Preparation method of a blood dendrobium plant preparation and application thereof in gynecological endocrine diseases

Abstract

The application provides a preparation method of a blood-ear dendrobium plant preparation and application of the blood-ear dendrobium plant preparation in gynecological endocrine diseases. The blood-ear dendrobium plant preparation comprises the following ingredients by weight: 15-20 parts of radix astragali, 8-10 parts of dendrobium officinale, 10-12 parts of mulberry leaves, 3-5 parts of blood-ear, 8-10 parts of ophiopogon japonicus, 6-8 parts of spina date seed, 5-7 parts of allium bakeri and 5-8 parts of gordon euryale seed. The blood-ear dendrobium plant preparation can produce gas by enzymatic reaction, prolong the floating time of the preparation in the stomach, slowly release the drug and improve the bioavailability. Meanwhile, the blood-ear dendrobium plant preparation has a significant improvement or treatment effect on various gynecological endocrine diseases such as endometriosis combined with insulin resistance, abnormal uterine bleeding, premature ovarian failure and perimenopausal metabolic syndrome, and provides a new solution for the treatment of complex gynecological endocrine diseases.

Description

Technical Field

[0001] This invention belongs to the field of modernization of traditional Chinese medicine, specifically relating to a method for preparing a Dendrobium officinale plant preparation and its application in gynecological endocrine diseases. Background Technology

[0002] Gynecological endocrine disorders such as polycystic ovary syndrome (PCOS), endometriosis with insulin resistance (EMS-IR), abnormal uterine bleeding (DUB), and perimenopausal metabolic syndrome (PMS) have become a major burden on the health of modern women. These diseases not only involve reproductive endocrine disorders, but also form a vicious cycle with systemic metabolic disorders (such as insulin resistance, chronic low-grade inflammation, oxidative stress, and gut microbiota imbalance), resulting in limited efficacy and significant side effects of existing treatments.

[0003] The current clinical treatment of gynecological diseases faces three major pain points: First, existing traditional Chinese medicines are mostly limited to the relief of single symptoms. For example, Guizhi Fuling capsules only target uterine fibroids and ovarian cysts caused by blood stasis and obstruction, and are difficult to deal with complex pathological states involving multiple systems, such as EMS-IR. Second, although Western medicine hormone therapy can suppress lesions in the short term, it will cause oxidative stress to worsen the condition. Clinical data shows that after using gonadotropin-releasing hormone agonists (GnRH-a), the SOD activity in the serum of patients decreased by 40%. Third, the vicious cycle of metabolic disorders and reproductive disorders has not been effectively blocked. For example, the risk of developing type 2 diabetes in PCOS patients is 4 times higher than that in the general population, and traditional treatment methods cannot simultaneously regulate reproductive endocrine and glucose and lipid metabolism.

[0004] To address the aforementioned issues, this invention, based on the theory of "oxidation-reduction-endocrine-metabolism" interactive regulation, has developed an innovative traditional Chinese medicine composition that combines the functions of targeting pathological processes and regulating system homeostasis. It is particularly suitable for treating gynecological endocrine diseases and related systemic dysfunctions, providing a breakthrough solution for the comprehensive treatment of complex gynecological endocrine diseases. Summary of the Invention

[0005] In view of the above-mentioned technical problems, the first objective of this invention is to provide a Dendrobium officinale plant composition.

[0006] The second objective of this invention is to provide a Dendrobium officinale plant preparation based on a Dendrobium officinale plant composition and a method for preparing the same.

[0007] A third objective of this invention is to provide the use of the aforementioned Dendrobium officinale plant preparation in the preparation of drugs for improving or treating gynecological endocrine disorders.

[0008] Technical Solution: A Dendrobium officinale plant preparation, comprising active ingredients and pharmaceutical excipients, wherein the active ingredients are a Dendrobium officinale composition comprising the following raw material components in parts by weight: Astragalus membranaceus 15-20 parts, Dendrobium officinale 8-10 parts, Morus alba leaf 10-12 parts, Dendrobium officinale 3-5 parts, Ophiopogon japonicus 8-10 parts, Ziziphus jujuba seed 6-8 parts, Allium macrostemon 5-7 parts, Euryale ferox seed 5-8 parts; the pharmaceutical excipients comprise the following components in parts by weight: microcrystalline cellulose 1.5-4 parts, lactose 18-24 parts, and magnesium stearate 0.6-3 parts.

[0009] The preparation method of the above-mentioned Dendrobium officinale plant preparation is characterized by comprising the following steps:

[0010] S1. Astragalus membranaceus, Dendrobium officinale, mulberry leaf, black fungus, Ophiopogon japonicus, Ziziphus jujuba var. spinosa, Allium macrostemon and Euryale ferox are pretreated, dried to constant weight, mixed evenly, pulverized and sieved to obtain the black fungus and Dendrobium officinale composition;

[0011] S2. Phospholipids and ergosterol were dissolved in a chloroform / methanol mixture, and the above-mentioned Dendrobium officinale composition and glucosinolate were added. The mixture was vortexed and mixed, and the organic solvent was removed by rotary evaporation to form a uniform lipid film. The film was hydrated with PBS, sonicated, and then ultrafiltered, centrifuged and spray-dried to obtain liposomes.

[0012] S3. Add chitosan to acetic acid solution and stir until completely dissolved. Add black mycosesin to PBS and then slowly add it to the chitosan solution. Sonicate under ice bath to prepare a mixture. Dissolve sodium tripolyphosphate in water and add it to the mixture while stirring continuously. After centrifugation, wash the precipitate with PBS and spray dry to obtain black mycosesin microspheres.

[0013] S4. Liposomes and black myrosinase microspheres are mixed, and microcrystalline cellulose, lactose and magnesium stearate are added and mixed evenly to obtain the Dendrobium officinale plant preparation.

[0014] Preferably, the phospholipid in step S2 is any one or more of Antarctic krill phosphatidylcholine, Antarctic krill phosphatidylethanolamine, Antarctic krill phosphatidylserine, and Antarctic krill phosphatidylinositol.

[0015] Preferably, the glucosinolates in step S2 include, but are not limited to, glucosinolates and sinigrin.

[0016] Preferably, in step S2, the mass ratio of phospholipids, ergosterol, and glucosinolates is 4.4~5.5:1~1.8:0.8~1.5.

[0017] Preferably, the volume ratio of chloroform to methanol in step S2 is 2~2.5:1~2.

[0018] Preferably, the temperature of rotary evaporation in step S2 is 40~50℃, and the rotation speed is 120~180rpm.

[0019] Preferably, the hydration temperature in step S2 is 50~60℃ and the hydration time is 30~60 min.

[0020] Preferably, the ultrasonic power in step S2 is 200~220 W and the ultrasonic time is 5~8 min.

[0021] Preferably, in step S2, the centrifugation speed is 10000~12000×g and the centrifugation time is 15~25min.

[0022] Preferably, the chitosan in step S3 is low molecular weight chitosan with a molecular weight of 50~150 kDa.

[0023] Preferably, the source of black mycosesin in step S3 includes, but is not limited to, the seeds, roots, stems or leaves of broccoli, cauliflower, radish, kale or rapeseed.

[0024] Preferably, in step S3, the mass ratio of chitosan, myrosinase, and sodium tripolyphosphate is 20~30:1~2.5:8~14.

[0025] Preferably, in step S3, the stirring speed is 300~600 rpm and the stirring time is 20~40 min.

[0026] Preferably, in step S3, the centrifugation speed is 5000~7000×g and the centrifugation time is 10~20 min.

[0027] The above-mentioned Dendrobium officinale plant preparations are used in the preparation of drugs to improve or treat gynecological endocrine disorders, including endometriosis with insulin resistance, abnormal uterine bleeding, premature ovarian insufficiency, and perimenopausal metabolic syndrome.

[0028] The dosage forms of the above-mentioned drugs for improving or treating gynecological endocrine disorders are tablets, pills, capsules, powders, or granules.

[0029] Beneficial effects:

[0030] 1. The *Dendrobium nobile* plant preparation prepared in this invention achieves autonomous gas production through an enzymatic reaction triggered in the gastric environment, allowing the preparation to float continuously in the stomach, prolonging the residence time of the active ingredients while maintaining controlled drug release. This overcomes the shortcomings of traditional oral preparations, such as short residence time and low bioavailability in the stomach. This invention co-encapsulates the *Dendrobium nobile* plant preparation and glucosinolate substrate, while separately microencapsulating myrosinase, spatially isolating it from the glucosinolate substrate to prevent pre-reaction during delivery, thus ensuring that the enzymatic reaction is triggered only in the stomach. When the preparation reaches the stomach, gastric juice permeates and releases myrosinase and glucosinolate, which undergo an enzymatic reaction to generate CO2 in situ, reducing the density of the preparation and causing it to float on the surface of the gastric juice. This achieves continuous floating in the stomach for 16 hours and sustained release of more than 85% of the drug within 24 hours.

[0031] 2. The *Dendrobium nobile* plant preparation prepared by this invention has significant advantages compared to conventional gastric flotation preparations. Traditional carbonate gas-generating systems are easily affected by individual gastric acid secretion and gastric emptying rate, resulting in short gas-generating duration and large fluctuations in flotation time. Furthermore, excessive carbonate may cause gastric discomfort. In contrast, the enzymatic gas-generating system of this invention, which generates CO2 gas from a specific substrate through enzyme catalysis, allows the preparation to float continuously, offering the following advantages:

[0032] (1) High substrate specificity: The high selectivity of black myrosinase and glucosinolate substrates avoids non-target reactions and reduces interference from byproducts;

[0033] (2) Controllable gas production rate: The release rate of enzyme and substrate can be controlled by adjusting the enzyme loading, substrate ratio or encapsulation wall material ratio, and the floating time can be extended to 16 h.

[0034] (3) High biocompatibility: The black myrosinase and glucosinolate substrates derived from cruciferous plants are generally safe and avoid the risk of electrolyte imbalance caused by carbonates. Detailed Implementation

[0035] The present invention will be further described below with reference to embodiments. These embodiments are illustrative of the present invention, but the present invention is not limited to these embodiments:

[0036] Example 1

[0037] This embodiment describes the preparation of a Dendrobium officinale plant preparation, including the following steps:

[0038] S1. Raw material pretreatment: Mix refined honey and water in a 1:1 mass ratio, add astragalus root and stir well, let it soak for 2 hours, stir-fry at 100℃ for 40 minutes, dry at 90℃ for 45 minutes, and set aside; freeze-dry fresh Dendrobium officinale and set aside; pick mulberry leaves after frost, microwave to kill the green, and dry at 100℃ for 40 minutes, and set aside; dry black fungus at 60℃ for 2 hours, and ultrafine pulverize (D90≤15 μm), and set aside; lightly moisten Ophiopogon japonicus with water, add water-milled cinnabar powder in a 40:1 mass ratio, stir well, and dry at 60℃ for 12 hours, and set aside; soak jujube seeds in 30℃ warm water for 10 hours to promote germination, and dry at 55℃ for 12 hours, and set aside; soak Allium macrostemon in aged vinegar for 3 days, and dry at 55℃ for 12 hours, and set aside; stir-fry Euryale ferox with wheat bran until slightly yellow, and dry at 60℃ for 10 hours, and set aside;

[0039] S2. Preparation of the Blood Ear Dendrobium composition: Mix 20 parts Astragalus membranaceus, 10 parts Dendrobium officinale, 10 parts mulberry leaf, 5 parts Blood Ear, 8 parts Ophiopogon japonicus, 8 parts Ziziphus jujuba var. spinosa, 7 parts Allium macrostemon and 5 parts Euryale ferox evenly, pulverize and pass through a 60-mesh sieve, and set aside.

[0040] S3. Preparation of liposomes: Weigh 5.4 g of Antarctic krill phosphatidylethanolamine and 1.2 g of ergosterol and dissolve them in a chloroform / methanol mixture (2:1, v / v). Add the above-mentioned Dendrobium officinale composition and 1.5 g of glucosinolate. Vortex mix well, remove organic solvent by rotary evaporation at 40°C and 150 rpm to form a uniform lipid film. Add 5 mL of PBS (pH 7.4), hydrate at 55°C for 30 min, sonicate at 200 W for 5 min (5 s on / 5 s off, ice bath), ultrafilter, centrifuge at 10000×g for 20 min, and spray dry to obtain liposomes.

[0041] S4. Preparation of black myrosinase microspheres: Weigh 100 mg of low molecular weight chitosan, add 10 mL of 1% acetic acid solution, and stir until completely dissolved; add 5 mg of black myrosinase to 1 mL of PBS (pH 5.0), slowly add the chitosan solution, and sonicate at 50 W for 30 s in an ice bath to obtain a mixture; weigh 50 mg of sodium tripolyphosphate, add 10 mL of water, and add the mixture dropwise at 1 mL / min using a syringe pump, stir at 500 rpm for 30 min, centrifuge at 5000×g for 10 min, wash the precipitate three times with PBS (pH 5.0), and spray dry to obtain black myrosinase microspheres;

[0042] S5. Mixing and tableting: Mix liposomes and black myrosinase microspheres, add 1.5 parts microcrystalline cellulose, 18 parts lactose and 0.6 parts magnesium stearate, mix evenly and then compress into tablets.

[0043] Example 2

[0044] The difference between this embodiment and Embodiment 1 is that the Dendrobium officinale plant preparation in this embodiment contains 15 parts Astragalus membranaceus, 9 parts Dendrobium officinale, 10 parts mulberry leaf, 3 parts Dendrobium officinale, 10 parts Ophiopogon japonicus, 6 parts Ziziphus jujuba var. spinosa, 7 parts Allium macrostemon, and 6 parts Euryale ferox.

[0045] Example 3

[0046] The difference between this embodiment and Embodiment 1 is that in this embodiment, the amount of Antarctic krill phosphatidylethanolamine added is 6.9 g, the amount of ergosterol added is 1.5 g, and the amount of glucosinolate added is 1.8 g.

[0047] Example 4

[0048] The difference between this embodiment and Embodiment 1 is that in this embodiment, the amount of low molecular weight chitosan added is 175 mg, the amount of black myrosinase added is 7 mg, and the amount of sodium tripolyphosphate added is 77 mg.

[0049] Example 5

[0050] The difference between this embodiment and Embodiment 1 is that in this embodiment, Antarctic krill phosphatidylethanolamine is replaced with Antarctic krill phosphatidylcholine.

[0051] Example 6

[0052] The difference between this embodiment and Embodiment 1 is that glucosinolates are replaced with sinigrin in this embodiment.

[0053] Comparative Example 1

[0054] The difference between this comparative example and Example 1 is that the Dendrobium officinale composition was directly compressed into tablets in this comparative example.

[0055] Comparative Example 2

[0056] The difference between this comparative example and Example 1 is that in this comparative example, the Dendrobium officinale composition and 25 mg NaHCO3 were mixed and then compressed into tablets.

[0057] Comparative Example 3

[0058] The difference between this comparative example and Example 1 is that in this comparative example, glucosinolates are replaced with neoglucosinolates.

[0059] Comparative Example 4

[0060] The difference between this comparative example and Example 1 is that black myrosinase is replaced with β-glucosidase in this comparative example.

[0061] Indicator Test

[0062] 1. Determination of in vitro buoyancy performance

[0063] The Dendrobium officinale plant preparation prepared according to this invention was added to 900 mL of 0.1 mol / L hydrochloric acid solution at a temperature of 37±0.5℃ and a rotation speed of 100 rpm. The start time and holding time were recorded.

[0064] Table 1. External Floating Performance

[0065]

[0066] As shown in Table 1, compared with Comparative Examples 1-4, the Dendrobium officinale plant preparations prepared in Examples 1-6 of the present invention can all float within 30 seconds and hold for more than 13 hours, indicating that the Dendrobium officinale plant preparations prepared in the present invention have good floating properties.

[0067] 2. Cumulative release rate determination

[0068] Two tablets of the Dendrobium officinale plant preparation prepared in this invention were placed in 900 mL of phosphate buffer at a temperature of 37±0.5℃ and a rotation speed of 100 rpm. 5 mL of the solution was taken at 12 h and 24 h and filtered through a 0.45 μm micromembrane. The absorbance values ​​of polysaccharides, flavonoids, saponins, alkaloids and volatile oils were measured at 490 nm, 415 nm, 550 nm, 525 nm and 255 nm, respectively. The cumulative release rate was calculated by substituting the values ​​into the standard curve.

[0069] Table 2. Cumulative release rate of active ingredients

[0070]

[0071] As shown in Table 2, the Dendrobium officinale plant preparations prepared in Examples 1-6 of this invention exhibit stable and continuous release within 24 hours, with a release rate exceeding 85% within 24 hours. In contrast, the Dendrobium officinale plant preparations in Comparative Examples 1-4 have a release rate exceeding 80% within 12 hours, and are essentially completely released after 24 hours. Therefore, the Dendrobium officinale plant preparations prepared in Examples 1-6 of this invention not only have good solubility in the gastrointestinal tract but also possess sustained-release properties, significantly prolonging the retention time of the active ingredients in the stomach, thereby achieving a continuous and stable drug delivery effect.

[0072] Example 7

[0073] This embodiment describes the effect of the Dendrobium officinale plant preparation prepared in Example 1 on polycystic ovary syndrome, including the following steps:

[0074] S1. Three-month-old female SD rats were acclimatized for one week and then randomly divided into a blank control group (n=10) and a model group (n=50). The model group was injected subcutaneously into the neck with 0.1 mL of 60 mg / kg DHEA daily, while the control group was injected with 0.1 mL of sesame oil containing 10% anhydrous ethanol. The injections were performed for 4 consecutive weeks, and vaginal smears were examined for 5 consecutive days to determine whether the model was successful.

[0075] S2. Fifty successfully modeled rats were randomly divided into a model control group and an administration group. The administration group was given Dendrobium officinale plant preparation via intraperitoneal injection at doses of 20, 40, and 80 mg / kg, administered once every 24 hours for a total of 4 weeks. The blank control group and the model control group were given 10 mL / kg of physiological saline daily.

[0076] S3. Four weeks after administration to the group, fasting for 12 hours was performed, and blood was drawn from the tail vein to measure fasting insulin and blood glucose. The insulin resistance index was calculated. After anesthesia with 10% chloral hydrate, blood was drawn from the abdominal aorta to measure testosterone, estradiol and luteinizing hormone levels.

[0077] Comparative Example 5

[0078] The difference between this comparative example and Example 7 is that the drug used in this comparative example is chlorpheniramine.

[0079] Table 3. Indicators of the polycystic ovary syndrome rat model

[0080]

[0081] Note: Compared with the control group of polycystic ovary syndrome model, * indicates P<0.05, and ** indicates P<0.01.

[0082] As shown in Table 3, compared with the blank control group, the rats in the model control group had significantly increased body weight, insulin resistance index (HOMA-IR), serum testosterone and luteinizing hormone levels, and significantly decreased estradiol levels, indicating that the polycystic ovary syndrome model was successfully established. After drug intervention (Example 7 and Comparative Example 5), the rats' body weight, insulin resistance index, serum testosterone and luteinizing hormone levels were significantly reduced, while estradiol levels increased, indicating that Dendrobium officinale plant preparations can effectively improve endocrine and metabolic disorders caused by polycystic ovary syndrome and have potential therapeutic effects on polycystic ovary syndrome.

[0083] Example 8

[0084] This embodiment describes the effect of the Dendrobium officinale plant preparation prepared in Example 1 on chocolate cysts accompanied by insulin resistance, including the following steps:

[0085] S1. Three-month-old healthy, non-pregnant female SD rats were acclimatized for one week and then randomly divided into a blank control group (n=10) and a model group (n=50). The model group was fed a high-fat diet. The rat model of endometriosis was established using autologous rat endometriosis modeling. Anesthesia was administered via intraperitoneal injection of 10% chloral hydrate (0.35 g / kg). The surgical area was shaved and disinfected with povidone-iodine. A 1.5-2 cm longitudinal incision was made 1 cm from the urethral opening on the midline of the abdomen towards the head. The right uterus was removed, the middle segment of the uterus was separated and cut off, the severed ends were ligated, and the cut uterus was longitudinally dissected. After rinsing with saline, the uterus was trimmed into 0.5 cm x 0.5 cm squares and sutured to the left ovary. No active bleeding points were observed. The peritoneal cavity was rinsed with saline and penicillin solution was instilled. The peritoneal cavity was closed layer by layer. Postoperatively, penicillin dissolved in 0.9% saline (160,000 / kg) was injected for 3 consecutive days. The rats were kept in normal clean-keeping conditions. On the 4th postoperative day, estradiol valerate (0.1 g / kg) was administered. The rats were administered the sample by gavage (mg / kg) for 5 consecutive days. Four weeks after the model was established, ultrasound examination was performed to check for cyst formation in the left ovary. Fasting blood glucose was measured by blood collection from the tail vein of the rats. A blood glucose value >16.7 mmol / L was considered a successful model.

[0086] S2. Fifty successfully modeled rats were randomly divided into a model control group and an administration group. The administration group was given Dendrobium officinale plant preparation by gavage at doses of 20, 40, and 80 mg / kg, administered once every 24 hours for a total of 4 weeks. The blank control group and the model control group were given 10 mL / kg of physiological saline daily.

[0087] S3. After 4 weeks of oral administration, the rats were fasted for 12 hours, anesthetized with 10% chloral hydrate, and euthanized after blood was collected from the abdominal aorta. The rats were then dissected, and the size of the cysts was measured. The expression levels of VEGF and CA125 and the insulin resistance index in the serum were also detected.

[0088] Comparative Example 6

[0089] The difference between this comparative example and Example 5 is that the drug used in this comparative example is leuprolide acetate.

[0090] Table 4. Indicators of a rat model of chocolate cysts with insulin resistance

[0091]

[0092] Note: Compared with the control group of chocolate cyst model, * indicates P<0.05, and ** indicates P<0.01.

[0093] As shown in Table 4, compared with the blank control group, the cyst volume of rats in the model control group was significantly increased, and the serum VEGF and CA125 levels and insulin resistance index were significantly increased, indicating that the chocolate cyst model with insulin resistance was successfully established. After drug intervention (Example 8 and Comparative Example 6), the cyst volume, serum VEGF and CA125 levels, and insulin resistance index decreased to varying degrees. With the increase of the dosage of Dendrobium officinale plant preparation (Example 7), the cyst volume, serum VEGF and CA125 levels, and insulin resistance index all decreased accordingly, indicating that Dendrobium officinale plant preparation has a definite curative effect on chocolate cysts with insulin resistance.

[0094] Example 9

[0095] This embodiment describes the effect of the Dendrobium officinale plant preparation prepared in Example 1 on perimenopausal syndrome, including the following steps:

[0096] S1. After one week of acclimatization to 3-month-old SD animals, they were randomly divided into a blank control group (10 animals) and a model group (50 animals). The model group was anesthetized by intraperitoneal injection of 10% chloral hydrate 0.35 g / kg. The hair in the surgical area was clipped and disinfected with povidone-iodine. An incision was made 1-2 cm below the lower edge of the last rib on the back and 2 cm lateral to the spine on both sides. The ovary was located, and the tissue between the ovary and the uterus was ligated with surgical sutures. The ovary was removed. After checking for no active bleeding points, the tissue was sent into the abdominal cavity. The abdominal cavity was closed layer by layer. The wound was wiped with 0.9% saline to remove bloodstains. Vaginal smears were examined on the 5th day after surgery and continued for 5 days to determine whether the model was successful.

[0097] S2. Fifty successfully modeled rats were randomly divided into a model control group and an administration group. The administration group was given Dendrobium officinale plant preparation via intraperitoneal injection at doses of 20, 40, and 80 mg / kg, administered once every 24 hours for a total of 4 weeks. The blank control group and the model control group were given 10 mL / kg of physiological saline daily.

[0098] S3. Four weeks after administration to the group, the patients fasted for 12 hours, were anesthetized with 10% chloral hydrate, and blood was drawn from the abdominal aorta to measure the levels of testosterone, estradiol, luteinizing hormone, SOD, and IL-2.

[0099] Comparative Example 7

[0100] The difference between this comparative example and Example 9 is that the drug used in this comparative example is estradiol valerate.

[0101] Table 5. Indicators of the rat model of perimenopausal syndrome

[0102]

[0103] Note: Compared with the control group of the perimenopausal syndrome model, * indicates P<0.05, and ** indicates P<0.01.

[0104] As shown in Table 5, compared with the blank control group, the serum estradiol level in the model control group rats was significantly reduced and the luteinizing hormone level was significantly increased, indicating that the perimenopausal syndrome model was successfully established. After drug intervention (Example 9 and Comparative Example 7), the serum estradiol level significantly rebounded while the luteinizing hormone level significantly decreased. In addition, the superoxide dismutase (SOD) activity was significantly enhanced and the interleukin-2 (IL-2) level was significantly increased, indicating that the Dendrobium officinale plant preparation not only improved the hormonal imbalance, but may also exert a comprehensive therapeutic effect by enhancing antioxidant capacity and regulating immune function.

[0105] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any person skilled in the art can make many possible variations and modifications to the technical solutions of the present invention, or modify them into equivalent embodiments, without departing from the spirit and technical essence of the present invention. Therefore, any simple modifications, equivalent substitutions, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention, without departing from the content of the technical solutions of the present invention, shall still fall within the scope of protection of the present invention.

Claims

1. A Dendrobium officinale plant preparation, characterized in that: The *Dendrobium nobile* plant preparation comprises active ingredients and pharmaceutical excipients. The active ingredients are a *Dendrobium nobile* composition, comprising the following raw material components in parts by weight: Astragalus membranaceus 15-20 parts, *Dendrobium officinale* 8-10 parts, mulberry leaf 10-12 parts, *Dendrobium nobile* 3-5 parts, Ophiopogon japonicus 8-10 parts, Ziziphus jujuba var. spinosa 6-8 parts, Allium macrostemon 5-7 parts, and Euryale ferox 5-8 parts. The pharmaceutical excipients comprise the following components in parts by weight: microcrystalline cellulose 1.5-4 parts, lactose 18-24 parts, and magnesium stearate 0.6-3 parts. The preparation method of the *Dendrobium nobile* plant preparation includes the following steps: S1. Astragalus membranaceus, Dendrobium officinale, mulberry leaf, black fungus, Ophiopogon japonicus, Ziziphus jujuba var. spinosa, Allium macrostemon and Euryale ferox are pretreated, dried to constant weight, mixed evenly, pulverized and sieved to obtain the black fungus and Dendrobium officinale composition; S2. Phospholipids and ergosterol are dissolved in a chloroform / methanol mixture, and the above-mentioned *Dendrobium nobile* composition and glucosinolates are added. The mixture is vortexed and mixed, and the organic solvent is removed by rotary evaporation to form a uniform lipid film. PBS is added for hydration, followed by sonication, ultrafiltration, centrifugation, and spray drying to obtain liposomes. The phospholipids are any one or more of Antarctic krill phosphatidylcholine, Antarctic krill phosphatidylethanolamine, Antarctic krill phosphatidylserine, and Antarctic krill phosphatidylinositol; the glucosinolates are any one or more of glucosinolates and sinigrin; the mass ratio of phospholipids, ergosterol, and glucosinolates is 4.4~5.5:1~1.8:0.8~1.5; the volume ratio of chloroform to methanol is 2~2.5:1~2; the rotary evaporation temperature is 40~50°C, and the rotary evaporation speed is 120~180 rpm; the hydration temperature is 50~60°C, and the hydration time is 30~60 minutes. The ultrasonic power is 200~220 W, and the ultrasonic time is 5~8 min; the centrifugation speed is 10000~12000×g, and the centrifugation time is 15~25 min; S3. Chitosan was added to acetic acid solution and stirred until completely dissolved. Myrosinase was added to PBS and then slowly added dropwise to the chitosan solution. The mixture was sonicated in an ice bath to obtain a mixture. Sodium tripolyphosphate was dissolved in water and added dropwise to the mixture while stirring continuously. After centrifugation, the precipitate was washed with PBS and spray-dried to obtain myrosinase microspheres. The chitosan was low molecular weight chitosan with a molecular weight of 50-150 kDa. The myrosinase was derived from the seeds, roots, stems, or leaves of broccoli, cauliflower, radish, kale, or rapeseed. The mass ratio of chitosan, myrosinase, and sodium tripolyphosphate was 20-30:1-2.5:8-14. The stirring speed was 300-600 rpm and the stirring time was 20-40 min. The centrifugation speed was 5000-7000×g and the centrifugation time was 10-20 min. S4. Liposomes and black myrosinase microspheres are mixed, and microcrystalline cellulose, lactose and magnesium stearate are added and mixed evenly to obtain the Dendrobium officinale plant preparation.

2. The use of the Dendrobium officinale plant preparation according to claim 1 in the preparation of a medicament for improving or treating polycystic ovary syndrome, chocolate cysts with insulin resistance or perimenopausal metabolic syndrome.

3. The application according to claim 2, characterized in that: The dosage form of the medicine for improving or treating polycystic ovary syndrome, chocolate cysts with insulin resistance or perimenopausal metabolic syndrome is tablets, pills, capsules, powders or granules.

Images