Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection

Inclusion Criteria:

1. Age range is 18 to 65 years old (including boundary values), with no genderrestrictions.

2. Weight not less than 50 kg, weight not more than 100 kg, body mass index [BMI=weight (kg)/height 2 (m2)] within the range of 19.0~30.0 kg/m2 (including critical values).

3. Planned elective surgery with an estimated duration of less than 6 hours.

4. The expected ANH blood collection volume is 10% to 15% of the total blood volume.

5. Prior to enrollment, the Hb level of the subjects was ≥ 110 g/L.

6. The American Society of Anesthesiologists (ASA) has a rating of I-III.

7. Voluntarily participate in this experiment and sign a written informed consent form.

Exclusion Criteria:

1. Individuals with a history of severe cerebrovascular disease or severe mentalillness, who have been deemed unsuitable by the researchers to participate in thistrial.

2. Previous indications include heart valve disease, aortic stenosis, and severeperipheral vascular disease (such as a history of arteriosclerosis), and theresearchers have determined that they are not suitable to participate in this trial.

3. Suffering from serious heart diseases, including but not limited to unstable angina,cerebrovascular accidents or transient ischemic stroke (within 6 months beforescreening), myocardial infarction (within 6 months before screening), New York HeartAssociation (NYHA) classification ≥ III, congestive heart failure, severe arrhythmiawith poor drug control, requiring mechanical maintenance (such as pacemakers),placing heart stents or abnormal results of echocardiography and/or 12 leadelectrocardiogram during screening, has clinical significance.

4. Patients with hypertension have poor blood pressure control (SBP ≥ 160mmHg and/orDBP ≥ 100mmHg), and cannot discontinue long-term antihypertensive drugs such asangiotensin-converting enzyme inhibitors/angiotensin II receptor antagonists andpotassium sparing diuretics 10 hours before surgery, and the researchers havedetermined that they are not suitable to participate in this trial.

5. Individuals with a history of liver cirrhosis or liver dysfunction during screeningand deemed unsuitable for surgery by researchers: AST or ALT>2 times the upper limitof normal values; Albumin level<35 g/L; Blood bilirubin is greater than 1.5 timesthe upper limit of normal value.

6. Patients with abnormal renal function assessment during screening and deemedunsuitable for surgery by researchers: Cr or BUN>1.5 times the upper limit of normalvalues.

7. There are any of the following respiratory management risks during screening: 1)history of asthma (such as allergic asthma), wheezing; 2) Individuals with sleepapnea syndrome;

8. Hematological disorders such as sickle cell anemia, thalassemia, andpheochromocytoma.

9. There is a significant risk of bleeding or coagulation disorders, and theresearchers assess that surgery is not suitable, including but not limited to: a)past/current thrombotic or thromboembolic events, or an increased risk of thromboticor thromboembolic events; b) Require the use of antiplatelet or anticoagulant drugs (such as warfarin and clopidogrel) other than aspirin (up to 100 mg/d); c) Having ahistory of gastrointestinal, intracerebral hemorrhage, or other events consideredsevere bleeding, such as bleeding caused by the use of nonsteroidalanti-inflammatory drugs; d) PT prolongation>upper limit of normal value of 3 secondsor APTT prolongation>upper limit of normal value of 10 seconds, and the researcherevaluates it as unsuitable for surgery; e) PLT<80 × 109/L.

10. Diabetes patients with poor control, such as glycosylated hemoglobin ≥ 7%, and theinvestigator judged that they were not suitable to participate in the trial.

11. History of malignant tumors (excluding non metastatic basal cell carcinoma orsquamous cell carcinoma, papillary thyroid carcinoma, and cervical cancer in situthat have been cured for ≥ 5 years and do not require follow-up).

12. Excessive blood volume (such as polycythemia vera) and fluid overload (such assystemic edema).

13. There is an active infection with poor control, which the researchers believe makesthe subjects unsuitable to participate in this clinical study.

14. Preoperative complications include pulmonary edema, dehydration, burns, intestinalobstruction, critical illnesses such as sepsis, multiple organ failure, respiratorydistress syndrome, organ transplantation, shock, etc.

15. When screening, there is a water electrolyte imbalance (such as hypercalcemia,hyperkalemia, etc.) and the researcher believes that the abnormality has clinicalsignificance and is not suitable to participate in this clinical study.

16. Having undergone major surgeries or surgical incisions that have not fully healedwithin the first 6 months of screening: Major surgeries include but are not limitedto any surgeries with significant bleeding risks, prolonged general anesthesiaperiods, or significant traumatic injuries.

17. Received anemia related treatment, colloidal solution, and/or blood products 14 daysbefore surgery.

18. Those who have received the vaccine within one month before surgery.

19. Individuals who are known to be allergic to any component of the investigationaldrug; Known to be allergic to meat, especially red meat (mammalian meat) or internalorgans; Known individuals who are allergic to lactose - α -1,3-galactose; Andsubjects with a history of severe allergic reactions (such as urticaria, angioedema,etc.).

20. Has a history of drug abuse in the past.

21. Patients who cannot discontinue corticosteroids, nonsteroidal anti-inflammatorydrugs, cyclosporine, tacrolimus, or succinylcholinergic drugs within 7 days beforesurgery (or within 5 half lives of the drug, whichever is shorter).

22. Pregnant or lactating women, as well as male subjects (or their partners) or femalesubjects who have a pregnancy plan or are unwilling to use at least one medicallyrecognized effective contraceptive measure (such as intrauterine device or condom)during the study period until 1 month after the last use of medication.

23. Those who have participated in any other non observational clinical trials and usedthe study drug or device within one month prior to the trial;

24. Participants may not be able to complete this study due to other reasons or may haveother reasons deemed inappropriate by the researchers to participate in the trial.