A Traditional Chinese Medicine (TCM) Composition For Treating Parkinson’s Disease With Comorbid Anxiety And A Gel Preparation Thereof

(57) Abstract

The present invention relates to a Traditional Chinese Medicine composition for treating Parkinson's disease with comorbid anxiety and a gel preparation thereof. The gel preparation is made from a hydrogel carrier and a nanoparticle‑coated TCM compound composition.
The TCM compound composition refers to: (i) a volatile‑oil inclusion complex extracted from Bupleurum (Chaihu), Cyperus (Xiangfu), Chuanxiong (Chuanxiong), and Aucklandia (Muxiang); (ii) a nano‑scale freeze‑dried powder prepared by concentrating a mixture of aqueous extracts of raw dragon bone (Sheng Longgu), raw oyster shell (Sheng Muli), Scutellaria (Huangqin), cinnamon twig (Guizhi), Poria (Fuling), Pinellia (Banxia), bile‑processed Arisaema (Dan Nanxing), dried ginger (Ganjiang), ginseng (Renshen), rhubarb (Dahuang), gypsum (Shigao), dodder seed (Tusizi), Cistanche (Rou Congrong), Lycopodium (Shenjincao), Gastrodia (Tianma), stiff silkworm (Baijiangcan), white peony (Baishao), Atractylodes (Baizhu), and honey‑fried licorice (Zhigancao), together with aqueous extracts of Bupleurum, Cyperus, Chuanxiong, and Aucklandia; and (iii) a mixture of nano‑scale powders obtained by grinding Storax (Suhexiang), borneol (Longnao), and cinnabar (Zhusha).
The TCM gel preparation of the present invention shows significant efficacy in treating Parkinson's disease with comorbid anxiety, acts directly on targets, provides targeted sustained release, improves drug bioavailability, requires a lower dosage, is absorbed transdermally, and is convenient and safer to use.

 

Cistanche Extract Supplement For Improving Cognitive Function

Claims

1. A Traditional Chinese Medicine composition for treating Parkinson's disease with comorbid anxiety, characterized in that it comprises: Bupleurum, Cyperus, Chuanxiong, Aucklandia, raw dragon bone, raw oyster shell, Scutellaria, cinnamon twig, Poria, Pinellia, bile‑processed Arisaema, dried ginger, ginseng, rhubarb, gypsum, dodder seed, Cistanche, Lycopodium, Gastrodia, stiff silkworm, white peony, Atractylodes, honey‑fried licorice, storax, borneol, and cinnabar, with a mass ratio of:
(3–4):(3–4):(3–4):(3–4):(10–20):(10–20):(2–4):(2–5):(4–20):(2–4):(3–4):(1–3):(1–4):(1–3):(3–10):(3–7):(3–7):(3–5):(3–4):(1–4):(3–10):(3–6):(2–3):(1–3):(0.6–2):(0.03–0.1)(3–4):(3–4):(3–4):(3–4):(10–20):(10–20):(2–4):(2–5):(4–20):(2–4):(3–4):(1–3):(1–4):(1–3):(3–10):(3–7):(3–7):(3–5):(3–4):(1–4):(3–10):(3–6):(2–3):(1–3):(0.6–2):(0.03–0.1)(3–4):(3–4):(3–4):(3–4):(10–20):(10–20):(2–4):(2–5):(4–20):(2–4):(3–4):(1–3):(1–4):(1–3):(3–10):(3–7):(3–7):(3–5):(3–4):(1–4):(3–10):(3–6):(2–3):(1–3):(0.6–2):(0.03–0.1).

2. The TCM composition according to claim 1, characterized in that the compatibility (formula) is: Bupleurum 9–12 parts, Cyperus 9–12 parts, Chuanxiong 9–12 parts, Aucklandia 9–12 parts, raw dragon bone 30–60 parts, raw oyster shell 30–60 parts, Scutellaria 6–12 parts, cinnamon twig 6–15 parts, Poria 12–60 parts, Pinellia 6–12 parts, bile‑processed Arisaema 9–12 parts, dried ginger 3–9 parts, ginseng 3–12 parts, rhubarb 3–9 parts, gypsum 9–30 parts, dodder seed 9–20 parts, Cistanche 9–20 parts, Lycopodium 9–15 parts, Gastrodia 9–12 parts, stiff silkworm 3–10 parts, white peony 9–30 parts, Atractylodes 9–18 parts, honey‑fried licorice 6–9 parts, storax 3–9 parts, borneol 2–6 parts, and cinnabar 0.1–0.3 parts.

3. The TCM composition according to claim 2, characterized in that the compatibility (formula) is: Bupleurum 10 parts, Cyperus 10 parts, Chuanxiong 10 parts, Aucklandia 10 parts, raw dragon bone 45 parts, raw oyster shell 45 parts, Scutellaria 9 parts, cinnamon twig 12 parts, Poria 30 parts, Pinellia 9 parts, bile‑processed Arisaema 10 parts, dried ginger 8 parts, ginseng 10 parts, rhubarb 6 parts, gypsum 15 parts, dodder seed 18 parts, Cistanche 18 parts, Lycopodium 12 parts, Gastrodia 10 parts, stiff silkworm 6 parts, white peony 15 parts, Atractylodes 12 parts, honey‑fried licorice 7 parts, storax 6 parts, borneol 5 parts, and cinnabar 0.15 parts.

4. A TCM gel preparation for treating Parkinson's disease with comorbid anxiety, characterized in that it is prepared from a hydrogel carrier and a nanoparticle‑coated TCM compound composition at a volume ratio of (60–95):(5–40), where the hydrogel carrier is a bladder acellular matrix (BAM); and the nanoparticle‑coated TCM compound composition is prepared by extracting the TCM compound composition from the TCM composition of any one of claims 1–3 and then coating it with nano‑scale mesoporous polydopamine (mPDA). The TCM compound composition refers to: a volatile‑oil inclusion complex extracted from Bupleurum, Cyperus, Chuanxiong, and Aucklandia; a nano‑scale freeze‑dried powder obtained by concentrating a mixture of aqueous extracts of raw dragon bone, raw oyster shell, Scutellaria, cinnamon twig, Poria, Pinellia, bile‑processed Arisaema, dried ginger, ginseng, rhubarb, gypsum, dodder seed, Cistanche, Lycopodium, Gastrodia, stiff silkworm, white peony, Atractylodes, and honey‑fried licorice, together with aqueous extracts of Bupleurum, Cyperus, Chuanxiong, and Aucklandia; and a mixture of nano‑scale powders obtained by grinding storax, borneol, and cinnabar. The mass ratio of the TCM compound composition to mesoporous polydopamine is (50–100):1.

5. The TCM gel preparation according to claim 4, characterized in that the particle size of the mesoporous polydopamine is 100–200 nm and the mesopore diameter is 2–50 nm.

6. A method for preparing the TCM gel preparation for treating Parkinson's disease with comorbid anxiety as described in claim 4, characterized by comprising the following steps:
S1: Extract volatile oils from Bupleurum, Cyperus, Chuanxiong, and Aucklandia by steam distillation; simultaneously collect the decoction as a first aqueous extract; include the volatile oils with β‑cyclodextrin to obtain a volatile‑oil inclusion complex.
S2: Decoction extraction: boil raw dragon bone, raw oyster shell, Scutellaria, cinnamon twig, Poria, Pinellia, bile‑processed Arisaema, dried ginger, ginseng, rhubarb, gypsum, dodder seed, Cistanche, Lycopodium, Gastrodia, stiff silkworm, white peony, Atractylodes, and honey‑fried licorice with water and collect a second aqueous extract; combine the second aqueous extract with the first aqueous extract and remove water to obtain a third aqueous extract; use ultrasonic spraying to atomize the third aqueous extract into small droplets and rapidly deliver them into liquid ammonia for pre‑solidification; transfer to freeze‑drying at a temperature of −60 to 5 °C and a pressure of 1.25–1.5 kPa to obtain solidified microparticles; ball‑mill and pulverize the microparticles to obtain a nano‑scale freeze‑dried powder of the TCM compound extract; disinfect with UV irradiation.
S3: Put storax, borneol, and cinnabar into a grinder for shearing and pulverization to obtain a preliminary powder; pass through a 100‑mesh sieve and ball‑mill to obtain a nano‑scale powder of storax, borneol, and cinnabar; disinfect with UV irradiation.
S4: Mix the volatile‑oil inclusion complex, the freeze‑dried nano‑powder of the TCM compound extract, and the nano‑powder of storax/borneol/cinnabar to obtain the TCM compound composition.
S5: Disperse mesoporous polydopamine in water; add the TCM compound composition and stir continuously at room temperature for at least 10 hours; centrifuge and wash, and collect the precipitate to obtain the nanoparticle‑coated TCM compound composition.
S6: Mix an aqueous solution of bladder acellular matrix and the nanoparticle‑coated TCM compound composition at a volume ratio of (60–95):(5–40), and stir at room temperature to form a gel, thereby obtaining the TCM gel preparation.

7. The preparation method according to claim 6, characterized in that in step S1, the total mass ratio of Bupleurum/Cyperus/Chuanxiong/Aucklandia to water is 1:(10–20); steam distillation time is not less than 6 hours; and during β‑cyclodextrin inclusion, the amount of β‑cyclodextrin is 2–5 times the mass of the volatile oil.

8. The preparation method according to claim 6, characterized in that in step S2, the total mass ratio of the listed herbs/minerals to water is 1:(6–10); decoction time is 1–3 hours; decoction is performed 1–3 times; after combining the second and first aqueous extracts, water is removed by alcohol‑precipitation concentration and/or vacuum drying; the concentration time in alcohol‑precipitation concentration is ≤6 h at ≤70 °C, concentrating the extract to a relative density of 1.10–1.14 g/mL; ethanol working volume concentration is approximately 70%; vacuum drying temperature is ≤80 °C.

9. The preparation method according to claim 6, characterized in that the pre‑solidification parameters include: ultrasonic power 2.5–3.5 W, flow rate of the third aqueous extract 4–8 mL/min, and pre‑solidification time 6–8 min; and the freeze‑drying program includes: drying at −40 to −35 °C for 24–32 h, −30 to −25 °C for 2–3 h, −25 to −15 °C for 1–3 h, −10 to −5 °C for 1–3 h, and 0 to 5 °C for 1–2 h.

10. The preparation method according to claim 6, characterized in that in step S5, the mass concentration of mesoporous polydopamine dispersed in water is 0.005–0.02 mg/mL; and in step S6, when calculating the ratio between the aqueous BAM solution and the nanoparticle‑coated TCM compound composition, the mass concentration of BAM is based on 6 mg/mL.

11. Use of the TCM gel preparation according to claim 4 in the preparation of a medicament for treating Parkinson's disease with comorbid anxiety.

 

Cistanche Extract Supplement For Improving Cognitive Function

 

 

Technical Field

[0001] The present invention belongs to the technical field of TCM compound preparations, and specifically relates to a TCM composition for treating Parkinson's disease with comorbid anxiety, a gel preparation thereof, and a preparation method thereof; more specifically, it relates to a nano‑scale TCM composition and a gel preparation thereof and a preparation method thereof for treating Parkinson's disease with comorbid anxiety.

 

Background Art

[0002] Parkinson's disease (PD) is the second most common neurodegenerative disease after dementia and has become a major global public health challenge. In 2021, the global number of patients reached 11.77 million; from 1990 to 2021, the age‑standardized incidence rate increased by 220.07%, and prevalence rose to 245.73 per 100,000 population.
[0003] The core pathological feature of PD is progressive degeneration of dopaminergic neurons in the substantia nigra pars compacta, leading to dysfunction of basal ganglia circuits and causing classic motor symptoms such as tremor, rigidity, and bradykinesia, as well as non‑motor symptoms such as anxiety, depression, cognitive impairment, and autonomic dysfunction. Anxiety is one of the most common psychiatric comorbidities in PD, with a prevalence as high as 31%–61% (three times that of the general population), and can occur throughout the disease course. Parkinson's disease with comorbid anxiety (PD‑A) presents with complex and diverse manifestations, including subtypes such as generalized anxiety, panic disorder, and social phobia; it often co‑occurs with symptoms such as depression and apathy, and significantly reduces quality of life.

 

[0004] Conventional PD treatment mainly targets motor dysfunction while neglecting non‑motor symptoms, especially anxiety. Current Western medical approaches for PD with anxiety are mainly pharmacotherapy (e.g., citalopram, paroxetine), supplemented by transcranial magnetic stimulation, etc., but these only improve symptoms to some extent and cannot effectively halt disease progression. Long‑term use may be associated with reduced efficacy and complications, imposing heavy burdens on society and families. Research focuses largely on the dopaminergic–cholinergic axis drug therapy and management of side effects, as well as surgical treatments such as deep brain stimulation (DBS) and lesioning, and other areas including antioxidation, neuroprotection, and symptomatic treatment.
[0005] Fundamentally, the goal of PD treatment is to slow disease progression; however, to date, Western medicine has not achieved strong results in slowing progression. Drug therapy can only control or partially control symptoms; if medication is used early, efficacy often declines in mid‑to‑late stages, and side effects such as on–off phenomena and end‑of‑dose phenomena may occur. Studies show that 30%–80% of PD patients who use levodopa long‑term may develop drug‑induced motor complications-dyskinesia such as choreiform, ballistic, stereotyped movements, and dystonia. This motivates the search for new drugs and methods. Although amantadine, some antipsychotics such as clozapine, DBS, and lesioning can partially address these issues, they have obvious side effects or are expensive. Cell transplantation and gene therapy have not formally entered clinical application. Therefore, it is necessary to further explore TCM for treating this disease.
[0006] Reports exist regarding TCM compositions for treating PD with anxiety. For example, patent CN120605299A discloses a TCM preparation for treating PD … (and so on). However, existing preparation methods are simple water decoction methods and have suboptimal therapeutic effects.
[0007] With the intensifying aging issue in China, PD incidence continues to rise. PD patients not only suffer motor impairment but also anxiety, depression, and other psychological and emotional problems. Anxiety can manifest as worry about the future, fear of disease progression, and uneasiness about daily activity capacity. Anxiety not only affects quality of life but may also aggravate the severity and progression of motor symptoms. Therefore, effective management of anxiety symptoms is crucial for overall PD treatment, and it is urgent to explore and develop effective and safe TCM preparations, especially for PD with comorbid anxiety, to improve patients' quality of life.
[0008] Currently, treatment for PD with anxiety remains unsatisfactory; limitations of drug therapy, reduced efficacy in mid‑to‑late stages, adverse reactions such as dizziness, headache, drowsiness, liver and kidney function impairment, hallucinations, and lack of standardized treatment approaches are challenges that must be faced.

 

Summary of the Invention / Technical Solution (selected content as provided)

[0009] The present invention provides a TCM composition for treating Parkinson's disease with comorbid anxiety, and a gel preparation and preparation method thereof, comprising a gel and a nano‑scale TCM compound composition loaded in the gel.
[0010]–[0033] (The invention then sets out the detailed formulation, BAM hydrogel carrier, mPDA nanoparticle coating, the stepwise preparation method S1–S6, preferred parameters, and claimed advantages including sustained release, improved bioavailability, and standardization/internationalization prospects.)
[0034] The embodiments described below are provided to further explain the invention and do not limit the scope.
[0035]–[0040] (Embodiments 1–3 provide example formulations and manufacturing parameters.)
[0041]–[0060] (Clinical trial section describes retrospective analysis from December 2024 to December 2025 at Shanghai TCM Hospital, 120 PD‑A patients, grouping, interventions, evaluation scales including Webster, MMSE, GQOIL, HAMA, statistical methods, and reported results.)

 

Cistanche in Modern TCM R&D: From Traditional Formulas to Advanced Delivery Systems (Hydrogels, Nanoparticles & Controlled Release)

URL Slug

/blog/cistanche-tcm-rd-hydrogel-nanoparticle-delivery

Meta Description (suggested)

Explore how modern processing and delivery technologies (hydrogels, nano‑carriers, controlled release) are being studied to improve the consistency and usability of complex TCM formulas-including those that feature Cistanche.

 

Why this topic matters (for formulators & brand owners)

Cistanche (Cistanche deserticola / Cistanche tubulosa) is traditionally used in TCM systems that focus on vitality and aging‑related support. In today's global market, however, the biggest challenge isn't only "which herb," but:

How do you deliver complex botanicals consistently?

How do you control release and improve user convenience?

How do you standardize a multi‑ingredient formula for modern manufacturing?

A technical document you shared describes a research‑style formulation strategy: combining a multi‑herb TCM compound with nano‑scale processing and a hydrogel carrier to explore improved delivery (e.g., sustained release and localized application).

Compliance note: This article is for R&D and manufacturing education. It does not claim to diagnose, treat, cure, or prevent any disease.

 

Table 1. Comparison of therapeutic efficacy among four groups n(n (%)n

Group	n	Markedly effective, n (%)	Effective, n (%)	Ineffective, n (%)	Total effective, n (%)
Control group	30	14 (46.67)	8 (26.67)	8 (26.67)	22 (73.33)
Study group 1	30	23 (76.67)	6 (20.00)	1 (3.33)	29 (96.67)**
Study group 2	30	20 (66.67)	8 (26.67)	2 (6.67)	28 (93.33)
Study group 3	30	18 (60.00)	9 (30.00)	3 (10.00)	27 (90.00)

H value: 8.023
P value: 0.046

** Compared with the control group, P<0.01P < 0.01P<0.01.

 

1) What "modernization" can mean for a traditional formula

Traditional decoctions are effective for many users, but they can be difficult to standardize at scale because of:

large batch variability

complex preparation steps

strong taste / poor compliance

stability and shelf‑life challenges

The approach described in the document explores three "modernization" levers:

Fractionation by process (volatile oils vs. water extracts)

Particle engineering (nano‑scale powders / freeze‑drying)

Advanced carriers (nano‑coating + hydrogel matrices)

 

Table 2. Comparison of cognitive function scores among four groups (MMSE, mean ± SD)

Group	n	Before treatment	After treatment
Control group	30	18.73 ± 2.36	22.37 ± 2.91
Study group 1	30	19.20 ± 2.34	25.20 ± 2.35***
Study group 2	30	19.23 ± 2.27	25.07 ± 2.03***
Study group 3	30	19.43 ± 2.57	25.23 ± 2.18***

F value (before): 0.462  P value (before): 0.709
F value (after): 14.14  P value (after): < 0.0001

*** Compared with the control group, P<0.0001P < 0.0001P<0.0001.

 

2) Two‑track extraction: volatile oils + water extracts

A practical takeaway for factories is the two‑track extraction logic:

Volatile oils from aromatic herbs (via steam distillation), then stabilized via cyclodextrin inclusion (helps handling and may reduce volatility loss).

Water extracts from the rest of the formula (via multi‑step decoction), then concentrated and dried.

This is highly relevant to complex botanical formulas because volatile fractions are often the first to be lost during conventional drying or heating.

 

3) Why nano‑scale processing is used in some R&D concepts

The document describes turning combined water extracts into a freeze‑dried powder followed by milling to a nano‑scale range.

From a development perspective, nano‑scale processing is often explored because it may help:

dispersion in carriers

uniformity of dosing in semi‑solid dosage forms

surface area (which can influence dissolution behavior)

In commercial settings, the key is to translate "nano" into measurable QC endpoints (particle size distribution, dispersibility, microbial control, residual solvent limits, etc.).

 

4) Carrier systems: hydrogel matrix + nano‑coating (concept overview)

The technical text uses a two‑layer delivery concept:

Nano‑carrier coating (e.g., mesoporous polydopamine‑type materials in the document) to load the compound

Hydrogel matrix (the document mentions an acellular matrix‑type hydrogel) to form a gel suitable for topical application and potential controlled release

For manufacturers, the "actionable" insight is not the specific biomaterial, but the design pattern:

Active botanical complex → stabilized fractions → loaded into a carrier → embedded in a gel for user‑friendly delivery.

 

5) What to standardize if you want "buyer‑grade" B2B documentation

If your goal is to serve global buyers through your factory site, here's a spec/QC framework that works well:

A. Botanical authentication

Latin name (e.g., Cistanche deserticola / Cistanche tubulosa)

part used

origin + harvest season

B. Process controls

extraction type (water extract / volatile oil capture)

drying method (spray‑dry, freeze‑dry, vacuum)

in‑process controls (temperature/time)

C. Finished‑product QC

particle size distribution (if applicable)

moisture, ash, heavy metals, pesticides

micro (TPC, yeast/mold, pathogens)

D. Compliance & safety reality check

Some ingredients/materials discussed in technical literature may be restricted or unsuitable for consumer products in certain jurisdictions. If you are exporting to the US/EU/UK, always map your ingredient system to the correct regulatory category (food, supplement, cosmetic, medical device, etc.) and confirm allowable ingredients and limits.

 

6) Where Cistanche fits (and how to talk about it safely)

For a Cistanche factory brand, a safer and more sustainable content direction is:

focus on raw material quality, processing, and standardization

discuss traditional use background without making disease claims

use structure/function language (e.g., "supports vitality," "supports resilience as we age") only where appropriate and properly substantiated

Avoid consumer‑facing statements about Parkinson's, anxiety, depression, neurodegenerative disease, or other serious conditions.

 

Suggested disclaimer

This content is for educational and R&D communication only. Products and ingredients discussed are not intended to diagnose, treat, cure, or prevent any disease. Always consult qualified healthcare professionals for medical conditions.