation (capsules) can all improve the unpleasant smell of the medicine itself to a certain extent, making the traditional Chinese medicine easier to take, thereby improving the patient's medication experience. Detailed Implementation

[0040] The present invention will now be described in more detail with reference to specific embodiments, so as to better demonstrate the advantages of the present invention.

[0041] Example 1: A traditional Chinese medicine preparation, by weight, is composed of the following traditional Chinese medicine ingredients: 155 parts of Ziziphus jujuba seed-Codonopsis pilosula compound extract, 32 parts of Cuscuta chinensis extract, 17 parts of Angelica sinensis extract, and 24 parts of Dendrobium nobile extract; and the water content of the Ziziphus jujuba seed-Codonopsis pilosula compound extract, Cuscuta chinensis extract, Angelica sinensis extract, and Dendrobium nobile extract is 30%; after mixing the above Ziziphus jujuba seed-Codonopsis pilosula compound extract, Cuscuta chinensis extract, Angelica sinensis extract, and Dendrobium nobile extract, diluting with water by 1:1, it can be taken directly after heating. This traditional Chinese medicine preparation is used to improve endocrine disorders.

[0042] The mass ratio of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in the jujube seed-codonopsis pilosula compound extract is 44:12:25:15:5. It can be understood that the content of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in the mixture of jujube seed extract and codonopsis pilosula extract (mixed at a mass ratio of 1:1.25) is determined and the corresponding content ratio is calculated and adjusted.

[0043] Example 2: This example differs from Example 1 in that, by weight, it is composed of the following Chinese herbal ingredients: 100 parts of Ziziphus jujuba seed-Codonopsis pilosula compound extract, 20 parts of Cuscuta chinensis extract, 10 parts of Angelica sinensis extract, and 10 parts of Dendrobium officinale extract.

[0044] Example 3: This example differs from Example 1 in that, by weight, it is composed of the following Chinese herbal ingredients: 180 parts of Ziziphus jujuba seed-Codonopsis pilosula compound extract, 40 parts of Cuscuta chinensis extract, 30 parts of Angelica sinensis extract, and 30 parts of Dendrobium officinale extract.

[0045] Example 4: The difference between this example and Example 1 is that the mass ratio of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in the jujube seed-codonopsis compound extract is 30:5:20:10:2.

[0046] Example 5: The difference between this example and Example 1 is that the mass ratio of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in the jujube seed-codonopsis compound extract is 5:2:4:2:1.

[0047] Example 6: This example differs from Example 1 in that the traditional Chinese medicine preparation is a capsule, and the preparation method of the capsule includes the following steps:

[0048] 1) Mix the compound extracts of jujube seed and codonopsis root, cuscuta seed extract, angelica root extract and dendrobium extract according to the weight proportions, and freeze at -20℃ to obtain a solid mixed medicine solution;

[0049] 2) The solid mixed drug solution is placed in a freeze dryer for freeze drying. The system is evacuated to an absolute pressure of 100 Pa and heated to 60 °C (the vacuum degree is maintained at 60 Pa ± 1 Pa during heating). The treatment lasts for 8 hours. The solid water in the solid mixed drug solution is removed by sublimation through vacuum and heating, so that the water content is less than 2%, and the freeze-dried mixed drug solution is obtained.

[0050] 3) The freeze-dried mixed drugs are pulverized to obtain drug powder that passes through a 160-mesh sieve. The drug powder is then packaged into capsules at a rate of 0.5g per capsule to obtain capsule dosage.

[0051] Example 7: This example differs from Example 1 in that the traditional Chinese medicine preparation is a pill, and the preparation method of the pill includes the following steps:

[0052] 1) Mix the compound extracts of jujube seed and codonopsis root, dodder seed extract, angelica extract and dendrobium extract according to the weight parts to obtain a mixed medicine solution. Then mix the mixed medicine solution with the pill matrix at a mass ratio of 5:14 and then add it into the pill making machine (Teddy MN-80 pill making machine) to make pills.

[0053] The pill matrix, by weight, consists of 27 parts starch, 3 parts gum arabic, and 5 parts honey.

[0054] 2) Place the prepared wet pills in a sugar coating machine (GEX GPT-300H sugar coating machine) and sprinkle on the top dressing powder, which is hawthorn fine powder, accounting for 8% of the total wet pills. Then dry the pills so that each pill has a moisture content of 3% of its weight. Screen the round plain pills with a particle size of 4-5mm, and coat the round plain pills with a thin film to obtain qualified pills.

[0055] Example 8: The difference between this example and Example 7 is that the mixed medicine solution and the pill matrix are mixed at a mass ratio of 1:2.

[0056] Example 9: The difference between this example and Example 7 is that the mixed medicine solution and the pill matrix are mixed at a mass ratio of 1:3.

[0057] Example 10: This example differs from Example 7 in that, by weight, the pill matrix consists of 20 parts starch, 2 parts gum arabic, and 4 parts honey.

[0058] Example 11: This example differs from Example 7 in that, by weight, the pill matrix consists of 30 parts starch, 5 parts gum arabic, and 6 parts honey.

[0059] Example 12: The difference between this example and Example 7 is that the prepared wet pills are placed in a sugar coating machine and sprinkled with a powder for covering. The powder is fine powder of dried tangerine peel and accounts for 7% of the total amount of wet pills.

[0060] Example 13: The difference between this example and Example 7 is that the prepared wet pellets are placed in a sugar coating machine and sprinkled with a coating powder. The coating powder is the powder prepared by the method in Example 1, and the powder accounts for 10% of the total amount of wet pellets.

[0061] Example 14: This example differs from Example 1 in that the traditional Chinese medicine preparation is granules, and the preparation method of the granules includes the following steps:

[0062] 1) Mix the jujube seed-codonopsis compound extract, dodder seed extract, angelica extract and dendrobium extract according to the weight parts, and reduce the water content from 30% to 10% to obtain a concentrated mixed medicine solution;

[0063] 2) Add starch and sucrose to the concentrated mixed medicine solution at a mass ratio of 10:17:3, granulate by extrusion, and dry at a low temperature of 45℃ for 30 minutes to obtain granules. The total amount of coarse particles larger than 2000μm and fine particles smaller than 180μm in the granules shall not exceed 12%, and it is advisable to take them with hot water.

[0064] Example 15: This example differs from Example 14 in that starch and sucrose are added to the concentrated mixed medicine solution in a mass ratio of 10:15:2.

[0065] Example 16: This example differs from Example 14 in that starch and sucrose are added to the concentrated mixed medicine solution in a mass ratio of 10:18:5.

[0066] Application Example 1 (Research on a Traditional Chinese Medicine Preparation for Improving Endocrine Disorders)

[0067] 1. Diagnostic Criteria: The diagnostic criteria for endocrine disorders are based on the "Standards for Diagnosis and Efficacy Evaluation of Diseases in Traditional Chinese Medicine" (see table below).

[0068] Table 1. Diagnostic criteria for endocrine disorders

[0069]

[0070]

[0071] 2. Patient inclusion criteria

[0072] Patients meeting the criteria for diagnosis of endocrine disorders, aged 18-55 years, regardless of gender, are eligible to participate in the study, sign an informed consent form, and undergo regular follow-up.

[0073] Notes: 1) Patients with abnormal liver function are not included in this study; 2) Patients with abnormal kidney function are not included in this study; 3) Patients with abnormal blood routine indicators are not included in this study; 4) Pregnant or lactating patients are not included in this study; 5) Patients with serious primary diseases of the heart, brain, lungs, liver, kidneys, and blood system are not included in this study.

[0074] One hundred patients diagnosed with endocrine disorders at a hospital in this city were selected as the study subjects (the participants were informed in advance that they would be assigned to a control group and a treatment group). The subjects were divided into a treatment group and a control group, and the basic information of the two groups is shown in the table below:

[0075] Table 2. Basic Information Statistics of Treatment Group and Control Group

[0076] Treatment group 50 17 / 33 21-43 control group 50 21 / 29 20-46

[0077] 3. Treatment and administration methods

[0078] 1) Treatment group: Traditional Chinese medicine preparation (decoction) (Example 1) was used, diluted with water by 1:1 and heated, one dose per day, taken on an empty stomach, for 7 days as one course of treatment, and five courses of treatment were taken.

[0079] 2) Control group: The original Chinese medicine preparation (decoction) was replaced with "155 parts of jujube seed-codonopsis compound extract" by "86 parts of jujube seed extract and 69 parts of codonopsis compound extract". The extract was diluted with water by 1:1 and heated. One dose was taken on an empty stomach. One course of treatment lasted for 7 days. Five courses of treatment were taken.

[0080] 4. Efficacy Evaluation Criteria: Referencing the efficacy evaluation criteria for endocrine disorders in the TCM industry standard "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine," as shown in the table below:

[0081] Table 3. Evaluation Criteria for Endocrine Disorder Treatment Strategies

[0082] get well Symptoms disappeared and physical signs returned to normal. Effective Symptoms have lessened and physical signs have improved. efficient Symptoms have lessened, but physical signs have not improved significantly. invalid Symptoms did not improve, and physical signs did not improve.

[0083] 5. Observation Methods: After 2 and 5 courses of treatment, the symptoms of endocrine disorders in patients were assessed, and the results were recorded and analyzed as shown in the table below:

[0084] Table 4. Symptom assessment statistics for the treatment group and the control group after two courses of treatment.

[0085] Treatment group 49 12 30 7 0 100％ control group 47 4 17 21 5 89.4％

[0086] (Note: Missing cases are those who stopped receiving clinical medication or were lost to follow-up.)

[0087] Table 5. Symptom assessment statistics for the treatment group and the control group after 5 courses of treatment.

[0088] Treatment group 48 41 5 2 0 100％ control group 45 19 10 12 4 91.1％

[0089] (Note: Missing cases are those who stopped receiving clinical medication or were lost to follow-up.)

[0090] The 44 patients in the treatment group (4 of whom were lost to follow-up) were followed up for six months, and none of them experienced drug side effects such as drowsiness. The 39 patients in the control group (6 of whom were lost to follow-up) were followed up for six months. Three patients experienced occasional arrhythmias within two weeks of stopping the medication, and two patients experienced drowsiness (lasting for half a month).

[0091] Examples of typical cases are shown in the table below:

[0092] Table 6 Typical Cases of Endocrine Disorders

[0093]

[0094] 6. Conclusion on Treatment Efficacy

[0095] Based on the comparative analysis of "Symptom Assessment Statistics" (see Tables 4 and 5) and "Typical Cases" (see Table 6), both the treatment group and the control group showed good endocrine disorder regulation effects after five courses of treatment.

[0096] In a treatment course of 2 courses and a treatment course of 5 courses, the cure rate in the treatment group was 85.4%, while the cure rate in the control group was 42.2%. Therefore, in terms of efficacy, the patients using traditional Chinese medicine preparations (decoctions) had a significantly higher rate of conversion from "significant effect" and "effectiveness" to "cure" than the control group.

[0097] During the follow-up of patients in the treatment group and the control group, no patients in the treatment group experienced drug side effects, while 5 patients in the control group experienced drug side effects. However, it cannot be ruled out that other factors may have caused these symptoms during this period. Based solely on the follow-up results, the control group had a 12.8% probability of drug side effects.

[0098] Therefore, we can preliminarily conclude that by adjusting the proportions of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in the jujube seed-codonopsis compound extract, the traditional Chinese medicine preparation can be made to be more targeted in regulating endocrine gland function, with faster efficacy, higher cure rate, and reduced potential side effects of the original drug.

[0099] Application Example 2 (Research on a Traditional Chinese Medicine Preparation for Improving Endocrine Disorders)

[0100] 1. Patient inclusion criteria

[0101] Patients meeting the criteria for diagnosis of endocrine disorders, aged 18-35 years, and diagnosed with endocrine disorders are eligible; they must also voluntarily participate in the study, sign an informed consent form, and be subject to regular follow-up.

[0102] Notes: 1) Patients with abnormal liver function are not included in this study; 2) Patients with abnormal kidney function are not included in this study; 3) Patients with abnormal blood routine indicators are not included in this study; 4) Pregnant or lactating patients are not included in this study; 5) Patients with serious primary diseases of the heart, brain, lungs, liver, kidneys, and blood system are not included in this study.

[0103] Twenty female patients diagnosed with endocrine disorders and treated at a hospital in this city were selected as the research subjects. They were all endocrine disorder patients with irregular menstruation, hirsutism and long-term infertility.

[0104] 2. Treatment and administration methods

[0105] The 20 patients were divided into five groups (patients were informed in advance that they would be assigned to different drug combinations), corresponding to different combinations of the traditional Chinese medicine preparations (decoctions) in Examples 1-5. Six sex hormone tests were performed on each female patient. Basic information of the female patients is shown in the table below:

[0106] Table 7. Statistics on basic information of female patients

[0107]

[0108]

[0109] (Note: The testosterone levels measured are the patient's testosterone levels during the follicular phase, which are usually less than 1.4 ng / dl.)

[0110] 1) Treatment group: Use traditional Chinese medicine preparation (decoction) (Example 1), dilute with water by 1:1 and heat, one dose per day, taken on an empty stomach, warm, for 7 days as one course of treatment, and take two courses of treatment.

[0111] 2) Treatment Group 2: Use traditional Chinese medicine preparation (decoction) (Example 2), dilute with water by 1:1 and heat, one dose per day, taken on an empty stomach, warm, for 7 days as one course of treatment, and take two courses of treatment.

[0112] 3) Treatment Group 3: Use traditional Chinese medicine preparation (decoction) (Example 3), dilute with water by 1:1 and heat, one dose per day, taken on an empty stomach, warm, for 7 days as one course of treatment, and take two courses of treatment.

[0113] 4) Treatment Group 4: Use traditional Chinese medicine preparation (decoction) (Example 4), dilute with water by 1:1 and heat, one dose per day, taken on an empty stomach, warm, for 7 days as one course of treatment, and take two courses of treatment.

[0114] 5) Treatment Group 5: Use traditional Chinese medicine preparation (decoction) (Example 5), dilute with water by 1:1 and heat, one dose per day, taken warm on an empty stomach, 7 days as one course of treatment, and take two courses of treatment.

[0115] 3. Observation Methods: Patients with endocrine disorders who underwent two courses of treatment underwent a second sex hormone panel test, and their testosterone levels were statistically analyzed (see table below).

[0116] Table 8. Statistics on testosterone levels after two courses of treatment.

[0117]

[0118] (Note: The values ​​in parentheses represent the decrease in testosterone levels compared to before medication.)

[0119] 4. Conclusion on Treatment Efficacy

[0120] According to the statistics of "testosterone levels after two courses of treatment" (see Table 8), in a study of 20 female patients treated for two courses, groups 1, 2, 3, 4, and 5 all showed good regulation of testosterone level reduction. Specific analysis is as follows:

[0121] In treatment group 1, the decrease in testosterone levels after two courses of treatment compared to pre-treatment levels was 0.59–0.71 ng / dl; in treatment group 2, the decrease was 0.43–0.55 ng / dl; in treatment group 3, the decrease was 0.41–0.52 ng / dl; in treatment group 4, the decrease was 0.39–0.45 ng / dl; and in treatment group 5, the decrease was 0.42–0.48 ng / dl.

[0122] Meanwhile, the normal testosterone level in women during the follicular phase is usually less than 1.4 ng / dl. Now, a testosterone level ≤1.4 ng / dl after treatment is recorded as a cured case. There were 4 cured cases in treatment group 1, 1 cured case in treatment group 2, 2 cured cases in treatment group 3, 3 cured cases in treatment group 4, and 0 cured cases in treatment group 5.

[0123] Therefore, preliminary conclusions can be drawn regarding medication for female patients with endocrine disorders. Adjusting the formulation of traditional Chinese medicine preparations has a certain impact on the efficacy of the medication. Among them, the traditional Chinese medicine preparation (decoction) in treatment group 1 (Example 1) has a more significant effect compared with other treatment groups. At the same time, after three courses of treatment, the testosterone levels of patients in each group reached normal levels, and 17 cases successfully became pregnant within six months of follow-up. Among them, three cases (27-year-old Wu, 33-year-old Zhou, and 31-year-old Wang) failed to become pregnant, which is presumably not due to long-term infertility caused by endocrine disorders. It has been suggested that the three patients and their husbands undergo other examinations, pending the results.

Claims

1. A traditional Chinese medicine preparation for improving endocrine disorders, characterized in that, By weight, it is composed of the following Chinese herbal ingredients: 100-180 parts of Ziziphus jujuba seed-Codonopsis pilosula compound extract, 20-40 parts of Cuscuta chinensis extract, 10-30 parts of Angelica sinensis extract and 10-30 parts of Dendrobium officinale extract; The jujube seed-codonopsis compound extract is obtained by determining the content of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in a mixture of jujube seed extract and codonopsis alkaloid extract at a mass ratio of 1:1.25, and calculating and adjusting the corresponding content ratio of each component. The mass ratio of jujube seed saponin a, jujube seed saponin b, codonopsis glycoside I, codonopsis alkaloid and codonopsis alkaloid in the jujube seed-codonopsis compound extract is (4.2~4.5):(1~1.5):(2.1~2.7):(1.2~1.6):(0.4~0.7). The traditional Chinese medicine preparations mentioned are pills, granules, or capsules.

2. The traditional Chinese medicine preparation as described in claim 1, characterized in that, By weight, it consists of the following Chinese herbal ingredients: 140-160 parts of Ziziphus jujuba seed-Codonopsis pilosula compound extract, 30-35 parts of Cuscuta chinensis extract, 15-20 parts of Angelica sinensis extract, and 20-25 parts of Dendrobium officinale extract.

3. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The traditional Chinese medicine preparation is in the form of pills, granules, or capsules, wherein the preparation method of the capsules includes the following steps: 1) Mix the jujube seed-codonopsis compound extract, dodder seed extract, angelica extract and dendrobium extract according to the weight parts, and freeze at low temperature to obtain a solid mixed medicine solution; 2) The solid mixed drug solution is placed in a freeze dryer for freeze drying. The solid water in the solid mixed drug solution is removed by sublimation through vacuum and heating to obtain freeze-dried mixed drug. 3) The freeze-dried mixed drugs are pulverized to obtain drug powder, and then the drug powder is packaged into capsules at a ratio of 0.4~0.5g per capsule to obtain capsule dosage.

4. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The preparation method of the pills includes the following steps: 1) Mix the compound extracts of jujube seed and codonopsis root, dodder seed extract, angelica extract and dendrobium extract according to the weight parts to obtain a mixed medicine solution. Then mix the mixed medicine solution with the pill matrix at a mass ratio of 1: (2~3) and then add it into the pill making machine to make pills. The pill matrix, by weight, consists of 20-30 parts starch, 2-5 parts gum arabic, and 4-6 parts honey. 2) Place the prepared wet pills in a sugar coating machine and sprinkle on the coating powder, which is hawthorn powder or dried tangerine peel powder, accounting for 7-10% of the total wet pills. Then dry the pills so that each pill has a water content of 2-5% of its weight. Screen the round vegetarian pills with a particle size of 4-5mm and coat the round vegetarian pills with a thin film to obtain qualified pills.

5. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The method for preparing the granules includes the following steps: 1) Mix the jujube seed-codonopsis compound extract, dodder seed extract, angelica extract and dendrobium extract according to the weight parts, and reduce the water content from 30% to 10% to obtain a concentrated mixed medicine solution; 2) Add starch and sucrose to the concentrated mixed medicine solution at a mass ratio of 1:(1.5~1.8):(0.2~0.5), extrude to granulate, dry, and obtain granules.

6. The use of the traditional Chinese medicine preparation as described in any one of claims 1-5 in the preparation of drugs for improving endocrine disorders.

Images