Traditional Chinese medicine composition for treating salivation of Parkinson's disease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine composition for treating salivation of Parkinson's disease as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises the following raw materials: rhizoma pinellinae praeparata, trichosanthes kirilowii maxim, coptis chinensis, fructus evodiae, fructus aurantii immaturus, inula flower, rhizoma zingiberis, vinegar schisandra chinensis and cuttlebone. According to the traditional Chinese medicine composition for treating the salivation of the Parkinson's disease, the nine medicinal materials are scientifically matched, all the medicinal materials perform respective functions and have a synergistic effect, single-prescription accurate treatment is achieved for the salivation symptom of the Parkinson's disease, and the salivation improvement effect is remarkable; meanwhile, the whole formula follows the compatibility principle of regulating cold and heat, toxic drugs are not used, the overall drug property is mild, the adverse reaction of gastrointestinal tracts easily caused when Parkinson's disease is treated by clinical Chinese and western medicines can be effectively reduced while the salivary treatment effect is achieved, the curative effect and the medication safety are considered, and the long-term medication requirement of Parkinson's disease patients is met.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition for treating drooling in Parkinson's disease, its preparation method, and its application. Background Technology

[0002] Parkinson's disease is a common neurodegenerative disease in middle-aged and elderly people. Its core pathological change is the progressive degeneration and necrosis of dopaminergic neurons in the substantia nigra of the midbrain. Clinically, it is typically manifested by motor symptoms such as resting tremor, rigidity, bradykinesia, and postural instability. As the disease progresses, patients often experience a variety of non-motor symptoms, among which drooling is one of the more common complications, occurring in 30%-80% of cases, and the incidence increases with the severity of the disease.

[0003] Currently, clinical treatment for Parkinson's disease primarily relies on Western medicine, with the core goal of improving motor symptoms. Commonly used medications include dopamine replacement therapy, dopamine receptor agonists, and anticholinergic drugs, which have shown some clinical efficacy in alleviating core motor symptoms such as bradykinesia, joint stiffness, and limb tremors. However, for drooling, a common non-motor complication of Parkinson's disease, Western medicine has not yet developed a clear and effective targeted treatment plan, and there is a lack of specific drugs for treating this symptom.

[0004] Traditional Chinese medicine (TCM) theory classifies drooling in Parkinson's disease under the categories of "drooling syndrome" and "tremor syndrome." Its pathogenesis is largely related to factors such as spleen deficiency, internal accumulation of phlegm and dampness, stomach dysfunction, and liver qi stagnation. The core pathogenesis lies in the dysfunction of the spleen and stomach, leading to abnormal saliva metabolism and leakage. Although TCM has a long history and rich experience in differentiating and treating drooling syndromes, there is currently a lack of standardized medicines or fixed formulas specifically for drooling in Parkinson's disease.

[0005] Current TCM treatments primarily rely on individualized diagnosis and treatment, requiring physicians to adjust medications based on the patient's specific syndrome pattern. This lack of standardized medication guidelines and treatment plans leads to inconsistent treatment outcomes and issues such as complex medication use, inconvenient administration, and unstable efficacy. Furthermore, due to the complex pathological mechanisms of drooling in Parkinson's disease, which are related to various factors including neurological disorders and the state of spleen and stomach function, conventional TCM formulas for treating drooling often fail to precisely address its specific characteristics and thus cannot achieve the desired therapeutic effect.

[0006] In summary, current clinical treatments for drooling in Parkinson's disease have significant shortcomings. Western medicine lacks specific and effective drugs, while traditional Chinese medicine lacks standardized, targeted formulas and medications. Existing treatment options are ineffective, lack specificity, and fail to alleviate the gastrointestinal discomfort and other adverse reactions associated with Western medications. Therefore, developing a highly targeted, convenient, safe, and effective drug for treating drooling in Parkinson's disease, which can also reduce the gastrointestinal discomfort associated with single-drug Western treatments, has become an urgent technical problem to be solved in this field. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings and deficiencies of the prior art and provide a traditional Chinese medicine composition for treating drooling in Parkinson's disease, its preparation method and application.

[0008] To achieve the above objectives, the technical solution adopted by the present invention includes: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating drooling in Parkinson's disease, comprising the following raw materials: Pinellia ternata, Trichosanthes kirilowii, Coptis chinensis, Evodia rutaecarpa, Citrus aurantium, Inula japonica, Zingiber officinale, Schisandra chinensis (processed with vinegar), and Cuttlebone.

[0009] Preferably, the raw materials include the following parts by weight: 10-20 parts of Pinellia ternata, 10-20 parts of Trichosanthes kirilowii, 5-15 parts of Coptis chinensis, 3-5 parts of Evodia rutaecarpa, 10-25 parts of Citrus aurantium, 10-20 parts of Inula japonica, 3-10 parts of Zingiber officinale, 10-20 parts of Schisandra chinensis (processed with vinegar), and 10-20 parts of Cuttlebone.

[0010] This invention addresses the drooling symptoms of Parkinson's disease by developing a specialized traditional Chinese medicine composition with Pinellia ternata, Trichosanthes kirilowii, and Coptis chinensis as the core ingredients, combined with Inula japonica, Evodia rutaecarpa, Citrus aurantium, Zingiber officinale, Schisandra chinensis (processed with vinegar), Cuttlebone, and other medicinal herbs. This formula precisely combines the efficacy of each medicinal herb to achieve synergistic effects. The core three herbs—Pinellia ternata (processed) – dry dampness, resolve phlegm, and relieve nausea and vomiting; Trichosanthes kirilowii (processed) – clear heat and resolve phlegm; and Coptis chinensis (processed) – clear heat and dry dampness. Together, they clear heat, resolve phlegm, and relieve chest congestion. Inula japonica (processed) is combined with Pinellia ternata and Trichosanthes kirilowii to further enhance the synergistic effect of resolving phlegm and relieving nausea. Evodia rutaecarpa (processed) disperses cold and relieves nausea; when combined with Coptis chinensis, it soothes the liver, clears heat, harmonizes the stomach, and relieves nausea. Citrus aurantium (processed) regulates qi and eliminates stagnation; Zingiber officinale (processed) warms the middle jiao, disperses cold, and warms the lungs to resolve phlegm. Both herbs balance qi circulation and warm the body to resolve phlegm. Schisandra chinensis (processed) astringes lung qi, effectively preventing upward reversal of lung qi; and Sepia esculenta (processed) neutralizes acid and relieves pain. The entire formula follows the principle of using both cold and hot herbs to harmonize yin and yang. Through the complementary and synergistic effects of multiple herbs, it achieves the core therapeutic effects of clearing heat, resolving phlegm, relieving nausea, and harmonizing the stomach, improving and reducing drooling symptoms in Parkinson's disease patients from the root cause of the disease.

[0011] The formulation described in this invention closely follows the symptom characteristics and pathogenesis of drooling in Parkinson's disease. Each medicinal material plays its specific role and works synergistically to enhance efficacy, forming a unique and effective formulation system. Experiments have confirmed that the absence, substitution, or deviation of the dosage of key medicinal materials in the formulation from the preferred range of this invention will significantly reduce the overall efficacy. This demonstrates the scientific rigor and uniqueness of the formulation of this invention, providing a reliable traditional Chinese medicine solution for the clinical treatment of drooling in Parkinson's disease. It fills the gap in targeted formulations for the treatment of related diseases with traditional Chinese medicine and has significant clinical application value.

[0012] More preferably, the ingredients include the following parts by weight: 10 parts Pinellia ternata, 10 parts Trichosanthes kirilowii, 10 parts Coptis chinensis, 3 parts Evodia rutaecarpa, 20 parts Citrus aurantium, 15 parts Inula japonica, 3 parts dried ginger, 10 parts Schisandra chinensis (processed with vinegar), and 15 parts Cuttlebone.

[0013] Experimental research has revealed that the above-mentioned optimal ratio is the key to maximizing the therapeutic effect of the prescription. It can significantly reduce the frequency and severity of drooling in Parkinson's patients, while also having good universality, making it applicable to most Parkinson's disease patients with drooling. This provides an efficient and widely applicable preferred technical solution for the clinical treatment of this disease with traditional Chinese medicine.

[0014] The traditional Chinese medicine composition is prepared by decoction. The specific method is as follows: add water to the medicinal materials and soak for 30-60 minutes, with the water level submerging the medicinal materials and exceeding the surface of the medicinal materials by 2-3 cm, then decoct for 20-30 minutes to obtain the first decoction; then add water to the dregs and decoct for 15-20 minutes, with the water level just submerging the medicinal materials to obtain the second decoction; then combine the decoctions, filter, and obtain the traditional Chinese medicine composition.

[0015] Secondly, the present invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating drooling in Parkinson's disease.

[0016] Preferably, the drug is an oral preparation.

[0017] Thirdly, the present invention provides a traditional Chinese medicine preparation for treating drooling in Parkinson's disease, comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0018] Preferably, the preparation includes decoction, granules, capsules or tablets.

[0019] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) The Chinese medicine composition for treating drooling in Parkinson's disease described in this invention is formulated with nine medicinal materials, including Pinellia ternata, Trichosanthes kirilowii, Coptis chinensis, and Evodia rutaecarpa. Each medicinal material performs its own function and works synergistically to achieve precise single-herb treatment for drooling symptoms in Parkinson's disease, and the drooling improvement effect is significant. (2) At the same time, the whole formula follows the principle of harmonizing cold and heat, does not use toxic drugs, and has a mild overall medicinal property. While exerting the therapeutic effect of treating saliva, it can also effectively reduce the gastrointestinal adverse reactions that are easily caused when treating Parkinson's disease with traditional Chinese and Western medicines in clinical practice. It takes into account both efficacy and medication safety, and is suitable for the long-term medication needs of Parkinson's disease patients. Detailed Implementation

[0020] To better illustrate the objectives, technical solutions, and advantages of this invention, the invention will be further described below with reference to specific embodiments. Those skilled in the art should understand that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0021] Example 1 This embodiment provides a traditional Chinese medicine composition for treating drooling in Parkinson's disease. The composition comprises the following raw materials in parts by weight: 10g of Pinellia ternata, 10g of Trichosanthes kirilowii, 10g of Coptis chinensis, 3g of Evodia rutaecarpa, 20g of Citrus aurantium, 15g of Inula japonica, 3g of Zingiber officinale, 10g of Schisandra chinensis (processed with vinegar), and 15g of Cuttlebone.

[0022] The traditional Chinese medicine composition is prepared by decoction, and the preparation method includes the following steps: S1. Preparation: Place the herbs in a clay pot, add cold water, ensuring the water completely submerges the herbs and is 2-3 cm above the herbs (about the height of one finger joint), and soak for 45 minutes to fully moisten the herbs, which is beneficial for the extraction of active ingredients. S2. Amount of water for boiling (key step): First decoction (first decoction): The amount of water added is the soaking water (submerging the herbs 2-3 cm). First, bring it to a boil over high heat, then turn to low heat and simmer for 25 minutes to obtain the first decoction. Second decoction (re-decoction): After pouring out the decoction, add hot water directly to the dregs. The amount of water should just cover the dregs. Bring to a boil over high heat first, then simmer over low heat for 15 minutes to obtain the second decoction. S3. Mixing the decoction: Simply mix the two decoctions thoroughly.

[0023] Example 2 This embodiment provides a traditional Chinese medicine composition for treating drooling in Parkinson's disease. The composition comprises the following raw materials in parts by weight: 10g of Pinellia ternata, 20g of Trichosanthes kirilowii, 5g of Coptis chinensis, 5g of Evodia rutaecarpa, 10g of Citrus aurantium, 20g of Inula japonica, 3g of dried ginger, 20g of Schisandra chinensis (processed with vinegar), and 10g of Cuttlebone.

[0024] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0025] Example 3 This embodiment provides a traditional Chinese medicine composition for treating drooling in Parkinson's disease. The composition comprises the following raw materials in parts by weight: 20g of Pinellia ternata, 10g of Trichosanthes kirilowii, 15g of Coptis chinensis, 3g of Evodia rutaecarpa, 25g of Citrus aurantium, 10g of Inula japonica, 10g of Zingiber officinale, 10g of Schisandra chinensis (processed with vinegar), and 20g of Cuttlebone.

[0026] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0027] Comparative Example 1 This comparative example provides a traditional Chinese medicine composition for treating drooling in Parkinson's disease. The composition differs from Example 1 only in that it lacks Evodia rutaecarpa and Trichosanthes kirilowii. The composition comprises the following raw materials by weight g: 10g of Pinellia ternata, 10g of Coptis chinensis, 20g of Citrus aurantium, 15g of Inula japonica, 3g of Zingiber officinale, 10g of Schisandra chinensis (processed with vinegar), and 15g of Cuttlebone.

[0028] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0029] Comparative Example 2 This comparative example provides a traditional Chinese medicine composition for treating drooling in Parkinson's disease. The only difference between this composition and Example 1 is that Pinellia ternata is replaced with Citrus reticulata peel, and Inula japonica is replaced with clove. The composition comprises the following raw materials in parts by weight: Citrus reticulata peel 10g, Trichosanthes kirilowii fruit 10g, Coptis chinensis fruit 10g, Evodia rutaecarpa fruit 3g, Citrus aurantium fruit 20g, clove 15g, dried ginger 3g, Schisandra chinensis fruit 10g, and cuttlebone 15g.

[0030] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0031] Comparative Example 3 This comparative example provides a traditional Chinese medicine composition for treating drooling in Parkinson's disease. The only difference between this composition and Example 1 is that the dosage of Evodia rutaecarpa and Coptis chinensis is reduced. The composition comprises the following raw materials in parts by weight: 10g of Pinellia ternata, 10g of Trichosanthes kirilowii, 3g of Coptis chinensis, 1g of Evodia rutaecarpa, 20g of Citrus aurantium, 15g of Inula japonica, 3g of Zingiber officinale, 10g of Schisandra chinensis (processed with vinegar), and 15g of Cuttlebone.

[0032] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0033] Example of effect This test aims to verify the therapeutic effect of the traditional Chinese medicine compositions for treating drooling in Parkinson's disease described in Examples 1-3 of this invention through a clinical controlled trial. Simultaneously, by comparing the efficacy with the compositions of Comparative Examples 1-3, it clarifies the influence of key raw materials and their dosages on the therapeutic effect. Specific test methods are as follows: 1. Test subject selection criteria: (1) Patients diagnosed with Parkinson's disease who meet the relevant diagnostic criteria of the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition); (2) There are clear symptoms of drooling, and the total score of the drooling frequency and severity scale is ≥4 points before treatment (that is, there is at least occasional drooling and it has a mild impact on life). (3) Age 45-80 years, gender not limited, clear consciousness, able to cooperate in completing the scale assessment.

[0034] 2. Grouping scheme: Following a randomized controlled trial, 60 patients meeting the screening criteria were divided into 6 groups, each receiving one of the traditional Chinese medicine compositions described in Example-3 and Comparative Examples 1-3, with 10 patients in each group. No statistically significant differences were found among the groups in baseline data such as age, gender, disease duration, and total pre-treatment drooling scale score (P>0.05). The traditional Chinese medicine composition was administered once daily, divided into two doses (once in the morning and once in the evening, taken warm), for a total of three doses. During the treatment period, all patients maintained their original basic Parkinson's disease treatment.

[0035] 3. Testing Method: (1) Before treatment (T0): One day before administration, two trained neurologists independently assessed the patient's drooling frequency and severity using a scale, and the average score of the two physicians was taken as the total T0 score; the drooling frequency scale is shown in Table 1 (assessing the frequency of drooling in the patient's conscious state), and the drooling severity scale is shown in Table 2 (assessing the degree of impact of drooling on the patient's appearance, daily life and social life). (2) After treatment (T1): One day after the end of the medication, the same group of physicians used the same method to assess the patients using the scale, and the average score of the two people was taken as the total T1 score; (3) Main observation indicators: Changes in the total score of the drooling scale before and after treatment (Δ total score = T0 total score - T1 total score). According to the efficacy judgment criteria, the number of cases with significant effect, effective, ineffective and worsening in each group was judged (the specific classification is: significant effect, total score decrease ≥3 points; effective, total score decrease 1-2 points; ineffective, total score no change; worsening, total score increase). The total effective rate of each group was calculated (total effective rate = (number of cases with significant effect + number of cases with effective) / total number of cases × 100%). (4) Safety indicators: During the administration period, observe whether the patient experiences adverse reactions such as nausea, vomiting, diarrhea, and rash, and record the number of adverse reactions and their severity.

[0036] Table 1

[0037] Table 2

[0038] 4. Test Results: After the test, all 60 patients completed the full course of treatment, with no dropouts and no serious adverse reactions. The changes in total scores on the scales before and after treatment in each group, as well as the results of efficacy assessment, are shown in Table 3 below.

[0039] Table 3 Table 3 shows that the total effective rate of Examples 1-3 was over 80%, and the total score of the drooling scale decreased by an average of more than 3.4 points after treatment, which was significantly better than that of the control groups 1-3. This indicates that the traditional Chinese medicine composition described in the examples of the present invention can effectively improve the drooling symptoms of Parkinson's disease patients. Both the frequency and severity of drooling can be significantly controlled, and the curative effect is definite.

[0040] In Comparative Example 1, the absence of Evodia rutaecarpa and Trichosanthes kirilowii resulted in an overall effective rate of only 20% and an average decrease in total score of only 0.9 points, significantly lower than the Example 1 group. This indicates that Evodia rutaecarpa and Trichosanthes kirilowii are indispensable key ingredients in the formula. Evodia rutaecarpa warms the middle jiao and dispels cold, relieves nausea and vomiting, while Trichosanthes kirilowii clears heat, resolves phlegm, and relieves chest congestion. The synergistic effect of the two can effectively regulate spleen and stomach function and inhibit excessive saliva secretion. The absence of these ingredients leads to the loss of the core therapeutic efficacy of the formula.

[0041] In comparative group 2, after replacing Pinellia ternata with Citrus reticulata peel and Inula japonica with cloves, the overall effective rate was only 30%, indicating a significant decrease in efficacy. Pinellia ternata dries dampness, resolves phlegm, and relieves nausea and vomiting; Inula japonica lowers qi, resolves phlegm, and relieves nausea and vomiting. Both play a crucial role in resolving phlegm and relieving nausea and vomiting, targeting the core pathogenesis of drooling in Parkinson's disease, which is "internal obstruction of phlegm and upward reversal of stomach qi." While Citrus reticulata peel and cloves also have the effects of regulating qi and relieving nausea and vomiting, their targetedness and strength in resolving phlegm and relieving nausea and vomiting are not as good as the original formula, and they cannot replace its core therapeutic effect.

[0042] In the comparative group 3, the total effective rate decreased from 90% in the first example group to 30% simply by reducing the dosage of Evodia rutaecarpa and Coptis chinensis (from 10 parts to 3 parts, and from 3 parts to 1 part). This indicates that the dosage ratio of Evodia rutaecarpa and Coptis chinensis is an important guarantee for the efficacy of the formula. The scientific combination of the two (Coptis chinensis clears heat and dries dampness, while Evodia rutaecarpa warms the middle and relieves nausea, combining cold and heat, and bitter and pungent properties) and precise matching of dosage can achieve the best synergistic therapeutic effect. Insufficient dosage will not achieve the expected therapeutic effect.

[0043] Clinical Case 1 Mr. Zhang, aged 74, was admitted to the hospital due to bradykinesia for over 10 years and fever for 2 days. He had been hospitalized multiple times at other hospitals and our hospital, and was diagnosed with Parkinson's disease. His admission symptoms included: fatigue, weight loss, depressed mood, general weakness, fever and chills, headache, cough, expectoration with excessive phlegm, cold abdomen, acid reflux, poor appetite, insomnia, normal urination, and hard, difficult bowel movements. His tongue was red at the tip, thin, with a white coating, and his pulse was wiry and thready.

[0044] Before treatment, the patient's drooling frequency was assessed at 4 points, severity at 5 points, and the total score was 9 points (sum of the two dimensions). After taking three doses of the formula described in Example 1, the patient returned for a follow-up visit. Drooling had decreased, sputum production had decreased, and mood and appetite had improved. A second drooling frequency and severity scale was performed: after treatment, the drooling frequency was 2 points, severity at 2 points, and the total score was 4 points (sum of the two dimensions). That is, the total score on the drooling frequency and severity scale decreased by 5 points before and after treatment, which was assessed as a significant effect.

[0045] Clinical Case 2 Mr. Liang, male, 80 years old, was admitted to the hospital due to slow movement for more than 10 years, which had worsened and was accompanied by drooling for one week. Our department diagnosed him with Parkinson's disease. His admission symptoms included: clear consciousness, fair mental state, drooling, and slow movement of the limbs, slightly more pronounced on the left side. This manifested as: difficulty with fine motor skills such as unbuttoning or tying shoes, putting on shoes, socks, or clothes, writing, washing his face, and brushing his teeth; reduced facial expressions; slowed speech and unclear, slurred speech; slight difficulty getting out of bed and turning over; shuffling gait, difficulty initiating movement, slight forward lean when taking steps, reduced automatic arm swinging while walking, occasional sudden stops during walking, and sometimes walking faster as he walked. Difficulty stopping, clumsiness when turning, and body freezing; no obvious involuntary tremors in the limbs and around the mouth; bilateral limb stiffness; no loss of smell; low mood, anxiety, poor sleep, difficulty falling asleep, light sleep and easy awakening; occasional dream talking, no shouting or kicking during sleep; normal bowel movements; 5-6 times / day urination at night, no dysuria; occasional daytime sleepiness, no hallucinations; occasional choking when drinking water, no difficulty swallowing; excessive sweating, no excessive sebum secretion. No headache or dizziness, no chills or fever, cough or phlegm, no chest tightness or pain, palpitations, no stomach pain or bloating, nausea or vomiting, no abdominal pain or diarrhea; mild edema in both lower limbs; good appetite. Red tongue tip with cracks, thick yellow and greasy tongue coating, and thready pulse.

[0046] Before treatment, the patient's drooling frequency was assessed at 3 points, and the severity at 4 points, for a total score of 7 points (sum of both dimensions). After taking three doses of the formula described in Example 1, the patient returned for a follow-up visit and underwent another drooling frequency and severity scale test. After treatment, the patient's drooling frequency was 2 points, the severity at 2 points, and the total score was 4 points (sum of both dimensions). This means the total score on the drooling frequency and severity scale decreased by 3 points after treatment, indicating a significant effect.

[0047] Clinical Case 3 Ms. Chen, female, 68 years old, was diagnosed with Parkinson's disease in our department. Upon admission, the patient presented with: clear consciousness, fatigue, involuntary tremors in the left limbs and around the mouth, more pronounced at rest, worsening with emotional stress, lessening during voluntary movements, and disappearing during sleep; slowed limb movement, more pronounced on the left side, manifesting as: difficulty with fine motor skills such as unbuttoning or lacing shoes, putting on shoes, socks, or clothing, writing, washing face, and brushing teeth; reduced facial expressions; slowed speech and slurred speech; difficulty getting out of bed and turning over; no difficulty initiating movement, but with a slight forward lean when taking steps, a dragging gait, and reduced automatic arm swinging movements, with no gait progression. The patient experiences sudden cessation of walking, without increasing speed or difficulty stopping, but slows down when turning; slight stiffness in both limbs; decreased sense of smell; occasional low mood; poor sleep, difficulty falling asleep, frequent sleep talking, and occasional shouting, punching, and kicking during sleep; bowel movements 2-3 times per day, dry and difficult to pass, intermittent use of senna leaves to aid bowel movements; normal urination; occasional choking when drinking water, no difficulty swallowing; occasional drooling during sleep; no excessive sweating or sweating, no excessive sebum secretion; decreased memory, mainly manifested as decreased immediate and short-term memory, long-term memory is still acceptable; occasional dizziness, headache, and drowsiness, without chills or fever, no sore throat or itchy throat, occasional nighttime cough, without phlegm, no palpitations, no chest pain or radiating pain, occasional bloating and abdominal distension with acid reflux, without nausea or vomiting, poor appetite, and recent gradual weight loss; dark red tongue with cracks, yellow and greasy coating, and a wiry and thready pulse.

[0048] Before treatment, the patient's drooling frequency was assessed at 2 points, severity at 3 points, and the total score was 5 points (sum of the two dimensions). After taking three doses of the formula described in Example 1, the patient returned for a follow-up visit and underwent the drooling frequency and severity scale again: after treatment, the patient's drooling frequency was 1 point, severity at 1 point, and the total score was 2 points (sum of the two dimensions). The total score on the drooling frequency and severity scale decreased by 3 points before and after treatment, which was assessed as a significant effect.

[0049] Clinical Case 4 Mr. Yin, male, 75 years old, was diagnosed with Parkinson's disease in our department. Upon admission, his symptoms included: clear consciousness, fatigue, and slow movements, manifested as: difficulty with fine motor skills such as unbuttoning, shoelaces, putting on shoes, socks, or clothing, writing, washing his face, and brushing his teeth; reduced facial expressions; slightly slower speech, with unclear and fluent speech; slight difficulty getting out of bed and turning over; dragging gait on the left side, occasional difficulty initiating movement, slight forward lean when stepping, reduced automatic arm swinging while walking, no sudden stops during walking, occasional increasing speed and difficulty stopping, and occasional difficulty turning; resting tremor, pill-rolling pattern, predominantly on the right side, accompanied by involuntary movements of both upper limbs; significant stiffness and tightness in the limbs; mood changes, prone to depression and anxiety, and reluctance to communicate. The patient experiences occasional dizziness, palpitations, chest tightness and pain; hearing loss, memory decline, poor sleep, reversed day and night, frequent talking in sleep, and RBD symptoms such as shouting, punching and kicking in sleep; slightly frequent urination, constipation with one bowel movement per day, intermittent use of glycerin suppositories for bowel movement, occasional incontinence, suspected hallucinations, choking when drinking water, no difficulty swallowing, drooling, excessive sweating, and excessive sebum secretion. There is no headache, chills or fever, sore throat or itchy throat, cough or phlegm, acid reflux or belching, abdominal pain or bloating, poor appetite, and significant recent weight loss. The tongue is dark red with a white, greasy coating, and the pulse is wiry and thready.

[0050] Before treatment, the patient's drooling frequency and severity were assessed at 4 points, with a total score of 8 points (sum of both dimensions). After taking three doses of the formula described in Example 1, the patient returned for a follow-up visit and underwent the drooling frequency and severity scale again. After treatment, the patient's drooling frequency and severity were both at 2 points, with a total score of 4 points (sum of both dimensions). This means the total score on the drooling frequency and severity scale decreased by 4 points after treatment, indicating a significant effect.

[0051] Clinical Case 5 Ms. He, female, 56 years old, was diagnosed with Parkinson's disease in our department. Upon admission, the patient presented with the following findings: She was alert and generally in good spirits, but exhibited slowed motor function in both limbs, more pronounced on the right side. This manifested as: difficulty with fine motor skills such as unbuttoning or tying shoes, putting on shoes, socks, or clothing, writing, washing her face, and brushing her teeth; reduced facial expressions; slowed speech, with less fluent and clear speech; slight difficulty getting out of bed and turning over; difficulty initiating movement, slow and limited walking, pain and discomfort in the left hip, dragging her feet on the left side, slight forward lean when stepping, reduced automatic arm swinging, occasional turning, and sudden stops during walking, without any increase in speed or difficulty stopping; involuntary tremors in the right limbs and head, more pronounced at rest and worsening with emotional stress. The symptoms are severe, relieved by voluntary movements; bilateral limb stiffness, more pronounced on the right side; involuntary swaying of limbs and body; medication takes effect in about 1-1.5 hours and lasts for about 3 hours, with abnormal movements related to drug concentration; decreased sense of smell, low mood, anxiety, poor sleep (can fall asleep but sleeps lightly and wakes easily, early awakening, no delirium or talking in sleep, no shouting or kicking during sleep), occasional constipation (recently resolved), occasional urinary incontinence, no dysuria, no daytime sleepiness, occasional auditory hallucinations, no visual hallucinations, occasional choking on drinking, difficulty swallowing, occasional nocturnal drooling, no excessive sweating, no excessive sebum secretion. Occasional frontal headache, no dizziness, no chills or fever, no cough or phlegm, no chest tightness or pain, no palpitations, no stomach pain or bloating, no abdominal pain or bloating; right forearm pain and discomfort, slightly limited flexion and extension, right hip pain and discomfort, affecting walking, appetite is good. Weight has decreased by about 5 kg in the past six months. The tongue is dark red with a white, greasy coating, and the pulse is thready.

[0052] Before treatment, the patient's drooling frequency was assessed at 2 points, severity at 3 points, and the total score was 5 points (sum of the two dimensions). After taking three doses of the formula described in Example 2, the patient returned for a follow-up visit and underwent the drooling frequency and severity scale again. After treatment, the patient's drooling frequency was 1 point, severity at 1 point, and the total score was 2 points (sum of the two dimensions). That is, the total score on the drooling frequency and severity scale decreased by 3 points before and after treatment, which was assessed as a significant effect.

[0053] Clinical Case 6 Mr. Zhong, male, 77 years old, was diagnosed with Parkinson's disease in our department. Upon admission, his condition was as follows: He was alert but in fair spirits, with weak and slurred speech; tremors in the tongue, jaw, and right upper limb, presenting as resting tremors; the right upper limb tremors manifested as rhythmic finger flexion and thumb opposition movements, resembling a "pill-rolling" motion; reduced arm swinging in the right upper limb; drooling; slightly slower walking; no fever or chills; no headache or dizziness; no choking on liquids, difficulty swallowing; no chest tightness, palpitations, or chest pain; no abdominal pain or diarrhea; good appetite; fair sleep; nocturia 4 times; frequent urination; sometimes constipation and straining during bowel movements. His tongue was dark red with a white, greasy coating; and his pulse was thready.

[0054] Before treatment, the drooling frequency was assessed at 3 points, the severity at 3 points, and the total score was 6 points (sum of the two dimensions). After taking three doses of the formula described in Example 2, the patient returned for a follow-up visit and underwent the drooling frequency and severity scale again: after treatment, the drooling frequency was 2 points, the severity at 2 points, and the total score was 4 points (sum of the two dimensions). That is, the total score on the drooling frequency and severity scale decreased by 2 points before and after treatment, indicating effectiveness.

[0055] Clinical Case 7 Ms. Yang*, female, 80 years old, was diagnosed with Parkinson's disease in our department. The patient presented with the following symptoms upon admission: clear consciousness, fatigue, and slow movement of the limbs, more pronounced on the right side. This manifested as: difficulty with fine motor skills such as unbuttoning or tying shoes, putting on shoes, socks, or clothing, writing, washing face, and brushing teeth; reduced facial expressions; clear and fluent speech, but at a lower volume; slight difficulty getting up and turning over; dragging gait on the right side, occasional difficulty initiating movement, slight forward lean when stepping, reduced automatic arm swinging while walking, and occasional sudden stops during walking, without increasing speed or difficulty stopping; involuntary tremors in the right limbs, more pronounced at rest, worsening with emotional stress and lessening with voluntary movements; stiffness in all four limbs, more pronounced on the right side; decreased sense of smell, no significant mood changes, poor sleep, difficulty falling asleep, occasional sleep talking, constipation, urinary urgency, occasional incontinence, no dysuria, no daytime sleepiness, no hallucinations, occasional choking when drinking, no difficulty swallowing, occasional drooling at night, no excessive sweating, and no excessive sebum secretion. The patient experiences chest tightness and shortness of breath, which worsens after walking, activity, or eating. They also experience a feeling of ear fullness, frequent sighing, and relief of chest tightness after deep breathing or oxygen therapy. There is no chest pain, radiating pain in the back or left upper limb, and the patient can lie flat at night without paroxysmal nocturnal dyspnea. The chest tightness and ear fullness are accompanied by dizziness, general weakness, but no vertigo, nausea, vomiting, tinnitus, hearing loss, headache, chills, fever, cough, or phlegm. Appetite is fair, but stomach discomfort easily occurs after eating. There is no nausea, vomiting, bloating, stomach pain, acid reflux, heartburn, abdominal pain, or diarrhea. The patient is generally sensitive to cold. They experience lower back pain and discomfort, but no numbness in both lower limbs. There has been no significant recent weight change. The tongue is dark red with a yellow, greasy coating, and the pulse is wiry and thready.

[0056] Before treatment, the patient's drooling frequency was assessed at 2 points, severity at 3 points, and the total score was 5 points (sum of the two dimensions). After taking three doses of the formula described in Example 1, the patient returned for a follow-up visit and underwent the drooling frequency and severity scale again. After treatment, the patient's drooling frequency was 1 point, severity at 2 points, and the total score was 3 points (sum of the two dimensions). That is, the total score on the drooling frequency and severity scale decreased by 2 points before and after treatment, indicating effectiveness.

[0057] Clinical Case 8 Ms. Zhang, female, 67 years old, was diagnosed with Parkinson's disease in our department. Upon admission, her symptoms included: alertness, fatigue, slow movements, and tremors in the head and limbs. The bradykinesia manifested as slow rising from a sitting position, and slight limitations in daily activities such as getting out of bed, turning over, unbuttoning or tying shoes, putting on shoes and socks, dressing, washing her face, and brushing her teeth. She also experienced involuntary tremors of the lips and limbs, primarily in the left lower limb and facial area, which were more pronounced when standing at rest, worsened by mental stress, and lessened by voluntary movements. She also experienced limb stiffness, which she felt was more pronounced on the left side. Walking was still possible, but she reported weakness in both upper limbs. She also reported recent memory decline, and was prone to irritability and mood swings, but without a pronounced "mask-like face" or "hurried gait." She occasionally experienced bloating, but no acid reflux, heartburn, nausea, vomiting, or diarrhea. She also experienced a bitter taste in her mouth, dry mouth, dizziness, headache, tinnitus, cough, sputum production, choking when drinking, or difficulty swallowing. She had no palpitations, chest tightness, or chest pain. The patient experiences lower back pain accompanied by numbness and pain in the lower limbs after prolonged sitting or standing, slightly limited lumbar mobility, fatigue, fair appetite, difficulty falling asleep, frequent awakenings, and difficulty falling back asleep after waking. The patient also experiences vivid dreams, night sweats with symptoms of restless breathing (RBD) such as hand and foot movements and talking in their sleep, decreased sense of smell, hoarseness, occasional drooling, and occasional urinary incontinence recently (2 times at night). Bowel movements occur once every 2-3 days, with no black stools. There has been no significant change in weight recently. The tongue is dark red with a white, greasy coating, and the pulse is wiry and thready.

[0058] Before treatment, the patient's drooling frequency was assessed at 2 points, severity at 3 points, and the total score was 5 points (sum of the two dimensions). After taking three doses of the formula described in Example 3, the patient returned for a follow-up visit and underwent the drooling frequency and severity scale again. After treatment, the patient's drooling frequency was 1 point, severity at 2 points, and the total score was 3 points (sum of the two dimensions). That is, the total score on the drooling frequency and severity scale decreased by 2 points before and after treatment, indicating effectiveness.

[0059] Clinical Case 9 Mr. Zhang*, male, 55 years old, was diagnosed with Parkinson's disease in our department. Upon admission, his symptoms included: clear consciousness, fatigue, and slowed motor function in both limbs, more pronounced on the right side. This manifested as: difficulty with fine motor skills such as unbuttoning or tying shoes, putting on shoes, socks, or clothing, writing, washing his face, and brushing his teeth; reduced facial expressions; slowed speech, with less fluent and clear speech; difficulty getting out of bed and turning over; shuffling gait, occasional difficulty initiating movement, slight forward lean when stepping, reduced automatic arm swinging while walking, no sudden stops during walking, occasional increasing speed followed by difficulty stopping, and difficulty turning. Flexible; occasional involuntary tremors in the right upper limb, which occur and worsen when emotionally stressed and are relieved when making voluntary movements; general stiffness, more pronounced on the right side; decreased sense of smell; anxiety and depression; normal sleep; frequent sleep talking; occasional shouting, punching and kicking during sleep; constipation, requiring enemas; frequent, urgent and painful urination; occasional urinary incontinence; no daytime sleepiness; no hallucinations; occasional choking when drinking water; no difficulty swallowing; occasional involuntary drooling; excessive sweating; and excessive sebum secretion. The patient experiences dizziness and general malaise, without vertigo, hearing loss, tinnitus, numbness or weakness on one side of the body, chills or fever, cough or phlegm, occasional shortness of breath, chest tightness or pain, palpitations, poor appetite, occasional abdominal distension and pain, nausea and vomiting, but without acid reflux or heartburn, hiccups or belching, and bilateral shoulder and lower back pain or discomfort, without radiating numbness or pain in the upper or lower limbs. There has been no significant change in weight recently. The tongue is dark red with a white, greasy coating, and the pulse is wiry and thready.

[0060] Before treatment, the patient's drooling frequency was assessed at 2 points, severity at 3 points, and the total score was 5 points (sum of the two dimensions). After taking three doses of the formula described in Example 3, the patient returned for a follow-up visit and underwent the drooling frequency and severity scale again. After treatment, the patient's drooling frequency was 1 point, severity at 2 points, and the total score was 3 points (sum of the two dimensions). That is, the total score on the drooling frequency and severity scale decreased by 2 points before and after treatment, indicating effectiveness.

[0061] Clinical Case 10 Mr. Zhang, male, 68 years old, was diagnosed with Parkinson's disease in our department. Upon admission, his condition was as follows: He was alert but fatigued; slowed movements in both limbs, more pronounced on the left side, manifesting as: difficulty with fine motor skills such as unbuttoning or tying shoes, putting on shoes, socks, or clothing, writing, washing his face, and brushing his teeth; reduced facial expressions; slowed speech, with less fluent and clear speech; slight difficulty getting out of bed and turning over; dribbling gait, but no difficulty in initiating movement; slight forward head tilt when walking; reduced automatic arm swinging while walking; no sudden stops during walking; no increasing speed or difficulty stopping; occasional difficulty turning; both upper limbs... The patient experiences occasional involuntary tremors, more pronounced at rest, worsening with emotional stress and lessening with voluntary movements; bilateral limb stiffness, more pronounced on the left side; no loss of smell, but experiences anxiety, depression, poor sleep, difficulty falling asleep, frequent sleep talking, occasional shouting, kicking, and punching during sleep; difficulty defecating (soft stools), frequent urination at night with urgency, hesitancy, and incomplete emptying; no daytime sleepiness, no hallucinations; occasional choking while drinking, no difficulty swallowing; occasional nocturnal drooling; no excessive sweating or oily skin. Neck pain and discomfort, no numbness in the upper limbs; blurred vision, easy tearing, no dryness, photophobia, pain, or congestion. No headache, dizziness, chills, fever, cough, phlegm, chest tightness, chest pain, palpitations, stomach pain, bloating, or abdominal pain and bloating; appetite is good. No significant recent weight change. Dark red tongue with a white, greasy coating; thready, wiry pulse.

[0062] Before treatment, the patient's drooling frequency was assessed at 2 points, severity at 4 points, and the total score was 6 points (sum of the two dimensions). After taking three doses of the formula described in Example 3, the patient returned for a follow-up visit and underwent the drooling frequency and severity scale again. After treatment, the patient's drooling frequency was 1 point, severity at 2 points, and the total score was 3 points (sum of the two dimensions). That is, the total score on the drooling frequency and severity scale decreased by 3 points before and after treatment, which was assessed as a significant effect.

[0063] Clinical Case 11 Yang** was admitted to our hospital and diagnosed with Parkinson's disease. Before treatment, the sum of the scores for the frequency and severity of drooling was 7. After taking three doses of the formula described in Comparative Example 1, the sum of the two scores was 6, a decrease of only 1 point. The improvement in the frequency and severity of drooling was limited, and the patient's accompanying symptoms such as acid reflux and loss of appetite did not show significant relief.

[0064] Clinical Case 12 Qiu** was admitted to our hospital and diagnosed with Parkinson's disease. Before treatment, the sum of the scores for the frequency and severity of drooling was 6. After taking three doses of the formula described in Comparative Example 2, the sum of the two scores was 5, a decrease of only 1 point. The improvement in the frequency and severity of drooling was limited, and the patient's symptoms such as excessive phlegm and acid reflux did not improve significantly.

[0065] Clinical Case 13 Luo** was admitted to our hospital and diagnosed with Parkinson's disease. Before treatment, the sum of the scores for the frequency and severity of drooling was 8 points. After taking three doses of the formula described in Comparative Example 3, the sum of the two scores was 7 points, a decrease of only 1 point. The patient's symptoms of chills and fever did not improve significantly, the reduction in drooling was limited, and accompanying symptoms such as acid reflux and bloating still recurred.

[0066] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A traditional Chinese medicine composition for treating drooling in Parkinson's disease, characterized in that, The ingredients include: Pinellia ternata, Trichosanthes kirilowii, Coptis chinensis, Evodia rutaecarpa, Citrus aurantium, Inula japonica, dried ginger, Schisandra chinensis (processed with vinegar), and cuttlebone.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The ingredients include the following parts by weight: 10-20 parts of Pinellia ternata, 10-20 parts of Trichosanthes kirilowii, 5-15 parts of Coptis chinensis, 3-5 parts of Evodia rutaecarpa, 10-25 parts of Citrus aurantium, 10-20 parts of Inula japonica, 3-10 parts of dried ginger, 10-20 parts of Schisandra chinensis (processed with vinegar), and 10-20 parts of Cuttlebone.

3. The traditional Chinese medicine composition as described in claim 2, characterized in that, The ingredients include the following parts by weight: 10 parts Pinellia ternata, 10 parts Trichosanthes kirilowii, 10 parts Coptis chinensis, 3 parts Evodia rutaecarpa, 20 parts Citrus aurantium, 15 parts Inula japonica, 3 parts dried ginger, 10 parts Schisandra chinensis (processed with vinegar), and 15 parts Cuttlebone.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is prepared by decoction. The specific method is as follows: add water to the medicinal materials and soak for 30-60 minutes, with the water level submerging the medicinal materials and exceeding the surface of the medicinal materials by 2-3 cm, then decoct for 20-30 minutes to obtain the first decoction; then add water to the dregs and decoct for 15-20 minutes, with the water level just submerging the medicinal materials to obtain the second decoction. The decoctions are then combined to obtain the aforementioned traditional Chinese medicine composition.

5. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating drooling in Parkinson's disease.

6. The application as described in claim 5, characterized in that, The drug is an oral preparation.

7. A traditional Chinese medicine preparation for treating drooling in Parkinson's disease, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1-3 and pharmaceutically acceptable excipients.

8. The traditional Chinese medicine preparation as described in claim 7, characterized in that, The preparations include decoctions, granules, capsules, or tablets.

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